Health Policy

FDA cautions India to raise standards on drugs



FDA has urged New Delhi to work with US regulators to help raise standards in the Indian pharmaceuticals industry. India has been dubbed “pharmacy to the world because of its share of the global market for cheap generic drugs, including 40 percent of all over-the-counter medicines sold in the US.

Ranbaxy, one of Indias biggest drug makers by sales, has been all but barred from the US after FDA sanctioned against all four of its domestic plants. Margaret Hamburg, commissioner of the Food and Drug Administration, urged her Indian counterparts to “come to the table and co-operate on efforts to stamp out substandard and fake medicines after lapses in quality at Indian plants.

US concern over Indian drug quality threatens to play into bilateral trade tensions after disputes over intellectual property. Pharmaceuticals are among Indias biggest exports, worth $13 billion. Some in India suspect the US of using quality as a pretext to protect its domestic industry from Indian competition.


FDA is planning to increase its number of inspectors in India from 12 to 19.

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