**Executive Summary**
This document is an answer to an unstarred question in Lok Sabha regarding the quality, standardization, and safety of AYUSH medicines in India, answered on February 13, 2026. It details the guidelines and steps taken by the government to ensure the quality of AYUSH medicines, including legal provisions and certification schemes. The document covers various aspects, from regulatory provisions to penalties for violations.
**Key Points / Main Content**
* **Regulatory Framework:**
* The Drugs & Cosmetics Act, 1940, and associated rules contain regulatory provisions for Ayurvedic, Siddha, Sowa-Rigpa, Unani, and Homoeopathy drugs.
* Compliance with Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of Drugs Rules, 1945 is mandatory for manufacturers.
* **Quality Control and Enforcement:**
* Drug Controllers/Licensing Authorities appointed by State/UT governments are responsible for enforcing quality control and issuing drug licenses.
* Drug Inspectors collect samples for quality testing in Drug Testing Laboratories; action is taken if drugs are "Not of Standard Quality."
* Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) sets formulary specifications and pharmacopoeial standards for ASU&H drugs.
* PCIM&H acts as Central Drugs Laboratory and conducts Capacity Building Trainings for standardization/quality control of ASU&H drugs.
* Rule 160 A to J of the Drugs Rules, 1945 provides regulatory guidelines for approval of Drug Testing Laboratories.
* 34 State and 108 Private Drug Testing Laboratories are approved for quality testing.
* **Certification and Schemes:**
* The scheme for Certification of Pharmaceutical Product (CoPP) is extended to ASU medicines.
* The Quality Certifications Scheme implemented by Quality Council of India (QCI) gives the Ayush mark based on third-party evaluation.
* Ayush Quality Mark for Ayush products has been launched during WHO Global Summit in December, 2025.
* The Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) scheme (2021-22 to 2025-26) aims to upgrade Ayush Pharmacies and Drug Testing Laboratories.
* **Curbing Fake Medicines and Penalties:**
* Definitions of misbranded, adulterated, and spurious ASU drugs are provided in Sections 33E, 33EE, and 33EEA of the Drugs and Cosmetics Act, 1940.
* Section 33EEC prohibits the manufacture of misbranded, adulterated, or spurious ASU drugs.
* Penalties for violations are described in Sections 33-I(1) and 27 of the Drugs and Cosmetics Act, 1940.
**Impact Analysis**
**AYUSH Medicine Manufacturers**
* **Impact:** Must adhere to stringent quality standards, GMP guidelines, and licensing requirements.
* **Action Required:** Compliance with regulatory provisions, participation in certification schemes, and adherence to testing protocols.
**Drug Controllers/Licensing Authorities**
* **Impact:** Responsible for enforcement, quality control, and issuance of drug licenses.
* **Action Required:** Conduct regular inspections, ensure compliance with legal provisions, and take necessary action against violations.
**Drug Inspectors**
* **Impact:** Responsible for collecting drug samples and sending them for testing.
* **Action Required:** Regularly collect samples from manufacturing firms and sale shops, and send them for testing to Drug Testing Laboratories.
**Consumers of AYUSH Medicines**
* **Impact:** Assurance of quality, safety, and efficacy of AYUSH medicines.
* **Action Required:** Trust in certified products and report any issues to relevant authorities.
Key Entities Referenced
Drugs & Cosmetics Act, 1940: The primary act regulating the quality, standardization, and safety of Ayurvedic, Siddha, Unani, and Homoeopathic drugs.
Ministry of AYUSH: The ministry responsible for issuing guidelines, implementing schemes, and establishing regulatory mechanisms related to AYUSH medicines.
Drugs Rules, 1945: Rules under the Drugs & Cosmetics Act, 1940, which provide specific regulations for Homoeopathic drugs and drug testing laboratories.
Central Drugs Standard Control Organization (CDSCO): An organization involved in administering certification schemes and inspecting manufacturing units for AYUSH medicines.
Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY): A Central Sector Scheme by the Ministry of AYUSH to strengthen and upgrade Ayush Pharmacies and Drug Testing Laboratories.
GOVERNMENT OF INDIA
MINISTRY OF AYUSH
LOK SABHA
UNSTARRED QUESTION NO. 2485
TO BE ANSWERED ON 13th FEBRUARY 2026
Quality of AYUSH Medicines
2485. Smt. Geniben Nagaji Thakor:
Will the Minister of AYUSH
be pleased to state:
(a) whether the Government has issued any guidelines regarding the quality, standardization
and safety of AYUSH medicines in the country;
(b) if so, the details thereof;
(c) the steps taken by the Government to curb fake AYUSH medicines; and
(d) the details of penal provisions in case of violations?
ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH
(SHRI PRATAPRAO JADHAV)
(a) and (b) The details of guidelines regarding the quality, standardization and safety of Ayush
medicines in the country are as follows:
1. The Drugs & Cosmetics Act, 1940 and Rules made thereunder have exclusive
regulatory provisions for Ayurvedic, 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. It is mandatory for the manufacturers to adhere
to the prescribed requirements for licensing of Ayush drugs including proof of safety &
effectiveness, compliance to Good Manufacturing Practices (GMP) for manufacturing
of Ayurveda, Siddha, Sowa-rigpa, Unani (ASSU) drugs and Homeopathy drugs as per
Schedule T & Schedule M-I of Drugs Rules, 1945 respectively and to maintain quality
standards of drugs as given in the respective pharmacopoeia.
12. As prescribed in Drugs and Cosmetics Act, 1940 and Rules made thereunder,
enforcement of the legal provisions pertaining to Quality Control and issuance of drug
license of Ayurveda, Siddha, Sowa-rigpa, Unani and Homoeopathy drugs, is vested
with the Drug Controllers/Licensing Authorities appointed by the concerned State/
Union Territory Government.
3. Drug Inspectors collect drug 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 drugs from the
market and initiating legal actions as per Drugs and Cosmetics Act, 1940.
4. 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.
5. PCIM&H also acts as the Central Drugs Laboratory for Indian Medicines and
Homoeopathy for the purpose of testing or analysis of ASU&H Drugs. Further, it
imparts Capacity Building Trainings at regular interval for standardization/quality
control/ testing or analysis of ASU&H drugs to Drug Regulatory Authorities, Drug
Analysts and other stakeholders on quality control of ASU&H drugs on laboratory
techniques and methods used to maintain the quality of ASU&H drugs.
6. Rule 160 A to J of the Drugs Rules, 1945 provides the regulatory guidelines for approval
of Drug Testing Laboratory for carrying out such tests of identity, purity, quality and
strength of Ayurvedic, Siddha, Sowa-rigpa and Unani drugs as may be required under
the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic,
Siddha, Sowa-rigpa and Unani drugs. As on date, 34 State Drug Testing Laboratories
and 108 Private Drug Testing Laboratories are approved for quality testing of
Ayurvedic, Siddha, Sowa-rigpa and Unani drugs and raw materials.
7. Further, 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
2of 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.
8. Ministry of Ayush has implemented Central Sector Scheme, Ayush Oushadhi Gunvatta
Evam Uttpadan Samvardhan Yojana (AOGUSY) with total financial outlay of Rs
122.00 crores for five years from 2021-22 to 2025-26. One of the components of this
scheme is to strengthen and up-grade Ayush Pharmacies and Drug Testing Laboratories
to achieve higher standards.
9. Ministry of Ayush has established an Ayush vertical in the Central Drugs Standard
Control Organisation (CDSCO) to inspect various manufacturing units in coordination
with the licensing authorities/drugs inspectors of respective States/Union Territories for
ensuring safety and quality of Ayush medicines.
(c) and (d) The steps taken by the Government to curb fake Ayush medicines and the details of
penal provisions in case of violations are as follows: -
1. Sections 33E, 33EE, and 33EEA of the Drugs and Cosmetics Act, 1940 define
misbranded, adulterated, and spurious Ayurveda, Siddha and Unani (ASU) drugs,
respectively.
2. Further, Section 33EEC prohibits the manufacture of any misbranded, adulterated, or
spurious ASU drug.
3. The penalties for manufacturing of misbranded or adulterated or spurious ASU drugs,
or for manufacturing ASU drugs without a valid licence, are mentioned under Section
33-I (1) of Drugs and Cosmetics Act, 1940.
4. Section 17, 17A and 17B of Drugs and Cosmetics Act, 1940 provides definition of
misbranded, adulterated and spurious Homoeopathic drugs. Section 27 of Drugs and
Cosmetics Act, 1940 provides penalties for manufacturing of misbranded, adulterated
and spurious Homoeopathic drugs or drugs manufactured, sold, or distributed without
a valid licence.
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