India's Drug Trials Industry Threatened Due To Slow Approvals

As per Reuters the case has driven Piramal Enterprises, an Indian drugmaker to look abroad to trial new drugs. Swati Piramal, vice chairperson, Piramal Enterprises said that India was losing its “innovation edge”.

ECCRO, a contract research organization that focuses on India, observed that global drugmakers are turning to Russia and Brazil for their trials since they struggle to get approvals in India. However, shifting drugs trials abroad could increase the cost for Indian companies. Deepak Malik, a healthcare analyst at Emkay Global said a $20,000 cost of trialing a drug in the U.S. is 10-20 times that in India.

As per the Indian Society for Clinical Research (ISCR) less than 1.5 percent of global trials happen in India. Last month the Supreme Court ordered the health ministry to administer all clearances for new drug trials. But, G.N. Singh, the drugs controller general of India, said there had been no changes to the approvals process. He said “There hasn’t been any halt in approving new clinical trials. We cannot suddenly wake up one day and decide ‘Ok, no more clinical trials in this country’” as reported by Reuters.