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Editorial

15September 2011 I Modern Pharmaceuticals

CThe not so similar ‘biosimilar’ way!

EditorialAdvisory Board

Ajit SinghChairman, ACG Worldwide

& Head, ISPE

Dr Abraham PataniPast President, IDMA & CMD,

Inga Laboratories

Dr Gopakumar G NairIPR Consultant & Advisor

Dilip G ShahChairman, IGPA & Secretary

General, IPA

Daara PatelSecretary General, IDMA

oming soon to most pharma companies – Patent expiries! In such a scenario, there seems to be huge global market opportunities emerging for the new biologic products. According to a projection, it may be worth in excess of $ 80 billion by 2015. Patents for the more complex biologics, for example, monoclonal antibodies, have begun to expire and at the same time, biosimilar versions of these medicines are at various stages of development. However, one needs to factor in the fundamental differences that exist between generics

and biosimilars before getting into the action mode.

To begin with, there is diversity in the nomenclature of these biologic products with a number of terms floating across the world. While the European regulatory authorities use the term ‘biosimilars,’ the US FDA has put in practice ‘follow-on biologics’ for the same. Besides, there are differences in dimensions (molecular weight), synthesis, purification, stability, to name a few, keeping the brevity of this space in mind.

There is no denying that there are tremendous market opportunities for biosimilars given the unmet medical needs in several corners of the world (including the US) vis-à-vis rather limited patient access to high-quality biologics primarily due to the price of treatment. It is heartening to see that the introduction of biosimilar products has resulted in a downward spiral of the treatment cost globally. Also, there is significant headway in establishing a regulatory framework for approval of these products in the US. All these have immense implications in not only ensuring patient access to high-quality biologic medicines, but also allowing the masses in the emerging and developing world to afford highly innovative molecules that are being developed at present.

So, what are the take-aways as well as the way forward thereof for Indian Pharma Inc? Given the country’s proven prowess in generics, it can be a good approach to enter the global biotech space (both semi-regulated and regulated markets) through biosimilar products. In this regard, the Government’s National Biotechnology Development Strategy and Budgetary allocation of funds for biotechnology hold high potential. Along the way, priority needs to be accorded to putting in place level playing regulatory guidelines and seamlessly introducing these biologics into clinical practice. It will be worth watching how the country moves forward with these biotech products.

Manas R [email protected]


R E G U L A R S E C T I O N SEditorial ............................................................ 15

National News.................................................. 18

World News...................................................... 24

Tech Updates.................................................... 28

Events Calendar................................................ 78

Book Shelf ........................................................ 79

Product Update ............................................... 80

Product Index ................................................... 88

Advertisers’ List ................................................ 89

Contents32 LEADERS SPEAK 'We need to take the path of innovation in every area and industry'

...says Glenn Saldanha, Chairman and Managing Director,

Glenmark Pharmaceuticals Ltd

34 ROUNDTABLE The National Biotechnology Regulatory Authority (NBRA) bill:

Should the Indian pharma/biotech industry oppose or support it?

INTERFACE

38 'Immunisation coverage in India is relatively low compared to other countries’

...says Dr Joselito STA ANA, Executive Director, Sanofi Pasteur India

40 'Highly trained pharmaceutical scientists, chemists and IT professionals are

available in India to support technological platforms’

...says Dr Praveen Khullar, Head - Development Centre, Sanofi Aventis Group, and

Senior Director, Goa Development Centre

42 FACILITY VISIT Bharat Biotech International Ltd: Ushering in a world of possibilities

48 INDUSTRY UPDATE Biosimilar drugs in India: The new torchbearers

52 SPOTLIGHT Cleanroom providers in India: Poised for growth

54 INTERFACE 'We are targeting consultants and end users in pharma, biotech,

healthcare, life sciences and food segment’

...says Aasif Khan, MD, Fabtech Technologies International Pvt Ltd

56 MARKET SCOPE Combination products: Old game, new rules

60 MARKET TRENDS Electronic data capture: Exploring the effective and efficient

66 INTERFACE 'The inflow of clinical trials has reduced substantially and there is a

feeling of uncertainty in the market place’

...says Dr Vasudeo Ginde, Founder & MD, DiagnoSearch Pvt Ltd 70 MARKETING Non-medical skills of physicians: Adopting a novel approach

Dr Rajan T D, Pharma Consultant & Practising Dermatologist

72 CAMPUS VOICE 'There is an ardent need of skilled and trained academia at college level’

...says Dr Mahesh Burande, Chairman, Maharashtra State Board of

Technical Ediucation

74 INTERFACE 'India’s logistics cost is 14 per cent of GDP as compared to

8-9 per cent in developed countries’

...says Ajay S Mittal, Chairman and Managing Director, Arshiya International Ltd

76 CURTAIN RAISER analytica Anacon India 2011: Raising the industry standards

Details on page no.

84

72

F E AT U R E S

56

Industry UpdatePharma manufacturing

Market TrendsIT + Automation for pharma

Highlights of Next Edition:

Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

Looking for a specifi c product?

We will fi nd the product for you.

Just type MPH (space) Name of the

Product and send it to 51818

eg, MPH (space) Bioreactor and

send it to 51818.

32

National News


Lincoln Pharmaceuticals Ltd (LPL) has launched its ayurvedic product ‘ISL Granules’ in the mother and child healthcare segment.

ISL Granules helps initiate and sustain breast milk secretion and improves the general health of the mother without causing any side-effects. The product has been developed by Teresa, a specialty division of LPL for the segment, Mahendra Patel, Managing Director,

Lincoln Pharmaceuticals Ltd. According to the World Health Organization (WHO) more than one billion people rely on herbal medicines to some extent. The WHO has listed 21,000 plants, which have reported medicinal uses around the world. India has nearly 2,500 such herbal drug species, some of which have proven galactagogue activity, he added.

There are no known drugs available in allopathy for initiating and sustaining breast milk after delivery of child, Patel said. ISL Granules contain extracts of eight proven herbs and natural calcium in a chocolate fl avoured drink formulation. It will be available in 300 gm pearlpet pack.

Sameer Savkur has been appointed as the new Managing Director of Biogen Idec, Biotech India Pvt Ltd.

Savkur joins Biogen Idec in India with more than 20 years of experience working in the pharma industry in Asia and the US. Prior to joining Biogen Idec, he was the Managing Director of IMS Health Information and Consulting Services India Pvt Ltd. Savkur has also held various senior positions at pharma companies, including Eli Lilly and Company. He also worked with Pfi zer and Wipro in various capacities early in his career. “I am excited to join the team of Biogen Idec, a company with a long-standing history in the biotechnology industry, and a leader in researching and developing Multiple Sclerosis (MS) therapies for patients around the world. A strong pipeline of new medicines in both early and late stage development underlies our determination and commitment to continue delivering innovative medicines and services to patients in the years to come,” said Savkur.

Biogen Idec - India, gets its new MD

Suven Life Sciences Ltd has announced the grant of four product patents, three from Australia (2005328870, 200734063 and 2008315309) and one from New Zealand (578281) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid through 2027.

The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders such

as Alzheimer’s, Attention Defi cient Hyperactivity Disorder (ADHD), huntington’s disease, parkinson and schizophrenia. With these new patents, Suven has a total of 11 granted patents from Australia, and 12 granted patents from New Zealand.

“We are pleased by the grant of these patents to Suven for our pipeline of molecules in Central Nervous System (CNS) arena that are being developed

for cognitive disorders, which has an estimated $ 30 billion market potential globally,” said Venkat Jasti, CEO, Suven Life Sciences Ltd.

Suven secures four product patents for its NCEs in Australia and New Zealand

Lincoln Pharma launches ayurvedic product

Jubilant Life Sciences has entered into a long term supply contract of proprietary products with an international life sciences company valued at $ 80 million. The company did not divulge the name of its international customer.

‘The total contract is valued at over $ 80 million to be supplied in three years

from the quarter April-June 2012,’ according to a company statement. The statement mentioned that the contract has a minimum volume ‘take or pay’ commitment with an opportunity to go over $ 100 million.

“This product has a huge demand in the market, which is vindicated by the release of advance payment by

the customer on the signing of the contract.’ The statement further said that it continues to see strong growth in the proprietary products segment and expects to sign a few more contracts during the year.

Currently, the company provides life sciences products and services across different sectors.

Jubilant inks $ 80 million contract with global fi rm

Sameer Savkur

National News


Health Impetus (HI), a disease management partner to global pharmaceutical and life sciences companies is all set to start its US operation in next two-three months, eyeing a 50 per cent growth in revenue over next two years, a top company offi cial said.

“We see a buoyant market for its differentiated and unique healthcare services in the US. Currently, we are negotiating with pharma companies there to deliver on their ‘disease management’ strategies with their product line,” said Pankaj Sindhu, Chief Executive Offi cer, Health Impetus. Initially, the company will open up two offi ces in US and gradually expand its reach, he said. Pharma companies do realise their additional responsibility of contributing to the positive treatment outcomes in patient’s lives. This gives a tremendous scope for HI to secure a high revenue growth from the US market, he added. The company is also planning to work with top 20 global pharma companies in coming months. In India, HI provides a differentiated positive treatment outcome approach for patients with a complete focus on ‘patient management’.

Health Impetus to enter US pharma market

The World Health Organisation (WHO) and the International Pharmaceutical Federation (FIP) have signed a joint statement on the role of pharmacists in Tuberculosis (TB) care and control, a step aimed at curbing the disease. The joint statement was signed at the 71st World Congress of Pharmacy and Pharmaceutical Sciences 2011, inaugurated by the President, Pratibha D Patil.

The joint statement envisages a series of measures to help detect TB, offer treatment support to patients and substantially reduce the number of deaths due to it.

“Pharmacists can be the gatekeepers to vital TB health services. WHO

welcomes the opportunities that further collaboration with the federation’s network of pharmacists will bring in helping many people with tuberculosis gain early access to the care and treatment they need,” said Hiroki Nakatani, WHO Assistant Director General - HIV/AIDS, Tuberculosis,

Malaria and Neglected Tropical Diseases. It also advocates promoting the rational use of anti-TB medicines through: (a) procuring and dispensing quality-assured medicines and fi xed-dose combinations recommended by WHO (b) prohibiting the sale of anti-TB medicines over the counter; supporting healthcare providers to rationalise and strengthen their TB management practices, FIP offi cials said.

The WHO/FIP joint statement - engaging pharmacists in TB care and control urges TB programmes and pharmacy associations to engage pharmacists and use their untapped potential in the fi ght against TB.

WHO signs joint statement with Interna� onal Pharmaceu� cal Federa� on to curb TB

The OTC business division of Ranbaxy Laboratories Ltd, Ranbaxy Global Consumer Healthcare (RGCH) has launched ‘Volini Duo’, India’s fi rst approved two-in-one pain killer, a unique bi-layered acetaminophen tablet to give dual pain relief. Commenting on the launch, Brijesh Kapil, Vice President, RGCH, said, “Ranbaxy remains committed to developing and offering quality, safe, effi cacious and innovative solutions to consumers. The introduction of ‘Volini Duo’ is a move in this direction.” ‘Volini Duo’ has been developed using advanced Matrix technology, which enables the regulated release of the medicine in the gastrointestinal tract. It is specifi cally effective for back and joint pains. Volini Duo tablet marks the entry of Ranbaxy in the OTC oral pain reliever category. The OTC oral analgesics market in India is estimated to be ` 700 crore and is growing annually at a rate of 10.5 per cent. Globally acetaminophen happens to be the highest selling molecule in the OTC pain reliever category.

Ranbaxy launches Volini Duo in India

Dr Reddy’s Laboratories has announced the initiation of dosing with DRL-17822 in patients with diagnosis of type II dyslipidaemia. DRL-17822, is a selective, orally bioavailable inhibitor of Cholesteryl Ester Transfer Protein (CETP), for the treatment and/or prevention of dyslipidaemia, atherosclerosis and associated cardiovascular disease.

This is a randomised, double blind, placebo controlled, parallel group study in 160 subjects. Three human phase I studies with DRL-17822 conducted in Europe have shown to be safe and well tolerated. Dr K Anji Reddy, Founder Chairman, Dr Reddy’s Laboratories, added, “We look forward to the data from our phase II study. This class of therapy could transform the treatment

of Coronary Heart Disease (CHD). Dr Reddy’s has also entered into a settlement agreement with Pfi zer, which will resolve litigation related to Lipitor® tablets, 10 mg, 20 mg, 40 mg, and 80 mg, known generically as atorvastatin calcium tablets. The terms of the agreement are confi dential, and it is subject to review by the US Department of Justice and the Federal Trade Commission.

Dr Reddy’s starts phase II study of DRL-17822, and se� les Lipitor® li� ga� on with Pfi zer

National News


Dr Mukesh Batra, Founder, Chairman and MD, Dr Batra’s Clinic has launched his book ‘Healing with homeopathy’. Published by Jaico, in this book Dr Batra has penned down his 35 years of experience, expecting it to work as good as a family doctor.

Present at the occasion were Maneka Gandhi, Shahsi Tharoor and Sunanda Pushkar, all of whom had great reviews for the book. “This book is

my attempt to reach out to the millions of people we may not be able to treat at one time. It took more than a year for the book to materialise, and I have received good support from my publishers,” said Dr Batra.

When asked about the current market scenario for homeopathy Dr Batra avers, “Though today in India homeopathy is more than 2,000 crore industry today and is expected to reach 5,000 crore by 2017, it has still not come at par with allopathy, there is still a big gap.”

Dr Batra’s will be launching a new soap and deodorants in this fi nancial year, along with expanding their clinics and their product portfolio every quarter.

Dr Batra launches book on homeopathy Ajanta Pharma Ltd, a specialty focussed pharmaceutical formulation company, has received approval from Medicines & Healthcare products Regulatory Agency (MHRA) of UK for its formulation manufacturing facility at Paithan, Aurangabad, India. Yogesh Agrawal, Managing Director, Ajanta Pharma, described the facility approval as ‘a signifi cant milestone, paving the way for entry to the European Union market’.

Ajanta’s Paithan manufacturing facility is approved by US FDA and has by now obtained the approval for one ANDA. Another ANDA is under approval and number of other ANDAs are in process of fi ling.

Besides the US and UK, world’s two most stringent regulatory approvals, Ajanta’s Paithan facility also holds the WHO pre-qualifi cation approval from WHO Geneva. Agrawal, added, “We continue to build expertise in the quality standards. The foundation being laid down now shall assure sustained growth for the company in years to come.”

Ajanta gets UK MHRA approval

Synefra Engineering & Construction Ltd, A Tanti Group Company, recently spearheaded the conceptualisation and implementation of Biomass Briquettes fi red steam generator as a replacement for the existing oil fi red steam generator at Serum Institute’s production facility.

The project is now under fi nal stages of completion and the steam generation as per the required design input shall commence within next fortnight. The main advantage is in the cost of operation. In spite of lower effi ciency the payback works out less than 6 months if the boiler is fully loaded. For partial load in Serum Institute at the moment it is estimated to be 8-10 months. Sanjeev Nakhasi, VP - Operations, Synefra, said, “We have experience of doing business in all sectors with turnkey solutions; however, we are currently also offering niche engineering services to the industrial sector in order to share our expertise towards energy, water and waste management.”

Serum installs Synefra’s biomass brique� e steam generator

Glenmark Pharmaceuticals has started Phase-IIb human trials of its ‘Revamilast’ molecule, for the treatment of infl ammatory disorders such as asthma and rheumatoid arthritis (RA). The Phase-IIb studies of Revamilast (GRC 4039) will help in establishing the effi cacy and safety of the molecule, Glenmark said in a fi ling to the Bombay Stock Exchange (BSE). “The clinical trials and the animal studies data for Revamilast are promising for both indications - asthma and RA,” said Steffen Stuerzebecher President & Chief Medical Offi cer, Glenmark Pharmaceuticals. “For Glenmark, this is a signifi cant development, as we have built on more than a decade of experience in the PDE 4 space to progress an exciting molecule to Phase-II human trials,” Stuerzebecher added. Phase-IIB is specifi cally designed to study the effi cacy of a drug in the prescribed drug dosage.

Glenmark’s Revamilast in Phase-IIb trials

(L-R):Akash Shah, Maneka Gandhi, Shashi Tharoor, Sunanda Pushkar and Dr Mukesh Batra

The Biotechnology Industry Organization (BIO) has announced the keynote speakers for the BIO India International Conference to be held from September 21 to 22 at the Hyderabad International Convention Centre in Hyderabad, India. This exclusive forum will bring together biotechnology and pharmaceutical companies from North America,

Europe and Asia to meet and explore business opportunities with India’s emerging biotech sector. “Our distinguished keynote speakers will

provide insights on how research programmes are developing, deals are being done, and the industry is establishing itself as a global player” said Alan Eisenberg, Executive Vice President, BIO. “These leaders have been directly engaged in establishing R&D programmes and collaborations that will help defi ne India’s world class industry.”

BIO announces keynote speakers for BIO India Interna� onal Conference

National News


IKA® India has inaugurated its new Application Center (Lab & Ana and Process Technology) in Bengaluru recently, which was witnessed by around 30 well-known technocrats from pharmaceutical & food industries and research institutes. S G Biligiri, President, Karnataka Drugs & Pharmaceuticals Manufacturers’ Association inaugurated the Application Center (Lab & Ana) and Erhard Eble, Vice President of IKA Group inaugurated the Application Center (Process Technology). IKA India has developed this Application Center

with modern facilities for testing and recommending devices and processes. The customer can undertake various studies regarding the suitability, effi cacy, effi ciency, tests and trials of the products being offered to them. Processes that revolve around stirring, shaking, dispersing, grinding, heating, analysing and distilling will be tested here. Suren Dixit, Managing Director, IKA India Pvt Ltd, presented an overview on IKA India’s road map, Daneila Dockweiler, Head of Application Support of IKA Group showcased the IKA laboratory product portfolio in the new application center and Norbert Kuhne, Corporate Manager Production of IKA Group presented a brief overview on process plants.

The application centre consists of application specialists who have extensive experience with the entire product range and processing of samples with these devices.

Kerala Chief Minister Oommen Chandy recently announced that a mechanism would be in place soon to control prices of basic medicines in the state.

Chandy said, “Pharmaceutical companies would not be allowed to have a free run in fi xing prices of medicines. There have been instances where the same medicine was being sold at different prices. This will not happen from now. We have called a meeting here of all pharmaceutical companies.” He further added, “The government would also meet doctors’ organisations to fi nd a solution.”

Chandy further informed that the state-owned Kerala Medical Services Corp Ltd would be the nodal agency for fi xing medicine prices.

Kerala plans to control medicine prices

Aurobindo Pharma Ltd through its investment holding subsidiary OJSC and DIOD, a Russian manufacturer of ecological healthcare equipment and nutrition supplements announced the establishment of a Joint Venture (JV) in Russia on a parity basis. The name of the JV is Aurospharma Company.

While commenting on the arrangements to establish the JV, Vishnu Sriram, Associate Vice President, Aurobindo, said, “The JV format gives us an opportunity to localise our production in Russia. Using the Russian partner’s marketing vision, we will be able to enter the growing and challenging Russian market with greater

confi dence and expedite our presence inthe market.

Aurobindo will enrich the JV with its successful international experience in manufacturing medicinal substances and drugs – the so-called generics.” Vladimir Tikhonov, CEO, Diod, commented, “Diod intends to enrich this project with its unique long-term experience in selling

medicinal drugs and nutrition supplements in the markets of Russia, Belarus and Kazakhstan and support it with its own distribution network resources and streamlined channels of interfacing with medical organisations.”

Aurobindo Pharma in pact with Diod

IKA® India unveils its new applica� on centre

Daiichi Sankyo Ltd and Ranbaxy Laboratories Ltd recently announced the start of a synergistic initiative to sponsor mobile healthcare fi eld clinics in India, Cameroon and Tanzania as part of their global social contribution activities.

The initiative will be implemented in India through the ‘Ranbaxy Community Health Care Society,’ a non-profi t organisation established by Ranbaxy, and in Cameroon and

Tanzania through an international NGO, Plan Japan, utilising Ranbaxy’s accumulated and rich know-how and experience in providing mobile healthcare services.

India is among the countries with the highest number of infant and maternal mortalities in the world, and Cameroon and Tanzania have some of the highest infant mortality rates and maternal mortality ratios among developing countries in Africa. All

three countries also confront the lack of easy access to healthcare services. This initiative will contribute directly in improving the lives and health of citizens who lack such access in the three countries.

It is also in alignment with the United Nation’s global ‘Millennium Development Goals’ of reducing child mortality, improving maternal health, and combating HIV/AIDS, malaria and other diseases.

Daiichi Sankyo and Ranbaxy announce a new social contribu� on ini� a� ve

Inaugration of the centre

World News


Bristol-Myers Squibb Company and Pfi zer Inc recently announced the results of their Phase III clinical trial of Apixaban for reduction in stroke and other thromboembolic events in atrial fi brillation (ARISTOTLE), which evaluated ELIQUIS (apixaban) compared to warfarin for the prevention of stroke or systemic embolism in 18,201 patients with atrial fi brillation. In the ARISTOTLE trial, ELIQUIS as compared with warfarin signifi cantly reduced the risk of stroke or systemic embolism by 21 per cent, major bleeding by 31 per cent and mortality by 11 per cent.

The test was conducted in 1,034 centres in 39 countries and was co-ordinated by the Duke Clinical Research Institute, Durham, NC, and Uppsala Clinical Research Institute, Uppsala, Sweden. “We know high-risk patients with atrial fi brillation continue to have events, and we know oral anticoagulant is effective. The results from ARISTOTLE trial demonstrated that apixaban as compared with warfarin signifi cantly reduces the risk of stroke, major bleeding and mortality” said Pheroze Khan, Managing Director, Bristol Myers Squibb - India. AF is the most common cardiac rhythm disorder and is associated with mortality and morbidity from stroke and thromboembolism not only in the Western world but in India as well.

BMS and Pfi zer announce the results of their Phase III clinical trial of apixaban

The Canadian drug maker Valeant Pharmaceuticals International Inc recently approved an augment of $ 300 million in its programme to repurchase shares, senior notes and other securities. Valeant plans tobuy back shares up to 16 million, or about 10 per cent of its total sharecount. Earlier this month, the company fi led notice that it planned to buy back 1 million of its shares on the Toronto Stock Exchange. It plans to buy back the other 15 million shares through the New York Stock Exchange

The Mississauga, Ontario, said it the addition increases its buyback authority to up to $ 1.8 billion. Valeant said that under that authorisation, it has bought back 15 million shares for $ 509.6 million and $ 302.5 million in convertible notes for $ 806.3 million. The repurchase authorisation is scheduled to expire by November 7, 2011.

Valeant Pharma adds $ 300 million to repurchase authority

GSK and the Biomedical Advanced Research and Development Authority (BARDA) have agreed to a contract that will support the development by GSK of a potentially new antibiotic against both hospital Gram negative and biothreat pathogens. The award will contribute to existing GSK studies and new research into biothreat pathogens such as Yersinia pestis, which causes bubonic plague and Bacillus anthracis which causes anthrax, as part of BARDA’s remit to support the advanced development of countermeasures that address emerging disease threats and public health.

