Rule 170 of the Drugs and Cosmetics Rules, 1945

Context: The Supreme Court has put a hold on a notification from the AYUSH Ministry that “omitted” Rule 170 of the Drugs and Cosmetics Rules, 1945.

• The Supreme Court noted that this notification contradicted an earlier Supreme Court ruling related to misleading advertisements by Patanjali Ayurved. This ruling required advertisers to submit self-declarations ensuring that no false claims were made before their advertisements were broadcasted in the media.

What is Rule 170?

• Rule 170, introduced by the Government of India in 2018, aims to regulate the manufacture, storage, and sale of Ayurvedic, Siddha, and Unani medicines, as well as control inappropriate advertisements related to these products.
• This rule mandates that AYUSH drug manufacturers must seek approval and obtain a unique identification number from the state licensing authority before advertising their products. The application process requires manufacturers to submit detailed information, including textual references, the rationale for claims made, evidence of safety and effectiveness, and details about the quality of the drug.
• According to Rule 170, applications for advertising will be rejected if:
  • The manufacturer fails to provide their contact details.
  • The advertisement contains obscene or vulgar content, promotes products claiming to enhance sexual organs, uses photographs or testimonials from celebrities or government officials, references any government organization, or makes false, misleading, or exaggerated claims.

Challenges in Regulating AYUSH Drugs

• Unlike allopathic drugs, which must undergo extensive clinical trials (Phases I-III) for approval as per the Drugs and Cosmetics Act, AYUSH drugs do not require such trials for approval.
• Most AYUSH drugs can be approved based on references from authoritative texts. However, there are exceptions for about 60 specific ingredients (such as snake venom, snakehead, heavy metals like arsenic and mercury, and compounds like copper sulfate), which require proof of safety and efficacy before they can be approved.