Indian Firms Get FDA Approval for 110 Generic Drugs

With over 150 FDA-approved plants, including facilities run by MNCs, India shipped pharmaceutical products worth over $ 4 billion to the United States in 2012, year clocking a growth of around 30 percent from the previous year.

Indian companies have tapped the U.S. market by focusing on opportunities in plain-vanilla generics segment. However, many continue to improve their product offerings and look at alternative avenues to generate higher margins.

These include difficult-to-make products having technological entry barriers, as also niche products that require dedicated facilities and clinical trials and are not economically viable for many generic players.

Lupin was the top Indian drug seller in the American market last year by prescriptions, followed by Dr Reddy's, Cadila Healthcare and Aurobindo Pharma, according to data compiled by IMS Health.

As the market for generic drugs, which usually sell at a fraction of cost to the original drugs, grows bigger with an estimated $ 100 billion worth medicines going off-patent over next 5 years, FDA has stepped up its inspections as well.

The new U.S. laws requires FDA to inspect overseas plants on the same schedule as domestic facilities, and to bring an end to its big backlog of drug applications within 5 years.

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