The US FDA will soon set up its first India office in New Delhi. The agency is estimated to spend about $ 5 million initially in setting up an office, said sources. It is for the first time that an international regulatory authority of FDA's stature will be setting up its office in India.
This office will facilitate Indian companies with the procedures of filing for marketing approval for products to be launched in US, application for site inspection and other procedures dealing with the US FDA, according to reliable sources.
The plan is also to appoint inspectors at the centre, who can immediately begin site inspection, without having to travel all the way from the US.
"As India is all set to implement the product patent regime, US FDA thinks this as the right time to set up its India office, which is likely to be within 1 or 2 years. The office will facilitate the exchange of communication between Indian companies and the US authorities, thereby saving a lot of time and resources," said a key source having contacts with the US FDA.
India filed more than 112 ANDAs (Abbreviated New Drug Approval) in 2003 and 392 in 2002. It remained at the first position with 126 DMFs (Drug Master Files) filed in 2003. Italy was at a distant second with 26 DMFs. More than 30 of its plants are US FDA approved. A lot of Indian manufactured products are being marketed in India.
"These approvals have been causing a lot of strain not only to Indian officials, but also to FDA inspectors. The new office is aimed towards reducing this strain," said sources.
All major Indian companies like Dr. Reddy's Labs, Cipla, Ranbaxy, Sun Pharma, Zydus Cadila, Orchid Pharma, Lupin and Nicholas Piramal are major exporters to the US market.