STANDARDIZATION OF AYUSH MEDICINES
Issued by AYUSH
Read or download the official PDF of this gazette notification issued by the AYUSH on 7th August 2026. Classified under Press Release.
Executive Summary & Key Takeaways
Executive Summary This report outlines the measures taken by the Ministry of Ayush to ensure the quality, standardization, and global promotion of Ayush medicines under the Drugs & Cosmetics Act, 1940. It highlights the regulatory framework for manufacturing, the role of testing laboratories, and various quality certification schemes like AOGUSY. The document also provides a five-year analysis of export values for Ayush products to major global markets up to March 2026.
Key Points / Main Content
Regulatory and Manufacturing Standards
- Manufacturers must strictly adhere to the Drugs & Cosmetics Act, 1940, and Drugs Rules, 1945, for licensing and manufacturing.
- Compliance with Good Manufacturing Practices (GMP) is mandatory under Schedule T (Ayurveda, Siddha, Unani) and Schedule M-I (Homeopathy).
- Medicines must meet quality standards prescribed in their respective pharmacopoeias regarding identity, purity, and strength.
Quality Control and Testing Infrastructure
- Drug Inspectors are authorized to collect samples for testing at 34 State/UT Drug Testing Laboratories; legal action is initiated for medicines found to be "Not of Standard Quality."
- The Ministry has approved 118 private Drug Testing Laboratories across India to conduct identity and purity tests.
- The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) serves as the appellate laboratory and develops official drug specifications.
Schemes and Quality Certifications
- The Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) supports pharmacies and labs in achieving WHO-GMP and NABL accreditation.
- The Ayush Quality Mark (AQM) and Ayush Premium Mark are awarded based on third-party assessments of national and international standards.
- The Central Drugs Standard Control Organization (CDSCO) issues the WHO Certificate of Pharmaceutical Product (WHO-CoPP) following joint inspections.
International Promotion and Exports
- Ayurveda and Yoga are included in ISO/TC249 to establish international standards for terminology and ingredients.
- The Ministry has signed 27 country-to-country MoUs and 57 institute-level MoUs to foster global academic and research collaboration.
- The Central Sector Scheme for Promotion of International Cooperation for Ayush provides support to manufacturers for product registration and export market development.
Impact Analysis
Ayush Drug Manufacturers Impact Manufacturers are subject to mandatory licensing, safety proofs, and strict adherence to GMP and pharmacopoeial standards. Action Required They must ensure compliance with Schedule T or M-I, seek quality certifications (AQM/Premium Mark) for market competitiveness, and align production with WHO-GMP standards for export.
Drug Regulatory Authorities and Inspectors Impact These bodies are responsible for market surveillance and maintaining the integrity of the supply chain through regular sampling. Action Required Inspectors must conduct regular sampling from retail and manufacturing sites and initiate legal proceedings against non-compliant entities.
Drug Testing Laboratories Impact Laboratories (both state and private) are the primary entities for validating drug quality and can receive financial/technical support under AOGUSY. Action Required Approved private labs must conduct tests in accordance with Drugs Rules, 1945, and strive for NABL accreditation.
Export and International Stakeholders Impact Stakeholders in countries like the USA, Germany, and UAE benefit from standardized, quality-assured Ayush products. Action Required Stakeholders should leverage existing MoUs and ISO standards to facilitate the international recognition and acceptance of Ayush systems.
Key Entities Referenced
Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945: The primary legislative framework containing exclusive regulatory provisions for the licensing, safety, and manufacturing standards (GMP) of Ayush medicines.
Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H): A subordinate organization under the Ministry of Ayush that develops official pharmacopoeial standards and serves as the Appellate Drug Testing Laboratory.
Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY): A Central Sector Scheme implemented to support Ayush pharmacies and laboratories in achieving international quality standards like WHO-GMP and NABL.
Promotion of International Cooperation for Ayush: A Central Sector Scheme designed to enhance global outreach, support manufacturers in exports, and facilitate international research and academic collaborations.
Ayush Export Promotion Council (AYUSHEXCIL): The body responsible for launching the Ayush Quality Mark (AQM) initiative and facilitating the international promotion and quality certification of Ayush products.
Official Gazette PDF Record
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See Full Document Text & PDF Transcript
AYUSH
STANDARDIZATION OF AYUSH MEDICINES
प्रव तथ: 07 AUG 2026 6:00PM by PIB Delhi
Ministry of Ayush has taken following steps to promote the production, quality, standardization and export
of Ayush medicines:
1. The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for
Ayush drugs. 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 and Schedule M-I of the Drugs
Rules, 1945 for Ayurveda, Siddha, Sowa-Rigpa, Unani and Homeopathy drugs respectively and to
follow the quality standards of drugs as prescribed in the respective pharmacopoeia.
Drug Inspectors collect medicine samples regularly from manufacturing firms or retail 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 to prevent the sale of such medicines in the market, along with legal proceedings as per the
provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder. There are 34 Drug
Testing Laboratories available in State/UTs for testing of the Legal Samples drawn by the Drug
Inspectors of concerned State/UTs.
