Wednesday, March 02, 2016


P A Francis
Wednesday, March 02, 2016, 08:00 Hrs  [IST]
Indian pharmaceutical industry has been passing through a difficult phase for the last five years with its export prospects getting threatened on account of regulatory actions by the US Food & Drug Administration (US FDA) and European Medical Agency (EMA). Regulatory inspections and actions by these agencies and consequent drop in exports have been hitting the profitability of India’s top large and medium scale pharma companies as their profits mainly come from generic exports to these countries. India supplies more than 30 per cent of the generic medicines sold in the US and nearly 25 per cent sold in the European Union. There has been a steady increase in issuance of warning letters and import alerts by the US FDA and EMA on Indian pharmaceutical manufacturing facilities with regulators’ increasing concern over the safety of drugs imported into their countries. The US FDA alone issued 15 warning letters to Indian pharma companies during 2015. Between 2008 and 2015, US FDA has issued around 50 warning letters on Indian companies and out of these, around 40 per cent were converted into import alerts. India has more than 600 US FDA approved manufacturing facilities located in different parts of the country. Warning letters are issued after regular inspections of the stringent manufacturing standards laid down by these agencies.

Quality issues arising out of regulatory actions by the US FDA and EMA have been an issue of serious discussion among the industry bodies and the concerned government departments for some time. Such repeated actions by the world’s top regulatory authorities not only affect India’s generic exports but also the reputation of India as a global supplier of quality generics at reasonable prices. Indian Pharmaceutical Alliance, a body of 20 large research based Indian pharma companies, has been addressing this issue quite seriously. It recently held a meeting of representatives from US FDA, UK MHRA, Drug Controller General of India and Indian drug exporters. Main complaints from regulators ranged from issues over hygiene and maintenance to concerns over documentation and data management. There is a growing feeling among the regulators that some Indian companies are still not taking enough steps to identify risks and failures at their facilities even after issue of several warning letters. Regulatory officials from the US, EU and UK at the meeting therefore said that they would step up the number of inspections in India, and are expecting better cooperation from the exporting companies and Indian authorities. That is indeed a legitimate expectation and Indian pharma exporters have to take this matter seriously considering the price these countries are offering to Indian products.