Executive Summary:
The Ministry of AYUSH addresses the quality, safety, and efficacy of AYUSH drugs in rural markets. The response details the regulatory framework, substandard drug cases, pharmacovigilance initiatives, and GMP promotion among manufacturers. Financial and technical assistance is provided through the AOGUSY scheme with a total financial allocation of Rs. 122.00 crores for five years.
Key Points / Main Content:
Regulatory Framework and Quality Assurance:
* The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 contain regulatory provisions for Ayurvedic, Siddha, Sowa-Rigpa, Unani, and Homoeopathy drugs.
* Manufacturers must adhere to Good Manufacturing Practices (GMP) as per Schedule T/Schedule MI of Drugs Rules, 1945.
* Drug Inspectors regularly collect medicine samples for quality testing, and legal actions are initiated if samples are found to be substandard.
* The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIMH) sets standards for ASUH drugs, compliance with which is mandatory for production.
* PCIMH also serves as the Central Drugs Laboratory for testing ASUH Drugs and conducts capacity-building trainings.
* Drug Testing Laboratories are recognized under Rule 160 A to J of the Drugs Rules, 1945.
* AOGUSY scheme supports AYUSH pharmacies and drug testing laboratories.
Substandard Drug Cases and Punitive Actions:
* Details of substandard, misbranded, and adulterated AYUSH drug cases reported from rural areas in the last three financial years are provided state-wise.
* Punitive actions taken against manufacturers and distributors are included.
Pharmacovigilance and GMP Promotion:
* AOGUSY scheme strengthens pharmacovigilance of AYUSH drugs, including surveillance of misleading advertisements.
* The Pharmacovigilance Program operates through a three-tier network: National, Intermediary, and Peripheral Pharmacovigilance Centers.
* Awareness programs on patient safety have been conducted, reaching 328709 beneficiaries across the country.
* The Ayush Suraksha IT portal was launched on May 30, 2025, for tracking misleading advertisements and adverse drug reactions.
* Ministry of Ayush encourages certifications of Ayush products.
* CDSCO issues WHO Certificate of Pharmaceutical Product (WHOCoPP) to Ayush drugs meeting standards.
* Quality Council of India (QCI) grants AYUSH standard and premium marks based on third-party evaluation.
Impact Analysis:
AYUSH Drug Manufacturers:
* Impact: Must adhere to GMP standards; potential for increased scrutiny and legal action if drugs are substandard.
* Action Required: Comply with GMP, ensure drugs meet quality standards, and prepare for inspections.
Drug Inspectors and Regulatory Authorities:
* Impact: Responsible for regular drug sample collection and quality testing; must take appropriate action against non-compliant manufacturers.
* Action Required: Conduct regular inspections, enforce quality standards, and take legal actions when necessary.
Patients/Consumers:
* Impact: Benefit from improved drug quality, safety, and reduced misleading advertisements.
* Action Required: Report adverse drug reactions and misleading advertisements through available channels like the Ayush Suraksha portal.
AYUSH Pharmacies and Drug Testing Laboratories:
* Impact: Opportunity to receive support through the AOGUSY scheme for upgrading facilities and achieving higher standards.
* Action Required: Apply for AOGUSY scheme benefits to enhance quality and standardization.
Key Entities Referenced
Ministry of AYUSH: The Indian governmental body responsible for the development and promotion of AYUSH systems of medicine.
Drugs and Cosmetics Act, 1940: Indian law that regulates the import, manufacture, distribution, and sale of drugs and cosmetics, including provisions for Ayurvedic, Siddha, Unani, and Homoeopathic drugs.
Drugs Rules, 1945: Rules formulated under the Drugs and Cosmetics Act, 1940, that provide detailed regulations for the manufacture, sale, and distribution of drugs, including AYUSH drugs.
Pharmacopoeia Commission for Indian Medicine Homoeopathy PCIMH: A subordinate office under the Ministry of AYUSH that lays down the formulary specifications and pharmacopoeial standards for Ayurveda, Siddha, Unani and Homoeopathy (ASUH) drugs.
Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana AOGUSY: A Central Sector Scheme implemented by the Ministry of AYUSH to support Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards.
Good Manufacturing Practices GMP: A system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Central Drugs Standard Control Organization CDSCO: The national regulatory body for Indian pharmaceuticals and medical devices, responsible for approving new drugs, conducting clinical trials, setting standards, and regulating the manufacture, sale, and distribution of drugs.
