In the ongoing Patanjali misleading advertisements case, the Supreme Court of India has called upon the Union government to respond to allegations that the clinical trial regulations for AYUSH drugs have been diluted, especially concerning new indications.
Key Concerns Raised
The bench, comprising Justices Hima Kohli and Sandeep Mehta, was informed by Amicus Curiae Shadan Farasat that significant changes have been made in the approval mechanism for AYUSH drugs without amending the governing rule, specifically Rule 158B(II)(A) of the Drugs and Cosmetics Rules, 1945. Farasat highlighted that traditional medicines, unlike modern/allopathy medicines, are not subjected to clinical trials for efficacy, especially for new indications where proof of effectiveness and safety studies are often not required.
Government Notification and Its Implications
The Amicus Curiae pointed out a 2018 government notification that has diluted the rule, allowing Ayurvedic drugs for new indications without proof of effectiveness. He argued that proof of effectiveness is crucial for advertising and understanding what the drug can do. The Additional Solicitor General, representing the Union, requested time to seek instructions on the matter.
Court’s Observations and Orders
The court took note of the Amicus’ submission regarding the substantive changes in the approval mechanism for AYUSH drugs and recorded the notification in the order. Several other suggestions were provided by the Amicus based on affidavits from various states/UTs.
Suggestions for Improvement
- Effective Use of Penalty Mechanisms: The Amicus noted that the existing penalty mechanisms under the Drugs and Magic Remedies Act, the Drugs and Cosmetics Act, and the Consumer Protection Act are not effectively used, with states/UTs often failing to impose penalties. The court directed state governments to respond to their inaction in enforcing these penalties.
- Prior Approval of Advertisements: Some states, including Goa, Jharkhand, NCT of Delhi, Orissa, and West Bengal, require prior approval of advertisements before issuing licenses. The Amicus suggested that this practice be adopted by all states/UTs to ensure proper labeling. The court ordered other state governments to respond to this suggestion.
- Inter-State Cooperation: The Amicus highlighted that consumer complaints are often forwarded to states where the manufacturing unit is located, but the receiving states frequently fail to take action. The court ordered the Ministry of AYUSH to set up a dashboard for states to report complaints and actions taken, making this data publicly available.
- Collaboration with ASCI: The Amicus mentioned the Government of India’s previous MoU with the Advertising Standards Council of India (ASCI) for handling misleading advertisements. The MoU, which ended in 2020, had significantly increased the number of complaints resolved. Senior Advocate Amit Sibal emphasized ASCI’s effectiveness in monitoring and recommending modifications for misleading ads. The court noted the decrease in complaints since the MoU ended and directed the Ministry of Consumer Affairs to file a response on this issue.
Case Title
Indian Medical Association v. Union of India | W.P.(C) No. 645/2022