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Monday, 10 February 2014

India to press for simplification of laws on generics during meeting with US FDA commissioner

India is expected to press for simplifying the guidelines and clauses for generic exports to the United States during the talks with US Food and Drug Administration (US FDA) Commissioner Margaret A Hamburg, who is slated to visit India from February 10 to 18.

The matter of simplification of laws for generics would be taken up in the wake of the recent instances of increased scrutiny by the US authorities on Indian companies putting pressure on the generic export. The issue is expected to come up in her meeting with her counterpart and also the industry captains from India.

However, Drug Controller General of India (DCGI) Dr G N Singh told Pharmabiz that as it was the meeting between the regulators of two countries, issues similar to the warnings to some particular companies like Ranbaxy would not figure in the talks. “We will be discussing the broader issues around the statutory guidelines and how to improve the systems by sharing the knowledge,” he said.

Dr Singh and US FDA commissioner will hold meeting here on Monday. This is her first visit to India and she would also hold discussions with several Ministers including the Union Health Minister Ghulam Nabi Azad. She would also visit Mumbai and Cochin during her week-long trip.

“US has a very strong system and we will have many things to learn. Likewise, they will also look to pick up lessons from Indian regulatory system. No formal agreement with US is planned at my level, but will be touching a number of regulatory issues including the clinical trials,” he said, indicating that he would take up the issue of simplifying the guidelines for generics in the US.

The industry, it is learnt, would be taking up with the US regulator the recent developments of increased regulatory enforcements on generic drug manufacturing facilities. She will meet them separately. While Ranbaxy's active pharmaceutical ingredient-manufacturing factory in Toansa (Punjab) is the latest to come under the US FDA scanner, other major drug makers such as Wockhardt, RPG Life Sciences and Agila Specialities have faced enforcements from the US regulator in the past year.

Reports also claimed that Indian officials would be discussing the issue of clinical trials, especially the suggestion to give equal consideration and protection to Indian subjects by the multinational companies, as they extend the same to those in the US.

Confirming the visit, the US FDA has issued a statement which said the trip by the Commissioner is aimed at further strengthening cooperation between the FDA and its Indian regulatory counterparts. “Indian regulators are important strategic partners to the FDA and regular engagement is essential. Currently, India is the second largest provider of finished drug products and the eighth largest exporter of food products to the United States,” the statement said.

“The FDA’s ongoing engagement with our regulatory counterparts in India is critical to our ability to effectively promote the health and safety of American and Indian consumers,” said Commissioner Hamburg. “I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration,” she said.

“The cooperation of United States and Indian food and drug officials is wide ranging, from sharing information on the conduct of clinical trials to jointly addressing product safety issues that may have an impact on both American and Indian consumers. Commissioner Hamburg will also meet with industry leaders in India to discuss the importance of maintaining high-quality standards in producing goods to ensure consumers have access to safe products,” the statement said.

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