Strengthening Quality and Regulation of Ayush Medicines: Government Initiatives

Regulatory & Quality Control Measures for AYUSH Medicines

Legal Framework

• Governed under Drugs and Cosmetics Act, 1940 & Rules, 1945.

• Mandatory compliance with:

  • Licensing requirements

  • Proof of safety & effectiveness

  • Good Manufacturing Practices (GMP) – Schedule T (Ayurveda, Siddha, Unani) & M-I (Homoeopathy)

  • Quality standards as per pharmacopoeias

Drug Testing Regulations

• Rule 160 A–J of Drugs Rules, 1945: Guidelines for approval of Drug Testing Laboratories (identity, purity, quality, strength).

Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H)

• Sets official standards for Ayurveda, Siddha, Unani & Homoeopathy (ASU&H) drugs.

Pharmacovigilance

• Pharmacovigilance Centres under Central Sector Scheme report adverse drug reactions (ADRs) to state regulators.

Central Sector Scheme – AOGUSY (2021–2026)

• Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana

• Upgradation of Ayush pharmacies & drug testing laboratories.

CDSCO – Ayush Vertical

• WHO-CoPP (Certificate of Pharmaceutical Product) issued for Ayush drugs meeting WHO standards.

Quality Certification – AYUSH Mark

• Implemented by Quality Council of India (QCI)

• Third-party evaluation of domestic & international compliance.

Research Initiatives in AYUSH

AYURGYAN Scheme – Ministry of Ayush (From FY 2021–22)

Type: Central Sector Scheme
Objective: To promote education, capacity building, and research in the Ayush sector.

Key Components:

1. Capacity Building & Continuing Medical Education (CME) in Ayush

   • Aims to enhance the skills of Ayush professionals and promote continuing education.

2. Research & Innovation in Ayush

   • Provides financial assistance to eligible organizations/institutions across India.

   • Supports:

     • Clinical Research

     • Fundamental Research

     • Pharmaceutical Research

     • Literary Research

     • Medicinal Plant Research

   • Mode: Extra Mural Research (EMR)

3. Ayurveda Biology Integrated Health Research (Added from FY 2023–24)

   • Focuses on interdisciplinary research integrating modern biology with Ayurveda.

Apex Research Councils

• Central Council for Research in Ayurvedic Sciences (CCRAS), Central Council for Research in Unani Medicine (CCRUM), Central Council for Research in Homoeopathy (CCRH), Central Council for Research in Siddha (CCRS) and Central Council for Research in Yoga & Naturopathy (CCRYN) under the Ministry of Ayush

• Core research areas:

  • Medicinal plant surveys, in-vitro propagation, drug standardization, pharmacological & clinical research, tribal healthcare, and documentation.

Information, Education, Communication (IEC) & Outreach

• IEC Scheme: Mass awareness on Ayush via:

  • National/State Arogya Fairs

  • Yoga Utsavs, Ayurveda Parvs

  • Multimedia campaigns (English, Hindi, regional languages)

• Outreach through health camps, expos, melas.

International Collaboration & Recognition

Global Engagement

• 25 Country-to-Country MoUs (Traditional Medicine & Homoeopathy)

• 15 Academic Chair MoUs with international institutions.

• 51 Institute-to-Institute MoUs (research & academic collaboration).

• 43 Ayush Information Cells in 39 countries.

Student Scholarships

• Scholarships/Fellowships to foreign nationals to study AYUSH in India.

Global Promotion Milestones

• Supported:

  • Ministry of Ayush has taken initiative for inclusion of ‘Traditional Medicine’ chapter in the International Classification of Disease (ICD-10 and 11)

  • supporting the scientific research, Ayush Export Promotion Council (AYUSHEXCIL), WHO Global Traditional Medicine Centre (GTMC) and celebration of Yoga and Ayurveda day etc. worldwide.