Lok Sabha Question No. 3334 (UNSTARRED), answered on 2025-08-08
Subject: AYUSH Aushadhi Gunvatta Evam Uttpadan Samvardhan
Ministry: AYUSH
Asked by: Dr. Rajkumar Sangwan

## GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA UNSTARRED QUESTION NO. 3334 TO BE ANSWERED ON 08 th  AUGUST 2025

## ' AYUSH Aushadhi Gunvatta Evam Uttpadan Samvardhan '

## 3334. Dr. Rajkumar Sangwan:

Will the Minister of Ayush be pleased to state:

- (a) the details of target set by the Government under the AYUSH Aushadhi Gunvatta Evam Uttpadan Samvardhan Yojana and the achievements made as a result thereof during the last five years ;
- (b) whether the Government has any action plan or  set  any  target  to  promote  the  export  of traditional  major  medicines  and  health  improvement  products  through  the  AYUSH Aushadhi Gunvatta Evam Uttpadan Samvardhan Yojana;
- (c) if so, the details thereof along with achievements made during the last five years;
- (d) whether the Government has taken any measures for effective quality control and safety monitoring of AYUSH medicines; and
- (e) if so, the details thereof?

## ANSWER

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

(a) to (c) In the year 2021, Ministry of Ayush has implemented a Central Sector Scheme- Ayush Oushadhi  Gunavatta  Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY),  with  total  Budget allocation of Rs. 122.00 crores for five years. The objectives of the Scheme are as under;

i. To enhance India's manufacturing capabilities and exports of traditional medicines and health promotion products under the initiative of Atmanirbhar Bharat.

ii. To facilitate adequate infrastructural & technological upgradation and institutional activities in public and private sector for standardization, quality manufacturing and analytical testing of Ayush drugs & materials.

iii. To strengthen regulatory frameworks at Central and State level for effective quality control, safety monitoring and surveillance of misleading advertisements of Ayush drugs.

iv. To encourage building up synergies, collaborations and convergent approaches for promoting standards and quality of Ayush drugs & materials.

2.  The  components  of  Central  Sector  Scheme-  Ayush  Oushadhi  Gunavatta  Evam  Uttpadan Samvardhan Yojana (AOGUSY) are as follows:
- i. Strengthening  and  up-gradation  of  Ayush  Pharmacies  and  Drug  Testing  Laboratories  to achieve higher standards.
- ii. Pharmacovigilance  of  Ayurveda,  Siddha,  Unani,  and  Homoeopathy  (ASU  &  H)  Drugs, including surveillance of misleading advertisements.
- iii. Strengthening  of  Central  and  State  regulatory  frameworks  including  Technical  Human Resource & Capacity Building programs for Ayush drugs.
- iv. 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.
3. Under first component of AOGUSY Scheme, Ministry of Ayush has financially supported 16 ASU  &  H  pharmacies  and  06  ASU&H  drug  testing  laboratories  till  date  to  achieve  higher standards. The details of Grant-in-Aid are attached as Annexure-I.

4. Under second component of AOGUSY  Scheme, Ministry of Ayush has implemented a Pharmacovigilance Program for ASU & H Drugs. This pharmacovigilance program is working through a three-tier  network  pharmacovigilance  centers  distributed  throughout  the  country  with  one  National Pharmacovigilance Coordination Center (NPvCC), 5-Intermediary Pharmacovigilance Centers (IPvC) & 97 Peripheral Pharmacovigilance Centers (PPvC). All India Institute of Ayurveda (AIIA), New Delhi under Ministry of Ayush is the National Pharmacovigilance Co-ordination Centre (NPvCC)  for the implementation of the National Pharmacovigilance program for Ayurveda, Siddha, Unani & Homoeopathy drugs. These centres are mandated to monitor and report the misleading advertisements to the respective State  Regulatory  Authorities  for  suitable  action  against the defaulter(s).  Also,  the  program  is  regularly

reporting Suspected Adverse Drug Reactions for ASU &H drugs. The objectives of the program are as below:-

- To improve patient healthcare and safety in relation to the use of medicines.
- To develop the culture of documenting adverse effects.
- To promote understanding, education and training in Pharmacovigilance and its communication to healthcare professionals and the public.
- Surveillance of misleading advertisements appearing in the print and electronic media.

## 5. The achievements made under the Pharmacovigilance Program in the last five years are attached as Annexure-II .

6. Under third component of AOGUSY Scheme, three trainings has been conducted for Ayush drug regulators, industry personnel and other stake holders.
2. (d) & (e) The details of measures taken by Government for effective quality control and safety monitoring of AYUSH medicines are as follows:-
1. The  Drugs  &  Cosmetics  Act,  1940  and  Drugs  Rules,  1945  have  exclusive  regulatory provisions  for  Ayurvedic,  Siddha,  Sowa-Rigpa,  Unani,  and  Homoeopathy  drugs.  It  is mandatory for the manufacturers to adhere to the prescribed requirements in compliance with the Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of Drugs Rules, 1945 including safety, effectiveness  and  quality  standards of drugs given in the respective pharmacopoeia.
2. Drug Inspectors collect medicine samples regularly from manufacturing firms or 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 the products from the market

and  appropriate  legal  actions  as  per  Drugs  and  Cosmetics  Act  1940  and  Rules  made thereunder

