Lok Sabha Question No. 403 (STARRED), answered on 2026-03-20
Subject: Standardisation and Quality Control of AYUSH Drugs
Ministry: AYUSH
Asked by: Shri Bhumare Sandipanrao Asaram, Shri Gyaneshwar Patil

## GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA STARRED QUESTION NO. 403 TO BE ANSWERED ON 20 th  MARCH 2026

## Standardisation and Quality Control of AYUSH Drugs

## 403. Shri Gyaneshwar Patil:

## Shri Bhumare Sandipanrao Asaram:

Will the Minister of AYUSH be pleased to state:

- (a)  whether  the  Government  proposes  to  establish  a  mechanism  to  address  the  issues  of standardisation and quality control of AYUSH drugs and products in the country;
- (b) if so, the details thereof along with the various efforts being made to improve the quality of AYUSH  drugs/products  in  the  country,  State/UT-wise  including  Madhya  Pradesh  and Maharashtra;
- (c) the additional measures taken or proposed to enhance research and development (R&D) in the field of AYUSH and collaborate with international organizations;
- (d) the details of the plan of the Government to promote the wider use of high-quality AYUSH drugs and products among the consumers; and
- (e) whether any shortfall has been observed in the manufacturing of various AYUSH drugs and if so, the details thereof?

## ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV)

- (a) to (e) A statement is laid on the Table of the House.

## THE STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 403 for 20 th  March 2026

(a) and (b) Ministry of Ayush has established adequate mechanisms for standardisation and quality control of Ayush drugs in the country. The details of these mechanisms, along with the various  efforts  being  undertaken  to  further  improve  the  quality  of  Ayush  drugs  across  the country, State/UT-wise including Madhya Pradesh and Maharashtra, are as follows:

1. The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions  for  Ayurveda,  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, second schedule (4A) of the Drugs and Cosmetics Act, 1940 provides standards for Homoeopathic drugs and  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 manufacturing units & medicines including proof of safety & effectiveness, compliance with the Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of Drugs Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.
2. Pharmacopoeia  Commission  for  Indian  Medicine  &  Homoeopathy  (PCIM&H),  a 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  and  compliance  to  this  quality  standards  are mandatory for the manufacturing for sale of ASU&H drugs across the country. So far, 2325 quality standards on raw materials (single drugs of plant/ animal/ mineral/ metal/ chemical origin) used in ASU&H drugs, 426 quality standards of ASU formulations and 2799 formulary specifications of ASU drugs has been published. In addition to above, supporting documents in the form of Macro, Microscopic & TLC Atlas on 392 single  drugs  incorporated  in  Ayurvedic  Pharmacopoeia  of  India  (API)  has  also published.  Further,  PCIM&H  also  acts  as  the  Central  Drugs  Laboratory  for  Indian Medicine and Homoeopathy for the purpose of testing or analysis of ASU&H Drugs.
3. 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  Ayurveda,  Siddha,  Sowa-Rigpa  and  Unani  drugs  as  may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurveda, Siddha, Sowa-Rigpa and Unani drugs. As on date, 108 private laboratories are approved or licensed under the provisions of Drugs Rules, 1945 for manufacturers. Further,  there  are  34  Drug  Testing  Laboratories  of  State/UTs  for  testing  quality  of

Ayurveda,  Siddha,  Sowa-Rigpa  and  Unani  drugs  and  raw  materials  including  legal samples.

4. 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 State/UT Drug Controllers/ Licensing Authorities appointed by the concerned State/ UT Government.
5. Drug Inspectors collect medicine 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 Standar d Quality', appropriate action is initiated such as preventing the sale of the drugs from the market and appropriate legal actions as per Drugs and Cosmetics Act, 1940 and Rules made thereunder.
6. Ministry of Ayush has established an Ayush vertical in the Central Drugs Standard Control  Organisation  (CDSCO),  which  includes  the  posts  of  1  Deputy  Drugs Controller,  4  Assistant  Drugs  Controllers,  and  4  Drug  Inspectors.  Drug  Inspectors posted  in  Ayush  vertical,  inspect  various  manufacturing  units  including  risk-based inspections  in  coordination  with  the  licensing  authorities/drug  inspectors  of  the respective States/UTs for ensuring safety and quality of Ayush medicines.

(c ) Government of India has established Central Council for Research in Ayurvedic Sciences (CCRAS), Central Council for Research in Unani Medicine (CCRUM), Central Council for Research  in  Homoeopathy  (CCRH),  Central  Council  for  Research  in  Siddha  (CCRS)  and Central Council for Research in Yoga & Naturopathy (CCRYN) under the Ministry of Ayush as apex organizations for undertaking, coordinating, formulating, developing and promoting research in Ayush system on scientific lines. Core Research activities comprise of Medicinal Plant  Research  (Medico-Ethno  Botanical  Survey,  Pharmacognosy  and  invitro-propagation technique),  Drug  Standardization,  Pharmacological  Research,  Clinical  Research,  Literary Research & Documentation and Tribal Health Care Research Programme. Research activities are carried out through its peripheral Institutes/Units located across the country and also in collaboration with various Universities, Hospitals and Institutes.

