 "Health Ministry revises pharma manufacturing rules under Schedule M")
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 Saturday. 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.
“The focus on risk management, qualification and validation of equipment, and self-inspection will be a vital contribution in ensuring compliance with global standards,” he added.
Earlier in August, the Ministry had set a six-month deadline for small manufacturers and 12 months for large units to get their World Health Organization-Good Manufacturing Practices (WHO-GMP) certification.
Schedule M of the Drugs and Cosmetics Act, 1940, includes requirements of facilities and their maintenance, personnel, manufacture, control, safety testing, storage and transport of material, written procedures and records, and traceability for pharmaceutical products.
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GMP, which includes standards for materials, methods, machines, processes, personnel, and facilities, was first introduced in 1988 under Schedule M. The revised rules are the first amendment in the Drugs and Cosmetics Rules since June 2005.
The revised Schedule M has 13 parts which provide GMP guidelines for the specific requirements for manufacturing pharmaceutical drugs. The revised rules include five new categories of drugs that were not previously covered under the erstwhile rules.
The new categories include pharmaceutical products containing hazardous substances such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products, radiopharmaceuticals, phytopharmaceuticals, and investigational pharmaceutical products for clinical trials for humans.
The revised rules will be implemented on the basis of company turnovers. Medium and small manufacturers with an annual turnover of less than Rs 250 crore will have to implement the revised rules within 12 months from its date of publication, whereas large manufacturers with an annual turnover of over Rs 250 crore will be given six months to do so.