3. 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.  As  per  the  Drugs  &  Cosmetics  Act,  1940  and  rules thereunder, the compliance to this 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.
4. 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.  Further,  it  imparts  Capacity Building Trainings at regular interval for standardization/quality control/ testing or analysis of ASU&H drugs to Drug Regulatory Authorities, State Drug Testing Laboratories (Drug Analyst)  and  other  stakeholders  on  quality  control  of  ASU&H  drugs  on  laboratory techniques and methods used to maintain the quality of ASU&H drugs.
5. Drug Testing Laboratories are being recognised under Rule 160 A to J of the Drugs Rules, 1945 for carrying  out  such  tests  of  identity,  purity,  quality  and  strength  of  Ayurvedic, Siddha, Sowa-Rigpa, Unani and Homoeopathy drugs. As on date, 108 private laboratories are approved or licensed under the provisions of Drugs Rules, 1945 for manufacturers. 34 Drug Testing Laboratories of State/UTs are testing quality of Ayurvedic, Siddha, SowaRigpa, Unani and Homoeopathy drugs and raw materials for legal samples.

6. The Pharmacovigilance Program for Ayurvedic, Siddha, Unani and Homoeopathy (ASU & H) Drugs monitor and report misleading advertisements. Also, the program is regularly reporting Suspected Adverse Drug Reactions for ASU &H drugs.
7. Ministry  of  Ayush  has  developed  and  launched  an  IT  enabled  online  portal  'Ayush Suraksha' for Ayush Health care professionals and public to track the reported misleading advertisements (MLAs)/Objectionable Advertisements (OAs) and Adverse Drug Reactions (ADRs) on 30th May 2025.

*****

## Annexure-I

The details of the incentives given for strengthening and upgradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards during the last five years are as follows:

| S. No.     | F.Y.           | State                                                                                                        | Component   | Pharmacy/ DTL                                                                       | Particulars                        | Amount released   |
|------------|----------------|--------------------------------------------------------------------------------------------------------------|-------------|-------------------------------------------------------------------------------------|------------------------------------|-------------------|
| 1 2021- 22 | Mizoram        | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL         | State Govt. of Mizoram                                                              | Rs. 1,800,000                      |                   |
| 2          | Pune           | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards |             | Pharmacy                                                                            | Inducare Pharma Pvt.Ltd. Pune      | Rs. 30,000,000    |
| 3          | Maharashtra    | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards |             | Pharmacy                                                                            | Ayurchem Private Ltd. Maharashtra. | Rs. 26,900,000    |
| 4          | Maharashtra    | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy    | Phytovedic India Pvt. Ltd. Maharashtra                                              | Rs. 21,461,000                     |                   |
| 5          | Kerala         | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy    | Visesh Ayurvedic Pvt. Ltd Pharmacy Kerala.                                          |                                    | Rs. 19,156,000    |
| 2022- 6    | Uttar Pradesh  | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy    | Amar Pharmaceuticals and labs (I) Pvt. Ltd. U.P                                     | Rs.                                | 14,343,000        |
| 23 7       | Uttar Pradesh  | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL         | Amar Pharmaceuticals and labs (I) Pvt. Ltd. U.P (DTL)                               | Rs. 7,767,000                      |                   |
| 8          | Madhya Pradesh | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy    | Shree Baidyanath Ayurved Bhawan Pvt. Ltd, Madhya Pradesh                            | Rs. 20,892,000                     |                   |
| 9          | Kerala         | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy    | Kollam District Ayurveda Oushdha Nirmana Vyavasaya Co-operative Society Ltd, Kerela | Rs. 6,429,000                      |                   |
| 2023- 24   | Tripura        | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL         | State Govt. of Tripura                                                              | Rs. 7,668,000                      | 10                |

|   11 |          | Madhya Pradesh    | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | Pharmacy   | Shree Baidyanath Ayurved Bhawan Pvt. Ltd, Madhya Pradesh         | Rs. 9,108,000   |
|------|----------|-------------------|----------------------------------------------------------------------------------------------------------------|------------|------------------------------------------------------------------|-----------------|
|   12 |          | Jammu& Kashmir    | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | DTL        | State Govt. J&K                                                  | Rs. 8,629,500   |
|   13 |          | Kerala            | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | Pharmacy   | Sitaram Ayurveda Pvt. Ltd, Thrissur, Kerala.                     | Rs. 5,000,000   |
|   14 |          | Kerala            | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | Pharmacy   | Pankajakasthuri Herbals India Private Limited, Poovachal, Kerala | Rs. 5,000,000   |
|   15 |          | Rajasthan         | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | Pharmacy   | BJain Pharmaceuticals Private Limited, Alwar, Rajasthan          | Rs. 5,000,000   |
|   16 |          | Assam             | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | Pharmacy   | Assam Ayurvedic Products, Guwahati, Assam (PSU)                  | Rs. 4,559,519   |
|   17 |          | Jammu& Kashmir    | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | Pharmacy   | Govt. Pharmacy, Jammu &Kashmir                                   | Rs. 10,500,000  |
|   18 |          | Gujarat           | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | Pharmacy   | State Pharmacy, Rajpipla, Gujarat                                | Rs. 4,420,248   |
|   19 |          | Mizoram           | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | DTL        | State Govt. Drug Testing Laboratory, Mizoram                     | Rs. 6,720,884   |
|   20 |          | Tamil Nadu        | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | DTL        | State Govt. Drug Testing Laboratory, Tamil Nadu                  | Rs. 2,000,000   |
|   21 |          | Arunachal Pradesh | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | Pharmacy   | State Pharmacy, Arunachal Pradesh                                | Rs. 6,702,164   |
|   22 |          | Arunachal Pradesh | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | DTL        | State Drug Testing Laboratory , Arunachal Pradesh                | Rs. 1,799,813   |
|   23 | 2024- 25 | Arunachal Pradesh | Strengthening and up-gradation of Ayush Pharmacies                                                             | Pharmacy   | State Pharmacy, Arunachal Pradesh                                | Rs. 7,042,077   |

