Compliance does not end with approval, says US FDA chief

Says US regulator plans to expand its India presence

Compliance does not end with approval, visiting US Food and Drug Administration (US FDA) Commissioner Margaret Hamburg told Business Standard, replying to a question on tough and repeated enforcements on Indian pharma companies. While pointing out that pre-approval inspection is a snapshot in time, she said companies would have to continuously maintain quality practices at every level to be able to supply to the US market. Indicating frequent inspections and stringent quality checks in future, Hamburg stressed the regulator would expand its presence in the country.

The FDA chief's firm stand on India, which implies no room for letting go, comes at a time when the Indian authorities are engaged in dialogue with the American regulator, seeking to ease the environment for domestic drug makers supplying to international markets, especially the US. The US and India on Monday signed a statement of intent that would make the American regulator inform its Indian counterparts on inspection of a pharma facility. It would also give representatives of Indian regulators to access the inspection site simultaneously.

"Companies must instill and maintain quality practices so they remain compliant with the FDA's requirements. This commitment to quality manufacturing must be accepted by everyone involved - from top CEOs to the foremen to line workers," Hamburg said.

The US FDA plans to set up more offices and increase its staff in India. "FDA's plans remain focused on Delhi and Mumbai, but we will increase our presence in India," Hamburg said. While the regulator has already got the approval from the Indian government to add seven drug investigators, this will increase its "presence to 19 American staff based in-country, including 10 dedicated specifically to drugs. Others include foods and devices inspectors and policy analysts".

This would essentially mean the regulator's activities in the country is likely to be stepped up.

On Monday, Hamburg met key Indian government authorities, including Health Minister Ghulam Nabi Azad and Commerce and Industry Minister Anand Sharma, who raised trade related concerns and insisted on early resolution of ongoing enforcements and issues with domestic pharma companies. She also met the Drugs Controller General of India GN Singh and state drug controllers on Monday to discuss manufacturing related issues faced by the companies, regulatory framework and capacity building initiatives. She met chief executive officers of leading domestic pharmaceutical companies on Tuesday at the Federation of Indian Chambers of Commerce and Industry (Ficci).

While Hamburg declined comment on queries related to ongoing troubles at Ranbaxy's Indian factories as they are facing investigation, she said, "While some Indian companies operate state-of-the-art facilities and meet current good manufacturing practices, others do encounter problems and operational challenges." Staff from the FDA's India office will work with these companies to identify the problems and will take "necessary steps to self-correct", according to the commissioner.

When asked whether the violations found by US FDA at Indian factories were alarming, Hamburg said similar problems exist around the world. "It's important to note that many Indian firms understand current good manufacturing practices (CGMPs) and use them. The problems encountered by FDA investigators in India are similar to those seen around the world in manufacturing."

She listed inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various processes used in manufacturing or testing and product adulteration or contamination as the problem areas in India.

Recently, leading domestic drug makers such as Ranbaxy, Wockhardt, RPG Life Sciences and Agila Specialities received enforcements from the US FDA following deviations from manufacturing norms in their factories in India.

FDA has chosen to make quality one of the highest priorities in 2014, according to Hamburg.

The American regulator, who is on a nine-day long visit to India, will head to Kochi on Wednesday to meet officials from the World Health Organisation and spice manufacturers.