SC directs Centre to set up dashboard on misleading ads on drugs, cosmetics
The Supreme Court noted huge gaps in the implementation of three laws governing health sector with little or no action reported by states and Union territories
The Supreme Court on Tuesday pulled up the Centre, states and Union territories for not using the legal machinery against manufacturers of drugs, cosmetics and health products indulging in misleading advertisements and issued directions to the Ministry of Ayush to create a centralised dashboard where citizens across the country can access information about the action taken on their complaints.
A bench headed by justice Hima Kohli noted huge gaps in the implementation of three laws governing health sector – Drugs and Magic Remedies (Objectionable Advertisements) Act (DMR), Drugs and Cosmetics Act (DCA) and Consumer Protection Act (CPA), with little or no action reported by states and Union territories in initiating prosecution and penalties against the defaulting manufacturers under these laws.
Finding this situation to be non-conducive for consumers, the bench, also comprising justice Sandeep Mehta said, “In prosecutions under these Acts (DMR, DCA and CPA), absence of action taken is a big deterrent in implementing the laws...this leaves common citizens helpless and in the dark about action taken on their complaints.”
Passing an order, the bench said, “We are of the opinion that the Ministry of Ayush must set up a dashboard on complaints received from states and action taken so that data is made available in the public domain and is accessible to all.”
The bench was hearing a petition filed by the Indian Medical Association (IMA) which came to court against misleading advertisements by Patanjali Ayurved and its proponent Baba Ramdev pointing out how some of the advertisements of drugs produced by the company violated provisions of the DMR and DCA.
IMA counsel Prabhas Bajaj pointed out that on April 15, the Uttarakhand licensing department banned 14 Ayurvedic products of Patanjali and Divya Pharmacy for promising cures that went contrary to the DMR and DCA but were still available for sale across the counter. He referred to certain media reports which gave evidence of the banned products being available for sale despite Patanjali assuring the court that physical and online sale of the 14 products had been stopped.
Senior advocate Balbir Singh appearing for Patanjali pointed out that on July 1, the Uttarakhand government passed an order lifting the ban after an expert committee found procedural lapses in the April 15 decision by the licensing authority. He further said that on July 8, the company received fresh show cause notice on the 14 products to which it replied on July 19.
The bench asked the Uttarakhand government why it was taking time to decide on this issue as already two weeks had lapsed. “This should not take time unless you want to give them a long rope. We also want to know why it took you a month to know about procedural lapses in your order. You should have taken a time-bound decision without waiting for our order.”
The court granted the state another two weeks to take a final decision on the ban on Patanjali products while posting the matter on August 20. Advocate Vanshaja Shukla representing Uttarakhand informed the court that the final decision of the state is awaiting legal opinion from the advocate general.
On the larger issue to plug gaps in the implementation of the law relating to misleading advertisements, the court received a voluminous note prepared by advocate Shadan Farasat, assisting the court as amicus curiae. On previous occasions, the court had indicated that it does not intend to restrict the scope of consideration to Patanjali and directed responses to be filed by all states and UTs on handling of complaints under the three laws, focusing on consumer health and well-being.
Noting a major lapse in the legal mechanism related to Ayush drugs, Farasat said that advertising of Ayush drugs is connected to the scientific basis for the claim made in respect of these drugs. He pointed out that unlike clinical trials for approving an allopathic drug, there is no requirement of clinical trials for either the efficacy or safety of Ayush drugs. This has been done pursuant to a notification issued by the ministry in July 2018.
The court observed, “Safety study is necessary. This notification dilutes the Drug Rules 1945 without giving any reasons,” as it sought Centre’s response on the same.
Farasat highlighted that penalty mechanism under the Acts remained “underutilised” even against repeat defaulters with almost nil prosecutions. He also highlighted lack of inter-state coordination as complaints get forwarded from one state to the state where the manufacturer is situated. Such complaints galore as the note submitted by Farasat indicates that Delhi forwarded 1622 complaints, Gujarat 714 complaints, the status of which are unknown.
Going through some of the affidavits filed by states, the bench said, “The affidavits show that in most cases, penalty imposed is nil. Similarly action taken is very poor. Despite statutes in place, states and UTs are taking it very lightly.” As 15 states and UTs were yet to file responses, the court granted them two weeks as a final opportunity failing which the concerned health secretary was directed to appear virtually on the next date of hearing.
Highlighting the position under each law, Farasat said that the Ministry of Consumer Affairs had entered into a Memorandum of Understanding (MoU) with the Advertising Standards Council of India (ASCI) in 2018 to monitor misleading advertisements through the Grievances Against Misleading Advertisements (GAMA) portal. From 2018 to April 2022, 2,573 complaints related to the health sector were registered, of which 2,505 were resolved. The MoU was not renewed after August 2020.
The court asked the Centre to respond why the MoU was not renewed as it saw that the complaints saw a sharp decline after 2022. The petitioner IMA pointed out that in 2022, the GAMA portal was integrated into the National Consumer Helpline portal which has received only 132 complaints in past two years. “The number of complaints received is abysmally low. This itself speaks much on the manner in which the ministry is bringing information of the portal to the public at large,” the bench said.
Farasat said that the ASCI, comprising largely of independent experts, would take initiative on its own to help consumers against misleading advertisements, which may not be the case with the ministry. ASCI was represented in court by senior advocate Amit Sibal who said that the council has dealt with 60,000 complaints of misleading ads in TV and print media and has secured 98% compliance, with the bulk complaints being addressed relating to health and health products.
The amicus further informed the bench that the GAMA portal received 728 complaints of misleading advertisements and violation of programme code against private broadcasters. Even the Ministry of Ayush, which signed an MoU with ASCI in 2017 for action on misleading ads, received 732 cases in one year. In addition, the National Pharmacovigilance Centre generated 36,040 reports of misleading advertisements and forwarded 31,238 reports to various states, Farasat said.
The top court, in its attempt to address the problem of misleading ads, had in May directed all advertisers and advertising agencies to submit a ”self-declaration certificate” before publishing or broadcasting any advertisement. The self-declaration certificate is to affirm that the advertisement does not contain misleading claims and complies with all relevant regulatory guidelines. Following the court order, the ministry of information and broadcasting has introduced a new feature on the Broadcast Seva Portal for TV and radio advertisements and on Press Council of India’s portal for print and digital/Internet advertisements.
The genesis of these proceedings began in 2022 when IMA approached the court against disparaging remarks by Baba Ramdev and Patanjali against modern medicine. The petition showed that Patanjali advertisements promising cures for lifestyle disorders and other illness violated the law under the DMR and DCA.
Section 3 of the DMR Act prohibits any advertisement claiming diagnosis, cure, mitigation, treatment or prevention of any lifestyle diseases such as blood pressure, diabetes, arthritis, asthma, cervical spondylitis, obesity, heart diseases, etc. Further, Patanjali’s claim to eradicate asthma and cure diabetes was in direct contravention to the DCA Rules, the IMA petition said.