110 Indian generics get FDA approval
September 16, 2013, 1:05 am

India is the biggest overseas source of medicines to the United States and is home to over 150 FDA-approved plants, including facilities run by global players [Getty Images]

This has taken India’s share in the Original Abbreviated New Drug Application (ANDA) approvals to nearly 40 per cent in the US market so far in 2013.

Since the beginning of 2013, the US Food and Drug Administration (FDA) has 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.

India is the biggest overseas source of medicines to the United States and is home to over 150 FDA-approved plants, including facilities run by global players.

Pharmaceutical exports from India to the United States rose nearly 32 percent last year to $4.23 billion.

The US market is home to generic drug spending of about $300 billion every year and India produces nearly 40 per cent of generic and over-the-counter products.

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.

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 per cent from the previous year.

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.

Indian firms have also increasingly come under the FDA scanner even as Indian generics make it the most lucrative choice for patients seeking cheaper treatment.

New U.S. legislation requires the agency to inspect global plants on the same schedule as domestic facilities, and to clear its backlog of drug applications within five years.

Source: Agencies