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Indian firms get FDA approval for 110 generic drugs

WASHINGTON: Drugmakers from India, the biggest overseas source of medicines sold in the US, 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 per cent in the US market so far in 2013, even as Indian companies are increasingly coming under the regulatory scanner here. 

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 PharmaBSE -1.26 %, ZydusBSE 1.29 %, GlenmarkBSE 0.10 %, Dr Reddy's, Emcure, WockhardtBSE -3.32 %, Torrent, ClarisBSE 1.90 %, Alkem, IpcaBSE 2.46 %, CiplaBSE 1.82 %, Famy Care,NatcoBSE -0.33 %, Hetero and Alembic. 

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

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 USD 4 billion to the United States in 2012, year clocking a growth of around 30 per cent from the previous year. 

Indian companies have tapped the US 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. 

LupinBSE 0.71 % 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 USD 100 billion worth medicines going off-patent over next 5 years, FDA has stepped up its inspections as well. 

The new US 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.