Bill creates Central Drugs Authority with power to sue and be sued

It aims to ensure the safety, efficacy, and quality of these products and to establish a new regulatory framework for their import, export, manufacture, distribution, and sale.

Who it concerns: The law affects manufacturers, importers, exporters, distributors, and sellers of drugs, cosmetics, and medical devices. It also applies to sponsors and investigators conducting clinical trials, as well as the Central Government and State Governments responsible for licensing and regulation.

What the bill does

• Establishes the Central Drugs Authority (CDA) as a body corporate with perpetual succession to exercise regulatory powers.
• Redefines the scope of the Act to explicitly include 'medical devices' and 'clinical trials' for drugs, cosmetics, and medical devices.
• Replaces the term 'Inspector' with 'Drugs Control Officer' throughout the Act.
• Updates references to the 'Dangerous Drugs Act, 1930' to the 'Narcotic Drugs and Psychotropic Substances Act, 1985'.
• Introduces definitions for key terms including 'bioavailability study', 'bioequivalence study', 'clinical trial', 'new drug', 'medical device', 'investigational new drug', and 'sponsor'.
• Specifies that the head office of the Central Drugs Authority shall be in the National Capital Region.
• Defines the composition of the Central Drugs Authority, including the Secretary to the Government of India (Ministry of Health and Family Welfare) as Chairperson.

Also in the document

• The Bill is an amendment to the existing Drugs and Cosmetics Act, 1940.
• It creates a new statutory body, the Central Drugs Authority, with the power to acquire property and sue or be sued.
• It introduces specific definitions for 'new drugs', including vaccines, stem cells, and gene therapeutic products, which are to always remain classified as new drugs.