building regulatory capacity indian experience
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BuildingRegulatory Capacity Indian Experience
Debasish PandaJoint Secretary
MINISTRY OF HEALTH, GOVT. OF INDIA.E-mail: debasish.panda@nic.in / www. cdsco.nic.in
Strong Pipeline
Good Quality
First on Market
International Sales Network
Low cost supply
Best People
Develop Products for
Markets
Strong External Growth
KEY EMPHASIS
SUCCESS
INDIAWorld’s largest democracy
Population: > 10,00,00,00,00
Area: 3,287,263 sq. km.Age distribution:
<14 yrs=33% 15-64 yrs=60% >65%=7%
China
US
India
JapanGermany
India
BrazilChinaRussia
India is an emerging economic superpower…
India would become the third largest economy after USA and China by 2050.
India's GDP will reach •$ 1 trillion by 2011•$ 2 trillion by 2020
•$ 3 trillion by 2025
•$ 6 trillion by 2032
•$ 10 trillion by 2038, and
•$ 27 trillion by 2050
In terms of GDP, India will overtake
• Italy by the year 2016•France by 2019
•UK by 2022
•Germany by 2023, and
•Japan by 2032
Among the BRIC group India alone has the potential to show the highest growth (over 5 percent) over the next 50 years.
China Overtakes the G3; India is Close Behind
India Shows Most Rapid Growth Potential of the BRICS
The Largest Economies in 2050
Changing Scenario in the Drug Sector
1947 1970 1990 2000 2006No. of Units
100 2000 6000 9000 10000
Volume of BusinessLocal $ 2.5 million $ 200
million$ 3 billion $ 5 billion $ 9billion
Export Nil $ 0. 5 billion
$ 1. 5 billion $ 3 billion $ 6 billion
Types / Categories of products
Tablets, Liquids Capsules Powders & Tinctures
APIsVaccines
MDIs, Injectables, LVP with FFS Technology
Biotech Products, Prefilled Syringes, NDDS
Biotech Products, Prefilled Syringes, NDDS, Medical Devices
Indian Pharmaceutical IndustryIndian Pharmaceutical Industry
Global ranking in volume terms 4th , Value terms 13th
Amongst top 3 worldwide API production centersProducts sold to over 100 countries World Class quality products
The size of Indian Pharmaceutical industry is about $15billion.
Indian Pharmaceutical IndustryIndian Pharmaceutical Industry
The domestic market is about $9billionExport of generics accounts for 40% of the Pharma sector revenuesMost competitive prices in the world ~ 8-10% of international pricesLargest number of USFDA approved site out side USALarge number of Drug Master File (DMF) filed by Indian pharmaceutical company to USFDA and got approval
Indian Pharmaceutical Industry: Indian Pharmaceutical Industry: EXPORTSEXPORTS
$6 bn
$0.01bn
$2.94bn$2.9bn
$3.53bn
$4.25bn
0
5000
10000
15000
20000
25000
30000
1980-81
1990-91
2000-01
2001-02
2002-03
2003-04
2004-05
2006-07
1980-811990-912000-012001-022002-032003-042004-052006-07
$2.10bn
$0.19bn$0.5bn
$1bn
$1.5bn
$2bn
$2.5bn
$3bn
$3.5bn
$4bn
$4.5bn
Impact on Globalization
Requirements due to GlobalizationGMPDMF ConceptNational Pharmacovigilance ProgrammeIndependent agency for standardsEffective market surveillanceConsumer Information (Package Insert)Registration of Foreign Site/Mutual RecognitionParticipation in Global Harmonization
DRUGS CONTROLLER (INDIA)
HEAD QUARTER SUB ZONALOFFICE (3)
ZONALOFFICE (4)
LABORATORY(6)
PORT OFFICE(7)
•New Drugs•CLLA•Imports•DTAB•I.P.•Parliament•Misc.
