Pharmaceutical export from India continues to be in trouble with the growing global competition and recurrent regulatory actions against some of the top Indian companies. India’s total pharmaceutical exports registered slowest growth rate of just 2 per cent at $14.84 billion during the financial year ended March 2014. The growth of Indian pharmaceutical exports during 2012-13 came down to 10.55 per cent over previous year with export of $14.6 billion. Whereas during 2011-12, the exports stood at $13.2 billion registering a growth of 23.7 per cent over 2010-11. The declining trend in pharmaceutical export from the country, in fact, started following stringent regulatory scrutiny of manufacturing plants of top Indian pharma companies by the US FDA and European drug authorities. The restrictions imposed on the export of Ranbaxy and Wockhardt by US authorities were mainly responsible for the dismal export performance of the country during 2013-14. And the prospects do not seem to be that promising for the current year as well indicating that the export target of 25 billion dollars set for 2014-15 is unlikely to be achieved in the near future.
The US continues to be largest market for Indian pharmaceutical products accounting for 25 per cent of total exports. And the pharmaceutical companies in the US have been objecting to the steadily rising imports of Indian generic drugs over the years. The frequent inspections of Indian manufacturing units by US FDA and finding faults with these facilities are all part of an agenda against growing influence of Indian pharma industry in the US. Introduction of 'Generic Drugs User Fee Amendment (GDUFA) on formulation exports in 2012 was intended to indirectly curb the import of Indian generics. This fee turned out to be a huge burden on several medium and small scale pharma exporters now. In the European Union, Germany and UK are steadily cutting down generic imports from India. Export prospects in other markets such as Latin America, CIS countries and Africa also do not look that promising as the governments in these countries have commenced indigenous production of drugs in a bid to achieve self reliance. Russia, a good market for Indian generic products until recently do not allow import of formulations now. To survive in such an adverse global environment, pharmaceutical exporters need some support and incentives from various government agencies. The Commerce Ministry’s initiative, in this regard, to set up an International Co-operation Cell (ICC) within the office of the DCGI to address export related queries more efficiently is a laudable step. Through this initiative, the Commerce Ministry hopes to boost the confidence of the exporters with a single window for better delivery of services. Extension of validity of CoPP licences and certificate of GMP required under WHO certification to 3 years are other two incentives the government can offer.