FDA opens offices in India (New Delhi and Mumbai)

[Ajit Basrur]

FDA opens offices in India

The U.S. Food and Drug Administration (FDA) opened two offices in New Delhi and Mumbai, India, as part of a new initiative to ensure safety and quality of drugs and food products flowing from India into the United States, the FDA said Thursday in a press release.

The FDA will post 10 experienced officials in India to work closely with industries that ship food and medical products to the United States, to improve safety and quality, which will facilitate the smooth flow of trade.

They will provide technical advice, conduct inspections of facilities that export to the United States, and work with Indian government agencies and the private sector to develop certification programs to allow the efficient flow of safe FDA-regulated goods between the United States and India.

These offices are part of the FDA's Beyond Our Borders Initiative, which will place 35 personnel in 14 locations around the world, mostly connected to U.S. embassies, consulates and missions. This initiative will expand FDA consumer-protection efforts beyond the United States to form collaborative partnerships with governments and industry on product safety.

India is the fourth largest exporter by volume of drugs and biologics, especially generic pharmaceuticals, to the United States. It is also a significant exporter of food products.

The FDA also plans to post personnel to several more locations in 2009 -- Mexico, South America, Europe and the Middle East.

 

[Ajit Basrur]

Does anyone have address of the FDA offices that are opened at Mumbai and Delhi - I tried various websites to get this address but in vain

 

[MIREGMGR]

They might not have an "open" address because of the potential for a flood of unqualified contacts.

As far as I know, those offices are initially intended to be used only as "home bases" for field inspectors, with filings still to be done to the USA.

Perhaps you could contact:

http://www.fda.gov/cdrh/international/contact.html#1

 

[Ajit Basrur]

Thanks - let me see if I get success !

 

[bio_subbu]

Thanks - let me see if I get success !

Hope that USFDA will have full fledged office in India by September 2009. When fully staffed, FDA will have 7 Staff in New Delhi and 5 in Mumbai. Those in New Delhi are based in the U.S. Embassy and include a Director and six senior technical experts covering medicines, foods and devices. The inspectors in Mumbai are based at the U.S. Consulate General and are Consumer Safety Officers with expertise in these same regulated-product areas. For more information refer here

 

[bio_subbu]

In addition to my previous post, find below UTVi news on “FDA enters India”. Also find the details from below youtube link

http://www.youtube.com/watch?v=KmVt4TXGT1o


The USFDA is here in Mumbai for good. The Indian division met members of India's pharmaceutical community today to discuss its role here in India.

Mumbai is to have 5 FDA inspectors, 2 for inspection of drugs, 2 inspectors who will oversee the Indian foods exported to the US & 1 inspector who will evaluate medical devices.

Bruce Ross, Director, USFDA India said, "We are ever mindful of the fact that in a foreign country, the USFDA does not have the authorities & other jurisdiction and we are here in India as in other countries at the express willingness of the host government, so what the competent authorities do with the pharma companies here is their business not the FDA's, we are only here because India represents a large part of drugs in the USA."

Only the 2 drug inspectors Mike Gavini & Pete Amin have begun work here in Mumbai, while the rest of the team is expected to join in a few months. The meeting was convened to address the setbacks and more importantly the advances made by India's much debated CRO or contract research outsourcing industry.

Dr. Vachharajani, VP Development, Advinus said, "The common themes that have emerged out are that when it comes to regulations India is by and large becoming as close to global standards and regulations by and large good clinical practices are being followed."

Of the topics discussed during the convention was the role of the Indian media in helping this industry. There were talks that poorly researched & negative news distributed in the public in the recent past had severely affected an already cynical industry attitude towards developing clinical trials in India.

Dinesh Jain, CEO, Aagami Inc said, "My request to the all the media persons is please bring out the positive news also, about whatever is happening in the industry. After all the industry is doing a lot of good service to the community, if not for the pharma community we would have no medicines."

The Pharma community present here made one thing clear, they are happy with the various initiatives made by the DCGI and other government bodies in making India an innovative leader in the Pharma world. And this has only made them more focused by putting in positive thinking and hard work in an industry which is 90% failure & 10% success.

 

[bio_subbu]

Does anyone have address of the FDA offices that are opened at Mumbai and Delhi - I tried various websites to get this address but in vain

U.S. Food and Drug Administration (FDA)
Department of Health and Human Services
Shantipath, Chanakyapuri,
New Delhi -110 021, India
Fax: 91-11-24198770