Further,  Ministry  of  Ayush  is  implementing  the  Central  Sector  Scheme,  namely Ayurgyan Scheme. The Scheme inter-alia has the components of (i) Research & Innovation in Ayush and ii) Ayurveda Biology Integrated Health Research. Under the Research & Innovation in Ayush and Ayurveda Biology Integrated Health Research components, financial assistance has  been  provided  to  the  Organizations/Institutions  for  research  studies  including  clinical research in Ayush systems of medicines.

Ministry  of  Ayush  is  implementing  the  central  sector  scheme  for  Promotion  of International  Cooperation  for  Ayush  (IC  Scheme).  Under  this  scheme  Ministry  of  Ayush provides support to Indian Ayush drug Manufacturers/ Ayush Service providers to give boost to  the  export  of  Ayush  products  and  services;  facilitates  the  International  promotion, development and recognition of Ayush systems of medicine; foster interaction of stakeholders and  market  development  of  Ayush  at  international  level;  promote  academics  and  research through the establishment of Ayush Academic Chairs in foreign countries and holding training workshop/symposiums for promoting and strengthening awareness and interest about Ayush Systems of Medicine at international level. Under this Scheme, 27 Country to Country MoUs, 16 Ayush Chair MoUs and 54 Institute to Institute level MoUs have been signed.

(d)  Ministry  of  Ayush  has  implemented Central  Sector Scheme Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) with financial outlay of Rs. 122.00 crores for five years since 2021-2022. The components of AOGUSY scheme are as follows -

A. Strengthening  and  up-gradation  of  Ayush  Pharmacies  and  Drug  Testing Laboratories to achieve higher standards.

- B. Pharmacovigilance  of  ASU&H  drugs  including  surveillance  of  misleading advertisements.
- C. Strengthening of Central and State regulatory frameworks including Technical Human Resource & Capacity Building programs for Ayush drugs.
- D. Support for development of standards and accreditation/certification of Ayush products & materials in collaboration with Bureau of Indian Standards (BIS), Quality Control  of  India  (QCI)  and  other  relevant  scientific  institutions  and  industrial  R&D centres.

Further Ministry of Ayush encourages following certifications of Ayush products as per details below: -

- An Ayush vertical has been created in Central Drugs Standard Control Organization (CDSCO)  to  strengthen  regulatory  measures  ensuring  safety  and  quality  of  Ayush drugs. Further, CDSCO issues WHO Certificate of Pharmaceutical Product (WHOCoPP) to Ayush drugs having compliance to such standards.
- Quality Certifications Scheme implemented by the Quality Council of India (QCI) for  grant  of  AYUSH  standard  and  premium  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.

Further,  Ayush  Quality  Mark for Ayush products and services for Global standards have been launched during WHO Global Summit in December 2025. This certification scheme strengthens consumer trust in Ayush products and services by ensuring internationally accepted standards of quality, safety, and efficacy.

Ministry  of  Ayush  has  published  the  National  List  of  Essential  Ayush  Medicines (NLEAM) comprising 201 Ayurveda, 200 Siddha, 200 Unani and 200 Homoeopathy drugs in year 2022. Further, under central sponsored scheme namely National Ayush Mission (NAM) scheme,  State/UT  Governments  are  provided  with  Grant-in-Aid  for  procurement  of  this NLEAM in the hospitals, dispensaries and co-located facilities.

(e) As per the information received from States/ UTs governments, details of shortfall observed in the manufacturing of various Ayush drugs are available at Annexure-I.

## Annexure-I

State/ UT-wise details of shortfall observed in the manufacturing of various Ayush drugs are as follows -

|   S.no. | Name of the State/ UT   | Details of shortfall noticed                                                                                                                                                                                                                    |
|---------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Madhya Pradesh          | Yes, non-compliance of Schedule T has been observed in 03 manufacturing unit namely M/s Siddhi Herbal Gwalior, M/s Shivam Pharmacy Gwalior and M/s Rabhiaans Herbals Pvt Ltd Indore. The license of the above three firms has been cancelled.   |
|       2 | Bihar                   | Shortfall has been noticed in compliance of Drugs and Cosmetics Act 1940 and Drug Rules 1945 in M/S Radha Homeo Laboratory, Gautam Buddha Road, Gaya ji, Bihar. Legal action has been taken as per Drug &Cosmetic Act 1940 and Drug Rules 1945. |
|       3 | Tripura                 | There is no manufacturing unit in Tripura.                                                                                                                                                                                                      |
|       4 | Odisha                  | NIL                                                                                                                                                                                                                                             |
|       5 | Maharashtra             | NIL                                                                                                                                                                                                                                             |
|       6 | Delhi                   | NIL                                                                                                                                                                                                                                             |
|       7 | Gujarat                 | NIL                                                                                                                                                                                                                                             |
|       8 | Puducherry              | NIL                                                                                                                                                                                                                                             |
|       9 | Uttarakhand             | NIL                                                                                                                                                                                                                                             |
|      10 | Uttar Pradesh           | NIL                                                                                                                                                                                                                                             |
|      11 | Haryana                 | NIL                                                                                                                                                                                                                                             |
|      12 | Kerala                  | NIL                                                                                                                                                                                                                                             |
|      13 | Himachal Pradesh        | NIL                                                                                                                                                                                                                                             |
|      14 | Goa                     | NIL                                                                                                                                                                                                                                             |
|      15 | Punjab                  | NIL                                                                                                                                                                                                                                             |

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