US regulator to train Indian drug makers

Plans at least three training sessions this year to bridge gaps in manufacturing practices.

The US Food and Drug Administration (US FDA) is planning to conduct at least three training sessions with India's drug industry during this year to bridge the gaps in manufacturing practices.

The American regulator is likely to conduct these training workshops in Hyderabad, Goa and Ahmedabad which are considered major manufacturing hubs of pharmaceutical companies. Going forward, the regulator may also hold such training sessions on a regular basis. Apart from the industry, inspectors of the domestic Central regulatory agency and state drug controllers may also attend these sessions to understand the regulatory requirements of the US FDA and develop a mutually conducive policy framework for future.

While Goa and Ahmedabad house various formulation manufacturing facilities including those of Cadila Healthcare, Torrent Pharma, Glenmark and others, most active pharmaceutical ingredient (API) and bulk drug making factories are located in Hyderabad and nearby areas.

The details of these sessions were discussed with the industry on Tuesday by US FDA India Head Altaf Ahmed Lal, who accompanied the US FDA’s visiting Commissioner Margaret Hamburg to a meeting with Chief Executives of major drug makers such as Ranbaxy, Cadila Healthcare, Torrent Pharma, Mylan and Wockhardt.

Hamburg, who is on a nine-day long (February 10-18) official visit to India, have been stressing on the need to compliance with regulatory norms. During her meetings with various Indian policy makers as well as regulatory authorities, Hamburg has maintained US FDA’s firm stand on quality and manufacturing practices. Even during her interaction with the industry she has emphasized on continuous compliance. However, the US FDA chief has also said the regulator will help the industry to implement best practices and address the lapses and deviations as found during recent inspections.



In her blog ‘Visiting India: Sharing a Vision for Strengthening Food and Medical Product Safety’, posted on Tuesday, Hamburg said, “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.” She has also stressed that though many Indian companies understand good manufacturing and quality processes, unfortunately these firms “have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms.”

Recently, some of the major drug makers such as Ranbaxy and Wockhardt have come under scanner of the US FDA with their factories facing a ban from the market.

Indian pharmaceutical companies are the second largest supplier of low-cost generic medicines to the US. While troubles in the regulator are haunting these companies as they clock around 40-50 per cent of their revenues from the US, the American regulator is also equally concerned as supplies from India are crucial for the US to maintain its health expenditure at a low level. Apart from pharmaceutical products, India is also the eighth largest food product supplier to the US.

This is also a reason for the US FDA increasing its presence in India since 2008, when it opened its first office in New Delhi. While in 2009, it opened its second office in India, last year it sought government approval to add more American staff here. Increasing presence will allow the regulator to hold more inspections and expand its local functioning going forward.