2. The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), a subordinate
organization under Ministry of Ayush, develops pharmacopoeial standards and formulary
specifications for Ayush drugs, which serve as the official compendia for determining their identity,
purity, and strength. Compliance with these standards is mandatory under the Drugs and Cosmetics
Act, 1940 and the Rules made thereunder. PCIM&H also functions as the Appellate Drug Testing
Laboratory for Ayush drugs and conducts regular capacity-building programmes for Drug
Regulatory Authorities, Drug Analysts, and other stakeholders on standardization, quality control,
and testing methodologies to strengthen the quality assurance system for Ayush drugs.
3. Drug Testing Laboratories are approved by Ministry of Ayush under Rules 160A to 160J of the
Drugs Rules, 1945, for carrying out tests relating to the identity, purity, quality and strength of
Ayush drugs. As on date, 118 private Drug Testing Laboratories have been approved by Ministry
across States and Union Territories for conducting such tests in accordance with the provisions of
the Drugs Rules, 1945.
4. Further, Ministry of Ayush is implementing a Central Sector Scheme, namely, Ayush Oushadhi
Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) to support Ayush Pharmacies and Drug
Testing Laboratories to achieve higher standards like World Health Organization Good
Manufacturing Practices (WHO-GMP) and National Accreditation Board for Testing and
Calibration Laboratories (NABL) respectively.
5. In addition, Ministry of Ayush has undertaken the following initiatives to promote quality assurance
and export of Ayush products:
World Health Organization Certificate of Pharmaceutical Product (WHO-CoPP) is issued by Central
Drugs Standard Control Organization (CDSCO) after joint inspection of manufacturing units bydrug inspectors posted in Ayush Vertical in CDSCO along with drug inspectors of States/UTs and
CDSCO for compliance with WHO Technical Report Series (TRS) guidelines for herbal medicines.
Ministry of Ayush has launched Ayush Quality Mark (AQM) initiative through the Ayush Export
Promotion Council (AYUSHEXCIL). Under this framework, the Ayush Quality Mark is being
granted after scrutiny and verification of valid quality certifications and statutory approvals issued
by the competent Government authorities, such as WHO-GMP, Ayush Premium Mark and other
recognised certifications, as applicable.
Ayush Standard Mark and Ayush Premium Mark are awarded to Ayush Drugs by Quality Council of
India (QCI) based on third-party assessment of compliance with prescribed National and
International quality standards.
Ayurveda and Yoga has been included under Sectional Committee 2 of ISO/TC249 to focus on
International Standards of Ayurveda and Yoga terminology, quality and safety of ingredients,
extracts, finished products, Ayurveda based dietary supplements, Yoga accessories etc.
The details of the total export value of Ayush and Herbal products and the major export destinations
during the last five years, year-wise are at Annexure-I.
The Ministry of Ayush is implementing the Central Sector Scheme, namely Promotion of International
Cooperation for Ayush to enhance the Global outreach of Ayush systems of medicine. The Scheme
provides support to Indian Ayush drug manufacturers and Ayush service providers to promote the export
of Ayush products and services. It also facilitates the International promotion, development, and
recognition of Ayush systems of medicine; fosters engagement with International stakeholders and market
development; promotes academic collaboration and research through the establishment of Ayush
Academic Chairs in foreign countries; and supports the organization for conducting training programmes,
workshops, and symposiums to strengthen Global awareness, understanding, and acceptance of Ayush
systems of medicine.
Further, Ministry of Ayush has signed 27 Country to Country MoUs, 16 Ayush Chair MoUs and 57
Institute to Institute level MoUs for the International promotion and propagation of Ayush systems of
medicine.
The Ministry of Ayush does not compile or maintain State-wise information relating to the production and
export of Ayush medicines.
Annexure-I
As per Directorate General of Commercial Intelligence and Statistics (DGCIS), the details of the total
export value of Ayush and Herbal products and the major export destinations during the last five years,
year-wise are as follows:
Export value of Apr 2020- Apr 2021- Apr 2022- Apr 2023- Apr 2024- Apr 2025-
Ayush and Mar 2021 Mar 2022 Mar 2023 Mar 2024 Mar 2025 Mar 2026
Herbal products
Country Value in Value in Value in Value in Value in Value in
US$ US$ US$ US$ US$ US$
USA 155288773 175434555 171782223 183494144 188541435 151566460
Germany 48728505 55040517 57620613 62706059 70766835 64318725Italy 21581559 24598012 28460362 36255641 41428324 36080325
UAE 22392114 26509215 26804164 25126803 33079568 32429729
Vietnam 12993529 9323499 1632711 4638837 6355158 24571563
France 17410491 19524096 19604147 16237548 23610349 24525755
Russia 9811206 9876543 16479958 13771735 17339046 19233750
United Kingdom 12891554 13144064 16628598 16196368 18177659 17109210
Nepal 15436861 20995439 14548951 15682339 16540826 16429711
China 24396211 25930789 26913292 27949899 20001849 16266523
This information was given by Union Minister of State (I/C) for Ayush, Shri Prataprao Jadhav in a written
reply in lok Sabha today.
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