Quality Council of India QCI: An autonomous body under the Department of Industrial Policy and Promotion, Ministry of Commerce and Industry, Government of India, that provides accreditation services in various sectors, including healthcare and quality standards for AYUSH products.
GOVERNMENT OF INDIA
MINISTRY OF AYUSH
LOK SABHA
STARRED QUESTION NO. 297
TO BE ANSWERED ON 08th AUGUST 2025
“AYUSH Drugs in Rural Markets”
297. Adv Priya Saroj:
Will the Minister of AYUSH be pleased to state:
(a) the existing regulatory framework and mechanisms for ensuring the quality, safety and
efficacy of AYUSH drugs and products available in rural markets across the country and the
number of drug testing laboratories dedicated to AYUSH products, State/UT-wise;
(b) the total number of cases of substandard, misbranded and adulterated AYUSH drugs
reported from rural areas in the last three financial years, State-wise and the punitive actions
taken against the manufacturers and distributors of such drugs;
(c) the details of initiatives taken by the Government to strengthen pharmacovigilance of
AYUSH drugs, especially in rural areas; and
(d) the measures being adopted by the Government to promote Good Manufacturing Practices
(GMP) among small and medium-scale AYUSH drug manufacturers operating in rural and
semi-urban areas and the details of financial or technical assistance provided for their
compliance?
ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH
(SHRI PRATAPRAO JADHAV)
(a) to (d) A statement is laid on the Table of the House.
1THE STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED
QUESTION NO. 297 FOR 08th AUGUST 2025.
(a) The details of existing regulatory framework and mechanisms for ensuring the quality,
safety and efficacy of Ayush drugs and products available in rural markets across the
country and the number of drug testing laboratories dedicated to Ayush products,
State/UT-wise 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.
Provisions relating to Ayurveda, Siddha 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, 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 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 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 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
2of 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. The details of number of drug testing laboratories dedicated to Ayush
products, State/UT-wise are available at Annexure-I.
6. Ministry of Ayush has implemented Central Sector Scheme Ayush Oushadhi Gunvatta
Evam Uttpadan Samvardhan Yojana (AOGUSY) to support Ayush Pharmacies and
Drug Testing Laboratories to achieve higher standards under one of the components.
7. Pharmacovigilance Program for Ayurveda, Siddha, Unani, and Homoeopathy (ASU &
H) Drugs is one of the components under the AOGUSY Scheme of Ministry of Ayush.
This is established with an objective of improving patient healthcare and safety in
relation to the use of medicines, developing culture of documenting adverse effects,
promoting education and training in Pharmacovigilance, and surveillance of misleading
advertisements appearing in the print and electronic media.
3(b) As per the information received from states/UTs governments, the details of the total
number of cases of substandard, misbranded and adulterated Ayush drugs reported from
rural areas in the last three financial years, State-wise and the punitive actions taken
against the manufacturers and distributors of such drugs are attached at Annexure-II.
(c) And (d) The details of initiatives taken by the Government to strengthen
pharmacovigilance of Ayush drugs, especially in rural areas; and the measures being
adopted by the Government to promote Good Manufacturing Practices (GMP) among
small and medium-scale Ayush drug manufacturers operating in rural and semi-urban
areas and the details of financial or technical assistance provided for their compliance
are as follows: -
1. 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/resources/pdf/schemes/aoushdhi.pdf
2. The Pharmacovigilance Program for Ayurvedic, Siddha, Unani and Homoeopathy
(ASU & H) Drugs has been implemented under Central Sector Scheme Ayush
Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY), which work
through a three-tier network of a National Pharmacovigilance Centre (NPvCC), Five
Intermediary Pharmacovigilance Centers (IPvCs) and 97 Peripheral Pharmacovigilance
Centers (PPvCs) established across the country. These centres are mandated to monitor
and report misleading advertisements to the respective State Regulatory Authorities for
4suitable action against the defaulter. Objectives of this program is to keep vigilance
over Ayush drugs and to reduce misleading advertisements to ensure the consumer
protection and prevent the dissemination of unverified claims by Ayush product
manufacturers.
3. To strengthen pharmacovigilance of Ayush drugs, regular awareness programs have
been conducted throughout the nation under the pharmacovigilance program for ASU
& H drugs for practitioners, healthcare workers and other different cohort including
general public to disseminate the awareness regarding patient safety. Till date 3464
awareness programs have been conducted with 328709 beneficiaries across the country.
