Lok Sabha Question No. 1010 (UNSTARRED), answered on 2025-12-05
Subject: Quality AYUSH Medicines and Products
Ministry: AYUSH
Asked by: Shri Janardan Singh Sigriwal

## GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA

## UNSTARRED QUESTION NO. 1010 TO BE ANSWERED ON 05 th  DECEMBER, 2025

## Quality AYUSH Medicines and Products

1010. Shri Janardan Singh Sigriwal:

Will the Minister of AYUSH

be pleased to state:

(a)  whether  any shortfall has been noticed in manufacturing of various AYUSH medicines and if so, the details thereof;

(b)  whether the Government proposes to formulate any mechanism to address the issue of standardization and quality control of AYUSH medicines and products in the country;

(c)  if  so,  the  details  thereof  along  with  the  efforts  to  improve  the  quality  of  AYUSH medicines/products, State/UT-wise, particularly in Bihar;

(d) the measures taken/proposed to be taken to enhance research and development in the field of AYUSH along with the efforts to collaborate with international organizations; and

(e)  the  plans  of  the  Government  to  promote  quality  AYUSH  medicines  and  products  for wider use by the consumers?

## ANSWER

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

(a)  As  per  the  information  received  from  States/  UTs  governments,  there  is  no  shortfall noticed in the manufacturing of various Ayush medicines .

(b)  and  (c)  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.  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 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.

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.  So  far,  2269  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 & Thin-layer chromatography (TLC) Atlas on 392 single drugs incorporated in Ayurvedic Pharmacopoeia of India (API) has also been published.

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.

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 Ayurvedic, 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.

As per the information received from states/UTs Governments including Bihar, the details  of  the  mechanism  to  address  the  issue  of  standardization  and  quality  control  of Ayush medicines and products in the country along with the efforts to improve the quality of Ayush medicines/products are attached at Annexure .

(d) Ministry of Ayush has established Central Councils for Research in Ayurveda, Yoga & Naturopathy,  Unani,  Siddha  &  Homoeopathy  as  apex  organizations  for  undertaking, coordinating,  formulating,  developing  and  promoting  research  in  Ayush  systems  on scientific  lines.  Core  Research  activities  comprise  of  Medicinal  Plant  Research  (MedicoEthno Botanical Survey, Pharmacognosy  and  in vitro-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  in  collaboration with various Universities, Hospitals and Institutes.

Further,  the  Ministry  of Ayush is implementing the Central Sector Scheme namely AYURGYAN Scheme from FY 2021-22. The Scheme has 03 components viz. (i) Capacity Building & Continuing Medical Education (CME) in Ayush (ii) Research & Innovation in Ayush from the FY 2021-22 and iii) Ayurveda Biology Integrated Health Research is also added under the scheme from FY 2023-24. Under the Research & Innovation in Ayush and Ayurveda  Biology  Integrated  Health  Research  component,  financial  assistance  is  being

provided to the Organizations/Institutions for research studies, for promotion of research in Ayush system.

The Ministry of Ayush is implementing the central sector scheme for Promotion of International  Cooperation  for  Ayush  (IC  Scheme).  Under  this  scheme,    Ministry  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 IC Scheme, 25 Country-to-Country MoUs, 15 Ayush Chair MoUs and 52 Institute-to-Institute level MoUs have been signed.

(e)  Ministry  of  Ayush  has  implemented  Central  Sector  Scheme  Ayush  Oushadhi  Gunvatta Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY).  The  total  financial  allocation  to  this scheme  is  Rs.  122.00  crores  for  five  years.  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.    Detailed guidelines of AOGUSY scheme are available at https://ayush.gov.in/images/Schemes/aoushdhi.pdf .

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  is  implemented  by  the  Quality  Council  of  India  (QCI)  for grant of Ayush mark viz. Ayush standard and Ayush premium marks to Ayurvedic, Siddha and Unani products on the basis of third party evaluation of quality in accordance with the status of compliance to GMP and WHO-GMP standards, respectively.

