First-time generic US drug approvals for Indian pharma firms slow down in 2015

Is Indian pharma facing an issue of high standards for drug manufacturing for the US market and delayed approval process in that country?

Indian drug companies got only 14 per cent of the total first-time generic drug approvals from the US Food and Drug Administration (FDA) in 2015, whereas the same was 21.8 per cent in the previous year. In absolute terms, Indian companies could get only 13 first-time generic approvals out of 88 approvals in 2015, whereas the same was 21 out of 96 last year.

While Aurobindo Pharma got approval for Revatio injection in April, Torrent, Alembic and Hetero could get first-time approvals for Arpiprazole, an antipsychotic blockbuster drug sold under the brand name Abilify. In May, Lupin got approval for Moxifloxacin, a fourth-generation antibacterial drug. While Glenmark got first-time approval for anti-cholesterol drug Zetia, Alembic and Lupin managed approvals for Pristiq, an anti-depressant.

In July, Lupin got approval for a combination drug and a month later, Sun Pharma got approval for Zenazine, a treatment for Hutington's disease. In December, Sun got a big boost with approval for generic of blood cancer drug Gleevec, which may help the company earn $250-300 million during the exclusive six months of generic sales. USV and Alkem Labs also got approvals for an ophthalmic product and an extended release drug.

In 2014, Dr Reddy's and Lupin had four each of first time generic drug approvals.

Many units of leading exporters to the US market like Sun Pharma, Dr Reddy's Laboratories and Wockhardt are facing failure to comply with current Good Manufacturing Practices (cGMP) for exports to the US market.

India exported about $15.5 billion worth of drugs during 2014/15 compared to $10.4 billion in 2010/11, and a majority of these exports were to the US market.