**Executive Summary**
This document is a response to Lok Sabha Unstarred Question No. 2484 regarding research collaboration for AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) products, to be answered on February 13th, 2026. The response outlines the developments in AYUSH, focusing on international collaboration, standardization efforts, and regulatory provisions for drug manufacturing. It includes details on MoUs, certifications, and agreements.
**Key Points / Main Content**
* **AYUSH System Development:**
* The Ayush healthcare systems have been subjected to unprecedented developments and are accepted for sustainable, inclusive and holistic healthcare solutions.
* Growth has been driven by structured developments of standards in alignment with global perspectives.
* **International Collaboration:**
* The Ministry of Ayush has strengthened global engagement through international cooperation, fostering joint research, knowledge exchange, and alignment with international standards.
* Efforts have enhanced global confidence in Ayush systems and improved international market access and visibility.
* Inclusion of Traditional Medicine (TM) Module-2 supports research and policy development, enhances insurance coverage, and global recognition.
* 27 Country to Country Memorandum of Understanding (MoUs) for Co-operation in field of Traditional Medicine and Homoeopathy with foreign nations.
* 16 MoUs with International Institutes for setting up of AYUSH Academic Chairs in foreign nations.
* 54 Institute to Institute level MoUs with foreign institutes for undertaking Collaborative Research/Academic collaboration.
* 44 Ayush Information Cells in 40 foreign nations for propagation and promotion of Ayush.
* Scholarships are offered to 104 foreign nationals for studying Ayush courses in India.
* **Product Certifications:**
* Scheme for Certification of Pharmaceutical Product (CoPP) as per WHO guidelines extended to ASU medicines, administered by CDSCO, with joint inspection by CDSCO, Ministry of Ayush, and State Licensing Authority.
* Quality Certifications Scheme by the Quality Council of India (QCI) for Ayush mark based on third-party evaluation of quality.
* Ayush Quality Mark launched during WHO Global Summit in December 2025.
* **Trade Agreements:**
* India-New Zealand Free Trade Agreement (FTA) signed in December 2025 promoting trade in Ayush and other traditional medicine services.
* India–Oman Comprehensive Economic Partnership Agreement (CEPA) includes Oman's commitment on Traditional Medicine.
* **Standardization in Drug Manufacturing:**
* The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for Ayurvedic, Siddha, Sowa Rigpa, Unani, and Homoeopathy drugs.
* Manufacturers must adhere to Good Manufacturing Practices (GMP) and quality standards as per Drugs Rules, 1945.
* The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) lays down standards for ASU&H drugs, and compliance is mandatory.
* PCIM&H acts as the appellate Drugs testing Laboratory for ASU&H Drugs.
* 34 State/UTs Drug Testing Laboratories and 108 private laboratories are approved or licensed under Drugs Rules, 1945.
**Impact Analysis**
**Ministry of AYUSH**
* **Impact:** The ministry is at the center of these initiatives. Strengthened global engagement and standardization efforts.
* **Action Required:** Continued implementation and enforcement of the mentioned schemes, MoUs, and agreements, and monitoring of the collaborations.
**AYUSH Drug Manufacturers**
* **Impact:** Manufacturers need to adhere to GMP, quality standards, and regulatory provisions to ensure safety and effectiveness of products. This impacts their production processes and quality control measures.
* **Action Required:** Compliance with certification schemes, quality control measures, and regulatory guidelines.
**Foreign Nations/Institutions**
* **Impact:** Increased opportunities for collaboration, research, and exchange programs related to traditional medicine.
* **Action Required:** Participation in collaborative research initiatives, implementation of MoUs, and support for Ayush promotion in their respective countries.
**Drug Regulatory Authorities and Drug Analysts**
* **Impact:** These stakeholders are essential for ensuring the quality of ASU&H drugs.
* **Action Required:** Participation in the capacity-building training provided by PCIM&H, to test for drug compliance.
Key Entities Referenced
Ministry of Ayush: The primary ministry responsible for the development and promotion of AYUSH systems (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy).
Drugs & Cosmetics Act, 1940: The principal law governing the regulation of drugs and cosmetics in India, including Ayurvedic, Siddha, Unani and Homoeopathy drugs.
Drugs Rules, 1945: Rules made under the Drugs & Cosmetics Act, 1940, providing detailed regulations for the manufacture, sale, and quality control of drugs, including ASU (Ayurvedic, Siddha, and Unani) drugs.
Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H): A subordinate office under the Ministry of Ayush responsible for laying down the formulary specifications and pharmacopoeial standards for ASU&H drugs.
International Ayush Fellowship/Scholarship Program: A program by the Ministry of Ayush offering scholarships to foreign nationals for studying Ayush courses in recognized Ayush institutions in India.
GOVERNMENT OF INDIA
MINISTRY OF AYUSH
LOK SABHA
UNSTARRED QUESTION NO. 2484
TO BE ANSWERED ON 13th February, 2026
“Research Collaboration for AYUSH Products”
2484. Shri Arun Govil:
Will the Minister of Ayush be pleased to state :
(a) whether there has been unprecedented development in the AYUSH medical system despite
the lack of standardization in AYUSH systems as per international requirements and if so, the
details thereof;
(b) the details of increased research collaboration, impact on standard setting and impact on
export of AYUSH products through the international collaborations and agreements entered
into by the Government during the last three years; and
(c) the status of measurable standardization in drug manufacturing among large Ayurvedic
companies in the country?
