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Indian Pharmacopoeia Commission
Dr. G. N. SinghSecretary‐cum‐Scientific Director,
JP 130th Anniversary SymposiumTokyo, Japan 15th Sept, 2016
Indian Pharmacopoeia Commission
Overview
• Indian Pharmaceutical Industry
• Pharmacopoeia and NFI
• IP Reference Substances
• International Cooperation & Harmonization
• Skill Development Programmes
• Way Ahead 2020
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Indian Pharmacopoeia Commission
Indian Pharmaceutical Industry – A Profile
3
Type of Manufacturing Unit Number of Units (Approx)
Formulations 4900
Active Pharmaceutical Ingredients 1500
Vaccines 30
Medical Devices 350
Miscellaneous (Surgical dressings, Blood banks, Disinfectants etc)
2850
Other IndustryCosmetics 2300
Ayurveda and Unani 4800
Homeopathy 1000
Whole sale and Retails 800,000
Indian Pharmacopoeia Commission
Indian Pharmaceutical Industry – A Profile
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Size of the Industry USD 32 Billion
Export USD 17 Billion
Domestic market USD 15 Billion
Average Growth Rate 9- 10 %
Imports USD 3.5 Billion
Exported to 205 countries / economies
Volume of Production 3rd Largest in the world
Value of production 10th in the world
USFDA Approved sites(Formulations + API)
605
EU GMP compliance sites 631
COPP holding sites 1400 (approx)
Indian Pharmacopoeia Commission
Indian Pharmacopoeia Commission
Sector‐23, Raj Nagar, Ghaziabad ‐ 201002, Uttar Pradesh
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Indian Pharmacopoeia Commission
Introduction
• The Commission has become operational from 1st Jan., 2009 as anAutonomous Institution, under administrative control of theMinistry of Health & Family Welfare, Government of India.
• The Indian Pharmacopoeia commission has a three‐tier policyformulation and execution setup comprising of the General Body,Governing body and Scientific Body with experts drawn fromvarious Science & Technology areas.
• The Secretary‐cum‐Scientific Director is the Chief Scientific andChief Executive Officer
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Indian Pharmacopoeia Commission
Composition of Commission
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IPC Secretariat
IPL
Governing Body
General Body
Scientific Body
IPC
Indian Pharmacopoeia Commission
Vision
To promote the highest standards of drugs for use inhumans and animals within practical limits of thetechnologies available for manufacturing and analysis.
MissionTo promote public health and animal health in India bybringing out authoritative and officially acceptedstandards for quality of drugs including activepharmaceutical ingredients, excipients and dosageforms, used by health professionals, patients andconsumers.
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Indian Pharmacopoeia Commission
Mandate
• To publish new edition and addendums of the Indian Pharmacopoeia.
• To publish the National Formulary of India.
• Certification and distribution of IP Reference Substances.
• National Coordination Centre (NCC) for running Pharmacovigilance Programme of India (PvPI)
• To establish working relations with other similarly placed institutions at National and International level.
• To organize educational programs, skill development and research activities.
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Indian Pharmacopoeia Commission
Publication of Indian Pharmacopoeia
(By IP Committee)
Edition Year I 1955Supplement 1960II 1966Supplement 1975III 1985Addendum 1989 & 1991IV 1996Addendum 2000Vet Supplement 2000 Addendum 2002
(By IP Commission)
Edition Year Addendum 2005V 2007Addendum 2008VI 2010Addendum 2012VII (New Edition) 2014Addendum 2015Addendum 2016VIII 2018
(Under Preparation)
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Indian Pharmacopoeia Commission
Latest Edition : IP 2014
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Indian Pharmacopoeia Commission
Monographs Developed
8861143
1623
1968
2756
0
500
1000
1500
2000
2500
3000
1985 1996 2007 2010 2014
No of M
onograph
s
IP
12
Indian Pharmacopoeia Commission
IP‐ Addendum‐2015 to IP‐2014
57 New Chemical monographs
13 New Herbal monographs
02 New Human Vaccines Monographs
10 Radiopharmaceutical Monographs
06 Revised monographs
29 Revised tests
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Indian Pharmacopoeia Commission
IP Addendum ‐2016
• 64 New Chemical Monographs
• 14 New Herbal Monographs
• 03 New Human Vaccines Monographs
• 03 Radiopharmaceutical Monographs
• 04 Biotechnology Products
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Indian Pharmacopoeia Commission
National Formulary of India
15
• A guidance document toMedical PractitionersPharmacist, Nurses, Medical andPharmacy Students, otherHealthcare Professionals andstakeholders in healthcareSystem.
