The much-awaited bill seeking to establish the Central Drugs Authority (CDA) that will issue licenses in 17 critical categories has been introduced in the Rajya Sabha.
The Drugs and Cosmetics (Amendment) Bill, 2013, a comprehensive legislation to cover various aspects of drugs and cosmetics including regulation of clinical trials and medical equipment sector, having separate chapters on clinical trials and medical devices, was piloted by Union health minister Ghulam Nabi Azad on Thursday.
Before moving the Bill seeks to replace the Drugs and Cosmetics Act, 1940, the Minister 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 licensing authorities and will periodically assess their functioning. It can also review, suspend or cancel any permission or license for drugs and cosmetics manufacturing. The new Bill also proposed centralised licensing 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 up to Rs.30 lakh.