Details are available as Annexure III.
4. 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.
5. Further Ministry of Ayush encourages following certifications of Ayush products as
per details below: -
• An Ayush vertical has been created in Central Drugs Standard Control
Organization (CDSCO) to strengthen regulatory measures ensuring safety and quality
of Ayush drugs. Further, CDSCO issues WHO Certificate of Pharmaceutical Product
(WHO-CoPP) to Ayush drugs having compliance to such standards.
• Quality Certifications Scheme implemented by the Quality Council of India
(QCI) for grant of AYUSH standard and premium 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.
*****
5Annexure-I
The details of number of drug testing laboratories dedicated to AYUSH products, State/UT-
wise are as follows: -
S.
State/UT Government/UTs Private drug testing
No. drug testing laboratories
laboratories approved under Rule
160 A to J of Drugs
Rules 1945.
1. Andhra Pradesh 01 00
2. Arunanchal Pradesh 01 00
3. Assam 01 00
4. Bihar 01 00
5. Chhattisgarh 01 00
6. Gujarat 01 06
7. Haryana 01 09
8. Himachal Pradesh 01 03
9. Jammu and Kashmir 01 00
10. Jharkhand 01 00
11. Karnataka 01 09
12. Kerala 02 09
13. Madhya Pradesh 01 06
14. Maharashtra 02 13
15. Manipur 01 00
16. Mizoram 01 00
17. Meghlaya 01 00
18. Nagaland 01 00
19. Odisha 02 04
20. Puducherry 01 00
21. Punjab 01 02
22. Rajasthan 01 10
23. Sikkim 01 00
24. Tamilnadu 01 12
625. Telangana 02 01
26. Tripura 01 00
27. Uttar Pradesh 02 05
28. Uttarakhand 01 05
29. West Bengal 01 01
30. Delhi 00 13
7Annexure-II
State/UT wise details of the total number of cases of substandard, misbranded and adulterated
AYUSH drugs reported from rural areas in the last three financial years, State-wise and the
punitive actions taken against the manufacturers and distributors of such drugs are as follows:
S.No State Replies
.
1. K erala Serial Name of substandard Name of Details of legal
Numb medicine manufacturer action
er
1 Mustharishtam M/S Valluwanad Product
Ayurveda suspended for
AA 02/22
Oushadhasala, one month
Keralassery
2 Hinguvachaadi Gulika M/S Nagarjuna Departmental
Herbal action-
XBGD
Concentrates Ltd. Suspension of
Kalayanthanni, production for
Thodupuzha 30 days
3 Mustharishtam M/S Sidda Herbal Product
Products, suspended for
Porathissery, one month
Irinjalakkuda,Thris
sur
5 Amruthrotharam Itoozhi Product
Kashayam vaidhyasala suspended for
,Mayyil,Kannur one month
6 Dhanwantharam Itoozhi Final complaint
Kashayam vaidhyasala filed before the
,Mayyil,Kannur court on
4/10/2024
7 Abhayarishtam M/s Bala Herbals, Final Complaint
Industrial Estate, Filed before
Karunagappally, Honourable
Kollam JFM Court-
Karunagappally
Case No ST
585/23
88 Dasamoolarishtam M/s PM Pharmacy Product
Kollam suspended for
one month
9 Haridrakhandam Chaithanya Product
Ayurveda suspended for
Pharmacy one month
Vadakara,Kozhiko
de
10 Gee Pee Choornam Sun Ayurvedic Took
Medicines departmental
,Ponnani,Malappur action
am
11 Ashokarishtam Batch Jayalekshmi Sent showcause
No 01/2025 Pharma notice and
stopped the sale
Mynagapally,Koll
of the product
am
12 Dasamularishtam M/s Vaidyasala Sent showcause
Veettil notice and
Oushadhasala, stopped the sale
of the product
Elamadu PO,
Kollam
13 Amrutharishtam M/s Vaidyasala Sent showcause
Veettil notice and
Oushadhasala, stopped the sale
of the product
Elamadu PO,
Kollam
14 Asokarishtam Sakthi Ayruveda Final complaint
Pharmaceuticals, is being
Thiruvananthapu prepared for
filing before the
ram
court.
