Drugs and Cosmetics Rules
- The Drugs and Cosmetics Rules, 1945 are the set of rules under The Drugs and Cosmetics Act, 1940.
- It contains provisions for the classification of drugs under given schedules.
- It also contains the guidelines of drugs for their storage, sale, display, and prescription of each schedule.
- The Ministry of Health and Family Welfare has notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945.
- The revision aims to ensure that the pharma sector recommits to the manufacture of safe, effective, and high-quality drugs in compliance with international quality standards, thus benefiting both patients and industry.
- The latest revision includes five new categories of drugs — pharmaceutical products containing hazardous substances such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products and radiopharmaceuticals.
- It also has additional sections including — introduction of 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.
- According to the notification, the manufacturer must assume responsibility for quality of pharmaceutical products to ensure that they are fit for use, comply with requirements of the license, and do not place patients at risk due to inadequate safety, quality or efficacy.
- Additionally, companies must market a finished product only after getting “satisfactory results” from tests of the ingredients and retain enough of the samples of intermediate and final products to allow repeated testing or verification of a batch.
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