Lok Sabha Question No. 2485 (UNSTARRED), answered on 2026-02-13
Subject: Quality of AYUSH Medicines
Ministry: AYUSH
Asked by: Smt. Geniben Nagaji Thakor

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 2485 TO BE ANSWERED ON 13 th  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.

2. 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

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.
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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