REVISED RULES FOR PHARMACEUTICAL MANUFACTURING PRACTICES

Context

1. Ministry of Health and family Welfare has issued revised rules to ensure good manufacturing practices (GMP) and premises, plant, and equipment requirements for pharmaceutical products.

• • GMP is a system for ensuring that products are consistently produced and controlled according to quality standards.

2.The revised rules fall under Schedule M of the Drugs and Cosmetics Rules, 1945, named Drugs (Amendment) Rules, 2023.

Key Highlights

1. Schedule M outlines GMP for pharmaceutical products, covering facilities, maintenance, personnel, manufacturing, control, safety testing, storage, transport, written procedures, records, and traceability.
2. The Ministry set a deadline to obtain World Health Organization-Good Manufacturing Practices (WHO-GMP) certification as follows:  

1. 6 months for medium and small manufacturers (annual turnover < ₹250 crore)
2. 12 months for large units (annual turnover > ₹250 crore)

Revised Schedule M Changes

1. Changes introduced: a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerized storage system for all drug products.
2. Manufacturer Responsibilities: Manufacturers are responsible for ensuring the quality of pharmaceutical products, compliance with license requirements, and avoiding risks to patients.
3. Marketing Regulations and sample retention: Companies can market finished products only after receiving "satisfactory results" on ingredient tests and must retain sufficient samples for repeated testing.
4. Schedule M Parts: The revised Schedule M consists of 13 parts providing GMP guidelines for specific manufacturing requirements.

New Categories of Drugs Included:

1. Pharmaceutical products with hazardous substances (sex hormones, steroids, cytotoxic substances)
2. Biological products
3. Radiopharmaceuticals
4. Phytopharmaceuticals
5. Investigational pharmaceutical products for clinical trials in humans

Benefits of Revised Guidelines

1. Ensures compliance with international quality standards.
2. Benefits patients and the industry by promoting the manufacturing of safe, effective, and high-quality drugs.

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