ANSWER
THE MINISTER OF STATE (IC) OF MINISTRY OF AYUSH
(SHRI PRATAPRAO JADHAV)
(a) & (b) The Ayush healthcare systems has been subjected to unprecedented developments
leading to their acceptance by large number of population for sustainable, inclusive and holistic
healthcare solutions. The growth of the Ayush sector has also driven by structured developments
of standards in alignment with global perspectives.
Ministry of Ayush strengthened global engagement in traditional medicine through
international cooperation, fostering joint research initiatives, knowledge exchange, and
alignment with international standards. These efforts enhanced global confidence in Ayush
systems and improved international market access and visibility of Ayush products.
The inclusion of Traditional Medicine (TM) Module-2 enables evidence-based
integration of traditional medicine into public health systems, supports research and policy
development, and enhances insurance coverage and global recognition of Ayush systems. By
aligning traditional knowledge with international standards, International Classification ofDiseases (ICD)-11 TM Module-2 strengthens India’s leadership in advancing traditional
medicine globally.
Ministry of Ayush has signed 27 Country to Country Memorandum of Understanding
(MoUs) for Co-operation in field of Traditional Medicine and Homoeopathy with foreign
nations, 16 MoUs with International Institutes for setting up of AYUSH Academic Chairs in
foreign nations, 54 Institute to Institute level MoUs with foreign institutes for undertaking
Collaborative Research/Academic collaboration and supported the establishment of 44 Ayush
Information Cells in 40 foreign nations for propagation and promotion of Ayush at global stage.
Ministry of Ayush offers scholarships to 104 foreign nationals for studying Ayush
courses in recognized Ayush institutions in India under International Ayush
Fellowship/Scholarship Program.
Ministry of Ayush encourages following certifications of Ayush products as per details
below: -
• The scheme for Certification of Pharmaceutical Product (CoPP) as per World Health
Organization (WHO) guidelines is extended to Ayurvedic, Siddha and Unani (ASU)
medicines. This scheme is administered by Central Drugs Standard Control
Organization (CDSCO) and the certificate is granted on the basis of joint inspection
of the applicant manufacturing unit by the representatives of CDSCO, Ministry of
Ayush and the concerned State Licensing Authority.
• Quality Certifications Scheme implemented by the Quality Council of India (QCI) for
grant of Ayush 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.
• Ayush Quality Mark for Ayush products and services for Global standards has been
launched during WHO Global Summit in December, 2025.
The India–New Zealand Free Trade Agreement (FTA) signed in December 2025 includes
an annex promoting trade in Ayush and other traditional medicine services, strengthening global
recognition, supporting medical value travel, wellness collaboration, and reinforcing India’s
position as a global health hub.
Further, the India–Oman Comprehensive Economic Partnership Agreement (CEPA)
includes Oman’s first comprehensive commitment on Traditional Medicine across all modes of
supply, creating significant opportunities for Ayush and wellness sectors in the Gulf region.
These initiatives have led to increased collaborative research and academic exchanges, progress
in international standard-setting for Ayush systems, greater recognition in global health
frameworks, and improved export opportunities through enhanced regulatory acceptance and
market access.
(c) As far as measurable standardization in drug manufacturing is concerned, the Drugs &
Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for Ayurvedic,Siddha, Sowa Rigpa, Unani, and Homoeopathy drugs. Provisions related to Ayurveda, Siddha,
Sowa Rigpa and Unani Drugs are contained in Chapter IVA and Schedule-I of the Drugs and
Cosmetics Act, 1940 and Rules 151 to 169, Schedules E (I), T & TA of the Drugs Rules, 1945.
It is mandatory for the manufacturers to adhere to the prescribed requirements of Good
Manufacturing Practices (GMP) including proof of safety & effectiveness as per Schedule T &
Schedule M-I of Drugs Rules, 1945 and quality standards of drugs given in the respective
pharmacopoeia.
Further, Ministry of Ayush, Government of India has established Pharmacopoeia
Commission for Indian Medicine & Homoeopathy (PCIM&H) as its subordinate office.
PCIM&H 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 the Drugs &
Cosmetics Act, 1940 and rules thereunder, the compliance to these quality standards are
mandatory for the production of ASU&H drugs being manufactured in India.
PCIM&H also acts as the appellate Drugs testing Laboratory for testing or analysis of
ASU&H Drugs. In addition, it conducts capacity-building trainings at regular intervals for the
standardization, quality control, and testing or analysis of ASU&H drugs for Drug Regulatory
Authorities, Drug Analysts, and other relevant stakeholders, with a focus on laboratory
techniques and methodologies essential for ensuring the quality of ASU&H drugs.
In addition, Rule 160 A to J of the Drugs Rules, 1945 provides the regulatory guidelines
for approval of Drug Testing Laboratory for carrying out tests of identity, purity, quality and
strength of Ayurveda, Siddha, Sowa Rigpa and Unani drugs as may be required under the
provisions of these rules. As on date, 34 State/UTs Drug Testing Laboratories and 108 private
laboratories are approved or licensed under the provisions of Drugs Rules, 1945 for quality
testing of Ayurvedic, Siddha, Sowa Rigpa and Unani drugs and raw materials.
**************