15 Balarishtam Sakthi Ayruveda Final complaint
Pharmaceuticals, is being
prepared for
9Thiruvananthapu filing before the
ram court.
16 Amrutharishtam Sakthi Ayruveda Final complaint
Pharmaceuticals, is being
Thiruvananthapu prepared for
filing before the
ram
court.
2. J harkhand Sl. Name of Manufacturer Action
Product
1. HE LLO-Jiv M/s Yuvnam Private Product approval
Limited, Gutuwa, cancelled
Ranchi
2. RE PL Renovision Export Case Filed
Orthovit Pvt. Ltd UNIT-II
Capsule Bhuyandih, Kamidih,
P.O. Chilgu, PS:-
Chandil, Dist:
Saraikela-
Kharsawan-832401
3. M enstrual Bharti Pharma, C-39, Product suspended for
Pain Min Phase2, Industries 60 days
30ml Area, Adityapur-
831013
4. Li v Drops Bharti Pharma, C-39, Product suspended for
30ml Phase2, Industries 60 days
Area, Adityapur-
831013
5. Ur ginia M/s Moxie Product
Tincture IP Pharmaceuticals Pvt. Cancel/Removed from
66 Ltd., Shed No.- B 12 approved products list
& 13, Jasidih
Industrial Area,
Jasidih, Deoghar-
814142
3. T ripura Year wise report Misbranded Not of standard Ayush
Ayush medicines medicines
2022-2023 62 03
2023-2024 07 -
2024-2025 36 -
2025-till date - 01
104. G oa
Product Mfg by Action
Name
01 case Avipattika M/s. Karnani suspended the
of NSQ r Churna Pharmaceutical manufacturing license of
drug (Tablets), s (P) Ltd; Fact: the firm M/s. Karnani
reporte B.N: F-67, Industrial Pharmaceuticals (P) Ltd
d HCT-21, Area, Bhiwadi - for the period of six
M/D: 302019 (RAJ), months.
12/2021, does not
Showcause Notice was
E/D: conform to
issued to Hospital
11/2024,: Description.
Pharmacy, North Goa
District Hospital, (Asilo
Hospital), Mapusa Goa,
from where the sample
was drawn.
5. M aharasht The total number of cases of substandard, misbranded and adulterated
ra AYUSH drugs reported from Maharashtra State in the last three
financial years are as follows: -
Period 01/04/2022 01/04/202 01/04/20 01/04/2025 to
to 3 to 24 to 30/06/2025
31/03/2023 31/03/202 31/03/20
4 25
Ayurvedi 834 761 343 23
c Samples
collected
Ayurvedi 526 476 343 23
c Samples
tested
No of 17 08 30 08
samples
declared
NSQ
No of 14 05 28 08
consent
for
prosecuti
on issued
6. W est S.No Year Total number of cases of substandard,
Bengal misbranded and adulterated AYUSH drugs
111 2022 11
2 2023 13
3 2024 09
7. O disha No cases of substandard, misbranded and adulterated AYUSH drugs
reported from rural areas in the last three financial years in the State of
Odisha.
8. G ujarat Total Number of Not of Standard Cases in the last three financial years
is 45 & the State Licensing authority has taken final departmental action
under the provisions of the Drugs and Cosmetics act, 1940 & Rules their
under.
9. U ttarakhan In the last two years total 123 Sample found substandard quality. The
d action is taken by the Drug Inspector as per Drug and Cosmetic Act
1940 Rules thereunder. And also, necessary action taken against the
manufacturers/Companies by State Licensing Authority.
10. H aryana Action has been taken as per Drugs and Cosmetics Act, 1940 and rules
framed thereunder.
11. U T of No cases reported in UT Ladakh.
Ladakh
12. M adhya No such data collected.
Pradesh
13. M anipur No report as such.
14. P uducherr NIL
y
15. D elhi NIL
16. A runachal NIL
Pradesh
12Annexure-III
The details of awareness programs have been conducted to strengthen pharmacovigilance of
Ayush drugs throughout the nation under the pharmacovigilance program for ASU & H drugs
for practitioners, healthcare workers and other different cohort including general public to
disseminate the awareness regarding patient safety are as follows: -
Year Awareness Program Beneficiaries
2018 1 50
2019 54 800
2020 60 4300
2021 118 14659
2022 292 23510
2023 586 43396
2024 1065 105148
2025 (Upto June 2025) 692 66255
Total 2868 2,58,118
13