Parliament Question: Standardisation of AYUSH Medicines

GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA UNSTARRED QUESTION NO-3339 ANSWERED ON- 07/08/2026 STANDARDISATION OF AYUSH MEDICINES †3339. SHRI ARUN GOVIL

Will the Minister of AYUSH be pleased to state:-

(a) the steps taken by the Government to promote the production, quality, standardisation and export of AYUSH medicines;

(b) the details of the total export value of AYUSH medicines and the major export destinations during the last five years, year-wise;

(c) whether the Government is implementing any new initiative or action plan to further boost the export of AYUSH medicines and if so, the details thereof; and

(d) whether the Government has any data available regarding the production or export of AYUSH medicines from Uttar Pradesh and the Meerut-Hapur region and if so, the details thereof? ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV)

(a) Ministry of Ayush has taken following steps to promote the production, quality,

standardisation 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 Controldepartment 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 QualityMark 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.

(b) 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.

(c) 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.

(d) 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 Herbal Mar 2021 Mar 2022 Mar 2023 Mar 2024 Mar 2025 Mar 2026 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 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 **********