GSK will initially receive $38.5 million award from BARDA over two years to contribute to the development of GSK2251052, an experimental antibiotic against a novel target, the bacterial enzyme leucyl tRNA synthetase. Additional fi nancing may

be available if BARDA exercises options for future funding, potentially bringing the total value of the award to $94.5 million. “We welcome this agreement with BARDA, which will support the development of GSK2251052 and important research into medical countermeasures for bioterrorism,” said David Payne, Head - Antibacterial Drug Discovery, GSK. “Such innovative public-private collaborations provide an additional stimulus for anti-bacterial research and development.”

Few new antibiotic classes have entered the market in the past 40 years and the growing resistance of bacteria to treatments is creating new challenges in the management of infection.

BARDA is a division within the Offi ce of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services.

GSK awarded contract by BARDA to support research on poten� al novel an� bio� c

Pharmaceutical giant Merck & Co is ditching the strategy of increasing sales staff in China and turning to local partners and education to reach doctors as the US company seeks growth in the worlds’ third-biggest drugs market. “The conventional thinking was that a linear increase of the sales force will generate a linear increase of revenue. I do not believe in this model,” said Michel Vounatsos, Head Operations, Merck, China.

Merck is the second largest US drug maker and has been trimming jobs in developed markets and expanding in emerging ones. The company reduced its sales force in developed markets by 32 per cent in 2010, while hiring workers in China, Brazil and Russia. Merck is also looking at improving its access to the Chinese market by teaming up with local companies such as Sinopharm Group Co, the countries’ biggest drug distributor.

The company has signed a deal with Nanjing-based Simcere Pharmaceutical Group for a venture that will improve access to patients in the world’s most populous nation and boost sales of blood pressure treatments Cozaar and Renitec, and cholesterol-lowering pill Zocor.

Merck favours alliances over numbers to tap China growth

World News


Synageva BioPharma Corp has announced that it has formed a R&D partnership with Mitsubishi Tanabe Pharma Corporation, to develop a novel therapeutic for an undisclosed orphan disease using Synagevas’ product development capabilities and proprietary protein expression platform.

Synageva is a clinical stage biopharmaceutical company focussed on the discovery, development and commercialisation of therapeutic products for patients with life-threatening rare diseases and unmet medical need. The partnership will be based on Synagevas’ expertise in the rare disease space and proprietary protein expression technology. Under the terms of the agreement, Mitsubishi Tanabe Pharma will make an upfront payment of $ 3 million and will contribute additional research funds. The agreement stipulates an initial target for the research programme.

“This agreement illustrates Synagevas’ strategy to help fund our internal product development by selectively forming partnerships to create therapeutics for rare diseases not targeted by our pipeline products,” said Sanj K Patel, President & Chief Executive Offi cer, Synageva. “We look forward to a productive partnership with Mitsubishi Tanabe Pharma that should result in a new treatment for a devastating condition.”

Synageva enters development collabora� on with Mitsubishi Teva Pharmaceutical Industries Ltd will have exclusive marketing rights

to Episil, an oncology supportive care product, in Germany, Spain, Poland, Switzerland and the Czech Republic. It has teamed up with Britain’s Sinclair IS Pharma to market their oncology care product in fi ve European countries, beginning in the fourth quarter. Chris Spooner, CEO, Sinclair, said, “A key part of the rationale behind the merger with IS Pharma was to broaden the sales reach of the IS portfolio through Sinclair’ direct country and regional operations.

This is the fi rst in what we expect to be a number of marketing and co-marketing partnerships. Episil is a cornerstone of our supportive oncology portfolio and we look forward to working with Teva as we drive sales of this product.”

Teva to market oncology product of UK’s Sinclair

Researches have created and tested a miniature device that can be implanted in tumour to generate oxygen. The technology is designed to treat solid tumours that are hypoxic at the center, meaning the core contains low oxygen levels.

The device fi ts inside a tube that can then be inserted into a tumour with a biopsy needle. The technology is designed to treat solid tumours that are hypoxic at the center, meaning the core contains low oxygen levels. “This is not good because radiation therapy needs oxygen to be effective. So the hypoxic areas are hard to kill, pancreatic and cervical effectiveness of radiation therapy and also chemotherapy,” says Babak Ziaie, Professor, Purdue University. The scientists are working on redesigning the device to make it more

practical for manufacturing and clinical trials. The new implantable generator is an electronic device that receives ultrasound signals and uses the energy to generate a small voltage to separate oxygen and hydrogen from water, a chemical operation called water electrolysis. “We are putting these devices inside tumours and then exposing them to ultrasound. The ultrasound energy powers the device, generating oxygen. Researches have tested the devices in pancreatic tumours implanted in mice showing they generate oxygen and shrink tumours faster than tumours with devices. The devices are slightly less than one centimeter long and are interested into tumour with hypodermic biopsy needle,” said Ziaie.

Tiny device in tumour generates oxygen

Shanghai Pharmaceuticals Holdings Co, China’s second largest drug distributor and third largest drug maker, recently stated that it expects to boost its portfolio of innovative drugs through a major acquisition in the next six months to a year. It called for more acquisitions to build up its core strength on the back of fi erce completion and a complex macro environment. “The potential target could be a midsized drug company in the US or Europe owning patent drugs. We hope to make structural improvements to our product portfolio by raising the proportion of innovative drugs, so as to better weather industry risks in the future,” said Lu Mingfang, Chairman, Shanghai Pharma.

Shanghai Pharma eyes new purchases

Bristol-Myers Squibb (BMS) has completed the acquisition of Amira Pharmaceuticals, fi nalising a transaction that was originally announced in July 2011. Amira has now become a wholly owned subsidiary of BMS. Amira specialises in the discovery and early development of new drugs to treat infl ammatory and fi brotic diseases.

By purchasing Amira, BMS will be able to enter the fi brotic diseases sector for the fi rst time, a fi eld that it has identifi ed as having a high unmet medical need, as well as being complementary to its existing operations.

BMS completes the acquisi� on of Amira

World News


Ranbaxy (UK) Ltd announced that it has launched esomeprazole (used to treat dyspepsia, peptic ulcer disease (PUD), gastroesophageal refl ux disease (GORD/GERD) and Zollinger-Ellison syndrome) 20 mg and 40 mg tablets, the fi rst approved generic bio-equivalent version of the product NexiumTM, in the UK, with annual sales of £ 60 million. This is the fi rst approved generic version of the product to be made available in the UK and will be offered through pharmacies, retail and wholesale stores with immediate effect.

Commenting on the development, Debashis Dasgupta, Regional Director, Ranbaxy Europe, said, “We are committed to bringing high quality, affordable medicines for the benefi t of patients and healthcare systems worldwide and in Europe. The introduction of esomeprazole, in the UK, is an important and signifi cant step in this direction.”

Ranbaxys’ continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies. The company has further strengthened its focus on generics research and is serving over 125 countries. Ranbaxy is also introducing many innovator products in markets around the world, where it has a strong presence.

Ranbaxy UK Ltd launches esmoeprazoleMakroCare (an international Drug Development and Commercialisation

services fi rm that is dedicated to support pharma, biotech and medical device companies to achieve high-level of performance) and LSK Global, a Korean CRO headquartered in Seoul, recently signed an alliance agreement.The agreement implies that the two companies will offer a wide range of services to pharmaceutical, biotechnology as well as device companies in key territories in Asia.

Talking about the alliance, Ashok Ghone, VP, Global Services, stated that, “Care and LSK Global operate in key strategic regions of US & Asia and the collaborative relationship between two companies provides opportunity, now that MakroCare can extend support, to their potential & existing customers that need services in Korea, LSK Global provides clinical services for phase I/II/ III studies and will utilizing Makroares’ USA and other Asian region strengths effectively.”

MakroCare has fi ve divisions - Consulting, CRO, SMO, Informatics, and Commz to support various aspects of product life cycle management. MakroCare has teams positioned worldwide in these divisions supporting several services.

MakroCare, LSK Global sign alliance agreement

German pharmaceutical company, Bayer, has been ticked off by the industry regulator over its use of Twitter for marketing purposes, indicating regulators’ growing unease about the use of the social media tool. The European law bans the advertising of prescription-only medicines to the public. Information can be supplied directly or indirectly, but rules dictate that this must be presented in a balanced way.

The Prescription Medicines Code of Practice Authority (PMCPA), the self-regulatory unit of the Association

of the British Pharmaceutical Industry, the industry trade body, stated that Bayer had brought discredit and reduced confi dence in the drugs industry after it tweeted the launch of two drugs – Levitra, an erectile dysfunction drug, and Sativex, a cannabis-based painkiller used for the treatment of multiple sclerosis. In relation to Twitter, the rules state that “if a company wants to promote a medicine via Twitter, it would have to ensure that the medicine is prescription only and the audience restricted to health professionals”.

German pharma company � cked off for Twee� ng launch of new drugs

DMV Fonterra Excipients GmbH & Co KG, has signed a business transfer agreement for the acquisition of the business and assets of Brahmar Cellulose Private Ltd (BCPL). “The acquisition of Brahmar Cellulose is a further step in achieving our ambition to become a leading supplier in pharmaceutical excipients and will give a stronger base for future developments in this area”, says Jan Jongsma, CEO, DMV-Fonterra Excipients.

The acquisition will create a unique market position for DMV-Fonterra Excipients and will improve DMV-Fonterra Excipients’ ability to support its customers with reducing

their supply chain and formulation costs by having a consistent, single source and single quality framework across their key products. DMV-Fonterra Excipients would sources its products in Europe and New Zealand, while Brahmar Cellulose would manufacture its products in India. It has also established a global sales network which will be able to incorporate Brahmar Cellulose

product range and will leverage its current quality and regulation framework and reputation to serve all levels of the pharma market.

DMV Fonterra Excipients to acquire Indian pharma company

World News


Evotec and Roche to develop compound that could slow the progression of Alzheimers’ Evotec AG and Roche AG recently announced that they have entered into an agreement for the development and commercialisation of Evotec’s Monoamine Oxidase Type B (MAO-B) inhibitor in patients with Alzheimers’ disease (AD). According to the agreement, Roche will pay Evotec an upfront fee of $ 10 million. Evotec could receive further development and commercial milestone payments of up to $ 820 million as well as tiered double-digit royalties on sales. Roche will initiate the study in 2012 to and will be responsible for all clinical development, manufacturing and commercialisation activities.

Dr Werner Lanthaler, CEO, Evotec said, “We are delighted to have Roche as our strategic partner to fi ght AD as they are committed to bringing innovative treatments to patients suffering from devastating neurodegenerative diseases, and are developing a number of approaches to tackle Alzheimers’. Their outstanding commitment to pharmaceutical innovation makes Roche the ideal partner to fi ght one of the biggest healthcare problems of our times.”

Evotec’s compound is a potent inhibitor of MAO-B, an enzyme that breaks down the chemical messenger dopamine in the brain and contributes to the production of free radicals, which cause oxidative stress and may contribute to pathogenesis of AD as demonstrated by the upregulation of MAO-B expression in the brain of AD patients.

Drugmaker Pfi zer Inc is aiming to boost sales of veterinary medicines in China, and its global dominance in the animal health business — via a Joint Venture (JV) with a Chinese startup company.

Pfi zer has reached a deal to jointly develop, manufacture and sell vaccines for animals with Jilin Guoyuan Animal Health Company Ltd. The JV, Jilin Pfi zer Guoyuan Animal Health Co, plans to start marketing its fi rst product — a vaccine against a reproductive and respiratory condition pigs get — next year. Executives from Pfi zer and the Chinese company are reviewing options and planning future strategy. That could include developing additional vaccines for pigs, poultry, cattle and perhaps pets, as well as new animal medicines. Pfi zer’s animal health business also will try to increase sales of its existing products by expanding its sales force in China, where 90 per cent of veterinary medicines currently sold are produced by domestic companies.

Pfi zer enters an animal health JV in China

Tech Updates


Wyatt Technology Corporation, the world leader in absolute macromolecular characterisation instrumentation and software, recently announced that its calypso composition-gradient multi-angle light scattering (CG-MALS) system achieves accurate measurements of biomolecular interactions. The calypso offers the unique capability of determining both the affi nity and binding stoichiometry for macromolecules in solution with no need for immobilisation or tagging, which may infl uence the interaction. This is demonstrated in a new application note, titled ‘measuring antibody-antigen interactions with the calypso’.

The new application note illustrates how calypso complements traditional MALS separation techniques, keeping the molecules in close proximity to probe their interactions. Calypso employs a series of unfractionated samples of different composition or concentration in order to characterise macromolecular interactions, including reversible self- and hetero-association of proteins, reaction rates and affi nities of irreversible aggregation, and viral coeffi cients. No special modifi cations, such as sample tagging or immobilisation procedures, are required. Instead, samples are unlabeled and entirely in solution. Furthermore, calypso’s automation capabilities enhance productivity by improving repeatability and reliability, while minimising time and effort.

Sermo, Inc, one of the largest online physician networks in the US, recently announced the launch of Sermo sponsorship, a portfolio of offerings that provides new opportunities for pharma, biotechnology and life sciences companies to engage physicians and educate them on new products and programmes. Sermo sponsorship is available on both web and mobile platforms, where physicians across 68 specialties discuss top issues in healthcare and consult each other on clinical cases in order to provide the highest quality care to their patients.

“Whether companies are launching new treatments or sharing new data from clinical trials, Sermo sponsorship enables them to reach, engage and infl uence the treatment decisions of their target specialists,” said Jon Michaeli, Vice President - Marketing, Sermo. “Industry research shows that peer infl uence has the greatest impact on clinical

decisions. Sermo’s social platform makes it easy for physicians to share new industry developments with their colleagues.”

Sermo introduces new sponsorship product

Bio-Rad Laboratories, Inc’s ProteOn™ HTG sensor chip provides a robust new alternative for pharma researchers studying polyhystidine-tagged protein interactions that can reduce cost per data point by 90 per cent.

Dr David Myszka, Director, Center for Biomolecular Interaction Analysis, University of Utah and Founder, Biosensor Tools, said, “Given the popularity of polyhistidine tags, these chips will open up additional

applications of the ProteOn technology.”

Polyhistidine tags are the most common tags used in protein interaction analysis because they are small and rarely interfere with the function, activity, or structure of target proteins.

To optimise the p o l y h i s t i d i n e - t a g g e d protein interaction workfl ow, Bio-Rad has also

introduced the ProteOn HTG reagent kit for use with the ProteOn HTG sensor chip.

Wya� Technology’s calypso CG-MALS system

Bio-Rad introduces new HTG sensor chip

SANYO’s MIR-S100C is a compact orbital shaker designed specifi cally for use in high humidity and/or elevated CO

2

concentration conditions. With the orbital shaker mounted inside the incubator and an independent controller placed externally, the MIR-S100C offers simple, secure operation suitable for cell culture applications within Good Manufacturing Practice (GMP) environments.

The structural design of the MIR-S100C incorporates antibacterial copper alloy stainless steel for the shaker section, with a small window that can be used for spraying disinfectant inside. The controller is a separate unit, preventing humidity from affecting the electrical components and enabling operation to be monitored without opening the incubator.

Revolution speed is adjustable from 40 to 200 rpm and the timer can be set for up to 99.9 hours or continuous operation. A soft start function protects against spilling or foaming of samples inside fl asks and test tubes by gradually accelerating at a user-selectable speed until the preset number of revolutions is reached. Security of operation is assured by a range of features, such as the non-volatile memory facilitating automatic recovery after a power interruption, speed error alarm and motor overload protection circuit.

SANYO launches orbital shaker

Tech Updates


Waters has recently introduced Xevo™ TQ and Xevo QTof, - a revolutionary advance in ease of operation. The benefi ts of the Xevo instruments and their

unique approach to problem solving have been widely adopted. The latest Xevo instruments - the Xevo TQ-S and Xevo G2 QTof - offer proprietary technological advances not found elsewhere so that one can meet the challenges, at the bench top, in ways not achievable before.

The highly advanced Xevo instruments bring high performance to any laboratory or scientifi c challenge. With this, one is able to push the limits of detection on assays, routinely identify compounds in complex samples, and ultimately discover your full potential. Of course, there are also differences based on your unique needs. The Xevo G2 QTof allows one to comprehensively identify and quantify compounds with exact mass, while the Xevo TQ-S allows you to accurately measure the concentration of target compounds present at very low levels in complex samples.

COVECTRA, a multi-layered brand protection solutions provider offering serialisation, authentication, and track and trace technology services, recently announced the launch of a new medication adherence programme designed to provide substantial benefi ts to pharmacies, and patients, while simultaneously addressing new regulatory guidelines recently established by the Food and Drug Administration (FDA). COVECTRA’s medication adherence programme features a serialisation solution, which offers a unique communication channel to improve adherence through early detection & correction of non-adherence. By encouraging

timely and accurate dosing of prescribed medications on the part of the patient, the adherence programme promotes appropriate refi lls for uninterrupted health care for the duration of the medication regimen. In addition to extensive patient monitoring capabilities, it offers a platform for targeted recalls, and provides extensive data for value mining. Another important benefi t of the COVECTRA

adherence programme is that it can help establish a direct link between the pharma company and the patient, thereby enhancing brand loyalty.

COVECTRA launches medica� on adherence programme

Waters launches Xevo system Roche launches analysis pla� ormRoche has recently launched a new analysis platform designed to help bio manufacturers monitor and optimise the production operations. The platform - the cedex bioprocess analyser is a continuous metabolite screening and substrate analysis system based on the Swiss drugmaker’s cobas instrument technology and is capable of measuring 14 different process parameters simultaneously. It is easy to operate, enabling continuous loading and unloading of diverse cup types as well as on board dilution of highly concentrated samples. New parameters can be implemented by ‘plug and play’ and a development channel for individual assay customisation is planned.

Thomas Baier, life cycle leader for custom biotech at Roche Applied Science, said, “Bioprocess analytics are performed throughout the process from cell line development to large scale manufacturing of commercialised therapeutics. “The majority of testing takes place during the upscale from plate-size to pre-clinical or early clinical studies supply - this is where the cedex bioprocess analyser fi ts in perfectly.” Demand for in-line processing technologies that provide near-instantaneous data is growing as the pharma industry begins to apply the principals of Quality by Design (QbD) and Process Analytical Technologies (PAT) to drug production.

GlaxoSmithKline (GSK), a leading pharma company, has recently partnered with Nigeria’s National Agency for Food and Drug Administration Control (NAFDAC) to provide a patient SMS verifi cation service for antibiotic, Ampiclox. The service will allow the Nigerians to instantly confi rm whether their pharmacy-bought Ampiclox is a genuine GSK product by sending a text message containing a 12-digit pin number labelled on each blister pack.

The verifi cation service will give the patients and stakeholders the power to fi ght back against

the menace of counterfeit pharmaceuticals, which claims hundreds of lives in Nigeria each year. Lekan Asuni, Managing Director, GSK, said, “ We are supporting this initiative by NAFDAC to ensure that the medicines bought in Nigeria are genuine. We have chosen Ampiclox because it is feared that there are its counterfeit products in the market.”

GSK introduces SMS service to combat counterfeits

Tech Updates


Unilife has recently developed the fi rst multi-chamber prefi lled syringes that have an in-built safety mechanism. The Unifi ll EZMix can hold two or more primary drug containers within a glass barrel, and can store a combination of liquid stable or lyophilized drugs along with up to 1 ml of diluent for reconstitution. However, unlike other dual or multi-chamber devices which have gone before it, the EZMix’s safety apparatus is inside the glass barrel. The inclusion of a safety appliance within the vial for multi-chamber delivery was previously thought impossible, because the plastic needed to create the device can interact with the lyophilized drugs. Unilife also anticipates added value because the device follows a growing market trend for lyophilised drugs, which make up a third of all US Food and Drug Administartion (USFDA)-approved drugs over the past three years.

Batavia Bioservices has gained access to Simulated Moving Bed (SMB) technology by collaborating with Xendo. Batavia Bioservices offers a portfolio of services focussed on the rapid and cost effective provision of high quality biopharmaceutical materials for research and pre-clinical studies. Activities at the Xendo unit include upstream and downstream processing, single use

fermentation systems, and continuous chromatography using SMB technology. Batavia Bioservices highlighted the microbial process understanding it will gain through the

collaboration. Transferring assets to Batavia allows Xendo focus on its other operations. In the collaboration Batavia will offer process development and analytical services and Xendo will handle engineering, regulatory and clinical support.

Unilife creates mul� -chamber syringe

Batavia gains bioprocessing assets in Xendo collabora� on

AstraZeneca has collaborated to research a scalable system based on inkjet printing for formulating personalised medicines. The research looked at using piezoelectric printing to formulate felodipine, a poorly soluble high blood pressure treatment marketed by AstraZeneca as Plendil.

In piezoelectric printing a voltage is applied to eject liquid from the nozzle, and in this case, on to a hydrophobic substrate. Printing thousands of spots with one or more drugs would create a formulation capable of delivering a therapeutic dose. Furthermore, the treatment would be tailored to the individual’s needs and could be produced at the point of care, a hospital for instance. The ubiquitous and inherently scalable nature of inkjet printing would make implementation at the point of care ad scaling of manufacture a possibility.

AstraZeneca eyes printers for personalised medicines

Thermo Fisher Scientifi c Inc, the world leader in serving science, recently announced that it has acquired TREK Diagnostic Systems, a global provider of microbiology solutions, including blood culture, microorganism identifi cation

and antibiotic susceptibility Testing (AST) products, from Magellan Biosciences. Based near Cleveland, Ohio, the company had full year revenue in 2010 of $ 34 million and has 150 employees. “The range of products manufactured by TREK ideally complements our existing portfolio of microbiological testing technologies,” said Marc N Casper, President & CEO, Thermo Fisher Scientifi c. “Advances in automation and the development of more rapid and reliable tests enable us to provide our customers with improvements in

productivity and effi ciency that are critical when responding to increasingly complex microbiological threats to human health.”

TREK’s other major brand, Sensititre, extends Thermo Fisher’s range of manual susceptibility testing and identifi cation products that provide microbiologists with a range of tools to determine the resistance status of a microorganism. Trek products now join the industry-leading Thermo Scientifi c portfolio; a portfolio that is relied on for its quality, accuracy, reliability.

Thermo Fisher Scien� fi c acquires TREK Diagnos� c Systems

Leaders Speak

32

‘We need to take the path of

innova� on in every area and industry’

…says Glenn Saldanha, Chairman and Managing Director,

Glenmark Pharmaceu� cals Ltd. He holds a Bachelor’s

degree in pharmacy from Mumbai University and is an

MBA from Leonard Stern School of Business, New York

University. Prior to Glenmark, Saldanha has worked with

Eli Lily, USA, and PriceWaterHouseCoopers, US.

Chandreyee Bhaumik

Glenn Saldanha joined Glenmark Pharmaceuticals Ltd in 1998 as Director and took over as MD & CEO in 2001, and now he looks after the entire operations of the organisation. During his tenure, he has managed to transform Glenmark from an Indian-driven branded generics business into a research-driven innovation-led organisation that focusses on discovering new molecules. Simultaneously, he has also built a strong branded formulations business across emerging economies including India and has established a strong foothold in the US generics market in a short period.

