Indian Firms Get FDA Approval for 110 Generic Drugs

Washington: Drugmakers from India, the biggest overseas source of medicines sold in the U.S., have got more than 100 generic drug approvals from the American health regulator FDA this year so far.

This has taken India's share in the Original Abbreviated New Drug Application (ANDA) approvals to nearly 40 percent in the U.S. market so far in 2013, even as Indian companies are increasingly coming under the regulatory scanner.

Since the beginning of 2013, the U.S. Food and Drug Administration (FDA) have approved nearly 290 ANDAs allowing pharmaceutical firms to manufacture and sell generic drugs as a safe, effective and low-cost alternative to the Americans.

At least 110 of these approved applications are from the Indian companies, or entities owned or controlled by an Indian firm, the FDA data showed.

These companies include entities belonging to Sun Pharma group, Lupin, Aurobindo Pharma, Zydus, Glenmark, Dr Reddy's, Emcure, Wockhardt, Torrent, Claris, Alkem, Ipca, Cipla, Famy Care, Natco, Hetero and Alembic.

The U.S. market is home to generic drug spending of about $300 billion every year and India produces nearly 40 percent of generic and over-the-counter products, while its share in the finished dosage medicine segment is about 10 percent.

While the FDA has stepped up its efforts to ensure that only good quality medicines reach the American shores, the demand for generic drugs is surging under President Barack Obama's healthcare programme.

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