SC seeks govt’s reply as Amicus reports dilution of clinical trial norms for AYUSH drugs
New Delhi: 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. 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.
In response, the court has directed the Union of India to address these contentions, recognizing the potential implications for public health and consumer protection.
Additional Solicitor General KM Nataraj (appearing for the Union) sought time to take instructions.
The case also brought to light several other critical issues in the regulation and advertisement of AYUSH drugs:
1. Ineffective Use of Penalty Mechanisms:
The Amicus noted a pattern of states and Union Territories not imposing penalties under existing laws, even when prosecutions occur. The court has directed all states to respond to this apparent inaction and explain their approach to enforcing penalties as deterrents. 2. Prior Approval of Advertisements:
It was revealed that only a few states, including Goa, Jharkhand, Delhi, Odisha, and West Bengal, require prior approval of advertisements before issuing licenses for medicines. The court has asked other states to respond to this practice, considering its potential adoption nationwide.
3. Inter-State Cooperation on Complaints:
The court addressed the issue of ineffective handling of consumer complaints when they are forwarded between states. To combat this, the Ministry of AYUSH has been directed to create a dashboard for all states to furnish details of complaints received, referred, and actions taken, ensuring transparency and accountability.
4. Collaboration with Advertising Standards Council of India (ASCI):
The court discussed the previous successful partnership between the government and ASCI in addressing misleading advertisements. Senior Advocate Amit Sibal, representing ASCI, highlighted the organisation’s effectiveness in monitoring misleading ads. ASCI has handled 60,000 complaints since its inception, with high compliance rates: 98 per cent for TV and print ads, 78-80% for digital ads, and 88 per cent for healthcare ads.
The court noted that during the 2018-2020 MoU between ASCI and the Ministry of Consumer Affairs, 2,573 health sector complaints were registered, with 2,505 resolved. However, complaints have significantly decreased since then. In the past two years, the Ministry received only 132 complaints, with 116 disposed of. The court expressed concern over this sharp decline, questioning the Ministry’s efforts to publicise its complaint portal.
The court directed the Ministry of Consumer Affairs to explain the reduction in complaints, especially considering ASCI’s proactive approach compared to the Ministry’s reactive stance.with agency inputs
