Revised Schedule M of Drugs and Cosmetics Rules, 1945

The Union Health Ministry announced the implementation of the revised Schedule M as part of the Drugs and Cosmetics Rules, 1945.

• This amendment introduces stringent Good Manufacturing Practices (GMP) and mandates the requirements of premises, plant, and equipment for pharmaceutical products.

Revised Schedule M of Drugs and Cosmetics Rules 1945:

Alignment with Global Standards:

• The revision aims to bring Indian GMP recommendations in line with international standards, particularly those of the World Health Organization (WHO).
• The focus is on producing globally acceptable quality drugs, ensuring patient safety and efficacy.

Key Changes in the Revised Schedule M:

• Introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), and product quality review (PQR).
• The inclusion of five new categories of drugs, including those with hazardous substances like:
  • Sex hormones,
  • Steroids,
  • Cytotoxic substances,
  • Biological products, and
  • Radiopharmaceuticals.
• Emphasis on the qualification and validation of equipment and a computerized storage system for all drug products.

Implementation Timeline and Compliance:

• Small and medium manufacturers with an annual turnover of less than ₹250 crore have 12 months to comply, while large manufacturers with more than ₹250 crore turnover have a six-month deadline.
• The revision mandates manufacturers to assume responsibility for the quality of pharmaceutical products, ensuring they meet the licence requirements and are safe for use.

Enhancements for Quality Control and Safety:

• The updated guidelines require companies to market products only after satisfactory results from ingredient tests.
• Pharma companies must report drug recalls, product defects, or faulty production, and implement a pharmacovigilance system for adverse drug reaction reports.
• Stability testing of drug substances as per recommended climate conditions is mandated.

Impact on the Pharmaceutical Sector:

• The Indian Pharmaceutical Alliance (IPA) views the revision as a positive step and a milestone for the Indian pharmaceutical industry.
• It is expected to elevate the quality standards of medicines, reinforcing the industry’s reputation and improving patient outcomes.
• The revisions are anticipated to benefit both patients and the industry by promoting the manufacturing of safe, effective, and high-quality drugs.

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