The offices of the Food and Drug Administration of India are being directed by Carl Sciacchitano, who is also advisor to the FDA for international scientific matters. The agency is looking for a new leader for the team after the departure of Altaf Lal a year after taking the job. Atul Agrawal, the security officer monitoring consumer, has also departed.
In February, FDA Commissioner Margaret Hamburg, visited India and expressed concern about the quality of generic drugs manufactured there. She promised then to increase to 19 from 12 the number of responsible for reviewing about 600 manufacturing plants local drug workers. Now, however, only eight employees are based there full time, said Christopher Kelly, a spokesman for the FDA.
The FDA "is in the final stages of hiring additional investigators" with the aim of expanding permanent office in time, Kelly said. Six employees are being rotated in three to four months at a time to help, said in an email.
Neither Lal Agrawal could not be reached for comment, nor has the agency refused to discuss the circumstances behind their departures, citing privacy rules. Lal Agrawal and returned to the U.S. Lal and left since the FDA said Kelly. Sciacchitano took over as acting director on June 1 and the FDA plans to find a permanent director "in the coming months," according to Kelly.
Prohibited plants
since the beginning of 2013, 25 plants in India have been added to the list of facilities prohibited from sending drugs to the U.S. Hamburg, the head of the FDA, visited India in early February and met with both drug manufacturers and health officials.
The amount of U.S. patients get medicines from India doubled to 12 percent in 2012 from 6 percent in 2008, becoming the second largest importer of drugs to the U.S. after Canada.
Prohibited plants include those run by Sun Pharmaceutical Industries Ltd. (SUNP), which is the largest drug manufacturer in India, Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL) warning letters and inspection reports allege companies manipulated quality testing and operation of insanitary conditions.
Both Sun and Wockhardt recalled generic drugs for depression or high blood pressure earlier this year because the drugs fail to comply with the dissolution tests that indicate whether a generic absorbs the same as copying treatment brand reports according to FDA enforcement.
The Indian government authorized the FDA to hire additional staff in March 2013, Kelly said, after Congress passed a law in 2012 that created a program user fee funded by the manufacturers of generic drugs in part to help increase staff and FDA inspections in outposts overseas including India.
"Different Culture '
"It's hard to make people stay there for long periods of time," said Robert Pollock, senior advisor Lachman Consultants who previously served as acting deputy director Office of Generic Drugs FDA. "It's so different from the U.S. culture is so different.''
The agency conducted 111 inspections of drugs in India in fiscal 2013, less than 20 percent of manufacturers registered in the country, according to data provided by the FDA Kelly drugs. This is an increase of 72 in FY2010 and 98 in FY2011, even though it is below 141 in fiscal 2012.
The FDA has increased its collaboration with Indian regulators through workshops and shadowing exercises to bring them up to speed on the rules of the FDA and help with the supervision of the generic drug industry.
"There are only so many companies that can inspect regardless of the number of people we have in the country," Agrawal said, according to a transcript of an industry conference in San Diego last month. "And only so much information you can gather. Eventually, we will have to establish that entwined relationship between us and them that we trust them in the long term."
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