Rule 170 was inserted to control inappropriate advertisements and exaggerated claims for Ayurvedic, Siddha and Unani medicines.
Published Aug 27, 2024 | 5:06 PM ⚊ Updated Aug 27, 2024 | 5:06 PM
Supreme Court of India. (Wikimedia Commons)
The Supreme Court on Tuesday, 27 August, stayed the 1 July order of the Ministry of Ayush omitting the Rule 170 of the Drugs and Cosmetics Rule 1945.
The apex court bench of Justices Hima Kohli and Sandeep Mehta was hearing Patanjali Ayurved Ltd’s misleading advertisements case.
“We think that this omission of Rule 170 done by the Union on 1/7/2024 flies in the face of this court’s order passed on 7 May. And we are not ready to accept it at all,” Justice Kohli said.
When Additional Solicitor General (ASG) KM Nataraj informed the court the order was withdrawn, the court questioned why the omission was not reversed.
“You have withdrawn the letter but the rule stands omitted..how can you take this decision of omitting this rule in the teeth of the court’s order?” the court asked.
“You cannot use a letter to put a rule on hold? The intention was to ensure that Rule 170 stays but you have omitted. Your letter is saying that Rule 170 is omitted. Any manufacturer can go around and make any ad,” the court said.
When the ASG said that an affidavit would be filed in that regard, the court opposed it.
“We will quash your notification right now. No affidavit. You are violating our order. We are going to quash your notification,” the court said and issued an order.
“Notification issued on 1 July, whereunder Drugs (4th Amendment Rules) 2024 have been notified, stating Rule 170 shall stand omitted.It is further submitted that in compliance with this court’s order, the ministry of Ayush has notified the omission of Rule 170. In our opinion, the aforesaid notification flies in the face of the order passed by this court. Instead of withdrawing the letter for reasons best known to the Ministry, a notification has been issued to delete Rule 170, which runs contrary to this court’s order. Till further orders, notification dt. 1 July omitting Rule 170 shall stand stayed,” the order read.
Rule 170 was inserted into the Drugs and Cosmetics Rules, 1945 in December 2018 to control inappropriate advertisements and exaggerated claims for Ayurvedic, Siddha and Unani medicines. It prohibited the advertisement of these medicines without prior clearance from the state licensing authority.
However, the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) recently recommended the omission of Rule 170.
This recommendation came after representations from the Association of Manufacturers of Ayurvedic Medicines seeking the repeal of the rule.
The Ministry of Ayush has now directed state licensing authorities not to take any action under Rule 170(1). The ministry argues that the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and the Consumer Protection Act already cover provisions for prohibiting misleading advertisements.
Health experts have criticised this decision, stating that the reasons for bringing in Rule 170 in the first place still exist. They point out that misleading Ayush advertisements continue to be prevalent despite existing laws. The omission of Rule 170 is seen as prioritising industry interests over public health.
The final notification to omit Rule 170 is still pending. However, the ministry’s U-turn on this rule aimed at curbing inappropriate advertising of Ayush medicines has raised concerns among health activists and experts.
Without the requirement for prior clearance from licensing authorities, the likelihood of misleading claims in AYUSH advertisements may rise, undermining consumer trust and safety.
The existing frameworks, such as the Drugs and Magic Remedies Act and the Consumer Protection Act, may not effectively prevent misleading ads, as they typically address issues post-publication rather than proactively.
The absence of stringent regulations could expose consumers to unverified and potentially harmful AYUSH products, impacting public health negatively.
Rule 170 was intended to be a preventive measure, requiring ads to be cleared by authorities before publication. Its omission leaves consumers vulnerable to potentially harmful or unverified claims.
(Edited by Muhammed Fazil with inputs from Sumit Jha)
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