On July 31, the Supreme Court called upon the Union of India to address concerns regarding the dilution of clinical trial rules for AYUSH drugs, especially in the context of new indications. This arose during the hearing of a case involving misleading advertisements by Patanjali.
A bench comprising Justices Hima Kohli and Sandeep Mehta was informed by Amicus Curiae Shadan Farasat that significant changes in the approval process for AYUSH drugs have occurred without amendments to Rule 158B(II)(A) of the Drugs and Cosmetics Rules, 1945. Farasat pointed out that traditional medicines do not require clinical trials for efficacy, particularly for new indications, as per the 2018 government notification, which he claimed diluted the rule.
Farasat argued that proof of effectiveness should be mandatory for new indications to ensure accurate advertising and drug efficacy. Additional Solicitor General KM Nataraj requested time to respond.
The Court recorded the Amicus’s suggestions and highlighted several issues based on affidavits from various states and union territories (UTs):
- Penalty Mechanisms: Farasat noted that despite existing penalty provisions under various Acts, states and UTs rarely impose penalties. The Court directed all state governments to explain their inaction.
- Prior Approval of Advertisements: Farasat suggested that states should adopt the practice of requiring prior approval for advertisements before issuing drug licences. The Court ordered states to respond to this proposal.
- Inter-State Cooperation: Farasat emphasised the need for better inter-state cooperation when consumer complaints are forwarded. The Court directed the Ministry of AYUSH to create a dashboard for tracking complaints and actions taken.
- Partnership with ASCI: The Amicus recommended reinstating the partnership between the Government of India and the Advertising Standards Council of India (ASCI) to monitor misleading advertisements, noting a significant drop in complaints since the MoU ended in 2020. Senior Advocate Amit Sibal supported this, highlighting ASCI’s high compliance rates with its recommendations.
The Court directed the Ministry of Consumer Affairs to explain the decline in complaints and the limited public awareness of the GAMA portal.
