Drug companies have often conducted clinical trials in India because of the country’s low costs, patient availability and technically proficient personnel. But in late 2012, amended regulations made securing permission for a clinical trial a much more rigorous process. This has lowered the number of trials in India, dropping from 500 in 2011 to just 20 in 2013. These regulations have also affected new drug discoveries and registrations, falling from 260 new drugs in 2008 to less than 25 in 2013. The approval process for global drugs sold in India has increased from 6 months to over 3 years.
Three new committees have been set up to clear clinical trials; however, they only approved clinical trials for 5 drugs over the September-December 2013 period. In late October, the Supreme Court suspended 157 trials that had been previously approved until the three new committees could review the cases.
Many multinational drug companies no longer consider India a potential clinical trial site; China is now the number one non-Western destination for trials. The U.S. National Institutes of Health shut down more than 35 clinical trials underway in India. Domestic companies have also moved trials abroad, increasing drug development costs up to 20 times. Piramal Enterprises, Biocon and Lupin have moved trials to countries like the Taiwan, Germany, the U.S., Canada, the Netherlands and Australia. Several Indian clinical research organizations (CROs) have set up trial centers in Southeast Asian nations like Malaysia and Thailand.
In early February 2014, the Indian Minister of Health and Family Welfare acknowledged that clinical trial regulations were hurting innovation and that the new norms might be relaxed.