THE DRUGS AND COSMETICS (AMENDMENT) BILL, 2013

'The Drugs and Cosmetics (Amendment) Act, 2013 is a legislation that aims to amend the Drugs and Cosmetics Act, 1940. The new Act introduces several changes, including the renaming of the Central Drugs Standards Control Organisation as the Central Drugs Authority. The Central Drugs Authority will be a body corporate responsible for exercising powers and performing functions under the Act. The authority will consist of members from various ministries, including Health and Family Welfare, Commerce, and Pharmaceuticals, among others. The Act also provides for the creation of posts within the authority and outlines the responsibilities and powers of the Drugs Controller General of India.

The legislation introduces new provisions related to clinical trials, including the requirement for permission from the Central Licensing Authority before initiating or conducting a trial. It also establishes an Ethics Committee responsible for approving clinical trial protocols and other related matters. The Act provides for rules and regulations to be made by the Central Government and the Central Drugs Authority, respectively, in relation to various aspects of the legislation.

Overall, the Drugs and Cosmetics (Amendment) Act, 2013 aims to strengthen the regulatory framework for drugs, cosmetics, and medical devices in India, with a focus on ensuring their safety, efficacy, quality, and conduct of clinical trials.'