Rule 170 of the Drugs and Cosmetics Act

Sept. 2, 2024

The Supreme Court recently stayed a Central government notification, whereby Rule 170 of the Drugs and Cosmetics Rules, 1945, was omitted.

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 of Ayurvedic, 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 the 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.