Thursday, Oct 30, 2014

USFDA to now ‘share info’ before facility inspections

New Delhi | Posted: February 11, 2014 3:01 am

ENS & PTI

Reacting strongly to the recent string of punitive actions by the US Food & Drug Administration (USFDA) against Indian pharmaceutical companies, India has asserted that in a number of cases, it felt the US drug regulator had imposed “disproportionately strong penalties”.

Following a series of meetings that visiting FDA Commissioner Margaret Hamburg had with representatives from the Indian government here on Monday, including commerce and industry minister Anand Sharma, health minister Ghulam Nabi Azad and Drugs Controller General of India GN Singh, both sides signed a pact under which the USFDA and the domestic drug regulator will now “share information” before undertaking inspections of companies and “collaborate” on inspection of drug units for Good Manufacturing Practices (GMP) compliance.

Sharma, in his meeting with the Hamburg, raised the issue of the USFDA not giving enough opportunity to Indian pharmaceutical companies to explain themselves before taking action against them for flouting quality norms.

“We are going to give a non-paper (to the US) on some of our concerns, when it comes to duration for the registration process for the filing,” Sharma was quoted by PTI as telling reporters after the meeting. Hamburg is in India on a week-long visit, her first.

Sharma said pharmaceutical issues were discussed “very clearly” as was cooperation in the sector. “These issues do come up before the countries. What is important is the willingness to address those issues and resolve matters, which we have definitely mentioned,” the minister said, according to the agency report.

During Hamburg’s meeting with Azad later in the day, both sides signed a Statement of Intent on Cooperation in the Field of Medical Products, under which the regulators will inform each other before undertaking inspections, allowing host-country inspectors to join inspections as observers.

Under the pact, the two countries will exchange “information relevant to lack of compliance with accepted GMPs, good clinical practices, or good laboratory practices, as appropriate, by manufacturers and sponsors of medical products”.

Drug companies which have faced adverse regulatory action by the FDA in recent months include Ranbaxy Laboratories, Wockhardt and Strides Acrolab.

Analysts see the agreement as a sign of the two countries appreciating the mutual benefits of pharmaceutical trade. India with its 530 USFDA-approved plants is keen to sustain and enhance its exports to the US, while the Obama Administration’s healthcare plan relies significantly on cheaper generic drugs from countries such as India.

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