Executive Summary:
The Ministry of AYUSH implemented the Ayush Aushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) in 2021 with a budget of Rs. 122.00 crores for five years to enhance manufacturing capabilities, upgrade infrastructure, strengthen regulatory frameworks, and promote quality standards for AYUSH drugs. The scheme supports pharmacies and labs, monitors drug safety, and conducts training programs. Measures for quality control and safety monitoring of AYUSH medicines are also detailed, referencing the Drugs & Cosmetics Act and the role of the Pharmacopoeia Commission.
Key Points / Main Content:
AOGUSY Scheme Objectives:
* Enhance India's traditional medicine manufacturing and exports.
* Upgrade infrastructure for standardization and quality manufacturing of Ayush drugs.
* Strengthen regulatory frameworks for quality control and safety monitoring.
* Promote collaboration for Ayush drug quality standards.
Components of AOGUSY Scheme:
* Strengthening Ayush Pharmacies and Drug Testing Laboratories.
* Pharmacovigilance of ASUH Drugs, including advertisement surveillance.
* Strengthening regulatory frameworks and human resource capacity building.
* Supporting standards development and accreditation/certification.
Financial Support:
* Financial support provided to 16 ASUH pharmacies and 6 ASUH drug testing laboratories.
Pharmacovigilance Program:
* Three-tier network of pharmacovigilance centers established nationwide.
* AIIA, New Delhi, is the National Pharmacovigilance Coordination Centre (NPvCC).
* Centers monitor misleading advertisements and report adverse drug reactions.
* Objectives include improving patient safety, documenting adverse effects, promoting pharmacovigilance education, and surveilling misleading ads.
Quality Control and Safety Measures:
* Drugs & Cosmetics Act, 1940 and Rules, 1945 provide regulatory provisions.
* GMP compliance as per Schedule T/Schedule MI is mandatory.
* Drug Inspectors collect samples for quality testing, with legal actions for non-compliance.
* PCIMH sets formulary specifications and pharmacopoeial standards.
* PCIMH acts as the Central Drugs Laboratory and conducts capacity building trainings.
* Drug Testing Laboratories are recognized under Drugs Rules, 1945.
* Pharmacovigilance Program monitors misleading advertisements and reports adverse drug reactions.
* Ayush Suraksha portal launched for tracking misleading ads and adverse drug reactions.
Impact Analysis:
AYUSH Drug Manufacturers:
*Impact:* Must adhere to GMP standards and quality specifications as per the Drugs & Cosmetics Act and pharmacopoeial standards set by PCIMH. Benefit from infrastructure upgrades and standardization support.
*Action Required:* Ensure compliance with regulatory requirements, participate in standardization efforts, and utilize available support for upgrading facilities.
Drug Regulatory Authorities (Central and State):
*Impact:* Responsible for enforcing quality control, safety monitoring, and surveillance of misleading advertisements related to AYUSH drugs. Benefit from strengthened regulatory frameworks and capacity building programs.
*Action Required:* Enforce regulations, conduct inspections, take action against non-compliant manufacturers, and participate in training programs.
AYUSH Healthcare Professionals:
*Impact:* Expected to report adverse drug reactions and misleading advertisements. Benefit from improved patient safety and increased awareness of pharmacovigilance.
*Action Required:* Report suspected adverse drug reactions and misleading advertisements through the Ayush Suraksha portal and participate in pharmacovigilance programs.
General Public/Patients:
*Impact:* Benefit from safer and higher quality AYUSH medicines, increased awareness of adverse drug reactions, and protection from misleading advertisements.
*Action Required:* Report any adverse drug reactions or misleading advertisements to healthcare professionals or through the Ayush Suraksha portal.
Key Entities Referenced
Ministry of Ayush: The Indian government ministry responsible for developing and promoting traditional medicine systems.
AYUSH Aushadhi Gunvatta Evam Uttpadan Samvardhan Yojana: A Central Sector Scheme to enhance India's manufacturing capabilities and exports of traditional medicines and health promotion products.
Atmanirbhar Bharat: An initiative of the Indian government to promote self-reliance and domestic production.
Bureau of Indian Standards BIS: The National Standards Body of India responsible for standardization, marking and quality certification of goods.
Quality Control of India QCI: An autonomous body that establishes and operates the National Accreditation Structure for conformity assessment bodies.
Pharmacovigilance Program for ASU H Drugs: A program implemented by the Ministry of Ayush to monitor the safety and efficacy of Ayurveda, Siddha, Unani, and Homoeopathy drugs.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Pharmacopoeia Commission for Indian Medicine Homoeopathy PCIMH: A subordinate office under Ministry of Ayush that lays down the formulary specifications and pharmacopoeial standards for Ayurveda, Siddha, Unani and Homoeopathy drugs.
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