Supreme Court stays Ministry of Ayush notification related to drugs, cosmetic rules

Supreme Court stays Ministry of Ayush notification related to drugs, cosmetic rules

Subject: Polity

Sec: Legislation in news

Context:

The Supreme Court stayed the July 1, 2024 notification issued by the Ministry of Ayush, omitting Rule 170 of the Drug and Cosmetic Rules, 1945 that deals with prohibition of advertisements of Ayurvedic, Siddha and Unani drugs without licensing authority’s approval.

More on News:

• The issue arose in the context of the hearing on a 2022 plea by the Indian Medical Association (IMA) against Patanjali Ayurved Ltd and its officials accusing them of making misleading claims and statements critical of modern medicine.
• 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’, the bench ordered.

Drugs and Cosmetics Rules, 1945:

• The Drugs and Cosmetics Rules, 1945 are the set of rules under The Drugs and Cosmetics Act, 1940.
• It contains provisions for the classification of drugs under given schedules.
• It also contains the guidelines of drugs for their storage, sale, display, and prescription of each schedule.

Central Drugs Standard Control Organization (CDSCO)

• CDSCO is the National Regulatory Authority (NRA) of India.
• Headquarters : Delhi.
• The Drugs & Cosmetics Act, 1940 and rules 1945 have entrusted various responsibilities to central & state regulators for the regulation of drugs & cosmetics.
• It envisages the uniform implementation of the Act & Rules for ensuring the safety, rights and wellbeing of the patients.

Under this act, CDSCO is responsible for:

• Approval of Drugs
• Conduct of Clinical Trials
• Laying down the standards for Drugs
• Control over the quality of imported Drugs in the country
• Coordination of the activities of State Drug Control Organizations
• Bring out the uniformity in the enforcement of the Drugs and Cosmetics Act.

Rule 170 of the Drug and Cosmetic Rules, 1945:

• State/UT Governments are empowered to enforce the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 & Rules there under and Rule 170 of the Drugs & Cosmetics Rules, 1945 pertaining to control and prohibition of misleading advertisements and exaggerated claims of drugs.