•GMP Audits•Coordinations with States
•GMP Audits•Coordinations with States
•Import•Export •Testing of drug
Samples•Validation of Test protocol
DRUGS CONTROLLER/ COMMISSIONER
DEPUTY DRUGS CONTROLLER
DRUGS TESTING LABORATOTY
DRUGS INSPECTOR
SUPPORTING STAFF
STATE DRUGS CONTROL ORGANISATIONSTATE DRUGS CONTROL ORGANISATION
GOVT. ANALYST
ANALYST
SUPPORTING STAFF
Drugs Inspectors About 1040Drugs Manufacturers : “ 9000Loan Licensees ” 2000cosmetics Manufacturers “: 2200Sales Premises “: 3,50,000
Strengthening of Drug Regulatory System
Capacity building of regulatory personnelAugmentation of manpower and infrastructure Legislative amendments
Penal ProvisionsCDA Bill
• Capacity building of regulatory personnel– Training under capacity building project at
National Institute of Pharmaceutical and Educational Research (NIPER) during Jan 2004 to June 2008.
– More than 500 Drugs Inspectors have been trained on GMP and other different aspects of Drug Regulations.
– More than 450 analysts from Govt. Testing laboratories have been trained on GLP and other aspects of Drug regulations.
Strengthening of Drug Regulatory System
Strengthening of Drug Regulatory System
• Augmentation of manpower and infrastructure– 68 new posts of Drugs Inspectors and 10 Posts of technical
officers have been created and steps are being taken to fill-up all these posts.
– New FDA building has been commissioned and started functioning.
– Process of bringing all the State and Zonal offices under a common server has been initiated.
– Five existing Drug Testing Laboratories under Central Govt. have been upgraded and created a new one.
– Modern equipment and financial assistance were provided to all 22 existing State Drug testing laboratories.
Strengthening of Drug Regulatory System
• Legislative amendments
– A bill has been introduced in the Parliament to amend Penal Provision (minimum 10 years which may extended to life imprisonment with fine of one million rupees for manufacture, sale and distribution of Spurious Drugs)
– A bill has been introduced in the Parliament to amend the Act for creation of “Central Drug Authority”
MINISTRY OF HEALTH, GOVT.OF INDIA
Central Drugs Authority
Chairman
Members (3-5)
Drugs Controller General (INDIA)
PROPOSED STRUCTURE OF CDA
Main divisions of CDA – 10Regulatory Affairs & EnforcementNew Drugs & Clinical TrialsBiological & Biotechnology ProductsDivision for PharmacovigilanceDivision for Medical Devises and Diagnostics
Contd..
Division for Imports Division for Organizational services Division for Training & Empowerment Division for Quality Control AffairsDivision for Legal & Consumer Affairs
Indian Pharmacopoeia Commission (IPC)
• IPC has been registered as a Society on 9th Dec. 2004.• It is an autonomous Institution under the Ministry of
Health and Family Welfare, Govt. of India.• Dedicated for setting of Standards for Drugs,
Pharmaceuticals and Health Care Devices/Technologies etc.
• To publish Indian Pharmacopoeia which is an official and legal book of Standards for Drugs (IP 2007 has been published in Dec 2007).
• Providing reference substances and training.
• Objective– To develop comprehensive monographs for Drugs to be
included in the Indian Pharmacopoeia (IP).– To develop monographs for Herbal Drugs, both raw
drugs and extracts/formulations therefrom.– To give special attention to detect impurity profile of
the raw materials.– Framing the monographs considering the level of
sophistication in analytical testing.
Indian Pharmacopoeia Commission (IPC)
Indian Pharmacopoeia Commission (IPC)
• Objective contd……– Distribution of IP Reference Standards including
Related Substances (RS), Impurities and degradation products.
– To collaborate with other International Pharmacopoeias to Harmonize with Global Standards (a MOU has been signed between IP Commission and USP Convention on 1st Aug. 2006).
– To review existing monographs periodically for up gradation/revision.
Indian Pharmacopoeia Commission (IPC)
• Scientific Wing– Research and Development– Pharmaceutical Chemistry – Pharmacology– Microbiology – Pharmacognosy– Medical Devices– Library, Information and Publications– Sample Warden– Reference Standard.