Glenmark’s branded generics is spread across fi ve regions today, viz Asia including India, Central Eastern Europe, Africa, Latin America and Commonwealth of Independent States (CIS). In less than half a decade, Glenmark has established itself among the top 25 generics companies in the US and a leading player in drug discovery. Saldanha has managed to strike six out-licensing deals in innovative R&D with big pharma. When asked about his journey in the pharma industry with special emphasis on drug discovery, Glenn remarks, “The journey has been both challenging and rewarding. Innovation in any sector and any industry takes a long time. It can take years of painstaking effort to get one innovative product to market and if there is a failure then all the investment goes in vain. Further, it also needs courage – the ability to overcome setbacks and start all over again.” Sharing this opinion he continues, “At Glenmark when we focussed on innovation, we were clear that our molecules had to be fi rst-in-class or best-in-class globally because we would out-license them at the clinical stage of

development. To achieve that objective we need to be better than the best in our chosen areas as we do not have deep pockets to fund trials in late stage clinical development, which could cost upwards of $ 100 million.” Glenmark then identifi ed the therapeutic areas and target areas were chosen. It then invested all its resources in those selected therapeutic areas. As Saldanha affi rms, “We believe that innovation is about intellectual capital & strategy and not about abundant monetary resources. Most important when one is involved in innovation, they have to create a product for the global mass and cannot be focussed on a region or a country.”

India calling...After working in the US for quite sometime, Saldanha decided to come back to India. And what encouraged him was his prediction that drug discovery was possible out of India. As Saldanha elaborates, “Working in the US was a

Modern Pharmaceuticals I September 2011

Leaders Speak


fascinating experience. The exposure was tremendous and it was in the US when I realised that drug discovery was possible out of India. We have an enormous talent pool of bright chemistry graduates and all one needed to do was to provide the necessary resources, infrastructure and guidance to develop a sustainable drug discovery programme in India.” He highlights, “Most importantly in our country we could do it at a fraction of the cost incurred in the US. The opportunity was huge and India was also opening up its economy in the 90s, and I felt it was the right time to return back to build the business.”

Business modelGlenmark followed the organic growth route. It has not ventured into any Contract Research and Manufacturing Services (CRAMS) or any contract-related businesses. The businesses can be classifi ed into four clusters: branded generic business, pure generics business, drug discovery & development and API business. When asked, “How does the pipeline currently look like,?” he replies, “We still have six molecules after outlicensing two molecules. All our remaining molecules have tremendous potential. We have several phase II data points coming out in the next fi nancial year and that is a huge achievement for our company. Any positive data from these phase II studies will have a huge signifi cance to our outlicensing programme.”

With many drugs going off patent, there are so many companies that have faced litigation. Saldanha voices his constant effort to avoid them and says, “Our strategy towards para IV has been on targeting niche opportunities where we are sole fi rst-to-fi le. We have consciously avoided the billion dollar opportunities wherethere are many fi lers. Hence, competition is severe and pricing of products gets substantially eroded after the products become a generic.”

When going about building the presence Saldanha wanted to position Glenmark as a specialty company in emerging markets. He says, “As a result of that strategy we focussed on launching differentiated

products and not generics across operating markets. We also have physical presence in most operating countries with our own sales force. This helps us communicate our product offering better and launch products for the local market.”

Striking professionalismEven with so many feathers continuously being added to his success cap, never has the ideal of professionalism been diluted. With a clearly defi ned and pronounced motto he moves on. Further, the primary factor accounting for this professionalism was that pharma is a technical fi eld that involves specifi c knowhow. Everybody cannot work in this industry. It is extremely essential to understand the science and the technicalities of the molecules. He adds that the company has hired the brightest of the talent from the leading technology and management institutes of the world.

What next?In 2008, one of the leading business magazines mentioned Saldanha as ‘One of the 21 leaders to watch out for in the 21st century’. Further, in that year, another leading business publication of the country ranked Saldanha as India’s most ‘Value’able Chief Executive Offi cer (CEO). Discussing the future path, he says, “We have made substantial progress in the last fi ve years to emerge as a leading player. The next fi ve years will be even more crucial because it will determine whether we make it to the big league of global pharma organisations. We presently have six molecules in human trials with two molecules in late

stage clinical development - this itself is a big accomplishment for any pharma organisation in the world as each of these molecules are potential blockbusters. Even if one of the three molecules in late stage clinical development makes it to the marketplace in the next fi ve years, it will be a big accomplishment.” This would make Glenmark the fi rst Indian company to develop an innovative drug that could be marketed globally. It will also change the perception about the Indian pharma industry globally, which has been known so far for its low cost generic medicines. Further, the fi nancial rewards for the organisation will also be signifi cant as peak sales opportunity for each of our molecules is ranging between $1-3 billion. This would truly transform the organisation into an Indian multinational.

For Saldanha innovation is always the driving word. Thus, he advises the next generation - the entrepreneurs in the making, to remain focussed on the key word ‘innovation’. He hopes that the industry will have a far sighted outlook in order to make the country a pharma destination.

According to him a major part of the Indian industry is concentrating into the services business. The services end is extremely vital to generate revenues for the short term, but one does not always have to lose sight of the imperatives. Sometimes success gets clogged up in the short term benefi ts in relation to making money and other imperatives that one loses the vision to look beyond at the long term imperative to where the industry is going. Thus, in order to have a far reaching impact, it is essential to innovate. He believes this is the guiding principle whether it is on generics or on the proprietary side.

Finally, he signs off saying, “If we want to progress as a nation we need to take the path of innovation in every area and industry because we will no longer be able to compete as a nation based on our cost advantage. Thus, tread the path of doing something innovative, something revolutionary as that will transform the organisation and also the nation.” MPh

([email protected])

We have made substan� al

progress in the last fi ve years. The next fi ve years will be even more

crucial because it will determine whether we

make it to the big league of global pharma

organisa� ons.

Roundtable


Should the Indian pharma/biotech

industry oppose or support it?

The Na� onal Biotechnology Regulatory Authority (NBRA) Bill

In the light of escalating worldwide food prices there is an urgent need to address the low productivity of our farms. GM crops can possibly provide the best solution to increasing crop yields and bring greater prosperity to farmers. Admittedly science does not have all the answers to long term effect of introduction of GM crops, however, adequate long term studies have been conducted before any new GM variety is released to market. A parallel can be drawn to testing of new drugs before allowing them to be marketed. Just because we do not always know every single long term effect of any new drug, that is not reason enough to allow people to die, and not introduce new therapies.

With rapid economic growth in the most populated countries (India and China), the demand for food is skyrocketing. We have to fi nd a solution to keep prices under control so we can feed our aspiring populations. Additionally,

China has introduced many GM crops already and has built up signifi cant experience in this area. We can benefi t from their experience and should draft the bill accordingly. The bill should take into account the fundamental rights of farmers, which are guaranteed by our constitution, but should also not stand in the way of progress. Whether we agree or not, genetic modifi cation of crops is a technology that is here to stay and the genie will not be put back in the bottle. So the question is whether we should join the league of modern nations (and draft laws to protect our interest using their laws as templates) by encouraging the advancement of science or be bystanders and allow the world to pass us by.

Ajay Bharadwaj Founder and CEO, Anthem Biosciences, Bengaluru

The long-pending NBRA Bill is fi nally expected to be passed in the monsoon session of the

Parliament. Though the decision is being postponed owing to recent na� onal events, the

hopes of biotech fi rms are rising everyday.

A National Biotechnology Regulatory Authority (NBRA) is being proposed under the Biotechnology Regulatory Authority of India (BRAI) Bill, 2011 as an independent, autonomous, statutory agency to be established by the Government of

India to safeguard the health and safety of the people and to protect the environment by identifying risks posed by or as a result of modern biotechnology used in producing drugs and in Genetically Modifi ed (GM) food and managing those risks through regulating the safe development and deployment of biotechnology products and processes.

The Food Safety and Standards Authority under the Food Safety and Standards Act, 2006 (FSSA, 2006) regulates the GM products in India. Also, other elements of biotechnology regulation are currently spread over multiple acts and some of these would be amended to establish and operate the NBRA.

Along with inviting criticism this bill also opens the gateway for better utilisation of biotechnology in the country. It will bring with it a smooth clearance window for biotech products, but in the process we should not overlook some of the shortcomings. There are certain drawbacks that should be given due attention and stalwarts from the industry discuss on the viability and need of this bill.

Titash Roy Choudhury

Roundtable


The global pharmaceutical R&D scenario is undergoing a major transformation. Gradually and steadily R&D is moving from chemistry to biology. It is estimated that by the year 2015, over 40 per cent of new drugs approved by the US Food and Drug Administration (FDA) are likely to be biologics. The research pathway in biologics is complex and the outcome is often uncertain. Also, with over $ 25 billion worth of biologic drugs going off patent by 2016, the entry of biosimilars is likely to stimulate this growing market. To seize this opportunity, we need a clear and well-defi ned regulatory pathway, apart from competencies and skills in biotech R&D, sizable investments and expertise in market development strategies.

With this background, the NBRA Bill drafted by the Department of Biotechnology (DBT) is a timely and welcome move. It will enable the biopharma industry one window approach rather than going through multiple government agencies such as Genetic Engineering Approval Committee (GEAC), DCGI, Review Committee on Genetic Manipulation (RCGM), state FDAs, etc. Similarly issues such as ‘interchangeability’ etc need regulatory clarity as manufacturing process is as important as the fi nished product when it comes to biosimilars.

Another important aspect is safety. However, there is little clarity in the bill on post-marketing surveillance of biopharma products. The bill also provides that anyone who misleads the public without any scientifi c evidence about the safety of the products will be punished with imprisonment. While this provision is largely in the context of GM foods fuelled by controversy about Bt. Brinjal, it appears to be against the citizens’ right to freedom of speech and has attracted criticism. It will also not be under the purview of RTI Act.

The bill also overrides the Drugs and Cosmetics Act. It remains to be seen how various states react to the bill, as even now there are several areas where DCGI and state FDAs do not see eye to eye.

From the pharmaceutical industry perspective, the bill is a major landmark in this complex and growing area. Being drafted by one of the most pragmatic and proactive government bodies - DBT, its success will depend on its effective implementation.

Dr Ajit DangiPresident & CEO, Danssen Consulting

Roundtable


NBRA is going to regulate the research, manufacture, import and use of products of modern biotechnology for human and veterinary health, agriculture, forestry and fi sheries and industrial manufacturing and in environmental applications. The creation of a central authority to regulate the biotechnology industry is a welcome move, since a clear pathway will emerge and will help faster roll out of products and services in this domain.

However, clarity on how the existing central regulatory mechanism such as the Central Drugs Standard Control Organisation (CDSCO) headed by the DCGI, and the state FDA will blend into the new framework is yet to emerge. Also, the bill does not include regenerative medicine,

which involves R&D in stem cells and their application, in its purview. Another aspect which needs to be looked into is the regulatory process followed for domestically manufactured biosimilar products versus imported products. Healthcare service providers are also, by and large, not sensitive to biosimilar quality aspects. This defi ciency needs to be addressed not only in patient interest, but also from the point of view of India not being seen as having lax quality standards in its regulatory process.

K V SubramaniamPresident & CEO, Reliance Life Sciences, Mumbai

Biotech products are produced by living organisms with high molecular complexity and are susceptible to smallest manufacturing process changes, while small molecules are produced by chemical synthesis with high levels of stability. Minor changes in the process or materials used in the manufacture of biotech products may have serious differences in treatment outcomes and side-effects. Hence, the regulatory approval process also has to be different. The NBRAI will therefore defi nitely be benefi cial for Indian biotech/pharma

sector as long as this will not be an additional regulatory body and will be under the umbrella of the Central Drug Authority. There should be one regulatory body at the centre for the entire healthcare sector with separate verticals for pharma, biotech, devices, diagnostic, hospitals, etc, under this one body.

Ranga IyerAdvisor, Pharmaceutical Research and Manufacturers of America (PhRMA)

The NBRA would, after enactment, be mainly responsible for the GM food safety assessment and any subsequent authorisation of the GM food as safe. The NBRA will also be responsible for regulating genetically modifi ed organisms with applications in human and veterinary health. Part II under the bill covers organisms and products for medicinal purposes such as vaccines, recombinant gene therapy products, plasma derived, stem cell based, synthetic biology products, etc.

The bill requires study in detail. On a cursory study, the clauses covering ‘offences & penalties’ seem to be very draconian and seem to be aimed more at silencing opposition to approvals granted by NBRA.

The most controversial provision of the bill seems to be Clauses 64 and 66. Clause 64 states, “If a person, without reasonable excuse, resists, obstructs, or attempts to obstruct impersonate, threaten, intimidate or assault an offi cer of the authority or any person assigned to discharge any function under this Act, or in exercising his functions under this Act, he shall be punishable with imprisonment for a term which may extend to three months and also fi ne which may extend to ` 5 lakh.”

Clause 66 states, “If any person contravenes or attempts to contravene or abets the contravention of the provisions of this Act or of any rules or regulations made thereunder, for

which no punishment is provided elsewhere in this Act, he/she shall be punishable with imprisonment for a term which may extend to two years and also with fi ne which may extend to ` 10 lakh.” This seems to be aimed at blocking all protests by persons, civil society groups or concerned scientists speaking against the NBRA. It appears to favour MNCs for fast-tracking their applications instead of protecting the health and environment of our people.

The chance of appealing to our courts against such measures is also taken away by Clause 70(1), which says, “No court shall take cognizance of any offence punishable under this Act or the rules or regulations made thereunder, save on a compliant made by the authority or any offi cer or person authorised by it.”

India is not yet fully geared to develop biological products, as it involves huge commitments in terms of time and fi nance. Patenting bio-developed products are also expensive and cumbersome. Enacting such a law at present would favour overseas companies to bring their patented high priced GM food products and biologicals into India without any hassle, and also stall competition and affordable alternatives.

Daara B PatelSecretary-General, Indian Drug Manufacturers’ Association (IDMA), Mumbai

Interface


Take us through your journey with Sanofi .I joined Sanofi Pasteur, Philippines in 1994 (formerly known as Pasteur Merieux Connaught) as Medical Director but continued doing my private paediatric practice on the side. In 2000, I was appointed as Sanofi Pasteur’s Medical Director for South East Asia. In early 2003, I was based in Sanofi Pasteur Headquarters in Lyon, France for almost 5 years initially as International Product Manager of Pediatric

Vaccine Franchise and later on promoted to become Business Operations Director for the emerging markets in Asia Pacifi c, based France. In 2007, I returned to Philippines as its fi rst Filipino Country Manager. In November 2009, I was expatriated to manage the affi liate of Sanofi Pasteur in India and the local domestic operations of Shantha Biotech, and the company’s business in Sri Lanka and Nepal. Now, based in Mumbai,

I am managing the vaccines business of the Sanofi Group, with almost 400 employees.

Your take on the Indian vaccine market.The Indian vaccine market is still relatively in its nascent stage considering its huge population of 1.2 billion, with more than 25 million newborns each year. The immunisation coverage in India is relatively low compared to other countries. Thus, it is extremely essential to create awareness about vaccine preventable diseases.

From a business point of view, the market presents tremendous growth

opportunities because huge potential is yet to be tapped. The improving economy of the country also increases the number of families who can afford out-of-pocket vaccinations in the private setting. With a huge birth cohort, the market is expected to have double digit growth rate in the next few years. In the past 2-3 years, the market has grown by at least 30 per cent.

What is your fl u campaign about?Infl uenza (often referred to as ‘fl u’) though prevalent all year round, peaks during the monsoon (July - September) and then again in winter (November - February).

Flu is considered to be an underestimated disease. Everyone is at the risk of being infected with the infl uenza virus and can spread the disease to others. When one person has the fl u, his resistance weakens which could possibly lead to secondary infections like pneumonia or could aggravate the existing medical conditions among those who have chronic medical conditions like diabetes, chronic lung and heart problems. Rarely, it can also lead to death. Children are particularly susceptible to fl u. The Center for Disease Control and Prevention (CDC) recommends that everyone who is 6 months and older should get vaccinated against ‘fl u’ every year, in order to be protected against the disease. Social media is a rapidly growing new medium among young women in India; many of whom are mothers are increasingly sharing the latest in their lives with their friends and family via updates on social media sites and blogs. Recognising the popularity of this medium, for the fi rst time, we are initiating a public awareness campaign in India using this platform called ‘Mothers against Flu’.

‘Mothers against Flu’ is a Facebook community that unites mothers from different parts of India with a single objective - to protect their children from the fl u virus by creating awareness about the steps they can take to protect against and prevent fl u.

It is also a platform for mothers to share ‘mummy stories’ and exchange views on childcare in general. There are also engaging and exciting quizzes and polls in which mothers can participate to get selected as ‘Super Moms’. MPh

([email protected])

...says Dr Joselito STA ANA, Execu� ve Director, Sanofi Pasteur India. In an interac� on on the

sidelines of the fl u vaccina� on campaign, he highlights the opportuni� es in the Indian vaccines

market and the precau� ons to be taken to prevent fl u.

‘Immunisa� on coverage in India is rela� vely

low compared to other countries’

Photo

by:

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ua

Nav

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Chandreyee Bhaumik

Children are par� cularly

suscep� ble to fl u. The

Center for Disease Control

and Preven� on (CDC)

recommends that everyone

who is 6 months and older

should get vaccinated against

‘fl u’ every year, in order to be

protected against the disease.

Interface


Tell us about the Goa Development Centre (GDC).GDC is a part of the newly constituted Industrial Development and Innovation organisation of Group Sanofi , which has been created with the aim of expanding the companies’ global R&D base. This center is spread

across 2,500 square meter state-of-the-art facility and was developed with an investment of over ` 85 crore. It develops a wide range of solid oral dosage formulations for the regulated and semi-regulated markets. It has also been accredited with the German FDA and has fi led four patents:

Irbesartan and Amlodipine Besylate tablets (Process claims)

Thiocolchicoside and Ketoprofen tablets (Process claims)

Ramipril and Amlodipine Besylate tablets (Process and product claims)

Olanzapine tablets (Process claims)

What kinds of services does the centre off er?GDC houses laboratories for formulation and analytical

development, and has a great plant to manufacture pilot scale batches of tablets and capsules in compliance with local and international regulatory requirements. The centre is armed with various sophisticated equipment, and under the guidance of accomplished scientists. The centre also provides expertise in developing robust, bioequivalent, patent

non-infringing generic drugs and fi xed-dose combinations. It has a strong support for re-engineering of existing formulations and trouble shooting, analytical method development and stability studies, transfer of technology of the product manufacturing process and analytical method to the commercial manufacturing site, life cycle management of exiting products, compiling Chemical Manufacturing & Control (CMC) dossiers and more.

Why did you plan to venture into R&D? The mission of Sanofi R&D is to develop appropriate therapeutic solutions for illnesses that are either poorly covered or completely ignored. One of the key principles of the Group’s strategy towards becoming a diversifi ed global healthcare leader is to increase innovation in R&D while being focussed on patients’ needs. By focussing on patients’ needs, we intend to become the most productive R&D organisation in the healthcare sector.

Why did you choose Goa? Today, the economy in India is growing rapidly and we have become the worlds’ second fastest growing economy with a Compounded Annual Growth Rate (CAGR) of 9 per cent for the past fi ve years. Driven by increased affordability and medical infrastructure expansion, the Indian pharmaceutical market is expected to triple by 2015.

...says Dr Praveen Khullar, Head of Development Centre, Sanofi Aven� s Group, and Senior

Director, Goa Development Centre. He discusses the Group’s strategy behind focussing on

innova� on, and the mo� ve behind se� ng up a plant in Goa.

‘Highly trained pharmaceu� cal scien� sts,

chemists & IT professionals are available in

India to support technological pla� orms’

Jasleen Kaur Batra

Today, the economy in India is

growing rapidly and we have

become the worlds’ second

fastest growing economy with

a Compounded Annual Growth

Rate (CAGR) of 9 per cent for

the past fi ve years.

Interface


Highly trained pharmaceutical scientists, chemists & IT professionals are available in India to support product development and technological platforms. India also has the advantage of cost competitiveness, and therefore more and more global players are setting up development centres and manufacturing sites in the country.

With an investment of approximately ` 100 crore, the centre was inaugurated in December 2007 representing Sanofi s’ largest investment in India. It is a part of the Industrial Development and Innovation organisation of Group Sanofi , created with the aim of expanding the company’s global R&D base.

A manufacturing facility already exists at Goa, hence setting up a development centre in the same location presented several synergistic opportunities for the company. One of the major reasons behind settingup the center in Goa was its recognition as a pharmaceutical hub. It provides a favourable business environment tothe pharmaceutical industry and several fi scal incentives, this state has developed infrastructure like transport, power, water availability and existence of auxiliary industries such as the packaging units as well as a peaceful social climate with communal harmony. All these put together are the necessities of the sector and having easy access to them in one location was a huge plus point.

Tell us about the projects in the pipeline. We are working on a number of projects extensively, which we cannot disclose at the moment. But broadly classifying we are working on generic formulations, fi xed dose formulations, super generics and Novel Drug Delivery Systems (NDDS) technologies. MPh

([email protected])

Facility Visit


Bharat Biotech International Ltd is a multi-dimensional biotechnology company that specialises in product-

oriented research, development and manufacturing of vaccines and biotherapeutics. It was set up in 1996 and since then has grown by leaps and bounds. Dr Krishna M Ella and Suchitra K Ella, Founding Directors, established the company with the intention to develop next-generation vaccines and bio-therapeutic vaccines. It has a state-of-the-art manufacturing facility and is the largest of its kind in Asia-Pacifi c. Today Bharat Biotech takes pride having sold more than 1.6 billion of affordable vaccines to more than 100 countries. It was a moment of pride for Dr Ella and his team, when on June 6, 2011 Bharat Biotech announced that ROTAVAC, India’s fi rst indigenously developed Rotavirus vaccine would be made available for $ 1 a dose, ROTAVAC expects India licensure during 2014

and WHO Prequalifi cation in 2015 for supply to UN agencies. This is made possible only with the help of funding agencies who share the same vision

Bharat Biotech augmented the development of vaccines in the mid 1990s and launched its fi rst product Revac-B with down research; this was the world’s fi rst cesium chloride-free recombinant Hepatitis-B vaccine, which hit the market in 1998. They further advanced their expertise and reputation in the market by developing BIOGIT, India’s fi rst indigenously manufactured probiotic yeast. The company has one of the leading brands in the product category with over 140 million doses dispensed till date with a strong pan-India presence. It was also the fi rst company to develop and launch INDIKINASE in 2003. INDIKINASE is poised to offer substantial market expansion opportunities) and anti-rabies vaccine INDIRAB, which is indicated for both prophylactic (pre-bite) and therapeutic (post-bite) treatments.

Journey so far...The company is the brain child of Dr Krishna Ella, a scientist by origin. He received the National Research Service Award from the National Institute of Health, Bethesda, Maryland and he became a part of the Research faculty at the Medical University of South Carolina, Charleston. He founded and established Bharat Biotech International Ltd in 1996 along with his wife Suchitra Ella. The company today is at the forefront of Indian biotechnology engaged in R&D, manufacturing and marketing of vaccines and bio therapeutics. The passion grew in them in the early 90s when they were in the US. The strong urge to come back to their nation was one of the key reasons behind establishing this company in India. “This particular industry at that time was not doing well; there were barely one or two bio technology companies in India with their own R&D and manufacturing unit.” She continues, “We did have doubts of doing things in India, especially in the area of academics and the activity that we were planning to get into. But our experience and training in the realm of biology, research, teaching, marketing, fi nancial administration gave us the boost to come here and set up our company. Both of us were risk takers and we wanted to plunge into this industry as entrepreneurs,” reiterates Suchitra K Ella, Co-founder and Managing Director, Bharat Biotech International Ltd.

