- The Union Health Ministry has proposed amendments to the Drugs Rules, 1945 to mandate the authorization of qualified personnel for drug batch release. - The move aims to strengthen quality assurance, accountability, and regulatory oversight in pharmaceutical manufacturing. - Qualified professionals with specified educational and professional experience will be legally responsible for testing and verifying drug batches before commercial distribution. - This initiative addresses concerns regarding drug safety, standard compliance, and international quality benchmarks for Indian pharmaceuticals. - **Drugs Rules 1945:** Subordinate legislation framed under the Drugs and Cosmetics Act, 1940, prescribing detailed procedures, standards, and requirements for the manufacture, sale, labeling, and import of drugs and cosmetics in India. - **Drugs and Cosmetics Act 1940:** The primary central legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics to prevent sub-standard products and protect public health. - **Central Drugs Standard Control Organization (CDSCO):** The national regulatory body under the Ministry of Health and Family Welfare responsible for approval of new drugs, clinical trials, standards setting, and quality control of imported drugs in India. - **Union Health Ministry:** The apex central government body tasked with formulating health policies, administering public health programs, and proposing statutory amendments related to pharmaceutical safety and healthcare infrastructure. **Introduction** The Union Health Ministry has proposed amendments to the Drugs Rules, 1945, to make it mandatory for pharmaceutical manufacturing units to designate qualified personnel responsible for authorizing drug batch releases. This regulatory change aims to enhance quality control, ensure stricter accountability in drug manufacturing, and align India's regulatory frameworks with global safety standards. **Core Issue and Detailed Points** - The Union Health Ministry has proposed amendments to the Drugs Rules, 1945 to mandate the authorization of qualified personnel for drug batch release. - The move aims to strengthen quality assurance, accountability, and regulatory oversight in pharmaceutical manufacturing. - Qualified professionals with specified educational and professional experience will be legally responsible for testing and verifying drug batches before commercial distribution. - This initiative addresses concerns regarding drug safety, standard compliance, and international quality benchmarks for Indian pharmaceuticals. **Key Statutory Bodies, Acts & Concepts** - **Drugs Rules 1945:** Subordinate legislation framed under the Drugs and Cosmetics Act, 1940, prescribing detailed procedures, standards, and requirements for the manufacture, sale, labeling, and import of drugs and cosmetics in India. - **Drugs and Cosmetics Act 1940:** The primary central legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics to prevent sub-standard products and protect public health. - **Central Drugs Standard Control Organization (CDSCO):** The national regulatory body under the Ministry of Health and Family Welfare responsible for approval of new drugs, clinical trials, standards setting, and quality control of imported drugs in India. - **Union Health Ministry:** The apex central government body tasked with formulating health policies, administering public health programs, and proposing statutory amendments related to pharmaceutical safety and healthcare infrastructure.