**Executive Summary**
This report details the regulatory framework and quality control measures implemented by the Ministry of Ayush to ensure the safety and effectiveness of Ayurveda, Siddha, Unani, and Homoeopathy (ASU&H) products. It outlines mandatory compliance with the Drugs and Cosmetics Act, 1940, and highlights the launch of the Ayush Quality Mark for Global standards in December 2025. Key actions include rigorous laboratory testing, the implementation of Good Manufacturing Practices (GMP), and financial support for research through the Ayurgyan Scheme.
**Key Points / Main Content**
**Regulatory Framework and Standards**
* The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) establishes official formulary specifications and pharmacopoeial standards for ASU&H drugs.
* Compliance with these standards is mandatory for all manufacturers under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
* Specific regulatory provisions are contained in Chapter IVA and Schedule I for ASU drugs, while Homoeopathic drugs are governed by separate specific rules (e.g., Rule 85, Schedule M-I).
**Manufacturing and Quality Assurance**
* Manufacturers must obtain licenses by providing proof of safety and effectiveness and adhering to Good Manufacturing Practices (GMP) under Schedule T (ASU) and Schedule M-I (Homoeopathy).
* The Central Drugs Standard Control Organization (CDSCO) has created a dedicated Ayush vertical to strengthen regulatory measures and issue WHO Certificates of Pharmaceutical Products (WHO-CoPP).
**Testing and Enforcement**
* PCIM&H serves as the Central Drugs Laboratory for testing and analysis; it also provides training to state analysts and regulatory authorities.
* A network of 108 private laboratories and 34 State/UT laboratories are recognized for testing drug identity, purity, and strength.
* Drug Inspectors are authorized to sample products from manufacturers and shops; products found "Not of Standard Quality" face market removal and legal action.
**Certification and Global Standards**
* The Quality Council of India (QCI) implements a certification scheme offering "standard" and "premium" marks based on third-party evaluations.
* The "Ayush Quality Mark for Ayush products and services for Global standards" was launched in December 2025 to increase consumer trust and ensure international quality benchmarks.
**Research and Development**
* Five apex Central Councils for Research coordinate scientific studies in Ayurvedic, Unani, Homoeopathy, Siddha, and Yoga & Naturopathy.
* The Ayurgyan Scheme provides financial assistance for research, innovation, and clinical studies in Ayush systems.
**Impact Analysis**
**Manufacturers**
**Impact:** Manufacturers are subject to strict mandatory compliance with pharmacopoeial standards and GMP. Failure to meet quality benchmarks results in legal action and product recalls.
**Action Required:** Must adhere to licensing requirements, maintain GMP-compliant facilities, and seek quality certifications (such as WHO-CoPP or QCI marks) to ensure market access.
**Drug Regulatory Authorities and Analysts**
**Impact:** These stakeholders are responsible for enforcement, sampling, and laboratory testing to maintain the integrity of the Ayush market.
**Action Required:** Drug Inspectors must regularly collect and test samples; analysts must undergo training provided by PCIM&H on laboratory techniques and methods.
**Research Institutions and Organizations**
**Impact:** Academic and research bodies are integrated into the national Ayush framework through funding and coordination by apex councils.
**Action Required:** Utilize financial assistance provided under the Ayurgyan Scheme to conduct clinical research and drug standardization studies.
**Consumers**
**Impact:** Consumers benefit from increased safety, efficacy, and trust in Ayush products due to standardized certification marks.
**Action Required:** Can look for Ayush "standard," "premium," or "global" quality marks to verify the quality of products and services.
Key Entities Referenced
Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945: The primary legislative framework and secondary rules governing the manufacturing, licensing, and quality standards for Ayurveda, Siddha, Unani, and Homoeopathy (ASU&H) drugs.
Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H): The subordinate office under the Ministry of Ayush that sets official pharmacopoeial standards and acts as the Central Drugs Laboratory for testing ASU&H medicines.
Central Drugs Standard Control Organization (CDSCO): The national regulatory body that maintains a dedicated Ayush vertical to strengthen safety measures and issues WHO Certificates of Pharmaceutical Products (WHO-CoPP).
Ayurgyan Scheme: A Central Sector Scheme aimed at promoting research, innovation, and clinical studies in Ayush systems through financial assistance to organizations and institutions.
Quality Council of India (QCI): The body responsible for implementing the Quality Certifications Scheme, which grants AYUSH standard and premium marks based on domestic and international compliance.