Indian Pharmacopoeia Commission
NFI‐ Special Features
• Total drug monographs 521
• Chapters 33
• Fixed dose combinations (FDCs) 33
• Immunological 20
• Vitamins 12
• Unique, highly informative and 22
useful Appendices
Indian Pharmacopoeia Commission
Availability of IP Reference Standards
17
2057
112
273
347
422466
550
10
100
200
300
400
500
600
2009‐10 2010‐11 2011‐12 2012‐13 2013‐14 2014‐15 2015‐16 2016‐17
No. of IPR
S
Year
Indian Pharmacopoeia Commission
Availability of Impurity Standards
18
1020
30
50
100
10
20
40
60
80
100
120
2012‐13 2013‐14 2014‐15 2015‐16 2016‐17
No. of Impu
rity Stan
dard
Year
AVAILABILITY OF IMPURITY STANDARD
Indian Pharmacopoeia Commission
Indian Pharmacopoeial Laboratory
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Indian Pharmacopoeia Commission
Indian Pharmacopoeial Laboratory
• ISO Guide 34 : 2009 for “Reference Material Producer”
• WHO Pre‐qualified for Quality Control Laboratory
• ISO/IEC 17025:2005 Accredited for Chemical and
Biological Analysis.
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Indian Pharmacopoeia Commission
International Cooperation
• World Health Organization (WHO)
• European Directorate for the Quality of
Medicines (EDQM)
• Japanese Pharmacopoeia (JP)
• United States Pharmacopeia (USP)
• Chinese Pharmacopoeia (ChP)
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Indian Pharmacopoeia Commission
International meeting of World Pharmacopoeias
• Active participation in World Pharmacopoeias
Meetings for WHO Good Pharmacopoeia Practices
(GPhP)
• Strengthening Global Pharmacopoeia Cooperation
• GPhP will enable transparency on development of
Pharmacopoeial Standards
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Indian Pharmacopoeia Commission
Second International Meeting ofWorld Pharmacopoeias
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18‐19 April 2013, New Delhi, India
Co‐hosted by the Indian Pharmacopoeia Commission and WHO
Discussion of DRAFT Good Pharmacopoeial Practices
Indian Pharmacopoeia Commission
JP ‐ IPC Meeting
24
PMDA , JP team visited at IPC on 28th May 2015
Indian Pharmacopoeia Commission
PMDA ‐ IPC Meeting
25
Group photo of IPC and PMDA team
Indian Pharmacopoeia Commission
International Cooperation
• Significant contribution in drafting Good
Pharmacopoeial Practices, Chapters on
Analytical Method Development, Validation
& Herbal monographs
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Indian Pharmacopoeia Commission
International Harmonization
IPC strengthen its efforts to work with
– Pharmacopeias,
– Industry,
– Academia,
– Regulators,
– Stakeholders
to develop harmonized global standards
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Indian Pharmacopoeia Commission
International Harmonization
• Discussion with other pharmacopoeias
• Exploring scientists exchange programme
• International training programme
• Resolving regional issues
• Conferences / symposia
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Indian Pharmacopoeia Commission
International Harmonization
• Focusing to Harmonize General Chapters of IP withother World Pharmacopoeias
• Updating the monographs with new Science andTechnology inputs
• Coordinating and contributing with WHO for GoodPharmacopoeial Practices for Chemical and HarbelMonographs
• Active participation in development of InternationalChemical Reference Standards organised by EDQM andWHO
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Indian Pharmacopoeia Commission
Skill Development
IPC organizes skill development programs/ workshops for professional:• Analysts (Hands on training)• Drug Regulators• Research Students• Stakeholders
Offers training for Analysts and Regulators fromSAARC & ASEAN countries
Offers support for Standards setting in Pharmaceuticals
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Indian Pharmacopoeia Commission
Way Ahead: 2020
• Targeting for 800 IPRS.
• Targeting 300 Impurity Standards
• Enhancing the scope of Green Analytical Chemistry.
• Establishing the State‐of‐the‐art laboratory as
Referral Laboratory for Analytical investigations.
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Indian Pharmacopoeia Commission
Way Ahead: 2020
32
To make functioning the Advanced Level Research Center by 2017
Indian Pharmacopoeia Commission
Expectations form JP
Mutual cooperation for developing the
Pharmaceutical Standards.
Bilateral cooperation on skill development of
Professionals including training for the trainers.
Knowledge sharing for mutual benefit and
opening new areas of collaboration.
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Indian Pharmacopoeia Commission
Expectations form JP
IPC offers Indian Pharmacopoeia as a
trustworthy Reference Pharmacopoeia to
PMDA and expects it to be utilize for
ensuring the Quality of Pharmaceuticals in
Japan.
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Indian Pharmacopoeia Commission
Thank you !!ありがとうございました
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Arigatou gozaimasu
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