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India defends drug safety as US FDA chief visits

Indian Minister for Commerce and Industry, Anand Sharma (L) shares a light moment with Commissioner for US Food and Drug Administration, Margaret Hamburg after a meeting in New Delhi on February 10, 2014
Indian Minister for Commerce and Industry, Anand Sharma (L) shares a light moment with Commissioner for US Food and Drug Administration, Margaret Hamburg after a meeting in New Delhi on February 10, 2014

India defended the safety standards of its vast generic drugs industry Monday as the US Food and Drug Administration chief arrived in the capital to discuss quality concerns.

FDA Commissioner Margaret Hamburg's trip follows a string of import restrictions slapped by the body on products made by Indian pharmaceutical heavyweights Wockhardt and Ranbaxy over safety concerns.

India's lower cost medicines should not be viewed as "cheap and spurious", Health Minister Ghulam Nabi Azad said in New Delhi as Hamburg opened her eight-day visit.

"Efficacy of the Indian drugs should not be judged on the basis of their cost," he said, adding that "the input cost in India is much less than that in the developing countries due to the less expensive human resources".

India's generics industry is a massive supplier of copycat lifesaving drugs to the United States and over 200 other nations, many of them poorer countries.

On the first day of Hamburg's trip, India's health ministry and the FDA signed a statement of intent on cooperation in the field of medical products between the two countries.

Speaking ahead of her talks with Indian government officials, Hamburg said the FDA’s "engagement" with its Indian regulatory counterparts was "critical to our ability to effectively promote the health and safety of American and Indian consumers".

"I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration," she said.

India's commerce minister Anand Sharma told reporters both sides believe "this is a partnership which is very important".

The two sides have agreed to create an "institutional framework" involving "sensitising and educating the pharmaceutical industry" over the certification of medicines, he said.

Hamburg was due to meet pharmaceutical industry representatives on Tuesday for talks organised by a national business group.

Her trip in India will also take her to the financial hub of Mumbai and Kochi in the southern state of Kerala.

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