AYUSH
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STANDARDIZATION OF AYUSH MEDICINES

प्रविष्टि तिथि: 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 by drug 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 Ayush and Herbal products

Apr 2020-Mar 2021

Apr 2021-Mar 2022

Apr 2022-Mar 2023

Apr 2023-Mar 2024

Apr 2024-Mar 2025

Apr 2025-Mar 2026

Country

Value in US$

Value in US$

Value in US$

Value in US$

Value in US$

Value in US$

USA

155288773

175434555

171782223

183494144

188541435

151566460

Germany

48728505

55040517

57620613

62706059

70766835

64318725

Italy

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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SR/SV/SG


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