Supreme Court Stays Ayush Ministry's Notification That Omitted Prohibition On Ads Of Ayurvedic, Unani & Siddha Drugs Without Approval

The Supreme Court today stayed a Central government notification dated 1 July, 2024, whereby Rule 170 of the Drugs and Cosmetics Rules, 1945 was omitted.

A bench of Justices Hima Kohli and Sandeep Mehta passed the order, observing that the omission was in the teeth of the Court's order dated 7 May, 2024. It recorded thus:

"Enclosed with the affidavit filed by the Ministry of Ayush is a notification issued on 1 July, 2024 whereunder, the Drugs (Fourth Amendment) Rules 2024, have been notified, stating that Rule 170 of the Drugs Rules shall stand omitted...Para 12 of the affidavit further states that in compliance to the directions of the Supreme Court to expedite the steps for notification dated 2 February 2024 vide order dated 7 May 2024, Ministry of Ayush has notified omission of Rule 170 and its related forms of the Drugs and Cosmetics Rules 1945 vide gazette notification dated 2 July, 2024...in our opinion, the aforesaid notification flies in the face of order passed by this court on 7 May, 2024 wherein it was observed...instead of withdrawing the letter dated 29 August, 2023 for reasons best known to the Ministry, a notification dated 1 July 2024 has been issued to omit Rule 170 from the Drugs Rules which runs contrary to the very directions issued by this Court. Till further orders, the effect of the notification dated 1 July 2024 omitting Rule 170 shall stand stayed. In other words, till further orders are passed, Rule 170 shall remain in the statute book."

It may be recalled that two larger issues had arisen during the hearing of the Patanjali contempt case in April, one of which was related to staying of action under Rule 170 by the Ministry of Ayush.

Rule 170 prohibits advertisements of Ayurvedic, Siddha, or Unani drugs without licensing authorities' approval. However, on August 29, 2023, the Ministry of Ayush sent a letter to all State/UT Licensing Authorities and Drug Controllers of AYUSH, directing that action under Rule 170 not be initiated/taken by them in view of a recommendation of the Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB) to omit the provision. The final notification towards omission of the Rule remained to be published at the time.

In April, the Supreme Court sought an explanation from the Union regarding the letter issued by the AYUSH Ministry. On May 7, the Union informed the Court that it will "forthwith" withdraw the letter in question.

Today, however, it was observed by the Court that instead of withdrawing the letter, the Centre issued a notification on 1 July 2024 to the effect that Rule 170 shall stand omitted. Further, an affidavit was filed stating that the same was done in compliance of the Court's order.

Noting that the Union's action was in teeth of the Court's order, the effect of the notification dated 1 July 2024 was stayed till further orders.

Courtroom Exchange

J Kohli (to ASG KM Nataraj): How did you issue the 1 July, 2024 notification?

ASG: It's withdrawn

J Kohli: No, it's not. You have omitted Rule 170.

ASG: That's what we had pointed out

J Kohli: No, we are not on the same page

J Mehta: That was not the intent. (Intention was) Withdraw the letter, not the Rule...

J Kohli: What you have withdrawn is the Rule, not the letter. This notification is in the teeth of the orders of this Court. How did you take this decision?

ASG: This decision is in accordance with the order of this Court itself. In para 12, it's pointed out...

J Mehta: The intention was to Enforce Rule 170. In view of this omission, any manufacturer can with impunity go around advertising its drugs, which was the entire subject matter...

Amicus Shadan Farasat: In their affidavit they say, "in compliance" of your Lordships' order

J Kohli: Maybe the prefix "non" got deleted in the typo

ASG: I will file an affidavit

J Kohli: This flies in the teeth. No affidavit. We are quashing your notification here and now. How could you file this with an affidavit explaining it? We are really surprised. You are violating our own order. This is not appreciated

ASG: Allow me to explain

J Kohli: We will stay it, you can explain it

Appearance: Amicus Curiae and Senior Advocate Shadan Farasat; ASG KM Nataraj (for Union)

Case Title: Indian Medical Association v. Union of India | W.P.(C) No. 645/2022