DRUGS AND COSMETICS RULES, 1945 (Syllabus: GS Paper 2 – Health & Gov. Policies)
Context: The Supreme Court stayed a July 1, 2024 notification issued by the AYUSH Ministry in which Rule 170 of the Drugs and Cosmetics Rules, 1945 was “omitted”.
Drugs and Cosmetics Rules, 1945
- About: The Drugs and Cosmetics Rules, 1945 are established under The Drugs and Cosmetics Act, 1940 which regulates the import, manufacture, and sale or distribution of drugs and cosmetics through licenses and permits.
- Objective: To ensure that the drugs and cosmetics marketed in India are reliable, efficient, and in compliance with national standards.
- Classification: The rules classify drugs into various schedules, each with specific guidelines.
- Regulations: The rules provide guidelines for the storage, sale, display, and prescription of drugs based on their classification.
- Appointment: Drugs Controller, India, or the Joint Drugs Controller (India) or the Deputy Drugs Controller (India) appointed by the Central Government.
- Features:
o Licensing: Rule 67 outlines the conditions required for obtaining licenses to manufacture and sell drugs.
o Labeling: Rule 97 specifies the labeling requirements for drugs, ensuring proper warnings and instructions.
o Schedule G: Includes hormonal medications, anticonvulsants, and hypoglycemic drugs; labels must caution usage under medical supervision.
o Schedule H: Drugs under this schedule require a prescription for sale and must display the "Rx" symbol and a warning.
ü If a Schedule H drug is also a narcotic or psychotropic substance, it must display the "NRx" symbol.
o Schedule M: The revised Schedule M focuses on Good Manufacturing Practices (GMP) and sets standards for pharmaceutical manufacturing premises and equipment.
o Rule 170: The Rule deals with the power to take action against objectionable or misleading advertisements about Ayurvedic, Siddha, and Unani drugs.
