In the past few months, a flurry of regulatory action on behalf of the US FDA has banned Indian drugmakers, including major players Ranbaxy and Wockhardt, from exporting drugs to the US.
Drug Controller General of India has announced that implementation of sudden inspections of pharmaceutical manufacturing facilities, but this may not be nearly enough. India experts believe the issues for drugmakers are far deeper than mere compliance infractions - pointing to the FDA's push for modernization as a major obstacle for Indian manufacturing.
The FDA's future vision of drug production involves high tech manufacturing processes, tighter globalized GMP requirements, implementation of QbD approaches and an overall reduction in dependence on imported medicines.
While all of these goals are good news for the U.S. drug industry, the implication of these advances on India's industry requires serious action on behalf of Indian drugmakers.