Medical DevicesThe current Indian medical device market is estimated to be worth around 3 billion USD and out of these $2.5 billion worth devices are being imported. Presently regulated as Drugs (which are notified by Government of India)Step to form separate regulations as per international normsDevelopment on the basis of Global Harmonization Task Force ( GHTF)Guidelines being formulated with active participation of all stakeholdersCore groups formed for recommendations
Biotech ProductsAll Biotech Products considered as New DrugsRequire permission from DCG(I) Approval of Genetic Engineering Approval
Committee (GEAC)Approval of Review Committee on Genetic
Manipulation (RCGM) under DBT
Stem Cell ResearchRegulated on the basis of guidelines for Stem Cell
Research and Therapy issued by ICMRNational Apex Committee for Stem Cell Research
and Therapy (NAC-SCRT)Institutional Committee for Stem Cell Research
and Therapy (IC-SCRT)Health Minister’s Screening Committee ( HMSC)Institutional Ethics Committee( IEC)Institutional Animal Ethics Committee (IAEC)
Stem Cell Research
Two centers recognized by Federal Government for stem cell researchNational Centre for Biological Sciences, BangaloreReliance Life Science Laboratories, Mumbai
E-governance
• IT enabled services• E-Filing of All Applications • Resource Center• Legal Affairs and Consumer Cell
National Pharmacovigilance Programme
N N N N N S S S S SS E E E E E W W W W W
CDS OC
S S S S S W W W WEEEEENNNNN
NPAC = National Pharmacovigilance Advisory Committee(CDSCO), ZRP = Zonal Pharmacovigilance Centre (Delhi & Mumbai), RPC = Regional Pharmacovigilance Center
(Delhi,Kolkata,Mumbai,Nagpur & Pandicherry)PPC = Peripheral Pharmacovigilance Centre (26)
N N N N N S S S S SS E E E E E W W W W W
CDS OC
S S S S S W W W WEEEEENNNNN
Aims and Objectives of National Pharmacovigilance
Programme
To generate broad based ADR data on the Indian population and share the information with global health-care community through WHO.
To ensure optimum safety of drug products in the Indian market .
To provide technical expertise for evaluating statutory AE reports furnished by sponsors conducting clinical trials in India.
Responsibilities of National Pharmacovigilance Advisory
CommitteeExamine the ADR data generated by centersRisk-benefit analysis of drugs marketed in the countryAdvise Government regarding safe use of drugsMonitor functioning of National Pharmacovigilance Programme and give inputs for the better functioning of the programme from time to time.
INTERNATIONAL COLLOBORATION
WHOHealth CanadaMOU with Brazil/South AfricaTechnical Corporation with USFDA(Clinical Trail, Pharmacovigilance programme,
Medical Devices , IT-Enabled Services etc.)
INTERNATIONAL COLLOBORATION
WHO /Health Canada• A team of WHO (HQ) and Health Canada visited India to
develop the road map for strengthening the Indian NRA in two phases.
• Ist Phase To recognize the biological Department, Develop appropriate documentation against a Quality Assurance SystemDeliver the Ist training programme.
• IInd Phase To establish two expert committees to provide technical expertise in the area of Vaccine Licensing and oversight registration of Clinical trials.To develop a continuous education programme.
INTERNATIONAL COLLOBORATION
• Road map of the activities– Phase –I
• April 08 : formal agreement between WHO/Health Canada and Indian Govt. to implement the Institutional development plan.
• May 08: Development of the training module for the in Country licencing course.
• May/June 08 : reorganization of the Vaccine cell• July 08 : Training course on licensing to be
delivered by Health Canada and WHO at Ottawa and Geneva.
INTERNATIONAL COLLOBORATION
• Road map of the activities– Phase –II
• Aug 08: Further Training of CDSCO personnel in India.
• Sept./Oct. 08: observed review applying the revised licenced process.
• Nov. 08: Advance training on Regulatory Inspections.
