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      USFDA sets up offices in India


      NEW DELHI: Consumers in India and US can now benefit from the enhanced safety of food, drugs and medical devices as the US Food and Drug Administration has set up its offices in India.

      US officials of Department of Health and Human Services, Mike Leavitt and Von Eschenbach, who were in India for the inauguration of offices in Mumbai and Delhi said, "India warrants attention because it exports a large volume of products to US and is an increasingly popular site for clinical trials." These offices are a part of the USFDA's `Beyond the Border Initiative' to expand consumer-protection efforts beyond America.

      The offices in New Delhi and Mumbai will work closely with manufacturers to share the best practices and to improve upon quality and safety aspects of food and medical products.

      It also plans to advise the government of India to strengthen its regulatory institution. An official in the ministry of health said that India could strengthen the regulatory framework with the help of FDA. USFDA will work closely with government agencies and the private sector to develop certification programmes for the Indian food and drug manufacturing industry.

      Indrani Kar, director, CII, said one major benefit of US FDA setting up shops in India will be the reduction in rejections of Indian exports at ports. This body will directly interface with the Indian exports to US, instead of partial rejections at the ports due to mismatch in expectations.

      Initially, FDA plans to post 10 officials in the country to work closely with industries that ship food and medical products to the US and facilitate smooth flow of trade. These officials include director with four inspectors and five senior technical experts who will cover food, medical devices and drugs respectively. This is important as India which is the largest exporter by volume of drugs and biologics to the US will have a smooth flow of trade between the two countries, said Amit Mitra, director general, Ficci.

      January 29, 2009


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