With an aim of strengthening the drug regulatory system in India, the government today introduced a Bill that provides for setting up of a Central Drugs Authority as an overarching body for regulation of drugs and cosmetics and seeks to bring 17 critical drugs under central licencing.
The Drugs and Cosmetics (Amendment) Bill, 2013 is a comprehensive legislation to cover various aspects of drugs and cosmetics including regulation of clinical trials and the medical equipment sector, having separate chapters on clinical trials and medical devices.
The bill that seeks to replace the Drugs and Cosmetics Act, 1940, was introduced in the Rajya Sabha by Health and Family Welfare Minister Ghulam Nabi Azad today, who also withdrew the Drugs and Cosmetics (Amendment) Bill, 2007.
The new Bill seeks to establish the Central Drugs Authority (CDA), a 19-member overarching body to regulate the drugs and cosmetics sector, that will be headed by the Secretary, Health and Family Welfare.
The CDA will specify regulations and norms for effective functioning of central and state drug licencing authorities and will periodically assess their functioning. It can also review, suspend or cancel any permission or licence for drugs and cosmetics manufacturing.
The new Bill also proposed centralised licencing in respect of 17 categories of very critical drugs.
The Bill also contains a separate Chapter for regulatory provisions for medical devices and for regulating clinical trials and exports of drugs and cosmetics.
While no person can conduct any clinical trial for a new drug or medical device or cosmetic, the Bill contains severe penal provisions for its violations that include imprisonment of maximum 10 years and penalty of upto Rs 30 lakh.
The new bill excludes all provisions relating to Ayush drugs for which a separate Bill will be brought in Parliament.