|   24 | Arunachal Pradesh   | and Drug Testing Laboratories to achieve higher standards                                                    | DTL      | State Drug Testing Laboratory , Arunachal Pradesh                                                                 | Rs. 1,724,400   |
|------|---------------------|--------------------------------------------------------------------------------------------------------------|----------|-------------------------------------------------------------------------------------------------------------------|-----------------|
|   25 | Kerala              | and Drug Testing Laboratories to achieve higher standards                                                    | Pharmacy | Pankajakasthuri Herbals India Private Limited, Poovachal, Kerala                                                  | Rs. 4,432,807   |
|   26 | Tamil Nadu          | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL      | State Govt. Drug Testing Laboratory, Tamil Nadu                                                                   | Rs. 5,100,000   |
|   27 | Rajasthan           | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy | BJain Pharmaceuticals Private Limited, Alwar, Rajasthan                                                           | Rs. 14,454,189  |
|   28 | Mizoram             | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL      | State Govt. Drug Testing Laboratory, Mizoram                                                                      | Rs. 3,940,500   |
|   29 | Tamil Nadu          | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL      | State Govt. Drug Testing Laboratory, Tamil Nadu                                                                   | Rs. 4,157,062   |
|   30 | Gujarat             | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy | State Pharmacy, Rajpipla, Gujarat                                                                                 | Rs. 20,000,000  |
|   31 | Mizoram             | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | DTL      | State Govt. Drug Testing Laboratory, Mizoram                                                                      | Rs. 1,800,000   |
|   32 | Tamil Nadu          | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards | Pharmacy | State Govt. Pharmacy, Tamil Nadu Medicinal Plant Farms &Herbal Medicine Corporation Limited (TAMPCOL), Tamil Nadu | Rs. 4,500,000   |

| 33   |          | Arunanchal Pradesh   | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | Pharmacy   | State Pharmacy, Arunanchal Pradesh   | Rs. 3,108,000   |
|------|----------|----------------------|----------------------------------------------------------------------------------------------------------------|------------|--------------------------------------|-----------------|
| 34   | 2025- 26 | Punjab               | Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards   | Pharmacy   | Shree Dhanwantari Herbals Pvt. Ltd.  | 28,500,000      |
|      |          |                      |                                                                                                                |            | Total                                | Rs. 324,615,163 |

## Annexure-II

The achievements made under the Pharmacovigilance Program in the last five years are as follow:

- To enhance understanding and promote effective communication regarding pharmacovigilance in the ASU&H sector, a series of awareness programs have been conducted over the past five years. These initiatives aimed at sensitizing stakeholders-including practitioners, manufacturers, healthcare professionals, and the general public-towards the importance of drug safety monitoring and adverse event reporting. The details of such programs conducted during the last five years are as follows:
- Reporting of Suspected Adverse Drug Reactions (ADRs) is one of the major components of this program. Reported such suspected case reports in last five years as below:
- Pharmacovigilance Program also aims at keeping a surveillance on misleading advertisements for ASU & H drugs, details of last five years as below:

| Year             |   Awareness Program |   Beneficiaries |
|------------------|---------------------|-----------------|
| 2021             |                 118 |           14659 |
| 2022             |                 292 |           23510 |
| 2023             |                 586 |           43396 |
| 2024             |                1065 |          105148 |
| 2025 (June 2025) |                 692 |           66255 |
| Total            |                2753 |          252968 |

| Year             |   Suspected ADR's |
|------------------|-------------------|
| 2021             |               360 |
| 2022             |               324 |
| 2023             |               420 |
| 2024             |               521 |
| 2025 (June 2025) |               382 |
| Total            |              2007 |

| Year             | Misleading Advertisements   |
|------------------|-----------------------------|
| 2021             | 8144 + 43 (COVID)           |
| 2022             | 7367 + 4 (COVID)            |
| 2023             | 7771                        |
| 2024             | 10161                       |
| 2025 (June 2025) | 6650                        |
| Total            | 40140                       |