Source-This post is based on the article “Ministry issues revised rules to ensure quality in pharma sector” published in “The Hindu” on 12th January 2024.
Why in the News?
The Ministry of Health and Family Welfare has notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945. This was done to ensure the production of high-quality drugs meeting international standards.
What are the updated rules notified by the Ministry?
| Five new categories of drugs | Pharmaceutical products containing hazardous substances such as: 1. Sex hormones 2. Steroids (anabolic and androgenic) 3. Cytotoxic substances (used to destroy cancer cells) 4. Biological products 5. Radiopharmaceuticals (used in nuclear medicine for diagnostic and therapeutic purposes) |
| Additional sections under Schedule M | 1. Introduction of a pharmaceutical quality system (PQS) 2. Quality risk management (QRM) 3. Product quality review (PQR) 4. Qualification and validation of equipment 5. Computerized storage system for all drug products |
| Other revised guidelines | 1. The manufacturer is obligated to take responsibility for the quality of pharmaceutical products, ensuring their suitability for use. 2. They also need to comply with license requirements and prevent any risks to patients arising from inadequate safety, quality, or efficacy. 3. Companies are required to market a finished product only upon obtaining ‘satisfactory results’ from ingredient tests. 4. They must also retain sufficient samples of intermediate and final products for potential retesting or batch verification. |
| Implementation | The updated rules apply to companies based on their turnovers 1. Small and medium manufacturers (annual turnover < Rs. 250 crore) must comply within 12 months of publication. 2. Large manufacturers (annual turnover > Rs. 250 crore) have a six-month deadline. |
What is Schedule M of the Drugs and Cosmetics Rules, 1945?
1) Schedule M of the Drugs and Cosmetics Rules, 1945, pertains to the Good Manufacturing Practices (GMP) for the manufacture of drugs.
2) The revised Schedule M has 13 parts.
3) Schedule M originated from the recommendations of the Hathi Committee in 1975, which proposed making Good Manufacturing Practices (GMP) mandatory for all drug manufacturers.
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