Indian Pharmacopoeia Commission - Pmda

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Indian PharmacopoeiaCommissionJP 130th Anniversary SymposiumTokyo, Japan15th Sept, 2016Dr. G. N. SinghSecretary‐cum‐Scientific Director,

Overview Indian Pharmaceutical Industry Pharmacopoeia and NFI IP Reference Substances International Cooperation & Harmonization Skill Development Programmes Way Ahead 2020Indian Pharmacopoeia Commission2

Indian Pharmaceutical Industry – A ProfileType of Manufacturing UnitNumber of Units(Approx)Formulations4900Active Pharmaceutical Ingredients1500Vaccines30Medical Devices350Miscellaneous (Surgical dressings, Bloodbanks, Disinfectants etc)2850Other IndustryCosmetics2300Ayurveda and Unani4800Homeopathy1000Whole sale and RetailsIndian Pharmacopoeia Commission800,0003

Indian Pharmaceutical Industry – A ProfileSize of the IndustryUSD 32 BillionExportUSD 17 BillionDomestic marketUSD 15 BillionAverage Growth Rate9- 10 %ImportsUSD 3.5 BillionExported to205 countries / economiesVolume of Production3rd Largest in the worldValue of production10th in the worldUSFDA Approved sites(Formulations API)605EU GMP compliance sites631COPP holding sites1400 (approx)Indian Pharmacopoeia Commission4

Indian Pharmacopoeia CommissionSector‐23, Raj Nagar,Ghaziabad ‐ 201002, Uttar PradeshIndian Pharmacopoeia Commission5

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 OfficerIndian Pharmacopoeia Commission6

Composition of CommissionGeneral BodyGoverning BodyIPCScientific BodyIPCSecretariatIndian Pharmacopoeia CommissionIPL7

VisionTo 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.Indian Pharmacopoeia Commission8

Mandate To publish new edition and addendums of the IndianPharmacopoeia. To publish the National Formulary of India. Certification and distribution of IP Reference Substances. National Coordination Centre (NCC) for runningPharmacovigilance Programme of India (PvPI) To establish working relations with other similarly placedinstitutions at National and International level. To organize educational programs, skill development andresearch activities.Indian Pharmacopoeia Commission9

Publication of Indian Pharmacopoeia(By IP Committee)(By IP umIVAddendumVet ndum2008VI2010Addendum2012VII (New Edition)2014Addendum2015Addendum2016VIII2018(Under Preparation)Year195519601966197519851989 & 19911996200020002002Indian Pharmacopoeia Commission10

Latest Edition : IP 2014Indian Pharmacopoeia Commission11

Monographs Developed30002756No of 996200720102014IPIndian Pharmacopoeia Commission12

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 testsIndian Pharmacopoeia Commission13

IP Addendum ‐2016 64 New Chemical Monographs 14 New Herbal Monographs 03 New Human Vaccines Monographs 03 Radiopharmaceutical Monographs 04 Biotechnology ProductsIndian Pharmacopoeia Commission14

National Formulary of India AguidancedocumentMedicaltoPractitionersPharmacist, Nurses, Medical akeholdersinandhealthcareSystem.Indian Pharmacopoeia Commission15

NFI‐ Special Features Total drug monographs521 Chapters33 Fixed dose combinations (FDCs)33 Immunological20 Vitamins12 Unique, highly informative and22useful AppendicesIndian Pharmacopoeia Commission

Availability of IP Reference Standards600550500466No. of IPRS4224003472733002001121005720012009‐10 2010‐11 2011‐12 2012‐13 2013‐14 2014‐15 2015‐16 2016‐17YearIndian Pharmacopoeia Commission17

Availability of Impurity StandardsAVAILABILITY OF IMPURITY STANDARD120100No. of Impurity Standard1008060504020302010102012‐13Indian Pharmacopoeia 18

Indian Pharmacopoeial LaboratoryIndian Pharmacopoeia Commission19

Indian Pharmacopoeial Laboratory ISO Guide 34 : 2009 for “Reference Material Producer”WHO Pre‐qualified for Quality Control LaboratoryISO/IEC 17025:2005 Accredited for Chemical andBiological Analysis.Indian Pharmacopoeia Commission20

International Cooperation World Health Organization (WHO) European Directorate for the Quality ofMedicines (EDQM) Japanese Pharmacopoeia (JP) United States Pharmacopeia (USP) Chinese Pharmacopoeia (ChP)Indian Pharmacopoeia Commission21

International meeting of WorldPharmacopoeias Active participation in World PharmacopoeiasMeetings for WHO Good Pharmacopoeia Practices(GPhP) Strengthening Global Pharmacopoeia Cooperation GPhP will enable transparency on development ofPharmacopoeial StandardsIndian Pharmacopoeia Commission22

Second International Meeting ofWorld Pharmacopoeias18‐19 April 2013, New Delhi, India Co‐hosted by the Indian Pharmacopoeia Commission and WHO Discussion of DRAFT Good Pharmacopoeial PracticesIndian Pharmacopoeia Commission23

JP ‐ IPC Meeting PMDA , JP team visited at IPC on 28th May 2015Indian Pharmacopoeia Commission24

PMDA ‐ IPC MeetingGroup photo of IPC and PMDA teamIndian Pharmacopoeia Commission25

International Cooperation Significant contribution in drafting GoodPharmacopoeialPractices,ChaptersonAnalytical Method Development, Validation& Herbal monographsIndian Pharmacopoeia Commission26

International HarmonizationIPC strengthen its efforts to work with– Pharmacopeias,– Industry,– Academia,– Regulators,– Stakeholdersto develop harmonized global standardsIndian Pharmacopoeia Commission27

International Harmonization Discussion with other pharmacopoeias Exploring scientists exchange programme International training programme Resolving regional issues Conferences / symposiaIndian Pharmacopoeia Commission28

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 andWHOIndian Pharmacopoeia Commission29

Skill Development IPC organizes skill development programs/ workshopsfor 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 PharmaceuticalsIndian Pharmacopoeia Commission30

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 asReferral Laboratory for Analytical investigations.Indian Pharmacopoeia Commission31

Way Ahead: 2020 To make functioning the Advanced Level Research Centerby 2017Indian Pharmacopoeia Commission32

Expectations form JP MutualcooperationfordevelopingthePharmaceutical Standards. Bilateral cooperation on skill development ofProfessionals including training for the trainers. Knowledge sharing for mutual benefit andopening new areas of collaboration.Indian Pharmacopoeia Commission33

Expectations form JP IPC offersIndian Pharmacopoeia as atrustworthy Reference Pharmacopoeia toPMDA and expects it to be utilize forensuring the Quality of Pharmaceuticals inJapan.Indian Pharmacopoeia Commission34

Thank you !!ありがとうございましたArigatou gozaimasuIndian Pharmacopoeia Commission35

Indian Pharmacopoeia Commission Introduction The Commission has become operational from 1st Jan., 2009 as an Autonomous Institution, under administrative control of the Ministryof Health& FamilyWelfare,Governmentof India. The Indian Pharmacopoeia commission has a three‐tier policy formulation and execution setup comprising of the .