US FDA to continue to target non-compliant Indian companies


All available enforcement tools to be utilised to bring facilities to compliance to ensure the protection of public health

US health regulator, the Food and Drug Administration, which has cracked down on Indian pharmaceutical companies that fail to comply with GMP standards, notably Ranbaxy Laboratories and Wockhardt, has decided to continue to focus on non-compliant companies.

US FDA spokesman Christopher C Kelly said all available enforcement tools would be utilised to bring non-complaint facilities in India to compliance to ensure the protection of public health. Around 40% of generic drugs and over-the-counter products sold in the US come from India.

In January 2014, the US drug regulator has decided to inspect a new facility belonging to Hyderabad-based Divi’s Laboratories. Divi’s Laboratories is considered a pioneer in the contract research and manufacturing services area. It already has an existing FDA-inspected facility in Visakhapatnam in South India.

Even as inspections continue, so do the crackdowns. At the end of 2013, the FDA served a Form 483, which has a list of objectionable conditions identified during its inspection, to Hospira's pharmaceutical manufacturing facility at Irungattukottai, Sriperumbudur.

The FDA issues a Form 483 at the conclusion of an inspection, on observing conditions that might constitute violations. The company has to respond with a corrective action plan. Hospira said the observations were primarily related to processes and procedures.

Of late, Indian facilities of many drug companies have been censured by the FDA and other international regulators for not complying with the required manufacturing norms. In 2013, there were around 20 Indian facilities that failed FDA inspections, several of them in Gujarat, as against seven in China, two each in Australia, Canada and Japan, and one each in South Africa and Germany.

Against this backdropt, the FDA has decided to enlist the help of local drug inspectors when visiting pharmaceutical facilities. According to H G Koshia, commissioner of the Food and Drug Control Administration of Gujarat, the government of India has initiated a process together with the US drug regulator, whereby local drug inspectors would accompany FDA officials during their plant visits.

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As part of the collaborative effort the local authorities had visited the facility of Marck Parenterals near Ahmedabad, Gujarat. There are around 32 FDA-approved manufacturing sites in Gujarat alone.