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Supreme Court Halts Omission of Key Rule Regulating AYUSH Drug Ads

Supreme Court Maintains Status Quo on AYUSH Drug Advertising Regulation

The Supreme Court has stayed the Central government’s decision to remove Rule 170 from the Drugs and Cosmetics Rules, 1945, which regulates advertisements for Ayurvedic, Siddha, and Unani drugs. The Court’s move comes in response to concerns over misleading advertisements and the government’s recent actions regarding the rule [Indian Medical Association & Anr v. Union of India and Ors].

Rule 170, introduced in 2018, mandated that advertisements for these traditional medicines must receive prior approval from a licensing authority to prevent misleading claims. Despite this, a 2023 government letter had instructed States and Union Territories to refrain from enforcing Rule 170, following recommendations from an advisory board for its removal. The rule was subsequently omitted by a notification issued by the Indian government earlier this year.

A Bench of Justices Hima Kohli and Sandeep Mehta expressed dissatisfaction with the government’s decision, highlighting that the rule must remain in effect for the time being. The Court criticized the omission, noting it contravened its earlier orders.

“In our opinion, this notification of omission contravenes this Court’s order from May 7. Instead of withdrawing the letter of August 29, 2023, the notification dated July 1, 2024, has been issued to omit Rule 170. We are giving time to clarify, but until then, the notification omitting Rule 170 will remain stayed,” the Court stated.

The rule, designed to address misleading advertisements, had been the subject of previous criticism from the Court, particularly in a case involving Patanjali Ayurved. The Court had earlier condemned the failure to apply Rule 170 against Patanjali for its misleading ads.

Additional Solicitor General (ASG) KM Nataraj informed the Court that the letter has been withdrawn but argued that the decision to omit the rule remained. The Bench was unimpressed, stressing that the rule must stay in force until a satisfactory explanation is provided.

“We will quash your notification immediately. You are violating our order. This cannot happen,” Justice Kohli asserted.

The matter is set to be reviewed again in October.

(With inputs from agency)

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