is taken very seriously, and is handled by the sponsor of the trial in accordance with all applicable regulations and guidelines," Quintiles said.
The Supreme Court last month ordered the health ministry to supervise all clearances for new drug trials, creating an added layer of decision-making.
Two activists told Reuters they believed the cases had stymied new drug trial approvals as senior government officials were too nervous to take decisions. "Unofficially they have decided not to sanction new clinical trials," said activist Amulya Nidhi.
However, G.N. Singh, the drugs controller general of India, said there had been no changes to the approvals process. "There hasn't been any halt in approving new clinical trials," Singh said. "We cannot suddenly wake up one day and decide 'Ok, no more clinical trials in this country'."
V.M. Katoch, the head of the state-run Indian Council of Medical Research (ICMR), which advises the drugs regulator on approvals, also disputed that approval times had slowed.
Referring to the allegations made in the Supreme Court, he said trials conducted without the patient's consent were a small number of aberrations. "That creates the impression that everything is wrong all around, which is not true actually," he said. "The ethical practices every year have become stronger and stronger."
However, Katoch acknowledged that recent negative publicity around drug trials in India had put the government "on the defensive" for a while.