SC seeks govt's reply as Amicus reports dilution of clinical trial norms for AYUSH drugs

In a significant development, the Supreme Court has called upon the Union government to address concerns regarding the dilution of clinical trial rules for AYUSH drugs, particularly in the context of new indications.

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This inquiry comes as part of the ongoing case involving misleading advertisements by Patanjali Ayurved.

The bench, comprising Justices Hima Kohli and Sandeep Mehta, was informed by Amicus Curiae Shadan Farasat about substantial changes made to the approval mechanism for AYUSH drugs. These alterations, notably, were implemented without amending the governing Rule 158B(II)(A) of the Drugs and Cosmetics Rules, 1945.

Farasat highlighted a key difference in regulation between traditional and modern medicines:

clinical efficacy trials are not mandatory for traditional medicines. He pointed out that a 2018 government notification had effectively diluted Rule 158B without formally amending it, allowing Ayurvedic drugs to be used for new indications without proof of effectiveness.

The Amicus emphasised the intrinsic link between a drug’s effectiveness, its advertised capabilities, and consumer safety. He argued for the necessity of effectiveness studies, even for new indications of traditional medicines.