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Rule 170 of the Drugs and Cosmetics Rules, 1945

  • 04 Sep 2024
  • 1 min read

Source: IE

Recently, the Supreme Court of India criticised the AYUSH ministry for its directive to state licensing authorities to disregard Rule 170 of the Drugs and Cosmetics Rules, 1945 which is designed to prevent misleading advertisements of AYUSH products.

  • Rule 170 was introduced in 2018 to regulate the advertisement of Ayurvedic, Siddha, and Unani medicines, requiring manufacturers to obtain approval and a unique identification number from state licensing authorities.
    • The rule aims to prevent misleading or exaggerated claims, obscene content, or references to government bodies in AYUSH product advertisements.
    • The rule mandates manufacturers must submit details like textual references, rationale, indication, safety, effectiveness, and quality. 
  • On 1st July 2024, the AYUSH ministry issued a notification instructing state authorities to disregard Rule 170. This directive followed the recommendation made by the Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB) in May 2023 to omit the rule, as amendments to the Drugs and Magic Remedies Act, 1954, were under consideration to tackle misleading advertisements.
    • ASUDTAB is an expert body that recommends actions relating to regulation of AYUSH drugs.

Read more: Regulating Misleading Advertisements in India

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