The pharmaceutical industry in India is primarily regulated by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. These laws provide the legal framework for the manufacture, distribution, sale, and import of drugs and cosmetics in India. Key features of the regulatory framework for the pharmaceutical industry in India include: Drugs and Cosmetics Act, 1940: The Drugs and Cosmetics Act, 1940, is the primary legislation that regulates drugs and cosmetics in India. It defines various terms related to drugs and cosmetics, establishes the Central Drugs Standard Control Organization (CDSCO) to regulate and oversee the implementation of the Act, and empowers state drug control authorities. Drugs and Cosmetics Rules, 1945: The Drugs and Cosmetics Rules, 1945, were framed under the authority of the Drugs and Cosmetics Act to provide detailed regulations and procedures. These rules cover a wide range of topics, including licensing of manufacturing, import, sale, and distribution of drugs and cosmetics, standards for drugs and cosmetics, clinical trials, labeling and packaging requirements, and Good Manufacturing Practices (GMP). Central Drugs Standard Control Organization (CDSCO): The CDSCO, under the Ministry of Health and Family Welfare, is the national regulatory body responsible for overseeing the approval and regulation of drugs and cosmetics in India. The CDSCO works in coordination with state drug control authorities to ensure compliance with regulatory requirements. Drug Controller General of India (DCGI): The Drug Controller General of India (DCGI) is the head of the CDSCO and plays a crucial role in granting approvals for the import, manufacture, and marketing of drugs and medical devices in the country. New Drugs and Clinical Trials: The regulatory framework also covers the approval process for new drugs and clinical trials through the New Drugs and Clinical Trials Rules, 2019, which replaced the earlier rules in this regard. These regulations are designed to ensure the safety, efficacy, and quality of drugs and cosmetics in the Indian market. The regulatory landscape may evolve, and it is advisable to refer to the latest versions of the Drugs and Cosmetics Act and Rules or consult with regulatory experts for the most current information.