Team Blitz India
NEW DELHI: With an aim to bring better compliance with quality standards, the Ministry of Health and Family Welfare (MoHFW) notified the revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945, in the Gazette of India on January 6. Schedule M prescribes the good manufacturing practices (GMP) for pharmaceutical products.
Some of the major changes introduced in the revised Schedule M include the introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerised storage system for all drug products.
The Central Government, after consultation with the Drugs Technical Advisory Board, notified the revised rules under the Drugs (Amendment) Rules, 2023. The revised Schedule M has been notified as rules to ensure good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products.
Speaking on the notification of revised Schedule M, Sudarshan Jain, Secretary-General, Indian Pharmaceutical Alliance (IPA), said that the revised regulations of Schedule M will help ensure compliance with international quality standards, benefiting both patients and the industry by promoting the manufacturing of safe, effective, and high-quality drugs.
