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India Strengthens AYUSH Medicine Quality, Safety & Global Standards: Govt Details Major Reforms
A Major Push to Make AYUSH Medicines Safer, Scientific & Globally Trusted
The Government of India has taken comprehensive and concrete steps to strengthen the quality, safety, research validation and regulatory oversight of Ayurveda, Siddha, Unani, Sowa-Rigpa and Homoeopathy medicines.
This information was shared by the Minister of State (Independent Charge) for Ayush, Shri Pratap Rao Jadhav, in a written reply in the Lok Sabha on 29 December 2025, highlighting how India is aligning its traditional medicine systems with modern scientific and global quality standards.
PCIM&H: Backbone of AYUSH Drug Quality Standards
The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), a subordinate organisation under the Ministry of Ayush, plays a central role in safeguarding AYUSH medicine quality.
Key Responsibilities of PCIM&H:
- Acts as the Appellate Drug Testing Laboratory for ASU&H drugs
- Lays down mandatory pharmacopoeial and formulary standards
- Defines parameters for identity, purity, strength and quality
- Supports regulators under the Drugs & Cosmetics Act, 1940
Compliance with PCIM&H standards is legally mandatory for all AYUSH drug manufacturers in India.
Expanding & Strengthening Drug Testing Infrastructure
To ensure scientific quality testing, the government has strengthened laboratory capacity under Rules 160A–160J of the Drugs Rules, 1945.
Current Status:
- 34 State Drug Testing Laboratories upgraded and supported
- 108 laboratories approved/licensed for testing AYUSH drugs and raw materials
- 3 Regional Research Institutes of CCRAS approved under Rule 160E
These laboratories conduct testing on behalf of licensed manufacturers and regulatory authorities.
Pharmacovigilance Programme: Protecting Consumers from Misleading Claims
India has implemented a robust nationwide pharmacovigilance system under the Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY).
Three-Tier Monitoring Network:
- 1 National Pharmacovigilance Centre (NPvCC)
- 5 Intermediary Centres (IPvCs)
- 97 Peripheral Centres (PPvCs) across India
What the Programme Does:
- Monitors adverse drug reactions
- Identifies misleading advertisements
- Reports violations to State Regulatory Authorities
- Protects consumers from unverified health claims
Impact so far:
- 3,533 awareness programmes conducted
- 3,18,575 beneficiaries reached
Global-Grade Certifications for AYUSH Products
To boost international acceptance and exports, the Ministry of Ayush encourages manufacturers to adopt recognised quality certifications.
WHO-Aligned CoPP Certification
- Extended to Ayurveda, Siddha and Unani medicines
- Issued by CDSCO
- Based on joint inspections by CDSCO, Ministry of Ayush & State Authorities
AYUSH Mark Certification (QCI)
- Implemented by Quality Council of India
- Based on third-party audits
- Ensures compliance with domestic & international quality standards
These certifications enhance consumer confidence and export readiness.
₹122 Crore AOGUSY Scheme: Raising Manufacturing Standards
The Central Sector Scheme AOGUSY (2021-22 to 2025-26) has a total allocation of ₹122 crore.
Focus Areas:
- Modernisation of AYUSH pharmacies
- Upgradation of drug testing laboratories
- Adoption of higher manufacturing standards
This scheme directly supports quality improvement at the grassroots level.
Strong Legal Framework Governing AYUSH Medicines
AYUSH drugs are regulated through exclusive legal provisions, ensuring they are not treated as informal or unregulated products.
Legal Coverage Includes:
- Chapter IVA & Schedule-I of Drugs & Cosmetics Act, 1940
- Rules 151–169, Schedules E(I), T & TA (Ayurveda, Siddha, Unani)
- Second Schedule (4A) & multiple rules for Homoeopathy
Mandatory Requirements:
- Good Manufacturing Practices (GMP) – Schedule T
- Compliance with official pharmacopoeias
- Proof of safety and effectiveness
CDSCO AYUSH Vertical: Stronger Inspections
- An AYUSH-dedicated vertical has been established within CDSCO.
- Conducts joint inspections with State Drug Inspectors
- Ensures uniform enforcement across States & UTs
- Strengthens regulatory coordination
Boosting Research, Innovation & Scientific Validation
To bring AYUSH systems closer to evidence-based medicine, the government has launched the Ayurgyan Scheme (since 2021-22).
Three Key Components:
- Capacity Building & Continuing Medical Education (CME)
- Research & Innovation in AYUSH
- Ayurveda Biology Integrated Health Research (ABIHR)
National Research Councils Powering AYUSH Science
Dedicated apex bodies under the Ministry of Ayush include:
- CCRAS – Ayurveda
- CCRUM – Unani
- CCRH – Homoeopathy
- CCRS – Siddha
- CCRYN – Yoga & Naturopathy
Research Focus Areas:
- Medicinal plant research
- Drug standardisation
- Pharmacological & clinical studies
- Tribal healthcare programmes
- Documentation of classical knowledge
Continuous Capacity Building for Regulators & Labs
PCIM&H regularly organises training programmes for:
- State Drug Regulators
- Enforcement Authorities
- Drug Testing Laboratories
- Quality Control & Technical Professionals
This ensures uniform interpretation of standards and updated scientific practices nationwide.
Why This Is Important for India & the World
These reforms ensure that AYUSH medicines are:
- Safe and effective for consumers
- Scientifically validated
- Manufactured under strict quality controls
- Ready for global markets
They also protect India’s traditional knowledge from misuse while enhancing its credibility in global healthcare systems.
Keywords: AYUSH Medicine Quality India,Ministry of Ayush Drug Safety,Ayurveda Siddha Unani Regulation
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