Context: The Ministry of Health and Family Welfare (MoHFW) released the updated regulations under Schedule M of the Drugs and Cosmetics Rules, 1945.
Revised Pharma Manufacturing Rules Under Schedule M to Ensure Quality Control
- Aim: The revised Schedule M has been notified as to improve adherence to quality standards, and ensure good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products.
- Drugs (Amendment) Rules, 2023: The revised rules have been notified under the Drugs (Amendment) Rules, 2023 after consultation with the Drugs Technical Advisory Board.
- Deadline to Obtain WHO-GMP Accreditation: The Ministry provided a six-month deadline for small manufacturers and 12 months for large units to obtain their WHO-GMP (World Health Organization-Good Manufacturing Practices) accreditation.
Schedule M
- It prescribes good manufacturing practices (GMP) for pharmaceutical products.
Good Manufacturing Practices (GMP)
- About: The GMP for pharmaceutical products includes standards for materials, methods, machines, processes, personnel, and facilities, and was first introduced in 1988 under Schedule M.
- Elements of GMP: It 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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Revised Guidelines For Pharma Manufacturing Rules
- Major changes introduced: The revised Schedule M includes:
- The introduction of a Pharmaceutical Quality System (PQS).
- Quality Risk Management (QRM).
- Product Quality Review (PQR).
- Qualification and validation of equipment.
- A computerized storage system for all drug products.
- Guidelines for Manufacturing Pharmaceutical Drugs: The revised Schedule M has 13 parts which provide GMP guidelines for the specific requirements for manufacturing pharmaceutical drugs.
- Introduction of Five New Categories of Drugs:
- The new categories(Not covered under Previous Rules) 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 human clinical trials.
- Application of Rules: The revised rules will be implemented based on 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 publication date, whereas large manufacturers with an annual turnover of over Rs 250 crore will be given six months.
Significance:
- 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.
Also Refer:
News Source: Business Standard
January 10, 2024