achal final credit ppt

8/8/2019 Achal Final Credit Ppt

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harmaceutical export promotionharmaceutical export promotionstrategytrategy

BY : ACHAL ROHITKUMAR DOSHIRoll Number : 08First Semester,Department of Pharmaceutical management,N.I.P.E.R.S.A.S.Nagar,Punjab


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Opportunity aheadOpportunity ahead

International co-operation&International co-operation&internal regulationinternal regulation

Promoting strategiesPromoting strategies

Role of PharmexcilRole of Pharmexcil

low Of Presentationlow Of Presentation

Current Pharmaceutical StatusCurrent Pharmaceutical Status


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Export of drugs,pharmaceuticalsand fine chemical increased at CAGR21.33% for 5 years 2003-2004 to 2007-2008 reaching Rs 39,139.57crores(8.61$bn)

Total pharmceuticalindustry size $18bn at end of 2007

Domestic pharmaceutical market $10.76bn in 2008

Expected to grow at 9.9% till 2010 and then 9.5% till 2015

4th in terms of volume but 14th in terms of value

API segment india ranks 3rdlargest with 500 different APIs

Current Pharmaceutical StatusCurrent Pharmaceutical Status

INDIAN PHARMACEUTICAL INDUSTRY


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Current pharmaceutical statusCurrent pharmaceutical status

CURRENT PLACE IN THE WORLD

Low-cost skilled producer of pharmaceuticals

Manufacturing base for APIs and formulation & emerging hub forbiotechnology, bioinformatics, contract research, clinical data managementand clinical trials.

US FDA inspected plants (119 plants), MHRA UK, MCA South Africa, TGAAustralia , HPB Canada have approved scores of plants in India .

One third of drug master files (DMFs) in USA.

Thirty percent of all approved ANDAs in the US are from India, ranking the

country number 2 next only to USA


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India good at chemistry but not so well in biology.

The number of approved GLP labs is very few.

The clinical investigators are a fraction as that of USA.

Considered as the Hub of the counterfeited and spurious medicines.

Tight price control regulations by DPCO and NPPA.

Lack of understanding of international Pharmaceutical marketing/pricingpractices and market environment in various countries.



Weakness of the indian pharma export.


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Import Of Pharmaceuticals


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US$mn

year


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Rs.Crores


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OpportunitiesOpportunities

The main opportunities for the Indian pharmaceutical industry are in theareas of:

Generics/ Bio pharmaceutical generics

Contract manufacturing services for MPCs

Contract R&D services like custom synthesis,clinical trials,clinical data management,bioequivalence testing,

Stability testing,chemistry and biology services.


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Each Member has the right to grant compulsory licenses and

the freedom to determine the grounds upon which such licenses aregranted.

In Thailand and South Africa, there are situations when patented drugsbecome too expensive for developing countries and consequently, theyimport cheaper copies of these drugs

Indian companies such as CiplaandAurobindohave been at the forefrontof exporting drugs in these situations.

TRIPS Doha round 2001:

Opportunity in Developing Economies


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Promotional StrategiesPromotional Strategies

Source : pharmexcil research


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Promotional strategiesPromotional strategies

Accelerating the Growth ofGeneric Pharmaceutical Industry

1.Building Portfolio for Untapped Highly Attractive Opportunities

2.Engineer Alliances to Protect Strategic Interests of the Country

3.Enhancing Pool of Trained Professionals

4.Treat Investments in Quality on Par with R&D to Enhance Quality and Skilled

Scientific Personnel

5.Reviving Indian Drug Intermediate Industry

6.Looking At Narcotics Formulations as an Important Opportunity and Not Just a

Menace


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7.Reviving Fermentation Capabilities of India

8.Attracting Talent to Chemistry, Biology and Law

9.Thrust in developing Economies

10.Shared Marketing Services

11.Identifying Strategies to Participate In Regional Clusters

12.Anti-diversion Mechanism in case of exports against compulsory

licensing

Accelerating the Growth ofGeneric Pharmaceutical Industry


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Enhancing Indias R&D

1.Treatment of R&D Expenditure for Tax Purposes

2.Permitting Commercial R&D Subsidiaries for Tax Exemption

3.Focusing on Immediately Commercialisable technologies By Government

Institutions

4.Banks should provide certain capital for taking up commercialisable R&D

5.Encouraging Public Private Initiatives in R&D

6.Intense scrutiny of patentability of research is needed for grant of funds

7.


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7.R&D Incubators to Promote Entrepreneurship and New Ventures

8.Enhancing Availability of Clinical Investigators/Researchers

9.Enhancing Capacity for Clinical Trials, Animal Toxicity/BE centres

10.Facilitate Learning and Legislation with Respect to IRBs

11.Service Tax Exemptions for Pharmaceutical R&D

12.VC Funding for CROs to Promote Value Chain in Drug Discovery

13.Major impetus to R & D should be given through the creation of synergybetween the industry and academia where the cluster model of the UnitedStates could be adopted.

14.

