Background: The seminar was jointly conducted by Export-Import Bank of India (Exim Bank) and Federation of Andhra Pradesh Chamber of Commerce and industry (FKCCI) at Hyderabad on May 10, 2002. The objectives of the workshop were to educate the drug manufacturing and marketing firms on various international regulations, including US-FDA regulations for products as well as for manufacturing plants.
Faculty: Mr. Imtiyaz Basade, Senior Manager, Regulatory Affairs, Dr. Reddy's lab, Mr. Pravir Choubey, Senior Manager, Regulatory Affairs, Dr. Reddy's Lab, Mr. V. Rajasekaran, Vice President and Head-Quality Assurance, Sashun Chemicals, and Mr. K K Vinupal, Deputy General Manager, Sashun Chemicals, Chennai were the speakers for the seminar.
Target Sectors:The seminar targeted manufacturers and exporters of bulk drugs and formulations.
Summary of Proceedings: Mr. Imtiyaz Basade made a presentation on 'Regulatory Requirements of Active Pharmaceutical Ingredients (APIs)'. In his presentation, Mr. Basade mentioned that drugs are divided into several major categories, each category is subject to specific regulatory requirements, under FDA regulations. The largest category of drugs from a regulatory standpoint is defined as 'new drugs', Mr. Basade said. The second largest category is investigational drugs - drugs that are intended solely for investigational use by qualified experts and labs. The presentation also covered drugs that are categorised by the law on the basis of dispensing requirements, viz., prescription drugs and non-prescription drugs, and their respective regulatory requirements under US-FDA.
Mr. Rajasekaran made a presentation on 'Registration Requirements for Documents and Drug Master Files of API's'. In his presentation, Mr. Rajasekaran mentioned the importance of API registration in order to market our products abroad. The presentation covered registration requirements for USA, Europe and Australian markets. As a pre-requisite of marketing API's in USA, the Indian firm needs to appoint an agent, listing of drug products and submission of Drug Master File (DMF), Mr. Rajasekaran said. As regards European markets, there are two procedures, viz., a) certificate of suitability and b) European Drug Master Files (EDMFs). While certificate of suitability is applicable only for products having matching monograph in the European Pharmacopoeia, EDMF procedure is normally adopted for products that are not listed in the European Pharmacopoeia. While concluding his presentation, Mr. Rajasekaran mentioned that good quality dossiers/DMFs result in early product approvals.
Mr. Pravir Choubey made a presentation on 'ICH Guidelines and their relevance'. The presentation gave an overview about the mandate of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Mr. Choubey mentioned that ICH is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. The ICH Topics are divided into four major categories viz., Quality Assurance, Safety issues, Efficacy and Multi-disciplinary topics, Mr. Choubey said.
Mr. Vinupal made a presentation on 'Drug Manufacturing Controls - US FDA Approval for Plants'. The presentation covered principles of quality management, quality consciousness of personnel working in the firms, design and construction of building and other facilities, maintenance and cleaning of process equipment, documentation system and specifications, sampling and testing of materials, production operations, in-process sampling and controls, packaging, labeling, storage and distribution procedures, testing, validation and analytical procedures, rejection and reuse policies, procedures for clinical trials etc. The presentation also included guidelines for contract manufacturers and manufacturing process by cell culture/fermentation.