Judicial Intervention on Regulatory Practices

Context:

The Supreme Court of India has imposed a stay on a recent notification from the Ministry of AYUSH that omitted Rule 170 from the Drugs and Cosmetics Rules, 1945. This rule grants the authority to address and take legal action against misleading or inappropriate advertisements concerning Ayurvedic, Siddha, and Unani medicines.

Relevance:

GS II: Health

Dimensions of the Article:

1. Drug Regulation in India
2. Overview of Traditional Indian Medicine Regulation
3. Supreme Court’s Role in Regulating Misleading Advertisements

Drug Regulation in India:

• The regulation of drugs and cosmetics in India is governed by the Drugs and Cosmetics Act, 1940, and its subsequent rules established in 1945, delineating responsibilities across central and state regulators.

Central Drugs Standard Control Organisation (CDSCO):

• Authority and Functions:
  • Operates under the Directorate General of Health Services and is India’s National Regulatory Authority.
  • Responsibilities include drug approval, clinical trial conduct, setting drug standards, quality control of imports, and coordination with state drug control organizations.
  • Recently, there has been a move to bring all medical devices under CDSCO’s scrutiny.

Drugs Controller General of India (DCGI):

• Serves as the head of the CDSCO.
• Specifically responsible for licensing blood products, vaccines, sera, and more.
• Sets manufacturing, sales, import, and distribution standards for drugs within India.

Overview of Traditional Indian Medicine Regulation

• The Drugs and Cosmetics Act of 1940 categorizes Ayurvedic, Siddha, and Unani treatments as medicinal products for internal or external use to address health issues in humans or animals.
• Establishes the Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB) to standardize these traditional medicines.
• The Central Government retains the authority to amend or introduce new regulations post-consultation with the advisory board.

Standardization Practices

• Good Manufacturing Practices: Detailed in Schedule T of the Act, which prescribes the manufacturing standards for Ayurvedic, Siddha, and Unani medicines to ensure quality and safety.

Supreme Court’s Role in Regulating Misleading Advertisements

• Case Against Misleading Claims: Following a contempt case against Patanjali Ayurved Limited, the Supreme Court mandated in May 2024 that advertisers provide self-declarations to avoid misrepresentations in product promotions.
• Regulatory Update and Legal Challenge:
  • On July 1, 2024, the Ministry of AYUSH announced the removal of Rule 170 from the Drugs and Cosmetics Rules, 1945, based on ASUDTAB’s recommendations.
  • The Supreme Court intervened, staying the government’s decision to abolish Rule 170, citing it as contrary to judicial directives.