*******

## Annexure

As per the information received from states/UTs Governments including Bihar, the details of the mechanism to address the issue of standardization and quality control of Ayush medicines and  products  in  the  country  along  with  the  efforts  to  improve  the  quality  of  Ayush medicines/products are as follows:

|   S. No. | Name of the State/ UT   | Details                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
|----------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|        1 | Uttarakhand             | State government nominated 14 Drug Inspectors in the State to check the quality and production of Ayurvedic &Unani medicines. There are 07 Drug testing laboratories (DTLs) are working in Uttarakhand in which 01 Government and 06 drug testing laboratories are approved by Ministry of Ayush in Private sector are sanctioned under Drug & Cosmetic Act 1940, Ruls1945 under rule 160A to 160J, for checking the quality of Ayurvedic & Unani medicines. Uttarakhand Ayurvedic University nominated as peripheral pharmacovigilance Centre for compiling and reporting of adverse drug reaction (ADR). All manufacturing Units are GMP certified, the respective District's Drug Inspectors regularly do inspection, and Sampling for testing. |
|        2 | Madhya Pradesh          | Madhya Pradesh have 01 state DTL and 07 Private DTLs for testing of Ayush medicine. In addition, 51 Drug Inspectors are notified in state for Ayush medicine. In addition 07 pharmacovigilance centers are working as monitoring system.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
|        3 | Delhi                   | Routine inspections and lifting of survey samples are undertaken as part of regular enforcement activities to improve the quality of Ayush medicines/products.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
|        4 | Puducherry              | ISM Expert Committee is Constituted in UT of Puducherry. Products were verified, evaluated and approved by ISM Expert Committee. Based on the recommendations from ISM Expert Committee, necessary product approval is issued. Product approvals are issued as per the rules 158(B) (II) A read with Chapter IVA of Drugs and Cosmetics Act 1940 &Rules 1945. Regular monitoring and Inspection is carried out by the Drugs Inspectors, Department of Drugs Control, Puducherry.                                                                                                                                                                                                                                                                   |

|   5. | Ladakh            | In UT Ladakh the Sowa Rigpa medicine suppliers are directed to ensure date of manufacturing and date of expiry on label.                                                                                                                                                                                                                                                                                                                                                                               |
|------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|    6 | Kerala            | The Government of Kerala has constituted an expert committee for the standardization of Ayurveda, Siddha, Unani Drugs. The committee had submitted a comprehensive draft report with recommendation for implementation of various steps to improve the quality of Ayurveda, Siddha, Unani Drugs.                                                                                                                                                                                                       |
|    7 | Tripura           | A State DTL has been established to test Ayush drugs for quality, purity, and strength. A central sector scheme (AOGUSY) implemented to provide financial assistance to drug testing laboratory to achieve higher standards. Drug inspectors conduct regular inspections of the market and draw samples for quality checking                                                                                                                                                                           |
|    8 | Haryana           | A State Ayurvedic Drug Testing Laboratory is functional in Haryana State. Moreover, 12 Private Drug Testing Laboratories are also granted licence for testing of ASU drugs/medicines under rule 160 B of Drug and Cosmetic Rules-1945.                                                                                                                                                                                                                                                                 |
|    9 | Arunachal Pradesh | State Drug Testing Laboratory (Ayush) and Govt. Ayurvedic Pharmacy are established in Arunachal Pradesh for quality control of Ayush Drugs.                                                                                                                                                                                                                                                                                                                                                            |
|   10 | Uttar Pradesh     | For testing/analysis, the State Government operates 01 Drug Testing Laboratory with 01 State Government Analyst, Ayurveda & Unani Medicine, Uttar Pradesh, and 04 Private Drug Testing Laboratories certified by the State Government under rule 160 A to J of the Drug and Cosmetics Act- 1945. One Pharmacovigilance Centre situated at Central Research Institute of Unani Medicine, Lucknow, Uttar Pradesh and 60 Drug Inspector Appoint in Uttar Pradesh Including Ayurveda and Unani Department. |
|   11 | Bihar             | The Drugs Control Administration, Department of Health, Bihar continuously monitor the Quality of drugs (Ayush) by performing sampling & testing of the marketed drugs in the state through its inspectorate staff. State Govt. has also notified government Analyst and Drugs Testing Laboratory, Agamkuan, Patna for the test and Analysis of Ayurvedic, Unani and Homoeopathic Medicines.                                                                                                           |
|   12 | Odisha            | One State Drugs Testing and Research Laboratory (ISM), Bhubaneswar is functioning in the State to address the issue of standardisation and quality control                                                                                                                                                                                                                                                                                                                                             |

|    |             | of AYUSH medicines and products in the State.   |
|----|-------------|-------------------------------------------------|
| 13 | Maharashtra | Nil                                             |
| 14 | Lakshadweep | Nil                                             |
| 15 | Gujrat      | Nil                                             |
| 16 | West Bengal | Nil                                             |