Goa Pharmaceuticals Manufacturers Association
 
Goa Pharmaceuticals Manufacturers Association
Meeting with the Drugs Controller General (India) held on 11th November 2019 at Taj Exotica, Goa.

Meeting was called by Goa FDA for interaction with the members of GPMA and the DCGI. Mrs. Jyoti Sardesai, Director FDA Goa gave initial introduction on purpose of the meeting.  Dr. V. G. Somani–DCGI and Mrs. Rubina Bose  DDC(I), CDSCO (WZ) graced the occasion. Dr. V. G. Somani, DCGI briefed on CDSCO’s various recent initiatives to streamline current regulatory processes and collaborative work with manufactures for strengthening the regulatory compliances.

The members present were addressed by the DCGI. DCGI suggested that quality of medicines at an affordable price is the key for the healthcare. He further mentioned that, in order to remain competitive worldwide in the pharma market, it is the high time for India to display high quality culture to the world. He assured that his office will provide all the necessary support to Industry towards faster clearances of applications in a simplified way through online SUGAM portal. Work is already in-progress to have a common software for grant of manufacturing and sale license by State Licensing Authority as well. There will be greater emphasis on regulatory interventions on ADRs through Pharmacovigilance system. DCGI clarified several points pertaining to questions raised by the members present, so as to strengthen the collaboration between the regulators and the Industry.

Dr. Praveen Khullar, President, GPMA deliberated on manufacturer’s expectations from authority to further simplify the regulatory process. He further assured that, GPMA will unconditionally support to licensing authorities in terms of collaboration in order to meet regulatory expectations.


posted on : 14 Nov '19

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