Mapping the road to success...Establishing such a huge facility and achieving recognition did not come easily. They were one of the fi rst few people to dream of establishing an R&D

In the biotechnology space, Bharat Biotech has emerged as one of the pioneers in R&D and

manufacturing of vaccines. Its competence has made it go global, and today it has earned a huge

name in the market.

Bharat Biotech Interna� onal Ltd

Ushering in a world of possibili� es

Jasleen Kaur Batra

Photo

by:

Sure

sh V

engap

ally

Facility Visit


and manufacturing unit. “The years 1996-98 were the most crucial years as there were funding, regulatory, marketing and human resource issues in India at that time. In India we faced problems while getting qualifi ed manpower for the pharmaceutical industry, though there was a huge demand for skilled expertise in the biotech industry. There were companies where a number of products were being manufactured, but there was no platform on a commercial level in India where R&D was taking place,” avers Suchitra Ella. Besides, the industry at that point was not as transparent and smooth as one would want it to be, which further added to the challenges of establishing a company. The basic aim of Bharat Biotech was to establish a set of products, which were high on quality and commercially viable. Being a part of the healthcare segment and that too in vaccines required the highest level of norms and guidelines to be followed. In that era, India did not possess the kind of technology that Dr Ella was planning to work on. “Everything had to be imported from other countries, the technology, raw material, equipment and more. As a country we lacked internationally validated and acceptable quality and the level of equipment that we used. Also, the vaccine industry at that point in time was confi ned to mostly the government labs. On the whole as a country, the regulatory mechanism was also absent and there were no guidelines to follow. We would run from pillar to post to educate ourselves and get the necessary approvals,” says Suchitra Ella. She further highlights on the challenges,

“At that time people were skeptical about high technology products, hence funding was a big issue. We showcased our projects to a number of banks and investors, but the system as a whole was extremely skeptical. Assuring that an Indian company would be able to deliver high quality product and standards in line with the foreign brands was a challenge then,” she informs.

Further, there was no Venture Capital (VC) funding at that time. And in India most of the institutions did not support the project as it needed a gestation period of at least 3-4 years. As coming out with a new molecule takes considerable research and more than 5-7 years of time. So even the VCs shied away from spending in biotechnology, which posed as a challenge for us, that we overcame gradually. “The investments came majorly from our pockets, Angel investors; an investor company in US saw the potential in our venture and supported us. We also received term funding from IDBI, but only after a year of starting the company. They came in 1997 in term loan and equity. The Technology Development Board of India, which comes under the Ministry

of Science and Technology, ensured that there was a commercial product from this technology. The advantage of having them on board was comforting and the interest rate was much lower as they were trying to promote technology and technology driven products,” informs Suchitra Ella.

She continues, “Once we launched our fi rst vaccine we were delighted since a lot of credibility came to us with that. Though we did not have deep pockets we somehow managed to sustain the products. It takes at least a ten year curve to come out of sustainable entity and to make it a larger enterprise. R&D is the backbone of such a company and we need to be involved in R&D right from the beginning. A lot of intellectual contribution to the company and the product has to be made and we did that and overcome all the speed breakers in our journey.”

When BBIL started manufacturing hepatitis B vaccine, the cost of preparative ultracentrifuge was prohibitively high. The necessity drove the company to develop an alternative technology relying on salt fractionation, patented as HIMAX technology, which

43

Suchitra K Ella

Co-founder and Managing Director, Bharat Biotech Interna� onal Ltd

Assuring that an Indian company would be able to deliver

high quality product and standards in line with the foreign

brands was a challenge then.

L-R: R&D Lab; Quality control department; Dr Krishna M Ella in the R&D Lab

Photo

by:

Sure

sh V

engap

ally

Photo

by:

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sh V

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ally

Facility Visit


was as effective as ultracentrifuge in separation of VLPs. The relatively lower capital investment and cost effective manufacturing process gave the company the edge to market its vaccine at very low prices that revolutionised the vaccine industry in India.

Current scenarioElla further continues on the company’s focus on biotechnology. “We could make generic products but we knew that it would not take us very far. There are very few players in the industry - including the MNCs. Innovation and Intellectual Property Rights (IPR) will be the way forward for all the companies in the biotech industry,” feels Ella.

But the scenario has changed now. The government as well as VCs have entered the industry. “It is only during the last 15 years that India has evolved in the biotechnology industry in terms of manufacturing. The state has improved today and has helped us grow,” feels Suchitra Ella.

BBIl has gone ahead of time to keep updated with the disease pattern that one can see not just in India but even in other countries as people migrate to different nation on a regular basis. “Today, the diseases are becoming global, thanks to the frequent travelling of people across countries. One needs to be prepared for tackling such global diseases. This preparedness comes only from our own R&D capabilities. We could come out with H1N1 vaccines in six month after we got the strains. The strains come from the US, and they are the raw material for our vaccines. There are a few diseases that can be

noticed in nations like Latin America, Africa, South Asian countries; we have infectious diseases, which we have not even seen, eg, Rotavirus is a cause of major concern as it kills more than 200 thousand children in India every year,” says Suchitra Ella.

Affordability is another factor that BBIL concentrates on; it has introduced new technology as well as manufacturing techniques that would help them reduce cost to make it more affordable. “The market size and the potential in our country is huge. But we also know the burden of the population. It is a situation where we need to develop cost-effective technology. Vaccines are preventive medicine and not curative and so it has to be affordable. The technology used to create the Hepatitis-B vaccine in 1998 was sold at about ` 1,500-2,000 per dose. Vaccines are extremely expensive and the Indian population cannot afford high cost technology even if it is available. India and the developing world needs low cost highly effective world class quality. Inspite of introducing high technology we have managed to reduce the cost by an approximate amount of 40 per cent and are trying to reduce it further,” avers Suchitra Ella.

Manufacturing processBiotechnology always starts from an academic background. Biotech entrepreneurs are people who pin up from great medical institution and come out and start their own R&D companies, which is later acquired by a biotech company. A few issues are faced while dealing with vaccines. Importing

strains is one of them. Continuous electricity, clean and pure water, high level of cleanliness, air purifi ers to keep the small particles away and such more are things that have to be given a lot of attention as they can infl uence the outcome of a research. “In India, most of the areas have electricity cuts. But we need to have a back up of 30 seconds for electricity as the processes are live and stopping the process is not possible. These are all biologically controlled products and it needs to be taken care of in a continuous process. We run 24x7 and have three shifts to ensure that the process is ongoing. There are a number of such minute details that a vaccine manufacturing company has to keep in mind, which makes the entire process further complex,” informs Suchitra Ella.

“When we take our product to an international level a few companies expect the trials to be repeated, especially phase III, as each country has their own set of regulations. It takes us at least about 18-24 months to register one product in other countries. A number of countries follow the WHO guidelines, which are stringent. It is only after we cross all these levels of quality check that the vaccine is allowed to be imported to different countries,” says Suchitra Ella. Over the years, Bharat Biotech has maintained high quality and reliability. Today, it is a global player and have faired well. It is currently working on a number of products, which are likely to change the shape of India and the healthcare system; looks like we are in good and safe hands. MPh

([email protected])

L-R: Quality Control department; a QC analyst working on Axsym equipment; packaging line

InvItatIon

new busIness opportunItIesinvites you to

AHMEDABAD14 - 17 Oct 2011

Gujarat University Exhibition Hall10 am - 7 pm

CU

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Exhibitor Profile

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Industry Update


Biotechnology as a prominent fi eld of science and technology emerged only in the 70s and is gradually being

integrated in various related sectors of life and biosciences. The progress made can hardly be overlooked, and with coming years the infl uence of biotech will spread to other unexplored areas. But in particular the contribution of biotech to the fi eld of medicine is fascinating, since the rise of biotech

drugs haVE changed the dynamics of the pharmaceutical market worldwide. “The promising era of biotech medicine is slowly moving closer to realisation. Many exciting new drugs for the treatment of diseases such as cancer, AIDS and arthritis are either on the market or are close to regulatory approval,” says Vijay Kumar Ambatti, President & CEO, Clearsynth Labs Pvt Ltd. It is this rising phenomenon of biotech drugs taking over traditional drugs that is drawing more

pharma companies in India to enter the biotech space.

In India, biotech entered the pharma sector pretty late as compared to its foreign counterparts. Given the biopharmaceutical rise from USA, and most of the market leaders today are USA-based. However, India is now gearing up to enter the biotech space.

Biotech vs tradi� onal drugsBiotech drugs are giving a stiff competition to traditional drugs worldwide. “Biotech drugs are completely different from traditional drugs, which are small molecule drugs. These are complex drugs, large biological molecules that are normally produced by different manipulations such as protein engineering or cell culture and likewise. Biotech drugs are highly targeted, specifi c molecules and they have brought in a lot of changes in the way pharma industry looks at biotechnology today,” informs Sarita G Bhat, Associate Professor & Head, Department of Biotechnology, Cochin University of Science and Technology.

There are the various advantages of biotech drugs over their traditional counterparts. First, biotech drugs are specifi c in their task and are designed for very specifi c purposes. “The main reason behind the rise of biotech drugs over traditional drugs is that most of the biotech drugs are highly targeted towards a certain disease and thus providing better relief to the patients.


The power and strength of the biotech fi eld of applied sciences has slowly come to the forefront

and is being exploited fully today, especially in the Indian pharmaceu� cal market. Moving on

from tradi� onal drugs, Indian pharma companies are trying to capture the growing market of

biopharmaceu� cals.

Biosimilar drugs in India

The new torchbearers

Industry Update


While in case of traditional drugs, the mechanism of action is generally not properly understood or the spectrum is very wide where it kills the cancerous cells but it kills all the other cells around it too, so the effi cacy is not good and has nasty side-effects. They are targeted towards disease which in past were incurable,” says Dr Cyrus Karkaria, President - Biotechnology, Lupin Ltd. Also, biotech drugs or biopharmaceuticals enjoy a higher approval success rate compared to traditional small molecule drugs. The consequences of the possible failure of New Chemical Entities (NCEs) in late stages of clinical trials are devastating and are de-motivating factors in NCE research. “In terms of safety profi les too, biologicals have an advantage. Biotech drugs also have a far lower starting base, consequently the growth rates appear higher,” says Hitesh Gajaria, Executive Director-Tax, KPMG.

Biotech drugs have been commonly associated with landmark breakthroughs in new medical therapies to treat hepatitis B, hepatitis C, cancers, arthritis, haemophilia, bone fractures, multiple sclerosis, and cardiovascular disorders. “We feel it is more preventive than curative and the concept ofcuring disease from early stage of human cycle has been playing animportant role and its awareness is increasing constantly all over the world,” says Ambatti.

Moving with the biotech waveIndia has predominantly been a generic market and has not yet entered the drug development process. It is the biosimilars market that India has been investing and its through biosimilars that India has entered the biotech space partially. In the recent years, quite a few pharma companies are looking at the biotech space as their next obvious way ahead.

“The Government of India has approved the National Biotechnology Development Strategy. The government allocated $ 375 million for biotech R&D in 2009, which was around 30 per cent of the total budget allocation for this sector. Against this backdrop, and in the wake

of the approaching patent cliff and the weak pipelines of new drug molecules, biotechnology appears as a new avenue that can be explored,” believes Gajaria. If one looks at most of the new drugs that have been

approved in the last few years, they have come from the biotech side and thus the traditional pharma pipeline is drying out especially in the Indian context where there is a limited amount of generic drugs that can be produced or which are coming off-patent. “As important generic drugs pipeline and its dependability is reducing, to keep the momentum of growth pharma companies have no choice but to get on to the fast track in launching biotech drugs eventually in the next three or four years down the line,” believes Ambatti.

Besides, there are a lot of biosimilar drugs that are coming off-patent in the coming years and this makes a lot of business sense for pharma companies depending on what space they are looking at to collaborate with biotech companies. “By 2015 biotech drugs worth $ 80 billionin global sales are going to lose exclusivity and will be available for generics manufacturing, thus providing a huge opportunity for generic players. Major Indian companies have shown interest in this segment and have invested

Vijay Kumar Amba�

President & CEO, Clearsynth Labs (P) Ltd

We feel it is more preven� ve than cura� ve and the

concept of curing disease from early stage of human

cycle has been playing an important role and its

awareness is increasing constantly all over the world.

With advances in

genomic research and the concept of

personalised medica� on no longer a myth, most big

companies are likely to view this segment as the future

of therapy and hence are a� racted towards it.

Dr Cyrus Karkaria

President - Biotechnology, Lupin Ltd

Most Indian companies are in the biosimilar space

than the new drug discovery space and part of it is

because innova� on is s� ll not as well established as its

foreign counterparts.

Industry Update


in biosimilars. They are targetingboth semi-regulated and regulated markets, and are likely to establish a foothold in the space as has been witnessed in the generics market front,” says Gajaria. Pharma companies that can acquire these drugs will go off-patent and will be able tocapture a huge market. “Pharma companies that would acquire the new biosimilars would be able to havenew usage for the drugs, which will help to keep the prices stable, since some of the biotech drugs are extremely expensive and this can be avoided,” says Bhat. Biotech companies per say because of their size and innovative nature is much more nimble than what a big pharma will be so if they can take advantage of that situation of being a collaborative partner or research partner then it will largely benefi t them. “If there is collaboration then it gets developed faster, it is a long development process and the clinical development pathway is fairly tedious and expensive. So that itself means a small biotech company cannot perform it all on its own, it does not have the fi nancial muscle for it while a big pharma will have the fi nancial power but not the speed.

So collaboration is the best way forward for both the sectors,” believes Dr Karkaria. Striking a similar chord on the advantages of Indian companies, Bhat avers, “It is

the expertise that is available with the Indian biotech companies that is making most of the big pharma companies in partnering with them, it is economical expert labour that is available here.

With advances in genomic research and the concept of personalised medication no longer a myth, most big companies are likely to view this segment as the future

of therapy and hence will be attracted towards it.

Business models Pharma companies in India are looking at the biotech space as their natural progression and with the growth coming from the biotech fi eld the pharma companies see a lot of potential in this. This is usually done through collaboration of pharma with any biotech company and they would typically have a project-based collaboration. For example: Collaborate on a certain anti-body or a promising drug. Sometimes a company might be able to offer

a platform technology, which the big pharma company can utilise to speed up their own drug development. At times it would just be a people-service model. So these are some of the typical models, and there are certain complex models too where they invest in a company itself and then wait and see if that particular compound is going to be promising and then they just buy out the company.

“There are four basic models of collaboration, discovery sourcing in which the biotech company agrees to undertake discovery work for a mix of milestone payments and/or royalty/licensing fees, co-development in which the pharma company and biotech company develop a compound together, out-licensing with buyback options in which the biotech company out-licenses research programmes or compounds to the pharma company with a buyback right for the future and in-licensing in which the pharma company in-licenses a technology from the biotech company. Any of these approaches can be adopted by fi rms to promote and enhance biopharmaceutical research, manufacturing and marketing,” says Gajaria. For example, Pfi zer entered into an agreement with Biocon to commercialise globally the latter’s four biosimilar products in the insulin segment such as recombinant human insulin, glargine, aspart and lispro.

But the business models to be followed by any big biopharma company depends on the sort of expertise they have in-house and their fi nancial capacity. “Let us assumethat there is a mid-cap company which still does not have the fi nancial muscle but could actually take a drug all the way through the clinic, will probably have a marketing tie-up or royalty based tie-up with a big pharma company. Sometimes there will be a 50:50 collaboration where they share cost equally and

Recent biotech forays

Company From the year 2010 to 2011

Ranbaxy Acquired Biovel Lifesciences, thereby increasing its focus on vaccines.

Cadila Healthcare Acquired Etna Biotech to engage in vaccine research and development.

Glenmark Signed an out-licensing deal with Sanofi for developing and commercialising Glenmark’s anti-infl ammatory drug.

Pfi zer Signed a deal with Biocon to have exclusive rights to commercialise Biocon’s drugs globally with certain exceptions, such as Germany, India and Malaysia, where Biocon will have co-exclusive rights.

Quick Picks

It is the expertise that is available with the Indian biotech companies that is making most of the big pharma companies in partnering with them, it iseconomical expert labour that is available here.

Industry Update


the adoption of all these various business models depends on the size and the projections of the drug. Most basic business model would be a collaborative model betweenthe two companies and sometimes it is market base and thus the models vary from a developed market like the US to developing markets like India,” explains Dr Karkaria.

Globally, many biopharmaceutical companies have experienced fi nancial pressures exacerbated by the global recession. “However, these pressures provided the incentive for the industry to take a fresh look at the innovation process as a means to accelerate drug development and make it more cost-effective. Forsome larger companies, this hasled to a relaxed ‘guardianship’ of intellectual property, as evidenced by sharing of assays and compound libraries with government and academic research organisations, as well as with smaller biotech companies, in an effort to facilitate identifi cation of early drug candidates. Biopharmaceutical companies are thinking big and to achieve this, they have taken the route of forging partnerships either in R&D, marketing or in manufacturing even in revenue sharing of profi ts,” informs Ambatti.

India: Hub of biosimilarsIndian pharma majors foresee increasing demand for biosimilar drugs globally. Biosimilars are the generic version of patented biotechnology drugs and are estimated to reach a market size of around $ 78 billion by 2013. In FY 2010, the biotech industry recorded revenues of $ 3 billion with a year-on-year (y-o-y) growth of 23 per cent over FY 2009. Biopharma accounts for more than 60 per cent of the total revenue ($ 1.95 billion) - comprising vaccines, therapeutic drugs, insulin, animal biologicals, statins and diagnostics.

“Indian biopharma industry started quite recently compared to what it was in Europe or America but it is trying to catch up now. The biosimilar market is probably the biggest market in India and that is growing at a healthy growth rate of 20 per cent.

Most Indian companies are in the biosimilar space than the new drug discovery space and part of it is because innovation is still not as well established as its foreign counterparts. However, the scenario is now changing as there are a few smaller biotech companies that want to make a difference and have also got scientists from other countries working in their company,” says Dr Karkaria.

Although biotech-based drugs account for only a fi fth of global drugs sales they are projected to grow at double-digit rates as sales of many conventional drugs decline, especially with a large number of

patent expirations looming ahead. “Add the fact that many biotech drugs produce enormous profi ts and it is easy to see why the sector looks like a juicy target, we feel Indian companies are actively working on below areas and some of them may be at advance levels such as, human growth hormones, recombinant insulins and modifi ed recombinant insulins, rheumatoid arthritis treatments, etc,” says Ambatti.

Future trends The current scenario is still in a nascent stage in the Indian market due to complexities involved and risk averting nature of pharma company entrepreneurs. Also, unclear policies and procedures from regulatory authorities form one of the blocks for hindrances. But the “future is all about R&D, working collaboratively with companies in developing new drugs and bringing it to market fast,” says Ambatti.

Future trends of biopharmaceuticals look very promising. “In the last 25 years there has been a huge change of technology in the fi eld of biotechnology and a huge change in drug development and those trends seem to still continue because we tend to keep understanding the various models, the causes of disease so the future for pharma is biotech. And in the next fi ve years, India is going to be the top market for biosimilars,” believes Dr Karkaria. MPh

([email protected])

Biopharma accounts for more

than 60 per cent of the total revenue ($ 1.95 billion) -

comprising vaccines, therapeutic drugs,

insulin, animal biologicals, statins

and diagnostics.

Hitesh Gajaria

Executive Director-Tax, KPMG

Major Indian companies are targe� ng both semi-

regulated and regulated markets, and are likely to

establish a foothold in the space as has been witnessed

in the generics market front.

Spotlight


The competitiveness and the urge to be at par with its international counterparts is driving Indian pharmaceutical market to focus on

high standards of quality and value. Though the technology of cleanroom was invented almost a century ago, with increasing world exposure and growing demands, Indian pharma companies are incorporating such technologies in their processes. Cleanroom is all about maintaining hygiene and cleanliness for any scientifi c work and is applicable in the fi elds of agriculture, food processing, electronics

and healthcare. “Basically cleanroom is a room in which the concentration of aerial particles is controlled and which is constructed and used in a manner to minimise introduction, generation & retention of particles inside that room. Here, in addition to aerial particles, temperature, humidity (optional) and room pressure are controlled & monitored,” says M L Panse, CTO & Head, Business Development, Ashrae Clean Room Presentations Pvt Ltd. Cleanroom as a technology has come into spotlight in the emerging market of Indian pharma and biotech.

The implementation of cleanroom technology in pharma and biotech space

is crucial and ever expanding. “The manufacturing of pharma and biotech products requires the appropriate level of quality be designed and constructed into the facility and systems where the manufacturing process is carried out. The plant layout needs prior approval at the time of issuing manufacturing license,” informs Panse. As per World Health Organization (WHO) Good Manufacturing Practices (GMP) guidelines the principle function of cleanroom is to provide protection to :- Products being manufactured in cleanroom Operators involved in manufacturing Environment in which the facility is

functioningThe main purpose of WHO GMP guideline is to ensure Product safety Operator safety Environmental safety

By complying WHO GMP guidelines, cleanroom technology would help in managing any adverse events.

Cleanroom’s advent in IndiaThe advent of cleanroom technology was fi rst encountered almost 100 years back and is rooted in the control of infection in hospitals. The work of Pasteur & Koch established that bacteria are responsible for infection and its spreading, in hospitals, especially in operation theatres, and hence means to eliminate them were found out. Sir John Simon, renowned surgeon and health reformer, fi rst advocated use of directional fl ow of air for contamination removal. This method was quickly adopted by the pharma industry and results in the emergence of new discipline ‘cleanroom technology’.

In India, the scenario was grim three decades ago with limited number of suppliers

With a growing number of Indian biotech and pharma players entering the world market,

maintaining high quality standards and credibility of a product is becoming essen� al. More

compe� � on means Indian players have to be at par with their global counterparts. This is one

of the basic drivers for demand of cleanroom technology in India.

Cleanroom providers in India

Poised for growth


Court

esy:

Ahla

da

Engin

eers

Pvt

Ltd

Spotlight


undertaking the task of building cleanrooms. Generally, air conditioning contractors used to take up this job as a part of their total contract, but specialised and skilled personnel were seldom available and expertise was limited. But this condition changed owing to the rapid growth of pharma industry, which resulted in considerable growth of the cleanroom market in India. This demand will remain so, as more and more industries and R&D centres will have prime requirement for cleanroom technology in future. “It is very crucial and important in both the fi elds of biotech and pharmaceuticals to get the good quality of the product,” says B Ram Babu, Director, Business Development, Ahlada Engineers Pvt Ltd, and it is this assurance of quality that cleanroom technology helps to fulfi ll.

“Today, India has the highest number of US FDA-approved plants outside the US. This is mainly due to rapid growth of cleanroom technology in India,” believes Panse. In India the demand for ‘quality cleanroom service provider’ is huge and is ever increasing and there are various drivers behind the demand. “The demand for cleanroom providers in India is due to rapid growth of pharma industry, ever increasing stringency of drug regulatory authorities to bring Indian Drugs at par with international standards, and increasing quest of Indian pharma companies to be at par with their Western counterparts, increased export of pharma products and arrival of MNC in India to set up their manufacturing facilities,” says Panse.

In addition to pharma & biotech industry, other industrial sectors such as electronic &

semiconductor, food processing, automobile, nanotechnology, defence and other research institutes are opting for ‘cleanroom technology’ while designing their facilities.

