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Supreme Court stays Central notification omitting Rule 170 of Drugs and Cosmetics Rules

The Supreme Court on Tuesday stayed a notification issued by the Ministry of Ayush on July 1, 2024, which omitted the prohibition on advertisements of Ayurvedic, Unani, and Siddha drugs without approval.

Noting that the omission of Rule 170 of the Drugs and Cosmetics Rules, 1945 was in the teeth of the Apex Court’s May 7, 2024 order, the Bench of Justice Hima Kohli and Justice Sandeep Mehta stayed the effect of the notification dated July 1, 2024 till further orders.

The Apex Court recorded in its order that the Ministry of Ayush had enclosed with its affidavit, a notification issued on July 1, 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 stated that in compliance with the directions of the Supreme Court to expedite steps for notification dated February 2, 2024 vide order dated May 7, 2024, the Ministry has notified omission of Rule 170 and its related forms of the Drugs and Cosmetics Rules 1945 vide gazette notification dated July 2, 2024.

The Bench noted that the notification flew in the face of the Apex Court’s May 7, 2024 order. It said instead of withdrawing the letter dated August 29, 2023 for reasons best known to the Ministry, a notification was issued on July 1, 2024, to omit Rule 170 from the Drugs Rules, which ran contrary to the very directions issued by this Court.

The Bench recorded that the effect of the notification dated July 1, 2024 omitting Rule 170, shall remain in the statute book till further orders.

During the hearing of the Patanjali contempt case in April, two main contempt issues came up, including the one related to staying of action under Rule 170 by the Ministry of Ayush.

Rule 170 prohibited advertisements of Ayurvedic, Siddha, or Unani drugs without licensing authorities’ approval.

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 could 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.

The Supreme Court sought an explanation from the Union government in April regarding the letter issued by the AYUSH Ministry. On May 7, the Central government informed the Apex Court that it would forthwith withdraw the letter in question.

The top court of the country today observed that instead of withdrawing the letter, the Centre issued a notification on July 1, 2024 to the effect that Rule 170 shall stand omitted. Further, an affidavit was filed stating that the same was done in compliance with the Court’s order.

Senior Advocate Shadan Farasat has been appointed Amicus Curiae in the matter. Additional Solicitor General ASG KM Nataraj represented the Union government.

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