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Rule 170 of Drugs Act
September 6 , 2024
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- The Supreme Court recently stayed a Central government notification, whereby Rule 170 of the Drugs and Cosmetics Rules, 1945, was omitted.
- The rule, introduced in 2018, is designed to prevent misleading advertisements of AYUSH products.
- Rule 170 aims to govern the manufacture, storage, and sale of medicines in the country.
- It is made “specifically for controlling inappropriate advertisements of Ayurvedic, Siddha and Unani medicines”.
- The rule prohibits AYUSH drug manufacturers from advertising their products without approval and allotment of a unique identification number from the state licensing authority.
- Like allopathic medicines, manufacturers of AYUSH drugs also have to seek a license from the drug controller.
- As per the Drugs and Cosmetics Act, phase I, II, and III trials for approval of new allopathic medicines to be conducted before a drug is cleared for marketing.
- However, such trials are not necessary for AYUSH drugs.
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