Digital market access and quality assurance framework for AYUSH products

Why in news

The Government has undertaken several measures to strengthen quality assurance and regulatory compliance of Ayush drugs, including those made available through digital commerce platforms.

Exam relevance

GS2, GS3 · Governance, Economy, Science & Technology, Society · Prelims · Mains

Key facts

1. The Government has undertaken measures to strengthen quality assurance and regulatory compliance of Ayush drugs.
2. These measures include drugs made available through digital commerce platforms.
3. The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for Ayurvedic, Siddha, Sowa-Rigpa, Unani, and Homoeopathy (ASSU&H) drugs.
4. Manufacturers must adhere to prescribed requirements for license to manufacture for sale, including proof of safety & effectiveness.
5. Compliance with Good Manufacturing Practices (GMP) as per Schedule T (for Ayurvedic, Siddha, Sowa-Rigpa, Unani drugs) and Schedule M-I (for Homoeopathy drugs) of the Drugs Rules, 1945 is mandatory.
6. Manufacturers must also follow the quality standards of drugs as prescribed in the respective pharmacopoeia.
7. Drug Inspectors of concerned State/UTs regularly collect medicine samples from manufacturing firms or retail shops for quality testing.
8. If any sample is found to be 'Not of Standard Quality', appropriate action is initiated, such as preventing the sale of Ayush drugs and legal actions as per the Drugs and Cosmetics Act, 1940 and Rules.
9. An Ayush vertical has been created in the Central Drugs Standard Control Organization (CDSCO).

Prelims pointers

• The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 regulate ASSU&H drugs.
• Schedule T of Drugs Rules, 1945 specifies GMP for Ayurvedic, Siddha, Sowa-Rigpa, Unani drugs.
• Schedule M-I of Drugs Rules, 1945 specifies GMP for Homoeopathy drugs.
• State/UT Drug Inspectors are responsible for collecting samples and initiating action against 'Not of Standard Quality' drugs.
• An Ayush vertical has been created within the Central Drugs Standard Control Organization (CDSCO).

Mains practice question

Examine the measures undertaken by the government to strengthen quality assurance and regulatory compliance of AYUSH products, particularly in the context of digital commerce. Discuss their significance for public health and the promotion of traditional medicine systems.

Static linkage

The regulatory framework for AYUSH drugs is primarily governed by the Drugs & Cosmetics Act, 1940, and the Drugs Rules, 1945. The establishment of an Ayush vertical within CDSCO signifies the government's focus on integrating and regulating traditional medicine systems within the broader national drug control and quality assurance mechanisms.

Significance

Strengthening quality assurance and regulatory compliance for AYUSH products is vital for safeguarding public health and building consumer trust in traditional medicine systems. It addresses the challenges posed by digital commerce in ensuring the quality and authenticity of products, thereby preventing the circulation of substandard or spurious drugs. This framework also supports the legitimate growth and global acceptance of India's traditional healthcare systems.