Dr Milind Joshi President Global Regulatory Management 04

Dr. Milind Joshi President – Global Regulatory Management 04. 03. 2006 BILATERAL TRADE & INVESTMENT OPPORTUNITIES - FORMULATIONS J. B. Chemicals & Pharmaceuticals Ltd. www. jbcpl. com © Copyright 2005 J. B. Chemicals Pvt. Ltd.

If opportunity doesn't knock, build a door. ~ Milton Berle www. jbcpl. com. ©

Management Export Legal Marketing Materials Regulatory Affairs Production R&D Medical QC Distribution www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. QA J. B. Chemicals & Pharmaceuticals Ltd.

Regulatory Affairs - A Tool For Regulatory Management Ø Raw material sourcing Ø Vendor changes Ø Formulation changes Ø Process improvements Ø New dosage for development Ø Packaging changes Ø Test method adjustments Ø Manufacturing site transfers Ø Export needs www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Regulatory Affairs The Regulatory Support Development, compiling and follow-up for registration in Unregulated and Semi regulated markets. Preparations of dossiers with necessary compliances Formulation development Analytical testing Quality Assurance Medical www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Regulatory Affairs - The Problem Solving Help Stability studies Formulation development Testing requirements Validation needs www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Regulatory Affairs Primary Function l Formulation registration CIS countries Azerbaijan Armenia Belarus Georgia Kazakhstan Kyrgyzstan www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. Moldova Russia Tajikistan Turkmenistan Uzbekistan Ukraine J. B. Chemicals & Pharmaceuticals Ltd.

Registration of Formulations Process v Information required and degree of assessment v Decision making v Registration validity and review v Appeal system www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Formulation Registration in CIS Markets § Registration requirements are equally stringent compared to regulated countries § Require technical data of regular export batches. Separate scale up/validation batches are not required. § Active and excipients complying with BP/EP/USP are acceptable. www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Russia and CIS Belarus Moldova Ukraine Russia Georgia Armenia Azerbaijan Turkmenistan Kazakhstan Uzbekistan Kyrghyztan Tajikistan www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Russia and CIS Countries Ø Total market of approximately US $ 4 -5 billion Ø Major CIS countries : Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine & Uzbekistan. Ø Each CIS country has its own regulation for product registration. However regulations not as stringent as USA, EU. Ø Requirements : FSC, COPP, Formulation and analytical data, Drug toxicity report, Clinical trial report, BE studies, stability data, product samples etc. www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Russia – New regulations New labeling requirement for Russian packs Representative office address § Complete Q. C. analysis of first 3 commercial batches for new product § Additional tests to comply as per ND (Normative Documents) Every batch analysis at Central Q. C. Lab www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Ukraine – New regulations of MOH Technological Normative Documentation (TND) Expert evaluation of Materials Ø Analytical validation Ø Process validation Ø PSUR (Periodic Safety Update Report) Ø Expert Report www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Russia and CIS Countries Lack of clarity and transparency in regulation Language barrier: e. g. Russia requires product pack in Russian language, Ukraine requires product packs in Ukrainian language. Russia requires conformity assessment certification for each and every batch of medicine entering into the market. Cost of certification is 3000 rubles. Latvia and Lithuania, have become a part of EU convention from May 2004. Expected revision in guidelines as per EU directive Ukraine prefers EU standards data www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Policy & Operation Standards and guidelines for registration Time limits Variation in registration scope Depth of assessment Plurilateral Regulatory standards Contd……… www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Policy & Operation § In past 2 -3 years RA has witnessed changes in the registration policy of many CIS countries Plant inspection required BE study on 18 to 24 volunteers Revised guidelines as per CTD Exhaustive analytical data requirement www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Opportunities in CIS Markets ÿ ÿ Faster registration compared to regulated countries Good International relation with India www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Critical Success Factors – Russia / CIS § Good Marketing set up § Non-trading offices in Moscow, Kiev & other cities § Proper strategy for new product introduction § Russian / Ukrainian translation § Increase coverage into newer territories § Create a hospital sales force § Synergy Contd……… www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Critical Success Factors - Russia & CIS § § § § US FDA / UK MHRA / 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 www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Major Achievements – Russia & CIS § Doktor Mom awarded the “Most Trusted European Brand” in cough and cold by Readers Digest for the last 5 years § Doktor Mom awarded Super Brand 2005 by “Russia council” § Second largest Indian company in Russia www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Recognition “We Russians love Mercedes and Doktor Mom” Komsomolskaya Pravda (Leading Russian Newspaper) www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.

Dream ü ü ü ü Comprehensive and up-to-date drug laws Unified but independent organization Competent human resources Freedom from political and commercial influence Adequate financial resources Clear and transparent standards and procedures Outcome oriented implementation and systematic evaluation ü Common guidelines for CIS similar to ASEAN www. jbcpl. com. © Copyright 2005 J. B. Chemicals Pvt. Ltd. J. B. Chemicals & Pharmaceuticals Ltd.