• Dec 08 : tentative date for WHO formal reassessment
Outsourcing Opportunities
Outsourcing Opportunities -
India
Bulk Drugs&
FormulationsManufacturing
BioinformaticsBiostatistics
SoftwareDevelopment
ContractMarketing &
Sales
International Clinical Trials
Technical Services
HerbalsNeutraceuticals
ContractR&D
TurnkeyProjects
Plant Machinery
&Pharma
Equipment
PrimaryPackaging Materials
Driving forces behind expansion of the industry
Driving ForceAdvantages in cost structure
Process -environment equation
Development of NCEs/ preliminary testing
Growing demand for multi-source products in emerging economies
Price pressure in generic segment
Companies moving up the value chain
Source
Affiliates of MNCs
Established companies with R&D infrastructure
Companies with:
- Technological competence
- Export/international
orientation
- Strong process skills
Advantage India
- Established Strengths in Process Chemistry– Rich Pool of Scientists– Diverse genetic pool such as Caucasians, Mongoloids
and Australians– Networking Ease– Clinical Trial Research - Superior Benefits
- Huge Patient Data- Diversity of Diseases- High quality hospitals- Competent Medical Professionals- Timely regulatory approvals- Low cost services- Increasing Acceptance of IPR
India - Opportunities1. Skilled Manpower : Availability of a talented pool of
English speaking doctors, basic research scientists & life science personnel.
2. Patient Enrolment : India constitute 1/6th of the entire
globe and patient enrolment can be really fast thereby expediting the
new drug development process. Most of the patients are treatment
naive as well.
3. Wide Spectrum of Disease: Presence of tropical and sub-tropical diseases increases the scope of research across various therapeutic areas in India.
India – Opportunities…
4. Economy: The cost of Manufacturing, Research & conducting clinical trials in India is low.
5. Economic Environment: Indian economic environment is quite favorable for foreign direct investment andGovt. of India allows 100% subsidiary of a foreign company .
6. Data Quality: Over the years Indian investigators have participated in several US & European registration trials and the acceptance of data by the respective regulatory agency speaks about the quality of data generated by Indian investigators
India’s Clinical Trials Market
Source: CenterWatch, 2003; Company reports and interviews
• 2002 Industry Spending on CR Services and Investigator Grants $100 to $150 Million
• Estimated Number of Active ICH-GCP Clinical Studies Conducted in 2002 40 to 50
• Estimated Number of Active GCP Trained Principal Investigators in 2002 200 to 250
• 2010 Projected Industry Spending onCR Services and Investigator Grants ~ $ 2 Billion
Applicable GCP Guidelines in India
• ICH GCP Guidelines, 1997• Ethical Guidelines for
Biomedical Research on Human Subjects,2006 (ICMR Code)
• Indian GCP guidelines (2001)in line with the latest WHO, ICH, FDA, and MHRAguidelines
• Revision of Schedule Y(2005)
Emerging Scenario (Clinical Research & Industry)
Vigilant Ethics Vigilant Ethics CommitteesCommittees
Ongoing reviews
AE AE ReportingReporting
GCPGCP QCQC
Regulatory Regulatory InspectionsInspections
Trained Trained InvestigatorsInvestigators
Credible DataCredible Data
Safe Pharmaco-
therapeutics
Regulatory body Approval Average Time
Drugs Controller General of India (DCGI)
•For Global clinical study•For Investigational New Drugs (IND)
•For New Drug Approval
4 to 6 weeks12 weeks
6 to 8 weeks
Drugs Controller General of India (DCGI)
Test license to import drugs for test and analysis
3 to 4 weeks
Drugs Controller General of India (DCGI)
NOC for export of New Drugs
3– 4 weeks
Drugs Controller General of India (DCGI)
Registration of foreign Mfg. Site and its products.
25 weeks
State Licensing Authority Grant of Mfg. License 12 to 25 weeks
- Typical Timelines for Regulatory Approvals -
Regulatory Approval
Recent India Regulatory Reform makes Approvals Possible within 6 weeks.
What India can offer to World market
Synthesis of Huge Quantities of APIs
for Clinical Trial Programs
Clinical Trials for a Large Number of
New Drugs
Software Solutions and Analysis of
Clinical Data
Toxicology & Pharmacology Studies
What India can offer to World market
Contract manufacturing for Global Supply of APIs
Quality Generic Products
Process Technologies
Pharmaceutical Manufacturing Equipment
Alternate Medicines - Ayurvedic & Herbal
MNC-India Partnership
MNCs who left earlier are back on
Indian shores.
World generic companies like
TEVA, Apotex, Hexal Pharma,
Altana Pharma have also set up
bases in India specially for
carrying out R&D in Pharma.
To summarize….
India has a great advantage to become a dominant player in the global pharmaceutical industry.
Compelling fundamentals will drive the growth of the clinical development sector in India
Potential for innovation & sector transformation
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