SC stays govt decision to omit misleading ads rule
Pulling up the Centre for taking this rule off the statute book, the bench said, “In our opinion, the notification (of July 1) flies in the face of the order passed by this court.”
The Supreme Court on Tuesday stayed a government order of July 1 that controversially ended the requirement for manufacturers of Ayurveda, Siddha or Unani drugs to seek prior licensing permission before publishing advertisements.
A bench headed by justice Hima Kohli took serious exception to the Centre issuing a notification that flew in the face of repeated court orders seeking to strengthen the legal mechanism against misleading advertisements of health and medicinal products as they affect the well-being of citizens.
Pulling up the Centre for taking this rule off the statute book, the bench, also comprising justice Sandeep Mehta said, “In our opinion, the notification (of July 1) flies in the face of the order passed by this court.”
The order was passed in a petition filed by the Indian Medical Association (IMA) against misleading advertisements by Patanjali Ayurved in violation of the various laws and rules governing the field. The court permitted the Centre to file its affidavit explaining the stand for issuing the July 1 notification, and said, “Till further orders, the notification dated July 1 omitting Rule 170 shall stand stayed. In other words, Rule 170 of the 1945 Rules shall remain in the statute book till further orders. “
The July 1, 2024 notification issued by the Union Ayush (ayurveda, yoga and naturopathy, unani siddha, and homoeopathy) ministry omitted Rule 170 of the Drugs and Cosmetics Rules, 1945 that was introduced to curb misleading advertisements. Under this rule, manufacturers of Ayush drugs could not directly issue any advertisement relating to the use of the drug for diagnosis, cure etc. of diseases without obtaining a unique identification number from the state licensing authority. It also contained a provision for the suspension or cancellation of licenses of drug manufacturers and rejection of advertisements if they carried vulgar and obscene content or photographs of celebrities endorsing the product.
The court, on May 7, directed the Centre that Rule 170 of the 1945 Rules cannot be put on hold so long as it remains enforceable in law. These observations were made in the context of an August 29, 2023 letter issued by the ministry of Ayush to all states and Union territories directing them to not take any action against manufacturers under Rule 170.
Additional solicitor general (ASG) KM Nataraj, appearing for the Centre, told the court that the letter has since been withdrawn. He pointed out that the letter was issued based on the decision of the Ayurvedic Siddha and Unani Drugs Technical Advisory Board (ASUDTAB), which recommended deletion of Rule 170. The ministry filed an affidavit on August 22explaining that the letter was issued following an order of the Delhi high court on May 1, 2023 in a batch of petitions asking the Centre not to act upon the recommendations of ASUDTAB as an interim arrangement.
The bench on Tuesdaytold Nataraj, “What you have withdrawn is the Rule, not the letter,” pointing out that the withdrawal of letter had no meaning if Rule 170 stood effaced. “Instead of withdrawing the letter, for reasons best known to the Ministry of Ayush, a notification has been issued to delete Rule 170, which is in the teeth of this court’s order. We do not accept this. What you have withdrawn is the rule, not the letter.”
Senior advocate Shadan Farasat, assisting the court as amicus curiae, said that the Centre must also clarify whether there is requirement for clinical trials for approving Ayush drugs. He informed the court that the aspect advertising of Ayush drugs is “intrinsically connected” to the scientific basis for the claims made in respect of these drugs. An affidavit by the Ayush ministry filed on August 22 clarified the position and said that the pilot studies required for proving the effectiveness of Ayush drugs will not mean full-fledged clinical trial. However, Farasat said that only clinical trial will prove the efficacy and safety of a drug.
The bench directed the Centre to issue a clarification to avoid any ambiguity on this aspect after ASG Nataraj assured the court that the government does not intend to dilute the Rule in any manner. The matter was posted for further hearing on October 15.
In its earlier hearing on July 30, the top court passed a slew of directions asking various ministries under the Centre seeking action on misleading advertisements received by the ministry of information & broadcasting and the ministry of consumer affairs. The court proposed having a centralised dashboard for convenience of citizens to access progress on their complaints.
Nataraj informed the court that the Centre is still in the process of consulting stakeholders, including states and Union territories on the dashboard. The court granted time for completing this exercise by September 26 and directed that an affidavit to be filed by end of next month.
In May, the top court, in its attempt to address the problem of misleading ads, 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 & broadcasting 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. However, the ministry informed the court on Tuesday that the Centre is exploring the possibility of having a unified portal in this regard.
IMA president RV Asokan, who is facing the ire of the court for giving an interview to a news agency on the ongoing court proceedings, said that he had published an apology in 20 editions of Hindi newspapers. The court directed him to produce physical copies of the printed matter as with the scanned images, the court was unable to make out the dimensions of the printed matter.
Asokan’s lawyer said that his interview was published online and not by any newspaper to which the bench said, “It was put out to all media...It has damaged you wherever it went. We will not hear you a bit until you show the physical copy of newspapers where you published the apology.” The court sought physical copy of the advertisements containing the apology as it observed, “The excerpt of the apology filed before us is illegible in as much as the font is miniscule,” the court said.
Senior advocate PS Patwalia appearing for him offered apologies on his behalf. The court replied, “He is not obliging anyone by tendering an apology.”
Asokan faced the heat for an interview given in May, when he termed the comments made by the court against the medical fraternity as “unfortunate” after the court questioned doctors for endorsing health care products without facing any accountability.
The matter will be next heard on October 15.