Indian government moves to ease export requirements for pharma companies

Capitalizing on export opportunities in regulated and semi-regulated markets has been the way forward for the Indian pharmaceutical sector, with exports set to cross $55 billion by 2020 versus current exports of $18 billion. Notwithstanding the recent US Food and Drug Administration warnings over deficiencies at manufacturing units of various Indian drugmakers, the government's ease-of-doing business drive is set to benefit several Indian drug manufacturers, reports The Pharma Letter’s India correspondent.

Companies such as Sun Pharmaceuticals, Cipla, Wockhardt, Ranbaxy Laboratories and Dr Reddy's Laboratories, which export their products to highly regulated developed countries, are set to flourish with the government scrapping the 'No Objection Certificate' required from the Indian Health Ministry for the export of drugs to developed countries including the USA, Canada, Japan, Australia and the European Union.

This is despite the fact that, in July last year, the European Union banned 700 generic drugs tested by GVK Biosciences following charges of manipulation of clinical trial data for bio-equivalence testing. The drugs tested by GVK were subsequently withdrawn from all EU markets last August. Huge delays