GS Paper - II

Justices Hima Kohli and Sandeep Mehta, while hearing the ongoing Supreme Court case against Patanjali Ayurved, pulled up the AYUSH ministry for its 1 July notification asking state licensing authorities “not to initiate/take any action under” Rule 170 of the Drugs and Cosmetics Act.

The rule, introduced in 2018, is designed to prevent misleading advertisements of AYUSH products. The AYUSH ministry’s 1 July notification reiterated its position made in a previous letter, dated 29 August 2023.

What is 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.

What are challenges to regulate AYUSH drugs?

• 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.
• However, such trials are not necessary for AYUSH drugs. 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.

Why did AYUSH ministry direct licensing authorities to ignore the rule?

• The Ayurvedic, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB), an expert body that recommends actions relating to regulation of AYUSH drugs, in a meeting in May 2023 said that Rule 170 could be omitted as amendments in Drugs and Magic Remedies Act — another law to govern such misleading advertisements — were also being taken up by the health and AYUSH ministries.
• It is in this context that the AYUSH ministry made its recommendation to ignore the rule.