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

This Bill amends the Drugs and Cosmetics Act, 1940, to include the regulation of medical devices and clinical trials alongside drugs and cosmetics. 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.

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.

• 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.

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