Indian Perspective. J. B. Chemicals & Pharmaceuticals Ltd. Dr Milind Joshi Global Regulatory Management 28 June 07
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1 President Dr Milind Joshi Global Regulatory Management 28 June 07 Drug Regulatory Process Indian Perspective Latin America Copyright 2005 J. B. Chemicals Pvt. Ltd.
2 Regulation Product regulation requires, a balance between protecting public health through an extensive evaluation of a particular product and promoting public health by making needed products available without undue delay.
3 Latin America Drug Exports Under-served patient population of more than 500 million Market worth about USD 41 billion Growth rate 8.5% every year Growth in Prescription Drugs sales 12.7% to USD 33.6 bn Expected to grow to USD 63 billion by 2012 Mexico - USD 14.1 bn Brazil - USD 13.6 bn Argentina - USD 4.7 bn Venezuela - USD 4.0 bn Colombia - USD 1.8 bn Chile - USD 1.5 bn Peru - USD 1.0 bn
4 Latin American Markets Brazil, Mexico, Venezuela, Ecuador and Colombia are some of the major pharmaceutical markets Brazil and Mexico considered Regulated Markets ANVISA : Stringent norms comparable to USFDA Brazil : As per ANVISA s norms,cros used for BE studies have to be approved and certified by the Brazilian authority. For BE studies, innovator product manufactured in Brazil has to be used for comparison
5 Latin American Markets Mexico : Largest LA Market. Brazil : Total market value of US $5.2 billion. Generic market of approx. US $1 billion. ANVISA has implemented generic law to facilitate generic market entry into the country Mexico: Extensive analytical raw data of 3 stability batches. Venezuela : Copies of source data
6 Latin America 1 Brazil 18 Bolivia 2 Mexico 19 Honduras 3 Argentina 20 Paraguay 4 Venezuela 21 Bahamas 5 Chile 22 Nicaragua 6 Colombia 23 Haiti 7 Peru 24 Barbados 8 Ecuador 25 Netherlands Antilles 9 Cuba 26 Suriname 10 Guatemala 27 Belize 11 Dominican Republic 28 Antigua and Barbuda 12 Costa Rica 29 Saint Lucia 13 Trinidad and Tobago 30 Guyana 14 Uruguay 31 Grenada 15 El Salvador 32 Saint Kitts and Nevis 16 Panama 33 Saint Vincent and the Grenadines 17 Jamaica 34 Dominica
7 Drug Regulation Product registration Marketing authorization Monitoring safety and efficacy post-marketing Regulation of drug production, import and distribution Drug marketing Drug information
8 Drug Regulatory Requirements - Technical Manufacturing Facility Inspections Analytical data API, Finished Product Specifications, MoA, References Samples and CoAs Analytical Method Validation (API, FP) Packaging Material Specifications Medical Data Product Information Dissolution Data Bio-equivalence Studies (Study site approval)
9 Drug Regulatory Requirements - Technical Manufacturing Formula and Justification Manufacturing Process Process Validation Batch Numbering Batch Records Stability Studies (Source Data) Accelerated Long Term
10 Drug Regulatory Requirements - Legal Free Sale Certificate / Product Permission GMP Certificate Manufacturing License Power of Attorney / Contract Trademark Registration Contract with local quality control facility
11 Critical Success Factors US FDA / UK MCA / TGA approved facilities Strong Regulatory Support Good Distribution Set up Price Competitiveness Good Marketing Support Strong group for registering products in place Expansion in new markets and new products under feasibility studies
12 Stability Issues CTD norms are taken as guidance for regulatory aspects during drug development Major discrepancies in requirements of storage conditions for various countries Stability studies on three batches - as per ICH guidelines / individual country norms? ICH Zone IV 30 C / 70% RH Mexico, Costa Rica, Chile, Dominian Republic, Colombia 30 C / 65% RH Venezuela, El Salvador as ICH
13 Thank you!!!
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