Suggesting that India's chief drug regulator may not be doing enough to protect certain volunteers in clinical trials, the Supreme Court ordered the agency to provide adequate oversight, particularly when drugs to treat the human papillomavirus (HPV) are concerned.
Central to the high court's concerns, it said, were Merck Sharpe & Dohme's Gardasil and GlaxoSmithKline's ($GSK) Cervarix, both HPV vaccines. The two justices presiding said they were not trying to run the Drugs Controller General of India, but they believed the poverty-stricken and others in trials should be protected at the informed-consent stage when testing HPV vaccines. Merck Sharpe & Dohme represents Merck ($MRK) outside of the U.S. and Canada.
The court said the procedure should be transparent and patients should be compensated when failures occur. It also urged follow-up action in such cases.
The two-person bench ordered the DCGI to provide its files covering trial procedures, especially those involving the two drugs, in time for a hearing the following day.
Pharmaceutical companies have challenged the necessity of the trials in the first place, noting both vaccines have been approved in many countries already. The matter is based on a public-interest suit challenging the licenses for the drugs on grounds the DCGI did not follow parliamentary orders for protecting patient safety.