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Mahesh

02/09/24 13:05 PM IST

Rule 170 of Drugs Act

In News
  • The rule, introduced in 2018, is designed to prevent misleading advertisements of AYUSH products. 
Rule 170
  • In 2018, the government brought in Rule 170 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 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, indication for use, 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, depicts photographs or testimonials from celebrities or government officials, refers to any government organisation, gives false impression or makes misleading or exaggerated claims.
  • 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.
Challenges
  • 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 or equivalence studies for generic versions have to be conducted before a drug is cleared for marketing.
  • According to the aforementioned act, most AYUSH drugs can be approved simply based on the rationale provided in authoritative texts of that particular stream.
  • Safety trials have to be conducted only for formulations that use around 60 specific ingredients listed in the act, such as snake venom, snake head, heavy metals such as arsenic and mercury, and compounds such as copper sulphate.
  • For licensing of drugs containing these ingredients and traditional drugs used for new indications, proof of effectiveness has to be provided as per the Act.
Source- Indian Express

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