Enhancing Indias R&D


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1.Government should promote capacity building in testing laboratories for stability

studies

2.Bioequivalence studies and third party analytical laboratories urgently through

policy action

3.Appropriate incentives and venture capital. Such facilities can be made available

to SMEs at Subsidized rates to reduce entry barriers and encourage

competition from start-ups in drug

4.Discovery and other key growth segments.

Contract Manufacturing



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Fostering Indian Clinical Trials Industry



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1.Enhancing Availability of Clinical Investigators/Researchers

2.Enhancing Capacity for Clinical Trials, Animal Toxicity/BE centres

3.Government Body Should Facilitate Learning and Legislation with

Respect to IRBs

4.Simplifying approval procedures for Clinical Trials Export/Import

Materials

5.Service Tax Exemptions for pharmaceutical R&D

6.VC Funding for CROs to Promote Value Chain in Drug Discovery

7.Decentralisation of Approval System


Fostering Indian Clinical Trials Industry


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In 2008, India exported herbal products worth US$ 116.8 million.

AYUSH products worth US$ 85.9 million.

In the last four years (2004-2008), growth in exports of AYUSH products

(CAGR:16.75%) was higher than that of herbal products (13.98%).

200,000 U.S. adults used Ayurvedic medicine in the previous year.Many of the significant Indian plants do not find place in the list of

importable herbs in many countries. For example,

TGA Australia does not recognize any of the Indian

pharmacopoeias while it recognizes Pharmacopoeia of the PRC of China


Background of AYUSH Industries in India


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World market for Natural Products US $ 62 billion and having

double digit growth.

Market for Dietary supplements growing in both USA and EU

markets.

More than 70% of population in developed countries have tried

and regularly depend on Natural products for health care

solutions



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Background of AYUSH Industries in India


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Focus Product scheme : Top 25 plants and top 50 formulation thrust

The Vishesh Krishi and Gram Udyog Yojana (VKGUY) should also includeextracts as well as compounds isolated from the herbs so identified underthe Focus product scheme.

Ethanol availability to recognized Ayush industries producing theseproducts should be on a fast track basis.

It is mandatory to submit batchwise testing report for all Herbal,AyurvedaSiddha, Unani medicines that are exported from approved laboratories,

certifying that heavy metals are within permissible limits

China has the maximum number of medicinal plant species (4,941), and itis also the worlds top exporter of medicinal plants

India 2nd in terms of volume, 4th after USA and Germany in terms ofvalue.


Helping The Ayush Industry


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Provide a meaningful financial assistance (for example Rs. 50 lakhs) as a

grant if the product satisfies certain parameters such as:

Complies with guidelines on heavymetal/pesticide/mycotoxin/microbial residues

Efficacy is proven by controlled trials

Analytical/chromatographic methods have been developed whichfacilitate both qualitative and quantitative estimation of ingredients

At least 2 publications in reputed journals of pharmaceuticals on the

product.


Helping The Ayush Industry


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1.Partner countries may not include pharmaceuticals in their sensitive lists.

2.Drug registration process in partner countries may be harmonized and shouldnot become a Non-Tariff Barrier (NTB).

3.NTBs such as sanitary and phyto-sanitary regimes may not be adopted or ifadopted may be harmonised.

4.A mutual pharmaceutical cooperation regime can be negotiated which can

complement each others capacities. Since United States adopts a marketrestrictive approach in respect to pharmaceutical exporting countries whichdo not have free trade agreements with United States, it may be a good ideato examine the likelihood of entering into an enabling agreement with the USwhich would negate this artificial barrier created by US

International CO-operation



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1.Multiple Approvals by Various Drug Regulatory Authorities2.3.Legislation for Import Permissions Should be Strengthened4.

5.Bioequivalence Studies for Generics in Local Populations An EmergingTechnical Barrier: Japan, Mexico and now Thailand, etc., want thebioequivalence to be studied in their local populations in their countries.

6.7.Drug Registration Fees : Realigning Registration Fees for Formulations APIs

and Intermediates on par with other countries

8.9.Reference Standards10.11.Requirement for Local Presence12.

Technical barriers to Trade



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7.Government Procurement : USA government bidding;

Eg, India chile usa case

7.Counterfeit & Spurious Drugs

8.Drug Regulatory Information Availability : language and subjective regulations.Centralised Regulatory Support for Export Promotion

9.European Regulation of REACH - an Emerging Barrier :Making indian price nomore competitive

Technical barriers to Trade



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1.Price Controls : Fixing the overall marketing expenditure and trade discounts aspercentage of sales for all existing products. Such a mechanism will helpavoidance of low investments in quality and help industry to reach global

standards.

2. Quality and GMP Regulation : For example, based on manufacturers fromcountries like India, Wal-Mart is able to give monthly supply of select drugs for justUS$ 4 per month. This clearly dispels the fear of cost escalation while pursuingquality.

3.Foreign Site Inspections

4. Orientation & Training of Personnel involved in Drug Regulation and control1.5. Amendments to procedures

Aligning Internal Regulation



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Role Of PharmexcilRole Of Pharmexcil


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Thank youThank you

Any

Questions..???????


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