Drive to Add FDA Drug Police in India Delayed

Print 22 July 2014
Anna Edney, Bloomberg

Five months after the top U.S. drug regulator promised to expand the office that polices Indian companies that make medicine for U.S. patients, an exodus of workers is cramping the effort.

The Food and Drug Administration offices in India are now being run by Carl Sciacchitano, who is also the FDA’s senior adviser for scientific international affairs. The agency is seeking a new leader for the unit following Altaf Lal’s departure a year after taking the job. Atul Agrawal, the supervisory consumer safety officer, has also departed.

In February, FDA Commissioner Margaret Hamburg visited India and expressed concerns about the quality of generic drugs made there. She promised then to increase to 19 from 12 the number of workers responsible for reviewing about 600 local drug-making plants. Now, though, just eight workers are based there full time, said Christopher Kelly, an FDA spokesman.

The FDA “is in the final stages of hiring additional investigators” with the continued goal of expanding the office over time, Kelly said. Six employees are being rotated in for three to four months at a time to help, he said in an e-mail.

Neither Lal nor Agrawal could be reached for comment, and the agency has declined to discuss the circumstances behind their departures, citing privacy provisions. Lal and Agrawal returned to the U.S. and Lal has since left the FDA, Kelly said. Sciacchitano took over as acting director June 1, and the FDA plans to find a permanent director “in the coming months,” according to Kelly.

Banned Plants

Since the start of 2013, 25 plants in India have been added to the list of facilities banned from sending drugs to the U.S. Hamburg, the FDA chief, visited India in early February and met with both drugmakers and health officials.

The amount of drugs U.S. patients get from India doubled to 12 percent in 2012 from 6 percent in 2008, making it the second-largest importer of drugs to the U.S. behind Canada.

The banned plants include those run by Sun Pharmaceutical Industries Ltd. (SUNP), which is India’s biggest drugmaker, Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL)Warning letters and inspection reports allege the companies manipulated quality tests and operated in unsanitary conditions.

Both Sun and Wockhardt recalled generic medicines for depression or blood pressure earlier this year because the drugs failed to meet dissolution tests that indicate whether a generic absorbs the same as the brand-name treatment it copies, according to FDA enforcement reports.

The Indian government authorized the FDA to hire additional staff in March 2013, Kelly said, after Congress passed legislation in 2012 that created a user-fee program funded by generic drugmakers in part to help the FDA increase staff and inspections in overseas outposts including India.

‘Different Culture’

“It’s difficult to get people to stay there for long periods of time,” said Robert Pollock, a senior adviser at Lachman Consultants who previously served as the acting deputy director in the FDA’s Office of Generic Drugs. ‘It’s so different than the U.S. The culture is so different.’’

The agency conducted 111 drug inspections in India in fiscal 2013, of less than 20 percent of registered medicine manufacturers in the country, according to data provided by FDA’s Kelly. This is an increase from 72 in fiscal 2010 and 98 in fiscal 2011, though it’s down from 141 in fiscal 2012.

The FDA has been increasing its collaboration with the Indian regulators through workshops and shadowing exercises to bring them up to speed on FDA standards and help with overseeing the generic-drug industry.

“There are only so many firms we can inspect regardless of how many people we have in country,” Agrawal said, according to a transcript of an industry conference in San Diego last month. “And only so much information we can gather. Eventually, we’re going to have to establish that interlocked relationship between us and them that we can rely on them in the long run.”

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