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Progress Report on Recommendations of 14th International Conference of Drug

Regulatory Authorities (ICDRA) from WHOSouth-East Asia Region (SEAR)

14th ICDRA, Singapore, December 2010

Dr K A Holloway, Regional AdviserEssential Drugs & Other Medicines, SEARO

New Delhi, India

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WHO South-East Asia Region11 countries

(Bangladesh, Bhutan, DPRK - North Korea, India, Indonesia, Nepal, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, Timor-Leste)

25% of world populationPopulation – ranges from 300,000 to >1 billion

Manufacturing capacities From nil to development of a New Chemical Entity and strong export industry

Regulatory Activities basic to sophisticated

Countries asked to submit progress reports post ICDRA 13Only some countries responded

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Strengthening Drug RegulationIndia: 2007 Bill to create a Central Drug Authority submitted by MOHFW to parliament has been revised by a Parliamentary Standing Committee and will be placed before Cabinet for approvalBangladesh: Department of Drug Administration under the Department of Health Services upgraded to Directorate General of Drug Administration, directly under MOHBhutan: DRA gained autonomy in 2008 and is collaborating with other law and enforcement agencies (Revenue & Customs and Food & Agriculture agencies) for implementing the Medicines Act 2003.Maldives: 1994 drug regulation revised to give stricter penalties for offences – now before parliament; importers given timeline of Dec 2009 to register all drugs

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ASEAN Harmonization of regulationIndonesia implemented ASEAN Common Technical Requirements and ASEAN Common Technical Dossier implemented in 2009

Indonesia conducted WHO Global Learning Opportunity trainings on Clinical Drug Evaluation and Clinical Trial Authorization for Africa & ASEAN

Sharing clinical trial evaluation and doing GCP joint inspections

Sharing Information between DRAs

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Counterfeit MedicinesPerceived as a problem in region; survey in Indian retail shops found 0.046% spurious drugs (11 out of 24,136 samples) Participation in IMPACT – disagreement on definitionSEAR focus on public health impact rather than IP issuesIntercountry workshop on counterfeits Aug 2008Regional Resolution SAE/RC62/R6 in Sept 2009 Agreement with WHA63(10) Substandard/spurious/falsely labelled/counterfeit medical products & formation of IGWG to decide on WHO’s role in combating counterfeit & IMPACTCountry actions

India: Whistleblower policy, designated special courts for speedier processing, stricter penalties – Rs.10 Lakh fine & life imprisonment Indonesia: Establishment of National Integrated Operation and Law Enforcement of Combating against Counterfeit with other Regulatory and enforcement agencies e.g. police and immigration

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Pharmacovigilance and clinical trials Pharmacovigilance (PV)

Nepal: DDA coordinates PV with 5 regional centres & liaises with Uppsala - 412 ADRs reported 2004-2010Bhutan: PV centre established at the DRA with 3 sub-centres in national hospitals/institutesIndia: Revised PV program operationalised in 2010, starting with 40 ADR monitoring centres and expanding to 140 centres in 2011Maldives: 3 focal points identified to collect ADR reports

Clinical TrialsIndonesia: increasing regulator role in clinical trial approval based on WHO and EMA GuidelinesIndia: Centralized Clinical Trial Register initiated 2009 with mandatory registration; draft guidelines & requirements for registration of trials developed to be incorporated as new Schedule Y1 in Drugs and Cosmetics Rules for Schedule Y1.Sri Lanka: Centralized Clinical Trial Register of similar level as in India

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Traditional MedicinesIndia: amendments to Drugs & Cosmetics Act concerning Ayurvedic, Siddha & Unani medicines

allow use of excipients, preservatives, antioxidants, flavouringagents, chelating agents in manufactureGMP guidelines on authenticity of raw herbal drugsProvide shelf-life/expiry dates for potency assurance5-year validity for GMP certificate for manufactureRule on issue of license for manufactureSchedule E1 describes poisonous substances

Bhutan: traditional medicine physicians sensitized on pharmacovigilance and ADR monitoringMaldives: new regulation drafted on import, sales, manufacturing and packaging

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WHO Activities 2008-2010Supported trainings on: GMP, Good Laboratory Practices, Medical Devices Tools for Pre-registration Evaluation, Clinical Trials Inspection, Medical Devices Regulation, cosmetics regulation, vaccine licensing pharmacovigilanceSupported development of: guidelines on GMP, method evaluation for bioequivalence studies, SOPs for DRA, SOPs for National Medicine Lab, SOPs for ethics committees in clinical trials, draft regulations for traditional medicineSupported studies in India on: Good Lab Practices compliance, Accreditation of pharmacies, use of INN, promotional practices of pharmaceutical firmsPrequalification of Indian manufacturers: more than 70% of manufacturers on the list are from India; there is also a WHO PQ lab for QC in India.

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Summary

Drug Regulation remains a high priority for countries of the regionFocus (quality, pharmacovigilance, counterfeits, prequalification, clinical trials) varies from country to country and is “reactive” rather than “proactive”Lack of “political will”, human and financial resources and expertiseSharing country experiences continues to be usefulMany country activities supported by WHODrug Regulation remains a challenge in SEAR