Due to fewer US Food and Drug Administration (USFDA) staff members in India, the number of inspections has been declining. However, the agency now intends to increase its manpower in the country, so that inspections are carried out regularly and efficiently.
Inspection record by US FDA:
|Fiscal Year||Other countries||India||China|
|2014 ( till 4 August)||598||90||88|
The USFDA follows the October-September fiscal year.
In 2014, 90 inspections have been carried out till 4 August and there were 70 instances where 'Form 483' was issued; versus 101 such forms in 2013 and 102 forms in 2012.
Form 483 is used by the FDA to document and communicate concerns discovered during inspections. In the past, other Indian drug makers such as Ranbaxy Laboratories and Wockhardt have been hit by bans, due to violation of manufacturing guidelines.
The USFDA conducted 598 investigations in foreign countries excluding China. There are 517 registered firms in China and 519 in India.
US Food and Drug Administration has offices in New Delhi and Mumbai that comprise of 14 staff members, but only six members are into investigation of medical products. And among these six, only three members are permanent.
Altaf Lal, director of Indian agency resigned from his post in May this year. Currently, Carl Sciacchitano, senior science adviser in USFDA's Office of International Programmes, is acting as director, India.
"Once fully staff-fed, this will increase our presence to 19 permanent American staff based in-country, including 10 dedicated to medical products," Financial Express quoted Spokesperson Christopher Kelly.
Additionally, Margaret Hamburg, Commissioner of USFDA said during an interview with Bloomberg that the agency slowly aims to expand their offices in India.
FDA activities in India involve engaging with Indian counterpart regulatory authorities to ensure the timely exchange of information regarding clinical trials that are conducted on fixed intervals.
India is second after Canada as drug exporter to the US, where it supplies about 40 percent of generic and over-the-counter drugs.