Rule 170 of the Drugs and Cosmetics Act

About Rule 170 of the Drugs and Cosmetics Act:

• It was introduced in 2018 to govern the manufacture, storage, and sale of medicines in the country, “specifically for controlling inappropriate advertisements ofAyurvedic, Siddha, and Unani medicines”.
• The rule was introduced after a parliamentary standing committee highlighted the problem of misleading claims, and the need for the AYUSH ministry to proactively pursue the issue.
• The rule prohibits AYUSH drug manufacturers from advertising their products without approval and allotment of a unique identification number from the state licensing authority. 
• The manufacturers have to submit details such as textual references and rationale for the medicine from authoritative books, indications for use, and evidence of safety, effectiveness, and quality of drugs.
• The rule states that the application will be rejected if the manufacturer does not provide their contact details, if the contents of the advertisement are obscene or vulgar, products for enhancement of male or female sexual organs,depict photographs or testimonials from celebrities or government officials, refers to any government organisation, gives false impressions, or makes misleading or exaggerated claims.

Q1: What is the Drugs and Cosmetics Act, 1940?

Drugs and Cosmetics Act regulates the import, manufacture, and sale or distribution of drugs and cosmetics through licences and permits. Its main objective is to ensure that the drugs and cosmetics marketed in India are reliable, efficient, and in compliance with national standards. The associated Drugs and Cosmetics Rules, 1945, which were formulated in association with the 1940 Act, provide provisions for classifying medications into schedules and instructions for the storage, sale, presentation, and prescription of each schedule.

Source: Supreme Court Stays Ayush Ministry’s Notification That Omitted Prohibition On Ads Of Ayurvedic, Unani & Siddha Drugs Without Approval

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