US drug regulator opens two offices in India

January 15th, 2009 - 10:03 pm ICT by IANS  

New Delhi, Jan 15 (IANS) To expedite the process for Indian drug companies to receive approval from the US Food and Drug Administration (FDA), America’s Health and Human Services (HHS) department Thursday announced setting up of two offices in Delhi and Mumbai.“Through these offices, we can work more closely with manufacturers to share best practices and ensure producers build quality and safety into food and medical products,” HHS Secretary Mike Leavitt told reporters via video from Washington.

“However, the approval will still be given from the US and the Indian offices will only facilitate the process,” he said.

US imports almost $2 trillion of goods annually, of which India is the fourth largest exporter by volume of drugs and biologics, especially pharmaceuticals, he said.

“Consumers in India and the United States will benefit from the enhanced safety of food, drugs and medical devices. If called upon, we are also prepared to work with the Indian government as it strengthens its own regulatory institutions,” Leavitt said.

FDA will post 10 experienced officials in India to work closely with industries that ship food and medical products to the US.

Along with the office director, FDA will have four inspectors and five senior technical experts who will cover food, medical devices and medicines.

The FDA officials will provide technical advice, conduct inspections of facilities that export to the US, and work with Indian government agencies and the private sector to develop certification programmes to allow the efficient flow of safe HHS/FDA-regulated goods between the US and India.

FDA has an in-country presence in China, Central America and Europe and is planning to post its officials to several more locations by this year end- including in México, South America, Europe and the Middle East.

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