Challenges ...Due to the explosion of information through the Internet and globalisation, customers have now become aware of the latest developments all around the world. Although in cleanroom technology they expect world class standards but they are not ready to pay the corresponding international price for it. “With increasing export of drugs, more manufacturers want their manufacturing facility accredited by international agencies like US FDA, UK MHRA and WHO GMP, etc but while

selecting cleanroom service providers, they usually look for economy without assessing competency of service providers. Indian drug regulatory authorities are also compelling small and medium scale pharma manufacturers to comply with the latest GMP guidelines and revised schedule while granting/renewing drug manufacturing license. This calls for setting up cleanroom facilities complying with the guidelines, set up by regulatory authorities in most cost-effective ways,” says Panse.

In short, the cleanroom service providers today face the challenge

of providing cleanrooms of international standards in a very economic way.

Innova� ons and future prospectsSome of the latest trends that have entered the market are:

Use of modular cleanroomsUse of isolator technologyUse of Building Management System (BMS), which complies 21 Code of Federal Regulations (CFR) Part 11Design of cleanrooms compatible to fully automated manufacturing process involving robots.

“One important aspect that needs to be seriously addressed is the economic viability of building high quality cleanrooms in terms of capital cost and operating cost. This would need detailed studies of the basic processes to be carried out, inside the cleanroom by specialised process consultants along with heating ventilation air conditioning (HVAC) design experts,” believes Panse.

The future of pharma and biotech companies depend upon the preparedness of these companies to be at par with Western companies in terms of quality of products and regulatory compliance while also being economical. And “…this can be achieved by partnering with an Indian quality conscious cleanroom service provider,” believes Panse. MPh

([email protected])

M L Panse

CTO & Head, Business Development, Ashrae Clean Room Presenta� ons Pvt Ltd

The demand for cleanroom providers in India is due to

the stringent drug regula� ons to bring India at par with

interna� onal standards, and increasing quest of Indian

companies to be at par with their Western counterparts.

B Ram Babu

Director, Business Development, Ahlada Engineers Pvt Ltd

It is very crucial and important in both the fi elds of

biotechnology and pharmaceu� cals to get the good

quality of the product.

Technology at a glance

Interface


What is your recently launched Ready-to-Plug Buildings (RPB) all about? Ready to plug buildings as the name suggests means external construction, internal infrastructure, viz, modular internal construction, HVAC, MEP. Providing building infrastructure wherein the client brings in the equipment and plug & play. RPB has many advantages since occasionally there are project delays due to coordination

hassles. Due to this, project managers may also miss out on important events, and hence this offering is a tribute to all the project personnel.

How many projects do you have in hand?Currently, we have the following projects on RPB basis:

Celon Laboratories Ltd, Hyderabad.

This includes HPF, onco block, admin, utility and guest house buildings. It is spread over a built up area of about 1,60,000 sq ft. The project value is approximately ` 500 million.

Arusha, Tanzania: This involves revamping of the oral solid formulations through a European project company. This project is fi nancial aid provided by the European Union to the Tanzanian Government.

It is complete turnkey project that involves modular partitions, HVAC, process equipment, electricals, utilities, fl ooring, etc. Arusha is complete turnkey project valued at EURO 2.8 million. Asia Labs, Syria: This is a biotech facility. Asia is complete turnkey less electrical. The project value is $ 4 million. Both international projects

are with process and packaging equipment as well.

How is RPB diff erent from turnkey applica� ons? Turnkey contracts include production and packaging machineries as well. One may also term RPB as a turnkey building. However, in RPB the clients have to specify their process defi nitions and then depending on their requirements we offer them buildings where they have to just connect the equipment and start manufacturing. This saves a lot of time for them. However, just before that after being briefed by the clients, we sort the drawings for execution from the client or their consultants.

Who will be your target audience? Since the life sciences industry is highly unorganised, we are targeting the main parts in the chain. And this would include consultants and users in sectors such as pharma, biotech, healthcare, food, etc.

How cost eff ec� ve will this turn out to be for your clients? There is both a direct and indirect cost saving involved.

Direct saving: Fabtech has in-house solutions in all disciplines; hence we become a single point of contact for all services including designs. Our network has several consultants whom we coordinate with. This saves time, overheads and separate consultancy charges.

Since we have all these services handy, a better cost-effective solution is extended to the client. Besides, Fabtech has added advantage of specialised construction technique (Plaswall and Plasmolite), which

...says Aasif Khan, Managing Director, Fabtech Technologies Interna� onal Pvt Ltd. From turnkey

applica� ons to ready-to-plug buildings, Fabtech has garnered exper� se and technical experience in

doing things by saving � me and yet being cost eff ec� ve. Khan elaborates on the advantages of ready

to plug buildings for its pharma and healthcare clients and his strategy to target other ver� cals.

‘We are targe� ng consultants and end users in pharma,

biotech, healthcare, life sciences and food segment’

Arshia Khan

Companies globally have

been facing the challenge

of skilled labour, which has

become severe with � me.

Now investors are looking for

be� er technologies, which

are sound, solid, faster,

provide good aesthe� cs, cost

eff ec� ve, etc.

Interface


are cost effective in terms of dead loads, offering a better quality and faster delivery, and help in saving structure cost.

Indirect saving: Our single point approach helps save time signifi cantly (almost 30 per cent less than the regular conventional way). This results in early production and Return on Investment (RoI). Most importantly, pharma companies are in the business of producing and selling drugs, which is their core focus. However, setting up of pharma projects, if left on to the experts, would help these companies focus on their core competence. As a matter of fact we have seen many owners, companies struggling with technical issues and thus losing focus of their main business.

What will a� ract your pharma and life sciences clients to opt for RPB over turnkey applica� ons? A simple solution and reduced co-ordination hassles would pull in more clients for us. We have a well established network of manufacturers and consultants who work together as a team.

What were the challenges faced while installing RPB? More or less most project managers and owners face the same technical challenges. The most frequent ones being project delays, lack of co-ordination and over heads. While with our innovative RPB solutions we offer a perfect blend of novel ideas and simple execution approach.

Tell us about the interna� onal market for Plaswall

and . Companies globally have been facing the challenge of skilled labour, which has become severe with time. Now investors are looking for better technologies, which are sound, solid, faster, provide good aesthetics, crack-free, seepage-free, termite-resistant, less labour oriented, light weight and overall cost effective. Our products fi t into all listed advantages.

Combination of Plasmolite and Plaswall are mostly welcomed everywhere. We found that there is lot demand in developing African countries and gulf countries and are handling many enquiries particularly from Tanzania, Nigeria, Angola, Mozambique, South Africa, Benin, DRC, UAE, Saudi Arabia, Qatar, Bahrain, Syria, Jordan, Egypt, Georgia, etc, among others.Main advantages of Plaswall and Plasmolite are: Less thickness of wall comparative to block and brick work

(Saving in space planning) Less dead load on structure due to light weight and less thickness Structure can be completed in time; 30 per cent to 60 per cent less

time than conventional construction Better fi nish Crack-free Seepage-free Better termite resistance No curing time required Walls ready to paint MPh

([email protected])

Market Scope


Parita Dholakia

Drug/medical device combina� on is taking healthcare to the zenith of health and success.

Industry experts predict that technology convergence is the new business model for growth

and profi tability. Some of these products use state-of-the-art and up-to-date technologies

and new rules, and bring in much more than the current scien� fi c trend has seen, thus

challenging exis� ng science and regulatory knowledge.

Market Scope


Market Scope


The pharmaceuticals, medical devices and biologics industry all over the world are struggling with patent expirations,

competition from generics, various litigations and so on. In such a scenario, combination products could be one of the ways to maintain a healthy balance sheet.

Combination products include combination of a drug, device or biological products incorporate cutting-edge novel technologies hold great promise for improved patient care. Several sectors have already seen the benefi ts of such products, and the current worldwide market is predicted to be at $ 9.5 billion. The combination product market is generally seen as an area with high growth potential and greater profi t margins while providing signifi cant positive benefi ts to patients. For example, pharmaceuticals facing patent expirations can get a new life if paired with a device as a combination product, thereby providing some relief to the industry. This convergence technology holds promises. Agrees Dr Robert Langer, David H Koch Institute Professor, Massachusetts Institute of Technology, “There is a rise seen in convergent technology and it is driven by both scientifi c and economic trends. Scientifi c research is leading to the generation of new, cross-disciplinary alliances.” Thus, it is the right method and time to play the old game with new rules.

Frui� ul venture During the past few years, the Food and Drug Administration (FDA) has revised and revisited several of the regulatory norms associated with combination products. With the continued evolvement of the fi eld, and the impact these products will have on the industry and society, it would become nothing short of a norm for pharma companies to be involved in the development of these products.

The use of single drug or device products is considered favourable by certain experts. There are certain

World Health Organization (WHO)-approved drugs for certain therapeutic treatments, and generally, people will continue using the same drug for the same treatment. However, over a period of time, drug resistance may develop and more effi cacy is observed with the use of combination. Under such circumstances, combining a drug and drug or using an approved drug with a different delivery system (ie, device) is worth the effort. Combination of drugs and devices not only gives better effi cacy, it also helps in reducing the time of action, and hence, treatment. In the words of Dr Rembert Pogge von Strandmann, Director - Clinical & Regulatory Department, Scientifi c PR, Eurocor GmbH, wholly owned subsidiary of Opto Circuits (India) Ltd, these products look fruitful and not futile, “Bringing the best from two worlds into one treatment option. is the biggest advantage of combination products. In most of our products pharmaceutical action is combined with mechanical labour.”

Development hurdles The convergence of genomics, diagnostics and therapies will lead inevitably to more personalised medicine, but many hurdles—scientifi c, regulatory, fi nancial and social—must be overcome. The development and marketing of a combination product is extremely diffi cult. Says, Dr von Strandmann, “Regulatory approvals and identifying target markets are some of the challenges commonly faced by developers of combination devices. The development of the product itself is a challenge. In the case of Eurocor, for our Drug-Eluting Balloon (DEB), we needed the balloon to elute the drug only at the site of deployment. We designed an innovative method for balloon catheter drug delivery with high patient compliance. Our DEBs have nearly no washout effects.” He further adds, “The production of combination products under Good Manufacturing Practice (GMP) is a challenge and the current approach using tight control and audits

Dr Robert Langer

David H Koch Ins� tute Professor, Massachuse� s Ins� tute of Technology

Combina� on products will not be a key to survival,

but yes, it would be one important branch where

companies would like to invest.

A product comprised of two or more regulated components; ie, drug/device, biologic/device, drug/biologic or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity.

Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products or biological and drug products.

A drug, device or biological product packaged separately that according to its investigational plan or proposed labelling is intended for use only with an approved individually specifi ed drug, device or biological product where both are required to achieve the intended use, indication or effect and where upon approval of the proposed product the labelling of the approved product would need to be changed. For a device drug/combination, option 3 would mean that the device label says, ‘for use with drug x for intended use y,’ and the drug label says, ‘for use with device a for intended use y.’

As defi ned in 21 CFR Part 3, the term ‘Combina� on products’ includes the following...

Market Scope


makes it more diffi cult.” The potential success of combination products has not eluded the medical device companies. Many of them are amplifying their efforts to improve upon existing medical devices and use new technologies to solve problems that limit physicians’ ability to treat patients. Medical device companies need an avenue to get drugs into their process and while pharma is still focussed on developing and selling drugs on their own, pharmaceutical companies should be ready for medical device companies to come knocking on their door. As Dr Langer says, “For pharma companies, it might be good to have a few combination products in the portfolio, but one needs to know the drug thoroughly to develop anything related to it.” The biggest challenge to manufacture combination products is the collaboration between drug and device companies. Limited number

of device or drug manufacturers have the organisational and technological expertise to develop, manufacture and launch a combination product in the market especially among the Indian players. The collaboration is diffi cult because of the differences in target customers, business models, practices and organisational structure. Further, adds Priyanka Shah, Analyst – Medical Equipment Division, GlobalData, “A key challenge is adherence of combination products to the required standards. Drug manufacturers follow current GMP (cGMP) and medical device manufacturers follow quality system but combination product must fulfi ll both set of rules. Also, the sterilisation and packaging procedures for combination products are completely different from those of individual drugs and devices. All these hurdles make it diffi cult for Indian pharma companies to enter the

combination products market.” With the rapid growth of the combination products market, it is expected that the regulatory authorities will also come up with stringent and transparent set of laws to review these products before launch.

Rigorous regula� onsOnce launched these combination products ensure signifi cant revenues for the pharma companies due to improved patient compliance. Clinical studies have proved that combination products result in fewer side effects and toxicity in patients and have higher rate of safety and effi ciency compared to the individual drug and device. This results in increased patient compliance and increased revenues for the companies.

Clinical trials of drug delivery devices, with a new drug (or new drug administration route or new formulation) in the US would usually be conducted under the Investigational New Drug (IND) requirements. Drugs studied under IND require drug GMP (21 CFR parts 210-211) for fi nished product. The only exception to drug GMP is the expiration date requirement, from which investigational drugs are exempted.

In the US, until more explicit FDA interpretations are available which preclude this approach, the investigational device components made for an investigational combination product are regulated by the Investigational Device Exemption (IDE) requirements. These requirements are detailed at 21 CFR 812, and exempt makers of investigational devices from most of the device GMP (21 CFR 820), with the exception of the design control segment at 21 CFR 820.30. In India, there are no properly defi ned regulations for combination products by the state or central authorities nor are there any specifi c regulations in India to evaluate the safety profi le of combination products. Combination products involving medical devices are regulated in India by Central Drugs Standard Control Organization (CDSCO) under

Dr Rembert Pogge von Strandmann

Director - Clinical & Regulatory Department, Scien� fi c PR, Eurocor GmbH, wholly owned subsidiary of Opto Circuits (India) Ltd

Bringing the best from two worlds into one treatment

op� on is the biggest advantage of combina� on

products. In most of our products pharmaceu� cal

ac� on is combined with mechanical labour.

Source: GlobalData

In India, there are no specifi c rules for the regulation of combination products; however the rules regarding development and sale of Drug Eluting Stents (DES) in India are clearly defi ned.

The offi ce of the Drug Controller General of India (DCGI) has recognised Sree Chitra Thirunal Institute for Medical Sciences & Technology, Trivandrum to test the quality of DES marketed in India. Regarding this, all the Port Offi ces in India are to draw and send one sample (comprising 3 stents) of each manufacturer from among the imported consignments of DES, for test and analysis.

In case of import registration of DES, at least 1,000 DES should have been sold in India prior to 1/3/2006.

If a manufacturer’s stents are already available outside India and the manufacturer is planning to introduce them in India, then a six months clinical trial has to be performed on at least 100 patients in India.

In case of a new stent, not available anywhere globally, 12 months clinical trials has to be performed on at least on 100 patients in India.

India: Pathway a combina� on product follows

Market Scope


the Drugs and Cosmetics Act and Rules.In the US, as single-entity products,

drugs are generally regulated by the Center for Drug Evaluation and Research (CDER), devices by the Center for Devices and Radiological Health (CDRH) and biologics by the Center for Biologics Evaluation and Research (CBER). In recent years, technological advances have led to a blurring of the historical lines of separation between the centres. Hence, there are several grey areas. However, with the increasing development and use of combination products, FDA has established and maintained several regulations for further clarity.

India taking the baitSeveral experts in the pharma industry are skeptical to invest in R&D, before gaining suffi cient profi tability. Believes Shah, “Currently, the combination products market in India is undergoing revolutionary changes. Many local players are entering the combination products market either to have a competitive edge, to increase their market share or for survival. Indian pharmaceutical giant Cipla launched ZOLMIST in 2010 in India, which is a drug-device combination in nasal form for the treatment of migraine. Eurocor GmbH, the wholly owned subsidiary of Opto Circuits (India) Ltd launched the MAGICAL drug-eluting stent system in India in February 2011.” For such, the idea of combining approved drugs seems rational. With approved drugs, the chance of failure minimises, unless one needs to use one category of drug for some other functional use while in combination. For example, one can use an anti-malarial drug for treating typhoid, but new trials and approvals are required. But with combination of drugs, the chances of success are higher than testing a random candidate and only if the revenue gained are on the higher side, companies would manufacture combination products. With respect to combinations using medical devices, these devices are not regulated by patent laws as stringent as drugs. Most medical device companies do not have the expertise to develop their

own drugs for developing combination products, so many are either partnering with pharmaceutical fi rms or hiring pharma experts. In India, only 12 medical devices are notifi ed, which are regulated (copper T, hypodermic needle, syringes, etc). Though the government may introduce an exclusive provision for medical devices in the near future, but as of today, these devices are approved by the Drug Controller General of India (DCGI) similar to drugs. Some of these are approved by the central government. But by far, in India, drug/drug or drug/biologicals combinations are approved. Combination using medical devices (stents, microchips) have their origin in the Western countries.

Further, in our country, drug-eluting stents contribute majorly to the total production and usage of combination products. Asserts Shah, “Rapidly increasing population and high incidence of cardiac diseases in India provides substantial opportunity not only for the local players but also for the world’s biggest pharmaceutical and medical device companies. There are about 80 million people suffering from cardiovascular diseases in India. In February 2011, Boston Scientifi c began the sale of its Promus Element Everolimus-eluting coronary stent and its Taxus Element Paclitaxel-eluting coronary stent in India. It is estimated that more than 1,50,000 drug-eluting stents are sold in India annually.”

Playing the game with new rulesIt might be too early to predict whether convergence technology would result in contributing the major part of the products available in the market. But it

defi nitely would and has led to the rise of a new genre of products available on the shelf. As Shah stresses, “One of the major benefi ts for companies manufacturing combination products is that these products are innovative ways to extend the lifecycle of their existing individual products. Most of the medical device and pharma companies start losing revenues once their products go off patent. If they are able to develop a combination product with their existing products then the company can fi le for a new patent as the combination product will be treated as a novel and innovative entity with enhanced usage.” But will it be a key to survival? Avers Dr Langer, “Combination products will not be a key to survival, but yes, it would be one important branch where companies would like to invest.” Pharma companies will like to look into playing this game with new rules, for as long as their profi t charts are ringing. In the near future, technologies such as nanotechnology will be used to develop combination products. Products such as nanoparticles coated with antibodies that bind to cancer cells are expected to come up. Researchers are also trying to develop miniscule particles that can travel through the body to detect and cure disease, self-replicating and self-assembling products for treatment of chronic diseases and artifi cial brain cell implants for Alzheimer’s disease. Given the transformation in medical practice promised by using these new rules and the opportunities for economic growth, now is the time for a major research effort in the fi eld. It would be well worth the investment. MPh

([email protected])

Priyanka Shah

Analyst – Medical Equipment Division, GlobalData

Many local players are entering the combina� on

products market either to have a compe� � ve edge, to

increase their market share or for survival.

Market Trends


Clinical trials play a key role in the pharma industry. Traditionally, pharma companies have been relying

on paper-based processes for recording patient data during clinical trials. But over the last decade, the pharma industry has been under tremendous pressure to improve the pipeline and enhance the quality of decision-making during clinical trials. Clearly, paper-based processes have serious limitations in terms of information availability and the speed of access to clinical trial data.

With advances in technology and communication, the shift to automation was inevitable and this was the genesis of EDC systems. An EDC system is fundamentally a computerised system used for the collection of clinical trial data in electronic format.

Decoding EDCThe ever intensifying competition and shrinking profi t margins have compelled life science organisations to think of ways to accelerate their drug development process so as to decrease the costs and more importantly time-to-market. Commenting on the utility of EDC, Ashit Panjwani, Executive

Director – Sales, Marketing & Alliances, SAS Institute (India) Pvt Ltd, discusses, “In the conventional paper-based trials nearly 25 per cent of the effort in the clinical development process is devoted to the patient encounter, including the collection of visit data and the subsequent cleaning of that patient data. EDC streamlines the data collection process thereby accelerating the availability, discrepancy resolution and the entire data management process. It also improves the quality of the clinical data and signifi cantly brings down the cost.”

Productivity is a key enabler of competitive advantage in the biopharma industry. Clinical data is the corporate asset providing evidence that their products are effective and safe. And how a company uses this effective technology to manage this vital asset determines its speed to market, and consequently its competitive edge.

Ilango Ramanujam, Vice President - Clinical Data Operations, TAKE Solutions, says, “EDC involves collecting clinical trial data in a way that it can be delivered to the sponsor or Clinical Research Organisation (CRO) in electronic form instead of paper. Its use has grown in recent years. This has not only eased the burden of paper work, but also made the process faster, cheaper and a lot less stressful.” He adds when used along with Clinical Data Management (CDM) systems, it also guarantees the quality and integrity of the data collected and the authenticity of the inferences made. He continues,

Chandreyee Bhaumik

With � me, companies are increasingly leveraging EDC and other tools to power global trials

and benefi t from the ability to analyse incoming data and performance metrics in real � me.

However, even with such development a more tech-fl uent user base demanding rich features,

ease of use and fl exibility with trial se� ngs is required.

Electronic data capture (EDC)

Exploring the eff ec� ve and effi cient

Market Trends


“Regulatory compliance processes for sponsor companies and CROs therefore become a lot simpler with use of such effective EDC technologies. By addressing the automation of digital data capture processes, it also sets the stage for superior collaboration, standardisation and innovation in the industry in general.”

Key highlights of EDC systems: Provide automated functionalities for data collection, reporting, query resolution, randomisation, and validation, among other features, for clinical trials Give organisations real-time access to the performance of the study medication being administered to volunteers/patientsEnhance the quality of the trial and the timeliness of completion (reducing budget over-heads)Help check any untoward occurrences with the study drug and monitor patient safety in real time Are compliant with data privacy and regulatory requirements, including 21 CFR Part 11 and Health Insurance Portability and Accountability Act (HIPAA), to protect the integrity of a clinical investigation.

Thus, with time EDC has emerged as a preferred method of capturing human trials data within life science organisations.

IT mantraThere are more than 60 EDC vendors in the market today, and the market is still evolving. According to J Sairamkumar, Vice President, Life Sciences Practice, Cognizant, Oracle (Oracle Clinical /Remote Data Capture), Oracle-Phase Forward (InForm) and Medidata (RAVE) are the leading product vendors in this space. He says, “Some of the other providers of EDC solutions include SAS, Unithink, Data Trial, DSG, eTrials, Octagon Research, Logos technologies, OpenCLinica (Open Source Solution), and Nextrials.” Further, Panjwani affi rms, “With industry leading technology and as leaders in this fi eld, we are committed

towards providing solutions with advanced analytics capabilities to our customers and prospects.”

Posi� oning IndiaThe US and other Western economies have been on the cutting edge of EDC technology adoption. Reports suggest that by 2012, around 60 per cent of all clinical trials (around 75-80 in new therapeutic areas) will be EDC-based in the US alone. According to Oracle Health Sciences Touch Briefi ngs, the spending on EDC solutions alone is estimated to exceed $ 3 billion by 2011, an estimated 15 per cent growth over that in 2007.

Panjwani says, “EDC market is in a high maturity stage in the US and most of the other developed countries, and it is extensively being used across phase I-IV clinical trials. “Even in India, the acceptance of EDC is rapidly increasing and it is soon expected to become a norm. Most of the leading

life science organisations have already adopted or are adopting EDC especially for the large global trials.”

