Parliament Question: AYUSH Aushadhi Gunvatta Evam Uttpadan Samvardhan

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

1ii. 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 2reporting 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.

(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 3and 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, Sowa- Rigpa, Unani and Homoeopathy drugs and raw materials for legal samples.

46. 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.

***** 5Annexure-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. Pharmacy/ Amount No. F.Y. State Component DTL Particulars released Strengthening and up-gradation of Ayush Pharmacies 2021- 1 Mizoram and Drug Testing DTL State Govt. of Mizoram Rs. 1,800,000 22 Laboratories to achieve higher standards Inducare Pharma 2 Pune Pharmacy Rs. 30,000,000 Pvt.Ltd. Pune Ayurchem Private Ltd.

3 Maharashtra Pharmacy Rs. 26,900,000 Maharashtra.

Phytovedic India Pvt.

4 Maharashtra Pharmacy Rs. 21,461,000 Ltd. Maharashtra Visesh Ayurvedic Pvt.

5 Kerala Pharmacy Rs. 19,156,000 Ltd Pharmacy Kerala.

Strengthening and up-gradation of Amar Pharmaceuticals Uttar 6 Ayush Pharmacies Pharmacy and labs (I) Pvt. Ltd. Rs. 14,343,000 2022- Pradesh and Drug Testing U.P 23 Laboratories to Amar Pharmaceuticals Uttar 7 achieve higher DTL and labs (I) Pvt. Ltd. Rs. 7,767,000 Pradesh standards U.P (DTL) Shree Baidyanath Madhya 8 Pharmacy Ayurved Bhawan Pvt. Rs. 20,892,000 Pradesh Ltd, Madhya Pradesh Kollam District Ayurveda Oushdha 9 Kerala Pharmacy Nirmana Vyavasaya Rs. 6,429,000 Co-operative Society Ltd, Kerela Strengthening and up-gradation of Ayush Pharmacies 2023- 10 Tripura and Drug Testing DTL State Govt. of Tripura Rs. 7,668,000 24 Laboratories to achieve higher standards 6Strengthening and up-gradation of Ayush Pharmacies Shree Baidyanath Madhya 11 and Drug Testing Pharmacy Ayurved Bhawan Pvt. Rs. 9,108,000 Pradesh Laboratories to Ltd, Madhya Pradesh achieve higher standards Strengthening and up-gradation of Ayush Pharmacies Jammu & 12 and Drug Testing DTL State Govt. J&K Rs. 8,629,500 Kashmir Laboratories to achieve higher standards Sitaram Ayurveda Pvt.

13 Kerala Pharmacy Rs. 5,000,000 Ltd, Thrissur, Kerala.

Pankajakasthuri Herbals India Private 14 Kerala Pharmacy Rs. 5,000,000 Limited, Poovachal, Kerala BJain Pharmaceuticals 15 Rajasthan Pharmacy Private Limited, Alwar, Rs. 5,000,000 Rajasthan Assam Ayurvedic 16 Assam Strengthening and Pharmacy Products, Guwahati, Rs. 4,559,519 up-gradation of Assam (PSU) Jammu & Ayush Pharmacies Govt. Pharmacy, 17 Pharmacy Rs. 10,500,000 Kashmir and Drug Testing Jammu & Kashmir Laboratories to State Pharmacy, 18 Gujarat Pharmacy Rs. 4,420,248 achieve higher Rajpipla, Gujarat standards State Govt. Drug 19 Mizoram DTL Testing Laboratory, Rs. 6,720,884 Mizoram State Govt. Drug 20 Tamil Nadu DTL Testing Laboratory, Rs. 2,000,000 Tamil Nadu Arunachal State Pharmacy, 21 Pharmacy Rs. 6,702,164 Pradesh Arunachal Pradesh State Drug Testing Arunachal 22 DTL Laboratory , Arunachal Rs. 1,799,813 Pradesh Pradesh 2024- Strengthening and Arunachal State Pharmacy, 23 25 up-gradation of Pharmacy Rs. 7,042,077 Pradesh Arunachal Pradesh Ayush Pharmacies 7and Drug Testing State Drug Testing Arunachal Laboratories to 24 DTL Laboratory , Arunachal Rs. 1,724,400 Pradesh achieve higher Pradesh standards Pankajakasthuri Herbals India Private 25 Kerala Pharmacy Rs. 4,432,807 Limited, Poovachal, Kerala State Govt. Drug 26 Tamil Nadu DTL Testing Laboratory, Rs. 5,100,000 Tamil Nadu BJain Pharmaceuticals 27 Rajasthan Pharmacy Private Limited, Alwar, Rs. 14,454,189 Strengthening and Rajasthan up-gradation of Ayush Pharmacies State Govt. Drug 28 Mizoram and Drug Testing DTL Testing Laboratory, Rs. 3,940,500 Laboratories to Mizoram achieve higher standards State Govt. Drug 29 Tamil Nadu DTL Testing Laboratory, Rs. 4,157,062 Tamil Nadu State Pharmacy, 30 Gujarat Pharmacy Rs. 20,000,000 Rajpipla, Gujarat Strengthening and up-gradation of Ayush Pharmacies State Govt. Drug 31 Mizoram and Drug Testing DTL Testing Laboratory, Rs. 1,800,000 Laboratories to Mizoram achieve higher standards Strengthening and State Govt. Pharmacy, up-gradation of Tamil Nadu Medicinal Ayush Pharmacies Plant Farms & Herbal 32 Tamil Nadu and Drug Testing Pharmacy Rs. 4,500,000 Medicine Corporation Laboratories to Limited (TAMPCOL), achieve higher Tamil Nadu standards 8Strengthening and up-gradation of Ayush Pharmacies Arunanchal State Pharmacy, 33 and Drug Testing Pharmacy Rs. 3,108,000 Pradesh Arunanchal Pradesh Laboratories to achieve higher standards Strengthening and up-gradation of Ayush Pharmacies 2025- Shree Dhanwantari 34 Punjab and Drug Testing Pharmacy 28,500,000 26 Herbals Pvt. Ltd.

Laboratories to achieve higher standards Rs.

Total 324,615,163 9Annexure-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:

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

Year Suspected ADR's 2021 360 2022 324 2023 420 2024 521 2025 (June 2025) 382 Total 2007 ➢ Pharmacovigilance Program also aims at keeping a surveillance on misleading advertisements for ASU & H drugs, details of last five years as below:

Year Misleading Advertisements 2021 8144 + 43 (COVID) 2022 7367 + 4 (COVID) 2023 7771 2024 10161 2025 (June 2025) 6650 Total 40140 10