AYUSH
Standardization and quality control of Ayush
products
Strict Quality Standards Ensure Safety and Effectiveness of
Ayush Medicines
Posted On: 18 MAR 2026 3:00PM by PIB Delhi
Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), subordinate office under
Ministry of Ayush lays down the formulary specifications and pharmacopoeial standards for Ayurveda,
Siddha, Unani and Homoeopathy (ASU&H) drugs which serves as official compendia for ascertaining the
quality (identity, purity and strength) of the ASU&H drugs. As per Drugs and Cosmetics Act, 1940 and
Drugs Rules 1945, compliance to these quality standards are mandatory for the manufacturing of ASU&H
drugs. PCIM&H also acts as the Central Drugs Laboratory for Indian Medicine and Homoeopathy for the
purpose of testing or analysis of ASU&H Drugs. Further, PCIM & H impart training to the Drug
Regulatory Authorities, State Drug Analyst etc on laboratory techniques and methods used to maintain
quality of ASU & H drugs.
The Drugs & Cosmetics Act, 1940 and Rules made there under have exclusive regulatory provisions for
Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homoeopathy drugs. Provisions relating to Ayurveda, Siddha,
Sowa-Rigpa and Unani Drugs are contained in Chapter IVA and Schedule- I of the Drugs and Cosmetics
Act, 1940 and in Rules 151 to 169, Schedules E(I), T & TA of the Drugs Rules, 1945. Further, Rules 2dd,
30AA, 67 (C-H), 85 (A to I), 106-A, Schedule K, Schedule M-I of the Drugs Rules, 1945 pertain to
Homoeopathic drugs.
Further, It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of
manufacturing units & medicines including proof of safety & effectiveness, compliance with the Good
Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of the Drugs Rules, 1945 for
Ayurveda, Siddha, Unani drugs and Homoeopathy drugs respectively and also to follow the quality
standards of drugs as prescribed in the respective pharmacopoeia.
Drug Testing Laboratories are being recognized under Rule 160 A to J of the Drugs Rules, 1945 for
carrying out such tests of identity, purity, quality and strength of Ayurveda, Siddha, Sowa-Rigpa and
Unani drugs. As on date, 108 private laboratories are approved or licensed under the provisions of Drugs
Rules, 1945 for manufacturers. 34 Drug Testing Laboratories of State/UTs are testing the quality of
Ayurveda, Siddha, Sowa-Rigpa and Unani drugs and raw materials for legal samples.
Drug Inspectors collect medicine samples regularly from manufacturing firms or sale shops within their
jurisdiction and send them to Drug Testing Laboratory under Drug Control department for quality testing
and if any sample is found to be ‘Not of Standard Quality’, appropriate action is initiated such as
preventing the sale of the products from the market and appropriate legal actions as per Drugs and
Cosmetics Act, 1940 and Rules made thereunder.(c) Ministry of Ayush encourages following certifications of Ayush products as per details below:-
• An Ayush vertical has been created in Central Drugs Standard Control Organization
(CDSCO) to strengthen regulatory measures ensuring safety and quality of Ayush drugs.
Further, CDSCO issues WHO Certificate of Pharmaceutical Product (WHO-CoPP) to Ayush
drugs having compliance to such standards.
• Quality Certifications Scheme implemented by the Quality Council of India (QCI) for grant
of AYUSH standard and premium mark to Ayurvedic, Siddha and Unani products on the basis
of third-party evaluation of quality in accordance with the status of compliance to domestic
and international standards.
Further, Ayush Quality Mark for Ayush products and services for Global standards have been launched
during WHO Global Summit in December 2025. This certification scheme strengthens consumer trust in
Ayush products and services by ensuring internationally accepted standards of quality, safety, and
efficacy.
(d) Government of India has established 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 as apex organizations for undertaking,
coordinating, formulating, developing and promoting research in Ayush system on scientific lines. Core
Research activities comprise of Medicinal Plant Research (Medico-Ethno Botanical Survey,
Pharmacognosy and cultivation), Drug Standardization, Pharmacological Research, Clinical Research,
Literary Research & Documentation and Tribal Health Care Research Programme. Research activities are
carried out through its peripheral Institutes/Units located across the country and also in collaboration with
various Universities, Hospitals and Institutes.
Further, Ministry of Ayush is implementing the Central Sector Scheme, namely Ayurgyan Scheme. The
Scheme inter-alia has the components of (i) Research & Innovation in Ayush and ii) Ayurveda Biology
Integrated Health Research. Under the Research & Innovation in Ayush and Ayurveda Biology Integrated
Health Research components, financial assistance has been provided to the Organizations/Institutions for
research studies including clinical research in Ayush systems of medicines.
This information was given by the Minister of State (IC) for Ayush Shri Pratap Rao Jadhav in a
written reply to a question in Rajya Sabha on 17th MARCH 2026.
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