Discussing the Indian scenario, Sairamkumar shares, “‘Pharmerging’ economies (emerging markets targeted by pharma companies), such as India, are witnessing high growth with signifi cant investments in R&D. Multinational pharma companies are striving to build clinical development capabilities within their local operating companies in India, and the country’s nascent CRO industry is enjoying healthy annual growth rate.” He continues that EDC adoption has been high among multinationals and large pharma companies in India. However, price sensitivity and the lack of communication infrastructure continue to impede the full adoption of EDC in India.

The growing number of technology solutions is fuelled by a rising interest among research centres or

Ashit Panjwani

Execu� ve Director – Sales, Marke� ng & Alliances, SAS Ins� tute (India) Pvt Ltd

In the conven� onal paper-based trials nearly 25 per cent of

the eff ort in the clinical development process is devoted to

the pa� ent encounter, including the collec� on of visit data

and the subsequent cleaning of that pa� ent data.

Study design and management

Study data defi nition

Conduct and validation

Data access and reports

CRF designEdit

check specs

Database design

Entry screen design

Data entrySAS

datasets

ViewsAnnotation Database design specs

Medical coding setup

Validation programming

Discrepancy Management

Quality review

Query management

CodingStudy scenario

• Study scenario created• CRF was designed• CRF annotated• Data design specs created• Edit specs document

• Data base designed• Edit checks programmed• Tested• Moved to production for

data entry

• 1st and 2nd pass data entry• EDC entry• Batch validation• Discrepancies• TMS in progress

were queried

• Data export

Source: Ilango Ramanujam

Market Trends


organisations, including sponsors, contract research organisations and investigational sites. Ramanujam says, “In the US and other developed countries the penetration of EDC systems is deep, end users are well advanced and profi cient in handling these systems. Further, developed value chains for conducting clinical trials, sound infrastructure and technology adoption have largely contributed for modernised clinical development.” He further adds, “India offers prodigious opportunity in this space but the full potential of EDC is to be realised by the majority of clinical development organisations, and it is clear that India is still further away from achieving this potential than the US or other developed countries.”

India has some fundamental challenges alongside the developed countries, with respect to acquaintance of EDC systems at the trail sites. Ramanujam continues, “Most Indian trial sites have infrastructural challenges and this poses issues to the sponsors who will increase the costs towards infrastructure grants. Thus, due to increased pressures by the sponsors, more trials in India are

moving towards EDC-based studies.” There are specifi c reasons that India is falling behind the West in terms of EDC implementations. Ramanujam cites factors such as lack of perceived Return on Investment (ROI), concerns with changing current processes, lack of interoperability with other systems, resistance from investigator sites and many others as the reasons for the difference.

Framing the advantagesThe scope of data capture, Case Report Form (CRF) design and CDM processes widely varies across companies. EDC has always benefi tted them in terms of speed, integrity, productivity and cost. And importantly the process of adoption frequently is not that of a ‘big-bang’ approach. However, most arguments for not adopting an EDC system originate from the perceived risk of operational disconnects in such a mixed environment, especially where paper-based health records are involved. Clearly, the solution to address this perception lies in having a consistent defi nition, data management processes and standards to enable objective evaluation of effi cacy

and safety in such an environment. According to Ramanujam, the use of EDC has affected signifi cant business processes in EDC-based clinical trials offer operational and cost-effective approaches for ongoing data entry via the Internet from clinical sites; medical monitoring; monitoring by Clinical Research Associates (CRAs), including initial review of data from their laptops and then performing source document verifi cation at the study site; identifi cation of potential errors by data management; and determination of the status of the clinical trial by project management. He adds, “Dynamic data validation queries in EDC provides an unique advantage of ensuring quality data during the data entry level, dramatic drop in the types of data errors found in paper-based CRF studies, such as out-of-range values or missing data that reduces time for data cleaning.”

EDC system modernises data collection process ultimately helping speedup the obtainability, inconsistency resolving and the entire data management process. Further, citing the pros Panjwani says, “EDC enables reduction in the trial duration by accelerating clinical trial start-up, data capture and discrepancy resolution. It improves the quality of data by reduction in the data errors. And it also provides immediate visibility of data leading to a much better control over the project. Additionally, it leads to signifi cant reduction in the overall cost.” Seconding the above thoughts, Sairamkumar opines, “EDC brings better and more proactive project management resulting in a better conducted and more effi cient trial and there is cost savings to the tune of approximately 30-40 per cent.”

The fl ip sideInitial implementation and maintenance investments deter organisations from adopting a full-fl edged EDC solution. Discussing this Sairamkumar says, “The ROI may not be fully justifi ed for small trials and

Ilango Ramanujam

Vice President - Clinical Data Opera� ons, TAKE Solu� ons

The poten� al lack of ‘24/7’ helpdesk support, as

well as lack of pa� ent training, can create issues for

pa� ents using e-diaries at home. Addi� onal issues

can crop up with mul� ple language e-diaries.

Study set up: Rapid creation of studies on the CDMS to match protocol specifi c data capture needs

Study data defi nition: Speedy creation of eCRF- data capture points, for the study, this module also help in setting up data point validation rules to ensure clean data entry

Study conduct: Supports data entry either remotely by Trial sites or by the in-house data entry personnel

Data extracts: Extracting the data from the CDMS to facilitate data analysis and interpretations by Biometrics to foster analysis

Clinical data management system has diff erent func� onal modules


Market Trends


for organisations that have a small volume of trials.” Further, training is one of the biggest stumbling blocks for EDC usage. There still appears to be an overall lack, perceived or otherwise, of suffi cient EDC education or training for site personnel. Elaborating on this Ramanujam explains, “There are too many individual EDC programmes for site personnel, especially those working on multiple studies for multiple clients. Discussing the cost factor he says that the upfront cost and set-up time for EDC are huge, especially for smaller studies. He adds, “The potential lack of ‘24/7’ helpdesk support, as well as lack of patient training, can create issues for patients using e-diaries at home. Additional issues can crop up with multiple language e-diaries.

There remains a lack of technology and infrastructure at certain sites throughout the world.”

Upgrading the exis� ngEDC is a fairly specialised solution that needs to be compliant with regulatory requirements such as 21 CFR Part 11. Sairamkumar says, “These are validated systems and need to be

hosted and maintained in a controlled environment with appropriate controls. The technology usually is a web-based front-end with a robust database. The EDC solution needs to cater to some sophisticated functionality of a fl exible study build, data management and data closure. Large EDC trials can have thousands of users using the system and hence system performance and usability need to be optimal and scalable.”

To derive the maximum benefi tfrom EDC, it needs to be upgraded and integrated with the other parts of the core clinical development process, such as data management, trial management and safety. Technology set up for most EDC systems include a hardware topology to match global network and accessibility needs and ensuring data security is one of the important business requirement, considering the current trends in eClinical space. More and more trials are getting globalised. Therefore, the key elements for EDC deployment and access to the systems need to be 24*7 with effi cient support helpdesks that can work round the clock. As Ramanujam says, “With major companies like Oracle coming out with life sciences-specifi c commercial off the shelf products, which meets international standards and are continuously evolved based on industry feedback, companies are looking out to leverage on these products that has scalable architecture, are performance tested and provide guaranteed support with enhancements.” MPh

([email protected])

J Sairamkumar

Vice President, Life Sciences Prac� ce, Cognizant

Mul� na� onal pharma companies are striving to build

clinical development capabili� es within their local

opera� ng companies in India, and the country’s nascent

CRO industry is enjoying healthy annual growth rate.

Incremental infrastructure needs with EDC goes beyond the already challenging procedures for paper studies.

Surrogate users are the site level at the point of data entry still pose some challenges, therefore there is a need for training at the site level.

Regulatory compliance requirements and protocol instructions where trial sites will need to have electronic signature procedures and forms and ongoing training in the EDC application. They must also be trained in appropriate (21 CFR 11) procedures for using the system and maintaining their accounts. They will also need passwords and password resets (at least until we use biometric identifi ers more widely).

EDC studies must be supported by a well-staffed help desk that can provide the technical support and direct callers to someone to answer clinical questions. Not only must the site staff be trained and supported, site computers must be qualifi ed; EDC vendors must verify that the site can actually use the EDC system and make a reliable connection.

Increased costs for the sponsors to provide equipment and resources at the site, or forgo the patients that the site might be able to enroll.

Handling interim changes in the study protocol, changes are needed in an EDC application; it is a more serious undertaking. Any change must be made carefully and it is immediately available to all sites when it is moved into production

Training or notifi cation is needed for the changes; all the sites must be prepared before the change is made available.

When an EDC study runs long enough for there to be an upgrade to the actual EDC system software, the impact is again to all the sites. Sponsors report that despite careful planning, upgrades and associated data migration have sometimes led to (recoverable but annoying) data losses and signifi cant down-time for the sites.

Data Security often poses an important loophole, therefore, industry standard data security model should be considered during deployment.

Loopholes of EDC


Interface


You ini� ated the se� ng up of Eli Lilly in-house clinical research management team in India in

1993, what made you leave that and start DiagnoSearch?Eli Lilly was a great organisation to work for and helped me extensively in achieving huge goals in a short period of time. My association with Eli Lilly began in 1993 and had the opportunity of initiate the in-house clinical research management team of Eli Lilly in India. The idea of becoming

an entrepreneur and setting up my own Clinical Research Organisation (CRO) company generated in 1994, when I visited a central laboratory, which Lilly was outsourcing to in

the US. It was then, that the idea of establishing my own lab in India took form, the set up and functionality of the laboratory was top notch. It got my attention to such an extent that establishing my own company was all I dreamt about. Looking back in time, I realised how naïve the thought was, but it was probably the fi rst thought of starting a CRO in India.

When I decided to take the plunge; central laboratory was to become the fi rst service offering of DiagnoSearch. The dream of creating an Indian global CRO was impossible to resist. The urge to give shape to my dream was the sole reason behind leaving Eli Lilly. Hence, DiagnoSearch came into being in 1995 and since then all the time and effort has been dedicated to the company.

How has the journey been with DiagnoSearch so far? Tell us about the challenges.The journey with DiagnoSearch over the past 15 years has been exciting to say the least. DiagnoSearch Life Sciences was founded in 1995 and since then we have been providers of clinical trials management services in India. We initially began as a central laboratory and quickly expanded and became a full-service contract research organisation focusing exclusively on ICH-GCP clinical trials. DiagnoSearch Life Sciences provided a full range of clinical trials management services including clinical monitoring clinical data management and central laboratory services. In the period from 1996 to 2003, we have conducted numerous clinical trials which contributed

…says Dr Vasudeo Ginde, Founder and Managing Director, DiagnoSearch Life Sciences Pvt Ltd. He

founded DiagnoSearch as one of the fi rst contract research organisa� ons in India. He is a physician

by training and over the past 15 years has taken DiagnoSearch to a full service CRO providing clinical

opera� ons company with more than 150 clinical trials for global pharmaceu� cal/ biotechnology clients.

He discussed the evolu� on of Indian CROs and challenges that lie ahead while shedding light on how

DiagnoSearch has evolved as a global CRO.

‘The infl ow of clinical trials has reduced

substan� ally and there is a feeling of

uncertainty in the market place’

Jasleen Kaur Batra

Clinical research in India will

bring in a lot of value to the

country much beyond what

small profi ts CRO may make.

On the other hand, not

being part of new drug

research will only take India

back a few years in terms of

standard of care.

Interface


to global data submissions. In October 2003 we were acquired by iGATE Corporation to anchor its life sciences division with the vision to extend the unique advantages of India to the clinical research and development market.

In April 2008, I exercised my power to buy-back iGATE Clinical Research International and re-established the company all over again. Today, we are ranked as one of the leading CROsin India and have received international recognition by the pharmaceutical industry for excellence in clinical trials management.

The initial years in any set up are the most crucial ones. The outsourced contract research market was almost non-existent at the time of our inception; there were barely a few pharmaceutical companies who practiced Good Clinical Practice (GCP) in India. Most of the work by these companies was performed in-house and very little was outsourced. Setting up a CRO in India was a challenging task. During our inception there was scarcity of ready-made trained human capital, neither clinical research professionals nor the pool of investigators were available for help. Another hurdle in our journey was being an Indian CRO we had to prove our authenticity and quality to every client. Delivering high quality trial for one client was not enough, the next client always wanted to start all over again, which was an extremely tedious task.

In the early years the outsourcing decisions were largely based on competence. But as India approached 2005 things started to turn. One required creating infrastructure and scale along with competence. This was driven by rapidly changing global standards. With paucity of talent, scaling up was a challenge in early years. Unfortunately, clinical research cannot be learnt in

classrooms. In 2005, we also witnessed a great hype regarding clinical research, which resulted in a number of business houses with deep pocket venturing into CROs without realising the intricacies of the industry. Setting up a CRO was perceived to be easy and quick money. This mushrooming of CROs without proper understanding was the biggest challenge. But overall, we as a team strived to rise above all the hurdles that came our way and today it feels good to be where we are.

What is your business model? How has been the growth of your company over the years?DiagnoSearch business model is largely to stay within our area of competence and achieve excellence within that. We are a full service

CRO with clinical operations, data management, bio-statistics, central laboratory, medical consulting and pharmaco-vigilance and central pharmacy services. Even the last of the service has over seven years of history and experience. Our focus has always been quality of delivery rather than driving volumes. We value profi ts as much as anyone else, but there are certain things we value more than profi ts. Quality and reputation is of supreme importance to us. Hence, when we decided to expand in Mexico and South Korea, we chose the diffi cult

path of doing it ourselves (and not by strategic alliances) because we want to control quality at every step. We were aware that we would encounter a number of problems and the process would be slow but we were ready to undertake that risk, just to maintain our quality standards. We have grown considerably in the last 5-6 years though we did nothave a great last year. We faced the same challenges as the entire industry but we are slowly and surely coming out of it.

The Indian regulatory authori� es are considered to be stringent in terms of giving approvals etc, is this in any way hampering the growth of CROs in India?I strongly feel the regulatory strictness is contributing a right step in right direction. Strict controls are required as the industry as a whole deals with the human life. The controls in fact should be extended to investigator doctors and every stakeholder as well. Once these controls are in place, the industry will show a fi rm, positive growth as transparency of conduct and accountability at every step is indeed the need of the hour.

How important is it to have a public private partnership (PPP) model for CRO?A PPP model is more appropriate for drug discovery initiatives. A large part of new drug research in the US happens out of universities and government institutes. This kind of infrastructure does not exist in India. PPP can help create infrastructure so that basic drug research can take a start up in India. Currently, there are very few initiatives public or private that are focussed on new drug discovery in the Indian market. If India’s dream is to have one in fi ve new drugs to come from India by 2020, then a focused PPP program can take us in that direction. For clinical research CROs, PPP is of limited value.

A PPP model is more appropriate for drug discovery

ini� a� ves. A large part of new drug research in the US happens out of

universi� es and government

ins� tutes.

Interface


Knowledge base and infrastructure today exists in India, though it needs a planned and meaningful scale up. However, PPP may not be the answer for that.

What are the problems faced by Indian CROs?As an Indian CRO, one needs to prove themselves to every client every time. One is as good as their last study. Also, as the clinical trials are going global, a CRO with presence only in India is less likely to be considered, even for only Indian portion. Then comes the question of your track record and references. The cost of errors in drug development is measured in time fi rst and money later. So there is no substitute to this scrutiny. May be global CROsin India do not have as much diffi culty in winning business even if they maynot have the same ‘on-ground’ experience in India or the scale, butI cannot be sure as I have never worked for a global CRO. Though DiagnoSearch has never faced employee attrition as a major challenge, retaining trained and experienced talent is also a challenge to Indian CROs.

What are the current trends in the market? What does the future look like for Indian CROs? Today, the industry is trying to reinvent itself. For most Indian CROs, last two or three years have not been encouraging. Some reports of questionable data quality from trials in India (conducted by Indian as well as global CROs alike) have not done any good to the industry. Global economic downturn has not helped either. The infl ow of clinical trials has reduced substantially and there is a feeling of uncertainty in the market place. Countries like South Korea and China are attracting more trials today than India despite all the advantages India boasts off. Several CROs are scaling down.

A lot of people point fi ngers at the regulatory scenario in India,but we look at it differently. We believe that considering what has been happening in clinical trials in India regarding data quality, ethics and patient rights, regulators have no option but to be strict and regulate the clinical trials in India. Overzealous media reporting has not helped either. Not every case reported in media may have truth in it but then considering the fact that we are in the industry that deals with life, CROs need to be a lot more responsible and circumspect about everything they do. The request to media and NGOs also is to be more responsible in reporting. Finally, clinical research in India

will bring in a lot of value to the country much beyond what small profi ts CRO may make. On theother hand, not being part of new drug research will only take India back a few years in terms of standard of care.

Paradoxically, we at DiagnoSearch are very unhappy at these diffi cult times. This is because when the dust settles in the next 12 to 18 months, the market place will be much more clean and productive. Only players with core competence of doing clinical research will survive or at least that is whatwe hope.

What are the key strategies that are adopted by CROs to a� ract more clients?In the changing and uncertain market place, your track record and quality delivery along with stable experienced teams and referencibility remain the best bets for attracting newer business. Add to that full service capability, wide therapeutic experience and you may have a good chance of impressing more clients. Traditionally, CRO contracts cannot be won by employing low pricing strategies. Also, over a period of time operating presence in key markets has also become important. The presence in key markets needs to be ‘own’ presence rather than so-called strategic alliance. This industry has a history of taking strategic alliances with a pinch of salt.

The state of CRO in India is not the same as it was 5 years ago. What are the factors behind this change?Many companies made hasty entry in CRO business around 5 years ago without much or any track record, experienced teams or deeper knowledge of clinical trials management. Just deep pocket is not a qualifi cation enough to start and run a successful CRO. Many successful generic-pharma executives also thought they could create and run successful CROs. But there are a lot of differences in clinical research and generic drug development. Several instances of questionable data quality, reports of malpractices and overzealous media have not helped. Also, the global economic uncertainty has had its effect.

Though one school of thought suggests that global economic slowdown should actually drive more business to emerging markets, this has not driven incremental business to India. Some regulatory initiatives have caused a little disruption but we feel it may be a step towards right direction. MPh

([email protected])

Countries like South Korea

and China are a� rac� ng more trials today

than India despiteall the advantages

India boasts off . Several CROs are

scaling down.

Marketing


Every industry has a general and usual strategy of promoting their business. Depending on the segment that they cater

to they would choose the appropriate medium through which their product or service would get maximum mileage. Fast Moving Consumer Goods (FMCGs) would publicise their products through advertisements in print and electronic media. They would participate in exhibitions and put up

promotional stalls. Tour operators and premium segment car manufacturers would obtain a mailing list of high-profi le individuals and send mailers. Confectionery manufacturers will hang colourful display cards in shops and put up banners during festive events.

Medical equipment and drug manufacturers place advertisements in physicians’ journals. They also put up stalls at clinical workshops and conferences to widen the exposure of their products. Pharmaceutical companies send medical reps to physician’s clinics to get individual attention of the doctor. These are time-tested techniques and have been successful for most companies. Yet, increasing competition has forced pharma manufacturers to rethink their strategies to edge out the rivals. For this, there is an increasing need to think, as they say, out-of-the-box!

Limita� onsOne of the major limitations of traditional marketing methods is the short duration of interaction between the Medical Representative (MR) and the physician. Doctors who are not very busy in their clinics are able to give plenty of time to the MR and his manager; however, it does not translate into large volumes of drug prescriptions. Conversely, the physician who is overloaded with patients is able to generate abundant prescriptions but allows very little time with the MR. The latter group provides only few seconds or minutes with the sales personnel and rapidly terminates the discussion in order to attend to the waiting patients.

The marketing managers usually try to work out novel strategies to get the required attention of these physicians towards their brands. One of the methods of getting the busy clinician to talk freely is to get him out of his clinical territory!

Ge� ng cozyMedical teachers and practicing physicians observe several aspects of pharmaco-dynamics, dosage diffi culties, adverse effects as well as patient behavior during the course of their work. Many of these observations are momentary and do not get expressed to the appropriate pharmaceutical representative either due to simple hesitation or their busy schedule. Getting the physician to talk freely provides insights into prescription patterns and allied issues. It is at these times that clinicians blurt out about trying newer drug combinations or complain about the non-availability of particular drugs.

An eminent Czech writer, Milan Kundera, once said, “Business has only two func� ons - marke� ng

and innova� on.” Pharmaceu� cal manufacturers have for years been focussing on marke� ng, it is

now � me to take a long, hard look at innova� on in marke� ng!

Non-medical skills of physicians

Adop� ng a novel approach

Dr Rajan T D Pharma Consultant & Practising Dermatologist

Marketing


Physicians who are restrained in their behavior within their clinics or hospitals are able to be normal human beings when they are drawn out of their cabins. Dinner meetings, clinical updates, surgical workshops on endoscopy, laser surgery, cosmetology, etc are opportunities drawn up or supported by drug manufacturers to get close to physician without the limitation of time. The Regional/Zonal managers make themselves available to meet the doctors in these leisurely surroundings.

Over the years these tactics have been employed repeatedly by most drug manufacturers and with novelty being lost, physicians have also got used to these practices. Pharmaceutical companies now need to look for newer ideas to impress physicians.

Taxa� on, banking, technologyDoctors are people who have spent their entire youth trying to hone their skills in learning their art and then putting their skills to practice. In the process they get drawn headlong into their career of caring, teaching, counselling and treating. This route alienates physicians from several other essential social activities. Young physicians have hardly any time to pursue their hobbies, learn about fi nancial matters, legal issues and attend to social events.

Many of these doctors make mistakes in maintaining their books of accounts and end up having to spend long hours to align their taxation papers as the fi nancial year ends. Information about loan facilities, moratorium period, penalties and waivers eligible from banks are known to budding clinicians. Most of them stumble their way and by the time they have mastered the legalities, they are already grey-haired and exhausted.

Young doctors are abreast with technology as they have ample exposure to computers during their college days. The older categories, who have been professors or senior private practitioners for over two decades, would not have had any technology exposure during their

college. Busy surgeons who have a load of patients always waiting for them hesitate to imbibe newer technological practices as they are accustomed to the conventional way. These people usually have no time to think of incorporating simpler methods of work till someone close pulls them up or an old pal convinces them during a weekend outing. Pharmaceutical companies are yet to realize that these shortcomings of doctors are clear-cut marketing opportunities.

Non-pharmacology meetsAmerican physician, Oliver Wendell Holmes had once said, “Man’s mind, once stretched by a new idea, never regains its original dimensions.”

Likewise, physicians can be drawn out of their cabins and exposed to areas that will help them in their chosen areas of work. Improving their style of functioning could help their patients as well and provide more free time to enjoy their life. Here are some areas of diffi culties that physicians face while building and sustaining their career and which are specifi c opportunities for pharma companies to use and hone the former’s skills: Setting up a clinic or hospital:

Beginner doctors are usually unaware of the legalities of setting up their private practice. What are the loan facilities available to a novice? Is there a period of time where the repayment schedule can be delayed? Are there concessions or penalties?

Government clearances: Setting up a general practice or consulting room in a residence is permitted under certain conditions. Local government bodies have guidelines for setting up nursing homes and hospitals, particularly in cities. These days it is compulsory to register with the municipal corporations. Radiologists doing ultrasonography need to register not only their clinics but also their machines. Clinics employing staff beyond a certain number also come under the purview of specifi c labour laws.

Maintaining books of accounts: Freshly practicing private practitioners are not trained in the process of medical accounting. Most of them are unaware that they are liable to pay professional tax the moment they get a job or enter private practice. Doctors get several deductions while computing their income tax provided the appropriate receipts and other documents are properly maintained.

