TAG: GS 2: POLITY
THE CONTEXT: The Supreme Court recently stayed a notification issued by the AYUSH Ministry in which Rule 170 of the Drugs and Cosmetics Rules, 1945 was “omitted”.
EXPLANATION:
Background: The Role of Rule 170 in Regulating Ayurvedic, Siddha, and Unani Drug Advertisements
- Rule 170 of the Drugs and Cosmetics Rules, 1945, plays a crucial role in regulating advertisements related to Ayurvedic, Siddha, and Unani drugs.
- The rule grants authorities the power to take action against objectionable or misleading advertisements concerning these traditional medicine systems.
- This regulation aims to protect consumers from false claims and ensure that advertising remains truthful and not misleading.
Supreme Court’s May 2024 Order and the Contempt Case Involving Patanjali Ayurved
- In May 2024, the Supreme Court issued a directive in a contempt case against Patanjali Ayurved Limited, co-founded by yoga guru Baba Ramdev.
- The Court’s May 7 order instructed the AYUSH Ministry to withdraw a letter it had sent to drug licensing authorities in August 2023, which stated that Rule 170 was no longer operational.
- This letter was based on a recommendation from the Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB) to omit the rule.
- Despite this recommendation, the Court found it imperative to enforce Rule 170, ensuring that the regulations against misleading advertisements remained effective.
The July 2024 Notification and Its Contradiction with the Supreme Court’s Order
- Contrary to the Supreme Court’s explicit order, the AYUSH Ministry issued a notification on July 1, 2024, omitting Rule 170 from the Drugs and Cosmetics Rules, 1945.
- This move did not comply with the Supreme Court’s instruction to reinstate Rule 170 by withdrawing the August 2023 letter.
- The Supreme Court Bench expressed their disapproval stating that the notification was directly against the Court’s earlier directives.
- It was emphasized that the May 7 order intended to enforce Rule 170 to prevent any manufacturer from advertising its drugs without restrictions.
- By omitting this rule, manufacturers could potentially make misleading claims about their products, risking consumer safety.
The Supreme Court’s Response to the AYUSH Ministry’s Actions
- During the proceedings on August 27, 2024, Additional Solicitor-General attempted to provide an explanation by promising to file an affidavit.
- However, the Supreme Court Bench was not persuaded by this approach.
- Justice voiced strong criticism, highlighting that the Ministry’s actions amounted to a violation of the Court’s order.
- It was questioned how the Ministry could justify its actions through an affidavit when it clearly went against the Court’s directions.
- The Bench, therefore, decided to quash the July 1 notification immediately.
- In its formal order, the Court noted that the Ministry had issued the notification to omit Rule 170 for reasons “best known to the Ministry,” but this action was in direct contradiction to the Supreme Court’s explicit instructions.
The Indian Medical Association’s Apology and the Supreme Court’s Displeasure
- The Indian Medical Association (IMA), which had initially filed the contempt case against Patanjali Ayurved, found itself in an awkward position.
- The Supreme Court took serious exception to remarks made by IMA President about a Supreme Court order during a media interview.
- As a result, IMA President was required to publish an unconditional apology, which appeared in 20 editions of the print version of The Hindu.
- However, the Court found the apology published in an illegible font, rendering it effectively meaningless.
- The Bench directed IMA President’s counsel to file copies of the relevant pages from each edition in which the apology was published.
- The Court sought to review these copies to ensure compliance with its directives.
Drugs and Cosmetics Act, 1940
- It regulates the import, manufacture, and sale or distribution of drugs and cosmetics through licences and permits.
- Its main objective is to ensure that the drugs and cosmetics marketed in India are reliable, efficient, and in compliance with national standards.
- The associated Drugs and Cosmetics Rules, 1945, which were formulated in association with the 1940 Act, provide provisions for classifying medications into schedules and instructions for the storage, sale, presentation, and prescription of each schedule.