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US and Indian regulators forge closer ties

FDA signs new agreement with India's Ministry of Health and Family Welfare

FDA headquarters White Oak

The FDA has strengthened ties with its Indian counterpart, signing a joint agreement to improve lines of communication and work together to ensure the safety and quality of products exported from India.

The State of Intent last week between the US regulator and India's Ministry of Health and Family Welfare was, FDA commissioner Margaret Hamburg said, “an important milestone”.

The FDA has run workshops for drug and food regulators in India and invited Indian regulators to observe its inspections of manufacturing facilities and clinical sites with operations in India.

Hamburg added: “Ensuring that the products distributed in the US meet our requirements for product safety and quality is among my top priorities as Commissioner.

“Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms.

“While the FDA will take appropriate action against any company that doesn't meet our requirements, we are also willing to work with them to address their issues.”

India is the third largest trade partner and second largest supplier of over-the-counter and prescription drugs to the US, but domestic companies have come under increasing scrutiny.

One company that has suffered from a number of regulatory issues is Ranbaxy, which last month clocked up a seventh plant that failed to meet FDA quality standards.

Hamburg was in India on her first official visit to the country as commissioner of the FDA said her office would also be focusing on issues of quality at home, through the creation of a new Office of Pharmaceutical Quality.

This would, she said, “create one voice for drug quality at the FDA and improve our oversight of quality through the lifecycle of a pharmaceutical product”.

“All companies must understand that quality is the basis for the public's trust and confidence in their products and maintaining high quality standards is part of the cost of doing business,” she concluded.

Article by
Dominic Tyer

19th February 2014

From: Sales, Regulatory



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