Clinical data management: The advent of computerization has evolved a new and easy mode of maintaining data of patients, their diseases, investigations and treatment. While young physicians are conversant with software for maintaining patient data on computers, their senior counterparts may need initiation. Drug companies could conduct workshops on using such software to ease the functioning of busy clinics.

Publishing articles: Busy clinicians across the world have a wealth of data. However, this data does not reach the mainstream of medical practitioners because not much of this information is organized and published in medical journals. Doctors can be coached on the process to be followed in order to publish their observations in clinical and research journals.

Legal aspects: Doctors are bound by certain laws pertaining to their practice. There are several established norms for documentation of their clinical work and ethics. Many legal disputes are brought to and subsequently settled by local Medical Councils for failure to implement these norms. Some of these cases serve as pointers to other physicians to avoid future legal complications.

It is pointless to mention that any of these activities are neither new nor unique. However, they appear to be diffi cult and time-consuming from the point of view of immediately generating large profi ts. Such activities provide an ethical medium for pharmaceutical companies to impress their target audience. MPh

([email protected])

Campus Voice

Modern Pharmaceuticals I September 2011

What is the state of pharmacy educa� on in India? What are the lacunae in the exis� ng system?Pharma education in India means just qualifying as a graduate. It does not provide training skills as required by the

Though the numbers of institutions have increased, almost 1,100 over a period of time, the quality of education still remains the same. A careful analysis highlights that only a few of the institutions near about 100 are equipped with good academic infrastructure employ an experienced faculty. Also,

stitute of d Research o improve

currently ustry.he lacunae

practical

ss about ds societydemia and s a career–academia

and

the gap lities and pharmacy system by

a platform industry

s impart dge, skills, id in the l o p m e n t competent ents in r to better a r m a c y

ofession in e country.

IPER not only develops competent pharma professionals but also ensures their competency. Besides, it makes sure that these professionals are picked by the best in the industry.

For the same it provides total profi ciency rating and pharma talent search developed at our training and placement department. Talent & Profi ciency (T&P) aims to build a national and international level portal of competent people that is PharmaResourceportal for the pharma industry globally. IPER also conducts one day training programme to train professionals. The aim is to help them achieve the vision of making the Indian pharma industry a Super Power by 2020.

How has pharmacy educa� on in India changed since its incep� on in BHU in 1932? What have been the major growth drivers?First pharmacy class in India dates back to 1860 when the medical college Madras started a 2-year course to train compounders to serve as pharmacist. They continued with as less as half dozen admissions per annum. However, since inception of various pharmacy courses, there is no looking back. Though according to PriceWaterhouseCooper’s global CEO survey 2011, 75 per cent of pharma and life sciences company CEO’s says that there is lack of skilled and competent people.

Growth factors include:During the 1940s and 50s, there was mushrooming of hospitals and pharma companies on a large scale and this required pharmacy professionals. The D. Pharm course served the need of hospitals for

...remarks Dr Mahesh Burande, Chairman, Maharashtra State Board of Technical Educa� on.

He highlights the need for an increased industry-academia interac� on and government help to

boost pharmacy profession in India.

‘There is an ardent need of skilled and

trained academia at college level’

Arshia Khan

72

Campus Voice


pharmacists/chemists and the B. Pharm course served the need of industrial chemists.

Along with that, several Indian entrepreneurs started pharma companies/business thus giving opportunities to Indian pharma graduates.

It is a common feeling that the medical prac� � oner is be� er placed for pharmacist jobs than the pharmacist themselves. What are your views?This is not true. Today, M. Pharm practice students are equipped to handle this job equally well and in the future this trend will continue. Pharmacist is always good as far as drug knowledge is considered.

In the West, pharmacy educa� on is pa� ent oriented and is responsible for healthcare management while in India pharmacy educa� on is industry oriented. Is it true? Please jus� fy.Yes, it is true; because in India pharmacy education emerged out of industrial need in 1940-50. And same trend is continuing.

What types of laws do we require to have well trained and skilled pharmacists available at each primary health centre and government hospitals?There is an ardent need of skilled and trained academia at college level. They must also have experience of working in an industry and hospital. They should update their knowledge and elicit a knowledge updation certifi cation like TPR from IPER. Compulsory projects which involves society, academia

and students Compulsory affi liation with hospitals and medical colleges Compulsory academia-industrial interaction for students

through projectsThere is lack of interaction between the pharma institutes /colleges and the industry in India. There are no regular updates of knowledge. Very few institutes have an in-depth research focus.

What is the diff erence between industrial pharmacy and clinical pharmacy?At present, India follows industrial pharmacy knowledge related to manufacturing of drugs but Pharm D programme, which is hospital oriented is a clinical pharmacy programme.

Pharma graduates B. Pharm from India are not eligible to take up jobs as prac� sing pharmacist in other countries where Pharm D has become the profession for prac� ce of pharmacy. How can this be addressed?This can be addressed when Pharm D course in India will become equivalent to Pharm D course of developed countries. For this we need trained and experienced Pharm D teachers and compulsion from the government for the post of clinical pharmacist in hospitals in India. MPh

([email protected])

Interface


What are the basic requirements to set up Free Trade and Warehousing Zone (FTWZ)?Government of India (GOI) introduced the FTWZ Policy, as a part of Foreign Trade Policy (FTP) 2004-2009 governed by the SEZ ACT, 2005 & SEZ Rules, 2006. Free Trade Zones (FTZ) have been attributed to the success of many economies such as Singapore and Dubai by leveraging these countries as logistics hubs. Further, GOI intent in launching

FTWZ policy was to boost India’s EXIM trade and foreign exchange earnings by making the best of India’s strategic geographical location, cost and skill arbitrage. India’s logistics cost is currently 14 per cent of Gross Domestic Product (GDP) as compared to 8-9 per cent developed countries. On a GDP of $ 1.6 trillion this converts to an ineffi ciency of $ 65 million. Much of this ineffi ciency is

due to the lack of logistics infrastructure like ports, logistics parks, roads, rail, etc. Thus, India has been losing investment to neighbouring economies due to the lack of FTWZs. Many companies are servicing the Indian market based out of Dubai and Singapore due to the lack of quality infrastructure, regulatory and operational hassles in India.

Arshiya FTWZ has changed the status quo by providing a state-of-the-art infrastructure with favourable environment to carry out imports, exports and re-exports with regulatory

and operational freedom that companies have for long been waiting for in India. A minimum 100 acres of contiguous land area and an investment of ` 100 crore is required to set up a FTWZ.

How does it benefi t the pharma industry?Indian pharma sector has substantial imports and exports. FTWZ as an

infrastructure for multiproduct warehousing, trading and value addition has innumerable benefi ts for manufacturers and suppliers in the pharma space for all their EXIM movements. The benefi ts that FTWZ offers encompasses superior infrastructure, operational and regulatory benefi ts. FTWZ offers customised storage solutions suited to the products of this sector with Heating Ventilation and Air Conditioning (HVAC) system, chillers, freezers, palletised racking system, etc that offer different storage solution as per the product requirements. Hygiene, safety, real time cargo visibility, etc have also been of primary importance in designing. Thus, FTWZ has suitable infrastructure for the pharma sector that offers product safety and offers bespoke storage solutions for the varied requirements.

How is FTWZ diff erent from SEZ?Based on whether the company is importing, exporting or re-exporting the following regulatory and operational benefi ts are available to pharma companies and their vendors that are not available at any bonded warehouses.

For imports: Duty deferment benefi ts help companies in freeing up working capital and also provide fl exibility towards end distribution in India. Companies can now import in bulk, taking advantage of price fl uctuations in the international market as well as reduce the cost of multiple shipments. This can also enable companies convert air shipments into sea shipments. Taxes like Special Additional Duty (SAD),

says Ajay S Mi� al, Chairman and Managing Director, Arshiya Interna� onal Ltd. He discusses the

vital aspects of having FTWZ for the pharmaceu� cal sector.

‘India’s logis� cs cost is 14 per cent of GDP as

compared to 8-9 per cent in developed countries’

Chandreyee Bhaumik

FTWZ as an infrastructure for

mul� product warehousing,

trading and value addi� on

has innumerable benefi ts for

manufacturers and suppliers

in the pharma space for all

their EXIM movements.

Interface


Value-Added Tax (VAT), Central Sales Tax (CST), Stamp duty are exempted for clearance/sale from FTWZ. Rental in the FTWZ, labour, Value-Added Services (VAS) and primary transportation from port to FTWZ are exempted from service tax. Companies can conduct quality control in the FTWZ prior to payment of customs duty thus allowing for hassle free re-exports of rejects.

For exports: Products from India entering the FTWZ are treated as export providing immediate export benefi ts to exporters. Exporters also benefi t from local tax exemption (eg, CST, Sales Tax, Excise & VAT) on all activities conducted inside the FTWZ. FTWZ rentals, labour, VAS are exempted from service tax. Companies are also able to meet their export quotas by exporting into FTWZ. Reverse logistics costs also reduce due to the capability of quality control before dispatch from India.

For re-exports: Income tax is exempted on re-export profi ts from FTWZ. Service tax is exempted on all activities conducted inside the FTWZ; including rental, labour, VAS. There is also exemption from custom and stamp duty on products imported into FTWZ meant for re-export out of India. Moreover, re-export is a hassle-free process as no duty payment is required in bringing the products into the FTWZ. Companies can now leverage India’s cost, skill and geographic positioning advantage as a hub for regional/global distribution post value addition activities.

Give an overview of the FTWZs all over the world. How is India placed in this regard?Some of the FTZ that has given a fi llip to trade in their country as well as in the region are mentioned below:Dubai: Established in 1985, Jebel Ali Free

Trade Zone (JAFZA) is spread across an area of 48 sq km, with over 6,400 companies operating in the

zone, including 120 of the Fortune Global 500 enterprises. Accounts for 25 per cent of all container throughputs at Jebel Ali port & 12 per cent of all air freight at Dubai International Airport.

Over the years it has created over 1,60,000 direct jobs in the UAE through its companies

Increased its revenue at an average of 34 per cent year-on-year

Contributed to Dubai’s GDP at 25 per cent on a year-to-year basis

Accounted for more than 50 per cent of Dubai’s total exports

Accounted for 20 per cent of all Foreign Direct Investment (FDI) infl ow into the UAE

Grown its customer base by over 60 per cent in the last four years

China: FTZs are operational since 1980 Waigaoqiao FTZ in Shanghai is spread

across an area of 10 sq km & over 9,300 companies registered in the zone, including 135 of the Fortune 500 companies

Other zones being - Zhuhai (3 sq km), Ningbo (2.3 sq km), Xiamen (5 sq km),

Futian (1.35 sq km), Shatoujiao (0.27 sq km) & Yantian Port(0.85 sq km)

Singapore: FTZs were fi rst established in the

island nation in 1969, today the entire country is a FTZ

Notable FTZs being – Keppel (2.59 sq km), Pasir Panjang (0.65 sq km), Jurong (0.61 sq km), Sembawang (0.19 sq km) & Air Logistics Park of Singapore at Changi Airport

Over 7,000 multinational companies operate through these zones

Overall, India is much better poised to leverage itself as a trading hub with FTWZ. We are a late entrant in this space but have tremendous advantages like strategic geographical location, cost and skill arbitrage, a high growth economy & a huge domestic market that will enable India to emerge as a preferred hub for carrying EXIM trade.

What is the business strategy adopted by Arshiya?In order to bring down the logistics cost in the country it is imperative to invest in logistics infrastructure and in line with this acute need Arshiya has also invested in rail infrastructure inclusive of modern rakes, customised containers & rail sidings at strategic locations. This was followed by the launching of FTWZs starting with the fi rst zone in Panvel, Mumbai & to be followed by Khurja near Delhi, Nagpur, Chennai & Haldia. FTWZs are a real boon for importers, exporters and re-exporters in effectively carrying out EXIM trade. We have also invested in Domestic Distriparks (DDPs) that are consolidation and distribution hubs for domestic cargo. Both FTWZs and DDPs are integrated with rail infrastructure for cost-effective and effi cient movement of cargo. Arshiya has also ventured into transport and handling to provide last mile connectivity and quality handling equipment and services.

Today, more than 100 companies from across sectors are operating out of Arshiya’s fi rst FTWZ in Panvel, Mumbai that has been operational since November 2010. This stands testimony to the need for such integrated infrastructure and services in India.

What are the challenges that you face?Arshiya believes that no problem is

insurmountable. There is always a way. There is a way to transcend boundaries to strengthen partnerships to keep bettering today’s solutions to change the face of logistics across the world.

With our fi rm belief in our vision we have never seen anything as a challenge while creating the integrated infrastructure & service driven entities. Moreover, the acute lack of quality logistics infrastructure, lack of organised logistics service providers, India’s staggering growth rate which has created a huge demand for effi cient logistics infrastructure and processes have been the driving force in our pursuit to excellence. MPh

([email protected])

Curtain Raiser


During the past few years, India has seen a continuous increase in demand for laboratory and analytical equipment.This

development will also be refl ected at this year’s analytica Anacon India. Organisers are expecting some 140 exhibitors from 13 countries that will present their latest products and innovations to an audience of Indian professionals on all three days of the fair. The Indian trade fair is being held at the Bombay Exhibition Centre from October 12–14, 2011. Visitors can also take part in the analytica Anacon India Conference, held at the same time as the fair.

Target group analytica Anacon India, the international trade fair and conference for analytical instrumentation, biotechnology, laboratory technology and services, will feature a portfolio of exhibits addressing the analysis, laboratory-technology, diagnostics and biotechnology sector in India, one of industry’s most important growth markets in Asia.

S Thyagarajan, President, Indian Analytical Instruments Association

(IAIA), informs, “India continues to be one of the few countries where there will be a signifi cant growth in the analytical instrumentation market due to the huge investment and growth taking place in pharma, biotechnology and food industries. The market is driven by increasing opportunities in generic market, fast growing clinical trial and Contract Research and Manufacturing Services (CRAMS) business, continuing expansion in pharmaceutical industry.” He further adds, “The report on biotech business is projecting business of $ 11.6 billion by 2017. The integrated food safety law passed by government recently refers to setting up of 250 state laboratories from 72 at present. Indian market is valued $ 1.5 billion for analytical and life science instrumentation today.”

ConferenceThe fi rst day of the conference will revolve entirely around the life sciences sector. Speakers will discuss the future of personalised genomes in medicine and the challenges and potential associated with vaccines. Day two will be dedicated to food safety. Presentations will focus on genetically engineered grains and the latest requirements in food safety and

quality assurance in India. The lectures on the third day will deal with the latest topics in the pharma industry, including the use of bioanalysis in the pharma sector. The analytica Anacon conference is traditionally organised by the IAIA. In addition to the conference, visitors can also attend a workshop titled ‘Validation of Analytical Methods for Food and Drug Administration (FDA) and EU Compliance’.

A retrospec� ve...Last year the event witnessed 148 exhibitors from 10 countries who presented their products and innovations for the analytical, laboratory-technology and biotechnology sectors. About 2,710 trade visitors demonstrated high interest in the latest measuring and analytical equipment as well as in innovations in the biotechnology sector. The analytica Anacon conference was also a popular highlight. Further, in keeping with the theme of the previous year, ie, ‘Analytical Instrumentation: Technologies for a better quality of life’, the conference focussed on the latest fi ndings for diagnosing cancer and new environmental-analysis techniques, among several other things. MPh

([email protected])

analy� ca Anacon India will showcase various exhibits & address the analy� cal, laboratory-technology,

diagnos� cs and biotechnology sector in India. Thus, this exhibi� on aims to cater to the increasing

demand of laboratory and analysis equipment.

analy� ca Anacon India

Raising the industry standards

Chandreyee Bhaumik

Court

esy:

IAIA

Events Calendar


National

2nd Pharmac India The three-day event will cater to the pharma and healthcare industry in the country. It aims to attract reputed professionals from the fields of pharmaceutical formulation, herbal products, veterinary drugs, medical & disposal products and pharmaceutical machinery & equipment. The event will have exhibitors such as contract manufacturers, liaison agents, sourcing companies, generic and OTC manufacturers & wholesalers, government suppliers, etc; September 17-19, 2011; Gujarat University Exhibition Hall, Ahmedabad, Gujarat

For details contact: Orbitz Exhibitions Pvt Ltd Tel: + 91 22 2410 2801Fax: + 91 22 2410 2805Email: [email protected]: www.pharmacindia.com

Pharma Supply Chain Forum 2011This event aims to bring the leading supply chain management practitioners from the pharma and biotech sector under one roof. The conference will have discussion forums, presentations and several case studies. Thus, it will provide the entire industry to meet, interact and discuss various issues pertaining to the field; September 21, 2011, Taj Lands

End, Mumbai

For details contact:KamiKaze B2B MediaTel: +91 22 2639 5102Email: [email protected]: www.elscconclave.com

14th IDMA-APA PAC

This event aims to cater to the pharma and research professionals. It will serve as a platform to the professionals in government laboratories and research institutions, approved testing laboratories, machinery manufacturers, academicians and many others. There will be discussions on how to prepare and face the WHO GMP audit, the validation of legacy systems, the regulatory flexibility in acceptable stability studies along with several other aspects; September 23-24, 2011, Hotel InterContinental The Lalit, Mumbai

For details contact:Indian Drug Manufacturers’ AssociationTel: + 91 9867634383Email: [email protected]: www.idma-assn.com

Analytica Anacon 2011

Analytica Anacon 2011 is the 6th international trade fair and conference for analytical instrumentation, biotechnology, laboratory technology and services, which aims to bring together the

international exhibitors and market leaders. This event will provide an excellent opportunity to showcase innovative products and solutionsin the industry; October 12-14, 2011; Bombay Exhibition Centre, Mumbai

For details contact:Sonia PrasharIndo-German Chamber of CommerceTel: +91 11 26878721 or 26111730Email: [email protected]: www.analyticaindia.com

CPhI India 2011

The event will feature key decision makers in the pharma industry from 92 countries, including India, China, US, UK, France, Italy, etc. The CPhI conference will include updates on latest innovations, technologies, trends and developments in the pharmaceutical industry in India; November 30 - December 2, 2011; Bombay Exhibition Centre, Mumbai

For details contact:UBM India Pvt Ltd Tel: + 91 22 6612 2600Fax: + 91 22 6612 2626-27Email: [email protected]: www.ubmindia.in

Pharmapack Bombay

The event aims to provide aninnovative platform to showcase the latest information, technology and products to a focussed and target audience. The event promises to cater to the exporters, importers, biotechnology companies, medical device manufacturers, biopharmaceuticals, etc; February 23-25, 2012, Bombay Exhibition Centre, Mumbai

For details contact: Intel Trade Fairs & Expositions Pvt Ltd Tel: + 91 22 2862 8126Fax: + 91 22 2281 9008

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumactics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details

Infomedia 18 Ltd,Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028.

• Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: [email protected]

RUDRAPUR: Uttarakhand, Sept 23-26, 2011, Gandhi Park

AHMEDABAD: Gujarat, Oct 14-17, 2011, Gujarat University Exhibition Hall

CHENNAI : Tamil Nadu, Dec 8-11, 2011, Chennai Trade Centre

INDORE: Madhya Pradesh, Jan 6-9, 2012, Poddar Plaza, Nr Gandhi Hall

AURANGABAD: Maharashtra, Feb 17-20, 2012, Garware Stadium

PUNE: Maharastra, Nov 18-21, 2011, Auto Cluster Exhibition Centre

Events Calendar


InternationalInter Med Pharm 2011

This event aims to provide opportunity for the pharma professionals. Key policy makers, trade visitors, pharma analysts, scientists and researchers are expected to gather here. Thus, this event hopes to offer solution to any pharma related query; September 15-17, 2011; Tashkent Republic of Uzbekistan

For details contact:TNT Productions IncTel: +1 703 4060 010 Fax: +1 703 4068 543 Email: [email protected]: www.tntexpo.com

Nigeria Pharma Manufacturers Expo 2011The three-day international exhibition aims to ensure focussed promotions and meaningful interaction for business. The show will be a catalyst to develop new business opportunities, technology and trade sources, new tie-ups and technology transfer. This event will serve as a unique platform to showcase pharma processing and packaging machinery and materials, API and bulk actives, analytical lab instruments and supplies, environment control systems and utilities, etc; September 19-21, 2011; Federal Palace, Victoria Island, Lagos, Nigeria

For details contact:PMG-MAN and GPE Expo Pvt LtdTel: +91 79 4000 8233Fax: +91 79 2687 1390Email: [email protected]: www.NigeriaPharmaExpo.com

LogiPharma Asia 2011

The 3rd annual LogiPharma Asia is the strategic platform where pharma supply chain and logistics professionals

meet to discuss the key challenges of the life science industry in Asia. The event will bring the key decision makers of the industry together. There will be discussion on the latest strategies to optimise cost, improve compliance and therefore performance; September 22-24, 2011, Grand Hyatt, Singapore

For details contact: Worldwide Business ResearchTel: + 65 6408 9217Email: [email protected]: www.wbresearch.com

Managing partnerships with CROs

The conference will address the critical subject of improving relationships between pharma & CROs both technical & academic. With the increasing reliance on positive and profitable relationships between these organisations, the conference offers case study presentations and instructional presentations on learning from and dveloping positive relationships to maximise your partnership.The speakers come from Big Pharma, CROs and academic partnerhsips and aims to provide for a balanced and dynamic agenda; October 3-4, 2011; Holiday Inn Bloomsbury, London, UK

For details contact: SMi ConferencesTel: +44 0 870 9090 711Fax: +44 0 870 9090 712Email: [email protected]: www.smi-online.co.uk

Public Health 2011

This international event will be focussing on pharma, techpharm, medical laboratory, emergency medicine, beauty and health products. This exhibition will be catering to various industry needs; October 11-

14, 2011; Kiev International Exhibition Center, Kiev, Ukraine

For details contact:Premier ExpoTel: +380 44 968645 Fax: +380 44 4968646 Email: [email protected]: www.publichealth.com.ua

ICSE Europe

The ICSE Europe aims at targeting the top leaders of the pharmaceutical industry. The event will organise an exhibition along with concurrent conferences. The exhibitors profile includes biotrails, pharmacology, pre-clinical, biotechnology, pharma equipment and machinery, production equipment, clinical research, patient safety monitoring, etc; October 25-27, 2011, Messe Frankfurt, Frankfurt, Germany

For details contact: UBM Live Tel: + 31 20 409 9544 Fax: + 31 20 363 2616Email: [email protected]: www.icseexpo.com

Cell-Based Assays

The event will consist of a two-day conference and a post-conference workshop, focusing on a range of topics relating to the challenges faced by those involved in using and developing cell-based assays; November 21-22, 2011; Marriott Hotel Reagents Park, London, UK For details contact: SMi ConferencesTel: +44 0 870 9090 711Fax: +44 0 870 9090 712Email: [email protected]: www.smi-online.co.uk

The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharmaceuticals

Book Shelf


Available at: Wisdom Book Distributors, Hornby Building, 1st floor, 174, D N Road, Mumbai 400 001 • Tel: 022-2207 4484/6631 8958 • Telefax: 022-2203 4058 • Email: [email protected]

Pharmaceu� cal Stress Tes� ng: Predic� ng Drug Degrada� on

Editors: Steven W Baertschi, Karen M Alsante, Robert A ReedPrice: ` 5995

Process Understanding: For Scale-Up and Manufacture of Ac� ve Ingredients

Editor: Ian HousonPrice: ` 6950

This book approaches the topic of stress testing with the underlying theme that stress testing is predictive in nature, multi–dimensional, ie, analytical, organic, physical, spectroscopic, and an integral part of the drug development process.

