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Workshop on Recent Amendments in Drugs and Cosmetics Rules, 1945 for Effective Implementation

A workshop on “Recent Amendments in Drugs and Cosmetics Rules, 1945 for Effective Implementation” was conducted on 14th September 2019 at Girijananda Chowdhury Institute of Pharmaceutical Science (GIPS), Guwahati. The workshop was organized by the Indian Pharmaceutical Alliance (IPA) in collaboration with Sun Pharma Laboratories Ltd., Guwahati, and in association with Girijananda Chowdhury Institute of Pharmaceutical Science (GIPS), Guwahati. The workshop was technically supported by the Central Drugs Standard Control Organisation (CDSCO), Govt. of India and State Food & Drug Administration (FDA), Assam. The dais was shared by Mr. R. Chandrasekhar, Honourable Deputy Drugs Controller (I), CDSCO; Mr. A. Senkathir, Deputy Drugs Controller (i/c) CDSCO, Guwahati; Mr. A. K. Nath, Joint Drugs Controller, State Food and Drug Administration, Assam; Dr. Narayan Goswami, Drugs Controller, Tripura; Mr. W. H. Patton, Drugs Controller, Nagaland; Mr. Madhukar Ramdin VP operations, Sun Pharma Laboratories Ltd. Guwahati and Prof. (Dr.) Gouranga Das, Principal, GIPS, Guwahati. The session was delighted by the gracious presence of Ms. Chandrima Baruah (IAS), Honourable Commissioner, Food and Drug Administration, Guwahati, Assam.

Delegates from various Pharmaceutical manufacturing unit, Drug control authority, CDSCO, Food & Drug Administration Assam and professional related to Drugs & Pharmaceuticals took part in the workshop. The gathering was addressed by eminent resource persons including Mr. R. Chandrasekhar, Mr. A. Senkathir, Mr. A. K. Nath and Mr. Rahul Gautam on different topics related to Amendments in Drugs and Cosmetics Rules like submission of stability study data for grant of manufacturing license of oral dosage form; safety data of excipients, regulatory requirements for grant of product approvals; regulatory requirements and currents problems in generic drugs approval and online application process through SUGAM portal.


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