Maharashtra to stop issuing license to branded drugs from October 20, 2012

Usha SharmaMumbai

Maharashtra has received the official communication from the Union Health Ministry to stop issuing license for the manufacture and sale of drugs on the basis of their brand name. The notice has been already communicated verbally to all the joint commissioners in Maharashtra and will get officially implemented within the state from October 20, 2012. However, states like Karnataka and Gujarat had not received any communication from the Centre. IDMA-GSB has decided to conduct an extraordinary EC meeting action on this issue.

Speaking with Express Pharma, Prakash R Uttarwar, Joint Commissioner (Headquarters), Food and Drugs Administration, Maharashtra said, “We have received an official communication via email from the Centre to stop granting approvals of manufacturing license of drug formulations to branded drugs. It will be effective from October 20, 2012.”

“It will be unfair to the pharmaceutical industry to make a judgement without taking a concern from the industry stakeholders. This move may hamper the growth of the Indian pharma industry as companies may not like to invest on its research and development works. This move will substantially reduce the price of medicines,” a senior official on condition of anonymity said.

“If the pharma industry has any problems with this move then they should convey their concern to the Centre via bodies like IDMA and OPPI. We will follow the order been given by the Centre,” Uttarwar said.

Chirag Doshi, Chairman, IDMA-GSB said, “The notification which has been issued by the Union Health Ministry needs to discuss the parameters concerned with the exporters. The Centre has not even consulted with the industry stakeholders before acting on it. To discuss all these issues, we have called for an extraordinary executive committee meeting tomorrow and have invited all eight local associations’ chairman of pharma manufacturing companies in Gujarat. We will be taking this issue further as it is not in favour of the industry.”

IDMA-GSB has invited associations from Rajkot, Sabarkantha district, Bhavnagar, Surendranagar, Navsari and Vadodara to discuss the Centre’s move. In Gujarat there are more than 90, 000 branded drugs available. Today the pharma industry in Gujarat nearly contributes 28 per cent to the total domestic market share. Also, there are 85 different pharma manufacturing plants located in the state.

Doshi continued that we are reviewing all the existing data before presenting it to the Centre. In the meeting we will discuss all the relevant matters related to this sensitive issue before in hand. Besides this agenda we do have other topics as well to discuss in the meeting.”

Dr BR Jagashetty, Karnataka Drugs Controller said, “So far, we have not received any official communication from the Centre, hence, we do not have any information on same.

All pharma firms applying for licence to market or manufacture fixed dose combination (FDC) drugs will have to submit their generic name and not as brands with immediate effect.

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