This edition extends it coverage to the oligonucleotides and proteins, and offers increased information covering formulated products and diverse dosage forms. There is also discussion of chemical stability and the physical aspects of stress testing, the concept by ‘Quality by Design’, the connection between stress testing and ‘real world’ stability through topics related to kinetics, predictive models and actual conditions experienced by drugs and drug products during shipping and distribution. Divided into 10 chapters, the book shows the relationship between stress testing and the assessment of potential genotoxic degradants, combination drug therapies andalternate dosage forms such as liposomal formulations. There is also discussion on updated methodologies for predicting drug stability and degradation pathways.

This book provides readers with a single source reference that benchmarks the current best practices of experienced pharmaceutical scientists/researchers. Thus, it seeks to be both a practical and scientifi c guide that will stimulate new ideas and further development of science.

Process understanding is the essential knowledge that allows the manufacture of chemical entities to be carried out routinely and to the required standard of quality. This book encompasses the multidisciplinary aspects required for successful process design, safety modeling, scale-up, pilot plant implementation, plant design as well as the rapidly expanding area of outsourcing.

It discusses what process understanding means to different disciplines and sectors throughout a product’s life cycle, factors important to the development and manufacture of chemicals. This book focusses on the fundamental scientifi c understanding required for the smoother technical transfer between disciplines, leading to more effective process development and manufacturing. A range of case studies are used to exemplify and illustrate the main issues raised.

This book will help pharma professionals and researchers. They will appreciate that process understanding can deliver a real competitive advantage within the pharma and chemical industry. This book serves as an aid to meeting the stringent regulations required by the relevant authorities through demonstrable understanding of the underlying science.

80

Product Update


and durable construction ensures that this cartoning machine is easy-to-operate and maintain. The cartoning machine is versatile and can be used for a variety of sizes. It is specially designed and developed specifi cally for frequent changeover. The machine picks a single-piece from a stack of pre-folded carton from carton magazine and erects it, fi lls with a product vertically through an open end and closes by tucking the end fl aps of the carton or applying glue or adhesive. The product might be dropped into the carton either mechanically or manually. Some of the advantages of the cartoning machine are: capable of both tuck & hot-melt glue sealing; small in size suitable for space sensitive operation; built with material compliance GMP; employs a wide array of safeguards; and built with quality material & parts.

Solid Pack Machines - Ahmedabad- Gujarat

Tel: 079-2583 1785, Mob: 097374 76777Email: [email protected]

Steam-sterilised plungerWestar offers Ready-to-Use (RU) steam-sterilised plunger. This can mitigate risk for chemical and physical deterioration of plungers through optimised steam sterilisation cycle

that, when compared to high-dose gamma irradiation, may: minimise impact on elastomers’ physical characteristics and on chemical oxidation and degradation during the plungers’ shelf-life; decrease the number and lower the levels of extractable with less potential for interaction between the plunger and the drug; and improve prefi lled syringe functionality due to lower and more consistent break loose forces. The RU steam sterilisation process is fully validated and backed by West’s technical and regulatory expertise. Plungers are available for rapid order fulfi llment in market-proven formulations from West and its long-time partner, Daikyo Seiko, Ltd. The plungers fi t standard pre-fi llable syringes and comply with United States, European and Japanese pharmacopeias.

West Pharmaceu� cals Ltd - Hyderabad - Andhra Pradesh

Tel: 040-4026 9378, Fax: 040-4002 1790Email: [email protected]

Cartoning machineSolid Pack Machines offers SPM-60 cartoning machine, which is an intermittent-motion vertical cartoning machine featuring a modular design, interchangeable assemblies and phase adjusters so that it can quickly and easily change over to other product sizes. Common sense design, quality components

Digital DP gaugePolmon offers digital DP gauge (DPI-53). This is designed to measure difference between two pressures in clean rooms replacing the conventional analogue gauge to eliminate the inherent problems. This works with AA, 1.5, four

batteries and has a minimum of 18 months battery life with one second update rate. This has optional clean room compatible SS fl ush mountable faceplate. The gauge ensures long-term stability and has temperature compensated DP measurement. This also offers software calibration.

Polmon Instruments Pvt Ltd - Hyderabad - Andhra Pradesh

Tel: 040-2305 3046/5970, Fax: 040-2305 5425Email: [email protected], Website: www.polmon.com

Digital colour mark sensorLubi Electricals offers SUNX (a brand of Panasonic) LX-100 series digital colour mark sensor that can detect any marking because it is equipped with red, green and blue LED light emitting element. Furthermore, to expand the functionality this sensor comes with dual mode, ie, mark mode (ultra high-speed response) and colour mode (high precision mark colour discrimination) to suit any application. The sensor comes with MODE NAVI technology for enhancing features and is easy-to-use. Other special features include: 4-digit digital display, super simple teaching, external teaching, 12-bit A/D converter, D-code, key lock, timer, NPN or PNP outputs, IP67 protection, etc. Amazingly all this comes in the size of 57 mm (W) x 24 mm (D) x 38 mm (H) body. The digital colour mark sensor can be used very effectively in many applications and industries, especially in packaging, food, pharma, textile, plastic, etc.

Lubi Electronics - Ahmedabad - Gujarat

Tel: 079-2220 5471, Fax: 079-2220 0660, Mob: 09327497006Email: [email protected], Website: www.lubielectronics.com

name:___________________________________________________designation:_________________________________________

Company:_______________________________________________________________________________________________

address:_______________________________________________________________________________________________

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1 See the index page in this issue. every product carries a number.2 Choose products of your choice from the list.3 Write their serial numbers (as per the index page) of your chosen product/s one-by-one in the boxes.4 fill in your complete contact details. 5 Send it to us at the address printed overleaf.

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Special Projectmodern Pharmacuticals

‘A’ Wing, Ruby House, 1st floor, J K Sawant marg Dadar (W), mumbai 400 028 INDIA

InfomedIa 18 LImIted

Product Update


Pharmaceu� cal metal detector Vedic Pac Systems offers Met 30+ pharmaceutical metal detector for detecting metallic contaminants in pharmaceutical and nutraceutical products manufactured by Lock Inspection Systems, UK. It can detect and reject microscopic metal particles in pharmaceutical production lines at speeds of up to 30,000 tablets per minute, even in diffi cult applications, such as

products with a high iron content or bulk presentations. Its design and construction complies with 21 CFR, Parts 210 and 211. Made of fully stainless steel construction, to withstand aggressive cleaning it is stable to extreme vibration such as that of a de-duster. It is available with automatic setup, 100-product memory, automatic product tracking, security codes, lock datacheck management system, touchscreen system, virtual engineer & modem support, super sensitivity, fail-safe reject options, status indicator lights, easy clean design, etc.

Vedic Pac-Systems Pvt Ltd - Mumbai - Mahrashtra

Tel: 022 2288 3827 / 2287 2126Email: [email protected], Website: www.vedicsystems.com

Product Update


Hydraulic cylinderShashwat Systems manufactures a variety of standard and custom-built cylinders. Special-purpose adjustable stroke cylinder with 30 to 35 per cent adjustment in stroke with cushioning is the company’s specialty. These cylinders fi nd their application in plastic injection moulding machines, where moulded goods are picked up by robots. This helps in exact positioning

of moulds with respect to robot pick-up device to ensure trouble-free functioning of system as well as reducing the cycle time by adjusting of travel. The cylinder comes in bore size up to 780 mm with stroke up to 1800 mm; bore size up to 250 mm with stroke up to 3000 mm; bore up to 150 mm with stroke up to 6000 mm; and pressure up to 160, 250, 400 bar. Applications are in machine tools, mobile machinery, marine equipment, steel mill equipment, packaging machinery, atomic energy equipment, defence equipment, mining equipment, power projects equipment, stabilisers & steering gears, forge & foundry equipment, plastic machinery, construction machinery, amusement parks, etc.

Shashwat Systems Pvt Ltd - Ahmedabad - Gujarat

Tel: 079-6521 4825, Mob: 09824051536Email: [email protected], Website: www.shashwatsystems.com, Certifi cation: ISO 9001:2008 by TUV SUD

86

Product Update


Capsule filling machineBosch (Packaging Technology Division) presents the GKF 702 capsule fi lling machine, which replaces the previous GKF 701 model. To keep up with the demands of modern pharmaceutical industry, the capsule fi lling machine has been designed to produce small batches right in the laboratory. The production parameters required later during production, such as the machine speed, can be

fully simulated. For laboratory use, a specially designed fi lling station, known as the Mini-Bowl was developed for small product batches between 100 and 300 milliliters, which give higher powder yields. This is especially suitable for expensive and limited powder volumes during the development phase, providing a very economic fi lling solution. A slide-gate system, from the GKF 1400/2500 series, is also available, providing signifi cantly higher batch yields and the option of fi lling free-fl owing granulates, or pellets, via the powder station. The GKF 702 is a future-proof machine. Its modular design offers the possibility to re-tool for any future fi lling needs; and any new developments from Bosch will be compatible with this machine type.

Bosch Ltd (Packaging Technology Division) - Verna - Goa

Tel: 0832-6692042, Fax: 0832-6692028, Mob: 091588 81011Email: [email protected], Website: www.boschindia.com

Benchtop NMR spectrometerCole-Parmer offers the world’s fi rst miniature NMR spectrometer (picoSpin), a true breakthrough in chemical instrumentation. Researchers and educators now have access to a revolutionary benchtop

NMR spectrometer, for numerous applications such as proton NMR spectroscopy, chemical education and research, analytical testing, quality control, process monitoring and control, and more. It is affordable and compact enough for any lab. The portable unit weighs just 10.5 lb (4.7 kg). The 45-MHz picoSpin spectrometer resolves proton chemical shifts with a resolution of 100 parts per billion using a very small sample volume of less than 20 microliters. Liquid samples are simply injected into an internal capillary via front-panel fi ttings. The unit’s fl uid capillary is contained within a cartridge and is easily replaced in the event it becomes blocked or contaminated. A highly stable temperature-controlled permanent magnet

ensures easy maintenance-free operation without the need for liquid cryogens.

Cole-Parmer India - Mumbai - Mahrashtra

Tel: 022-6716 2222/ 209, Fax: 022-6716 2211Email: [email protected],[email protected], Website: www.coleparmer.in

Pharmaceu� cal refrigeratorGrabner International offers pharmaceutical refrigerators and freezers from Kirsch (Germany), that have robust construction. These are available in various versions produced by modern high-volume methods. These refrigerators and freezers are characterised by especially thick housing insulation of high-quality, pressure-foamed, environmentally compatible material that have low energy consumption. The operating temperature is maintained automatically by an interior thermostat or an electronic, microprocessor-controlled temperature and defrost regulator with digital display, even in the event of changing ambient temperatures. These pharmaceutical refrigerators feature automatic defrosting, re-circulating air-cooling, melt water evaporation, temperature gear by electronic thermostat, key switch protected control panel, minimium/maximum temperature memory, safety control device prevents freezing, optical and acoustic warning, potential free contact/interface RS485, etc.

Grabner Interna� onal - Delhi

Tel: 011-25887300/25881917, Fax: 011-25732664Email: [email protected], Website: www.grabinternational.com

Overhead s� rrerIKA offers overhead stirrer with a technology designed to optimise complex stirring applications. The stirrer features high energy, safe, silent, easy, vibration-free and intuitive operation of laboratory stirring. IKA stirring technology is like a bolt of energy, a light at the end of the tunnel. Impeccably designed with enhanced capabilities, the stirrer accommodates a vast range of applications. It stands out because of its indispensable features including: electronic safety circuit, push-through agitator shaft, digital display and ability to control the rheological changes using labworldsoft software. IKA provides the perfect solutions for all laboratory stirring needs at a great value, backed by performance, warranty and service support. IKA equipment meets and exceeds CE, UL standards and fulfi lls international safety regulations.

IKA India Pvt Ltd - Bengaluru - Karnataka

Tel: 080-2625 3925, Fax: 080-2625 3901, Mob: 09845387684Email: [email protected] , Website: www.ika.in

Product Update


The information published in this section is as per the details furnished by the respective manufacturer/

distributor. In any case, it does not represent the views of Modern Pharmaceuticals

Fluid bed dryerAero Therm offers fl uid bed dryer having batch capacity of 15 to 500 kg. A digital temperature indicator controller gives accurate temperature control. The control action can be switched on-off or PID as per control accuracy required. Construction of dryer can be made of ms /aluminium/ss 316/ss 304 as per requirement. Flame

proof & spark proof version is also available. Heating can be electrical/thermic fl uid or steam radiator/oil fi red hot air generator.

Aero Therm Systems Pvt Ltd - Ahmedabad - Gujarat

Tel: 079-2589 0158, Fax: 079-2583 4987Mob: 098250 08720Email: [email protected]

Vial & bo� le cap sealing machineAnju Pharmaceuticals offers vial and bottle cap sealing machines that are compact, versatile and elegantly fi nished devices for sealing vials & bottles of various sizes and BT (transfusion) bottles or similar containers with aluminium or plastic caps. The vials ready for sealing are placed one-by-one on the self-lifting stainless steel platform. This platform lifts upward automatically. As a result, the vials touch the sealing head. Suffi cient time is provided to remove the vial platform after the completion

of sealing operation. The features of the machine include: perfect & uniform sealing, therefore no manual involvement; no repeated setting required; sealing rollers rotate on bearings to give smooth motion for uniform sealing; minimum time require for changeover from one size of vial to another and does not require lubrication.

Anju Pharmaceu� cals - Indore - Madhya Pradesh

Tel: 0731-252 3968/7415, Fax: 0731-285 6142Email: [email protected]

Product Index


Sl No Product Pg No

1 Accelerated ageing test .............................................. 412 Access control ............................................................... 833 Acoustic enclosure ......................................................... 64 Air die grinder.............................................................. 135 Air fi lter................................................................... 21, 236 Air shower controller................................................... 837 Analytical instrument.................................................. 908 Analytical instrumentation......................................... 399 Anti-allergic .................................................................. 6910 Automation software................................................... 3711 Axial fl ow fan ............................................................... 8312 Ball valve ..................................................................... 1313 Benchtop NMR spectrometer .................................... 8614 Biodiesel ........................................................................ 4115 Biological safety cabinet........................................ 21, 2316 Blow-fi ll-seal machine................................................... 717 Booklet & leafl et label ................................................... 918 Capsule fi lling machine ............................................ 8619 Cardiovascular system................................................. 6920 Cartoning machine...................................................... 8021 Central nervous system............................................... 6922 Centrifugal air blower ................................................. 8323 Chromatography.......................................................... 9024 Cleanroom clock.......................................................... 2725 Cleanroom door..................................................... 21, 2326 Cleanroom monitor .................................................... 2727 COD analyser ............................................................... 7328 Column & chemistry................................................... 3929 Column ......................................................................... 9030 Compositional & trace metal analysis....................... 4131 Coolant pipe................................................................. 1332 Counter & power supply .................Front inside cover33 Data logger ................................................................. 2734 Dehumidifi er ................................................................ 5535 Diesel fuel...................................................................... 4136 Digital & GPS clock..................................................... 2737 Digital colour mark sensor......................................... 8038 Digital differential pressure transmitter/indicator... 2739 Digital DP gauge.......................................................... 8040 Dispensing booth................................................... 21, 2341 Door interlock system................................................. 8342 Drive .................................................... Back inside cover43 Dry vane pump.............................................................. 644 Duel fuel burner .......................................................... 8345 Duo labels ....................................................................... 946 Electrical (both ht & lt)............................................. 8347 Elemental analysis........................................................ 9048 Empower....................................................................... 3949 Encoder ..............................................Front inside cover50 Exhibition - EngineeringExpo ................................... 8451 Exhibition - Global Pharmaceutical Summit-2011....1052 Failure analysis........................................................... 4153 Fan fi lter unit.......................................................... 21, 2354 Filler compositional analysis ...................................... 4155 Fire alarm...................................................................... 8356 Flag label ......................................................................... 957 Flameproof clock ......................................................... 2758 Fluid bed dryer....................................................... 83, 8759 Foot valve...................................................................... 1360 Fuel ............................................................................... 41

61 Gas detector................................................................ 7362 Gases.............................................................................. 4163 Gear oil.......................................................................... 4164 Geared box.................................................................... 3165 Geared motor ............................................................... 3166 Hand valve .................................................................. 1367 Hanger label.................................................................... 968 Heart valve frame......................................................... 4769 HEPA fi lter terminal housing............................... 21, 2370 Hot water generator .................................................... 8371 HPLC....................................................................... 39, 9072 Humidity transmitter .................................................. 2773 Hydraulic cylinder ....................................................... 8574 Hydraulic hose ............................................................. 1375 Hydraulic solenoid valve............................................. 1376 Indirect air heater...................................................... 8377 Industrial building ....................................................... 8778 Industrial chilling equipment..................................... 3579 Industrial control/sensing device....Front inside cover80 Industrial oven ............................................................. 8381 Industrial pump........................................................... 8582 Informatics.................................................................... 3983 Injectable manufacturing line .............................. 21, 2384 Inspection system......................................................... 1185 Inverter/variable frequency drive....Front inside cover86 ISO cylinder.................................................................. 1387 Kamlok & drylok coupling....................................... 8588 Laminar air fl ow workstation ............................ 21, 2389 Level controller..................................Front inside cover90 Loading arm ................................................................. 8591 Lube - engine oil .......................................................... 4192 Mass spectroscopy ..................................................... 9093 Material identifi cation................................................. 4194 Measuring & monitoring relay .......Front inside cover95 Metallography............................................................... 4196 Molecular spectroscopy............................................... 9097 Motion control..................................Front inside cover98 Nozzle .......................................................................... 8599 Nutrition ....................................................................... 69100 Online b2b marketplace ..................................... 17, 88101 Oven .............................................................................. 87102 Overhead stirrer ........................................................... 86103 Packaging solution ..................................... Back cover104 Pass box interlock system ........................................... 83105 Pass box................................................................... 21, 23106 Peristaltic pump ........................................................... 87107 Pesticide spray hose ..................................................... 13108 Petrol & fuel oil............................................................ 41109 Pharmaceutical metal detector................................... 83110 Pharmaceutical packaging solution.............Back cover111 Pharmaceutical refrigerator ........................................ 86112 Photo electric sensor ........................Front inside cover113 Plant & machinery for sale......................................... 87114 Polymer characterisation ............................................ 41115 Pre-engineered/pre-fabricated modular panel...21, 23116 Prefi lled syringe component.........................Back cover117 Pressure gauge .............................................................. 13118 Programmable logic controller .......Front inside cover119 Programmable terminal...................Front inside cover120 Proximity sensor ...............................Front inside cover

121 PTFE Tefl on braided hose .......................................... 13122 PU tube ......................................................................... 13123 Pump ............................................................................... 6124 Quick-change terminal housing........................ 21, 23125 Rapid endotoxin detection system .......................... 85126 Receptacle...................................................................... 85127 Regulator....................................................................... 13128 Return air riser ....................................................... 21, 23129 RFID ...................................................Front inside cover130 Rock drill hose ............................................................. 13131 Roots blower................................................................... 6132 Safe change housing ............................................ 21, 23133 Safety light curtain............................Front inside cover134 Sampling booth...................................................... 21, 23135 SEZ developer...........................................Front gatefold136 Sight fl ow meter........................................................... 85137 Solenoid valve............................................................... 13138 SS hose clip ................................................................... 13139 Steam boiler.................................................................. 83140 Steam-sterilised plunger.............................................. 80141 Steel wires & duct hose ............................................... 13142 Sterilising & depyrogenating tunnel.................... 21, 23143 Switching relay ..................................Front inside cover144 Swivel............................................................................. 85145 Synchronised digital clock .......................................... 27146 Tefzel HHS isotactic PP material............................... 5147 Temperature transmitter............................................. 27148 Temperature/differential pressure indicator ............. 27149 Tempurature controller....................Front inside cover150 Testing............................................................................ 41151 Thermic fl uid heater.................................................... 83152 Thermoplastic valve & piping system ......................... 5153 Three parameter display ............................................. 83154 Timers.................................................Front inside cover155 Transmission fl uid ....................................................... 41156 Tray dryer...................................................................... 83157 Twin-screw co-rotating extruder ............................... 47158 Twin-screw element..................................................... 47159 Twin-screw extruder.................................................... 47160 UHPLC........................................................................ 90161 UPLC............................................................................. 39162 Vacuum booster pump ............................................... 6163 Vacuum pad.................................................................. 13164 Vacuum system .............................................................. 6165 Vial & bottle cap sealing machine ............................. 87166 Vision sensor .....................................Front inside cover167 Wireless clock............................................................. 27

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Our consistent advertisers

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Ace Instruments 27T: +91-40-23078848

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Charles River 85T: +91-80-25588175


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Eltech Services Pvt Ltd 83T: +91-40-27759895


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Engineering Expo 84T: +91-9819552270


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Everest Blowers 6T: +91-11-45457777


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Fabtech Technologies Intl Pvt Ltd 21,23T: +91-22-61592900


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Fluid Energy Controls Inc 85T: +91-44-42083536


W: www.fecindia.com

Gracure Pharmacuticals Ltd 69T: +91-11-47770900


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IC ICE Make Refrigeration Pvt Ltd 35

T: +91-2764-291022


W: www,icemakeindia.com

IndiaMART InterMESH Ltd 17,88

T: +1800-200-4444


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J B Sez Pvt Ltd FGF

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Omron Automation Pvt Ltd FIC

T: +91-80-40726400


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Premium Transmission Ltd 31

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Ravel Hiteks Pvt Ltd 87

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Reynders Label Printing India Pvt Ltd 9

T: +91 149 3305400


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Ringier Events 10

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Salesworth Synergies Pvt Ltd (Rommelag) 7

T: +91-80-25274495


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Salesworth Synergies Pvt Ltd (Seidenader) 11

T: +91-80-25274495


W: www.seidenader.de

Samson Extrusion Ind Pvt Ltd 13

T: +91-22-23422238


W: www.samson-grp.com

Shiva Analyticals (India) Ltd 41

T: +91-80-27971322


W: www.shivatec-india.com

Siemens Ltd 37

W: www.siemens.com/pharma

Steer Engineering Pvt Ltd 47

T: +91-80-23723309


W: www.steerworld.com

Thermo Fisher Scientific Sid Division 90

T: +91-22-67429494


W: www.thermofisher.com

Thiruvensun Bio Botanica Pvt Ltd 87

T: +91-9894795094


Uniphos Envirotronic Pvt Ltd 73

T: +91-22-6123500


W: www.uniphos-she.com

UNP Polyvalves India Pvt Ltd 5

T: +91-265-2649248


W: www.polyvalve.com

Waters (India) Pvt Ltd 39

T: +91-80-28371900


W: www.waters.com

West BC

T: +91-40-40021790


W: www.westpharma.com

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92

RNI No: MAHENG / 2008 / 27125

Postal Regd No: G / NMD / 122 / 2011 - 13

Posted at P.C Stg. Offi ce, GPO, Mumbai 400 001

On 19th & 20th Of Every Month

Date Of Publication: 16th Of Every Month

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