The Ministry of Health and Family Welfare (MoHFW) in India has announced revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945, aimed at enhancing compliance with quality standards in pharmaceutical manufacturing. 

The updated Schedule M, which prescribes good manufacturing practices (GMP) for pharmaceutical products, introduces significant changes, including the incorporation of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), and criteria for equipment qualification and validation. 

The move is seen as a step towards aligning with international quality standards and ensuring the production of safe and high-quality drugs.

Key changes in the revised Schedule M include the introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), equipment qualification and validation, and a computerized storage system for all drug products. 

The Central government, in consultation with the Drugs Technical Advisory Board, notified the amendments to the Drugs (Amendment) Rules, 2023. The revisions aim to uphold good manufacturing practices and establish requirements for premises, plant, and equipment in pharmaceutical product manufacturing.

Sudarshan Jain, Secretary-General of the Indian Pharmaceutical Alliance (IPA), highlighted the positive impact of the revised regulations on compliance with international quality standards. He emphasized the focus on risk management, equipment qualification, and self-inspection as crucial contributions to ensuring global compliance.

The revised Schedule M consists of 13 parts, providing GMP guidelines for specific requirements in pharmaceutical drug manufacturing. Notably, the amendments cover five new categories of drugs not previously included, such as pharmaceutical products containing hazardous substances, biological products, radiopharmaceuticals, and investigational pharmaceutical products for clinical trials. 

The implementation of the new rules will be based on company turnovers, with smaller manufacturers given 12 months and larger manufacturers six months to comply.