BioCentury
ARTICLE | Politics & Policy

Bill would overhaul India's drug approval authority

September 11, 2013 12:54 AM UTC

A bill introduced in the upper house of the Indian parliament would establish the Central Drugs Authority (CDA) and centralize licensing for 17 categories of drugs and therapeutics, including vaccines, mAbs and cell therapy, stem cell or gene therapy products. Under the bill, the existing Central Drug Standard Control Organization (CDSCO) would essentially be renamed the CDA, which would be headed by the secretary of India's Ministry of Health and Family Welfare (MHFW). According to the bill, the Drugs Controller General of India (DCGI) would act as the country's central licensing authority and would have power to "issue, renew, suspend or cancel licences or certificates or permission, as the case may be, for import, export or manufacture of drugs, cosmetics or medical devices or permission for conducting clinical trials."

The bill also covers regulations on clinical trials and includes a section that specifies that the DCGI would decide the cause of injury or death for patients enrolled in clinical trials. In January, MHFW issued new regulations that require clinical trial sponsors to provide compensation to patients who suffer injury or death during or as a result of the trial, including as a result of the "failure of investigational product to provide intended therapeutic effect." ...