Posted 05 February 2014 | By Alexander Gaffney, RAC, 

As Commissioner Hamburg Plans Official Visit to India, Regulatory Compliance in the Spotlight

The commissioner of the US Food and Drug Administration (FDA), Margaret Hamburg, is at long last headed to India.

The long-planned trip will reportedly focus on strengthening regulatory ties between FDA and the region's regulators, the Union Health Ministry and the Central Drug Standards Control Organization (CDSCO). The former is similar to the US Department of Health and Human Services (DHHS), while the latter is similar to FDA. India also has local regulatory departments in many of its federal states.

"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," Hamburg said in a prepared statement. "I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration."

According to FDA, Hamburg's visit will include visits to Delhi, Cochin and Mumbai, where she will meet with regulators, legislators and policy officials involved in healthcare product and food regulation.

Awkward Timing

The meeting comes at a somewhat awkward time for both Hamburg and India.

The US and India have been embroiled in a fierce diplomatic imbroglio over the last few months after US law enforcement officials arrested and allegedly strip-searched an Indian diplomat on charges of under-paying one of her employees. The matter reportedly delayed Hamburg's trip by at least several weeks.

For India, Hamburg's trip comes just as regulatory scrutiny of the country's pharmaceutical manufacturing operations is at its highest. As Regulatory Focus has reported, FDA inspectors have found troubling patterns of data falsification at many of the country's top companies, leaving some subject to consent decrees and import alerts.

The subject will reportedly be a target for discussion. "Commissioner Hamburg will … 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," FDA wrote.

That could leave Hamburg with tough questions to answer and tougher advice to dispense during her nine-day trip to the region-her first during her tenure as FDA commissioner.

 

FDA Statement