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GOVERNMENT OF INDIA
MINISTRY OF AYUSH
RAJYA SABHA
UNSTARRED QUESTION NO. 2725
TO BE ANSWERED ON 17TH MARCH, 2026
Quality control of Ayush drugs
2725 Shri Raghav Chadha:
Will the Minister of Ayush be pleased to state :
(a) the details of AYUSH drug manufacturing units inspected in the last five years, State-wise
and year-wise;
(b) the number and percentage of samples found sub-standard or misbranded, year-wise and
State-wise;
(c) whether repeated non-compliance by licensed manufacturers has been observed and, if so,
the details thereof; and
(d) the measures taken by Government to strengthen vigilance and enforcement systems?
ANSWER
THE MINISTER OF STATE (IC) OF MINISTRY OF AYUSH
(SHRI PRATAPRAO JADHAV)
(a) As per the information received from State/UT Licensing Authorities, the details of Ayush
drug manufacturing units inspected in the last five years is placed at Annexure-I.
(b) As per the information received from State/UT Licensing Authorities, the number of
samples found sub-standard or misbranded is placed at Annexure-II.
(c) As prescribed in the Drugs and Cosmetics Act, 1940 and Rules 1945 made thereunder,
enforcement of the legal provisions pertaining to Quality Control and issuance of drug license
of Ayurveda, Siddha, Sowa-rigpa, Unani and Homoeopathy drugs, is vested with the State
Drugs Controllers/ State Licensing Authorities appointed by the concerned State/ UT
Government.
As per the information received from State/UT Licensing Authorities, no instances of
repeated non-compliance by licensed manufacturers have been observed.(d) The Government of India has taken following measures to strengthen vigilance and
enforcement systems for Ayush drug manufacturing units in order to ensure the quality, safety
and regulatory compliance of Ayurveda, Siddha, Sowa-rigpa, Unani and Homoeopathy
(ASSU&H) medicines.
i. Enforcement of the Drugs and Cosmetics Act, 1940:
Manufacturing, sale and distribution of Ayush drugs are regulated under the Drugs and
Cosmetics Act, 1940 and Rules, 1945, which mandate licensing, inspection and compliance with
prescribed standards. Manufacturing without a valid license is prohibited, and State Licensing
Authorities conduct inspections and enforcement through drug inspectors.
ii. Mandatory Good Manufacturing Practices (GMP):
Ayush drug manufacturing units are required to comply with Good Manufacturing
Practices (GMP) for obtaining and retaining manufacturing licenses. GMP ensures proper
infrastructure, quality control systems, documentation, and hygiene standards during
manufacturing.
iii. Strengthening of Drug Testing Infrastructure:
The Government provides financial assistance to States/UTs for establishing and
upgrading State Drug Testing Laboratories (DTLs) and strengthening regulatory mechanisms.
These laboratories test Ayush medicines for identity, purity, strength, heavy metals, microbial
load and pesticide residues as per pharmacopoeial standards.
iv. Implementation of “Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana
(AOGUSY)”:
This Central Sector Scheme (2021–2026) aims to improve the quality of Ayush drugs by:
i. Strengthening drug testing laboratories
ii. Upgrading Ayush pharmacies
iii. Improving manufacturing standards and regulatory oversight
v. Creation of Ayush Vertical in Central Drugs Standard Control Organization (CDSCO):
An Ayush vertical has been established in CDSCO to strengthen regulatory coordination
between the Centre and States and ensure better monitoring of quality and safety of Ayush
medicines.
vi. Pharmacopoeial Standards and Quality Control:
The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H)
develops pharmacopoeial standards and formulary specifications for Ayush drugs. Compliance
with these standards is mandatory for manufacturers.vii. Pharmacovigilance Programme for Ayush Drugs:
Ministry of Ayush is implementing a Pharmacovigilance Program for Ayurveda, Siddha,
Unani and Homoeopathy (ASU&H) drugs under its Central Sector Scheme-Ayush Oushadhi
Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY). The program operates through a
dedicated three-tier network comprising 01 National Pharmacovigilance Co-ordination Centre
(NPvCC), 05 Intermediary Pharmacovigilance Centres (IPvC) and 97 Peripheral
Pharmacovigilance Centres (PPvC) across the country. The All India Institute of Ayurveda
(AIIA), New Delhi under Ministry of Ayush serves as the NPvCC for the implementation of the
program. All PPvCs/IPvCs routinely report Misleading Advertisements (MLAs)/Objectionable
Advertisements (OAs) and suspected Adverse Drug Reactions (ADRs) to the respective State/
UT Licensing Authorities for necessary action.
viii. Quality Certification and Third-Party Evaluation:
Quality Certifications Scheme is implemented by the Quality Council of India (QCI) for
grant of Ayush 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.
ix. Digital and Consumer Vigilance Measures:
Ministry of Ayush has developed an IT enabled online portal “Ayush Suraksha” and
launched the portal on 30th May, 2025 to enhance regulatory transparency and accountability
in the Ayush sector. The portal features a centralized dashboard for real-time tracking of
suspected Adverse Drug Reactions and capturing of Misleading Advertisements/Objectionable
Advertisements for prompt regulatory action and in-depth data analysis. The portal allows
consumers and Ayush healthcare professionals to report and regulatory authorities to monitor
misleading advertisements and adverse drug reactions.
*************Annexure-I
As per the information received from State/UT Licensing Authorities, the details of Ayush drug
manufacturing units inspected in the last five years are as follows:
S. No. State/UT Year Number of inspections conducted
1. Himachal Pradesh 2021-22 119
2022-23 110
2023-24 91
2024-25 65
2025-26 72
2. Odisha 2021-22 36
2022-23 29
2023-24 08
2024-25 12
2025-26 08
3. Tamil Nadu 2021 337
2022 396
2023 442
2024 513
2025 643
4. Kerala 2021 241
2022 432
2023 372
2024 314
2025 342
5. Maharashtra 2021-22 182
2022-23 279
2023-24 371
2024-25 384
2025-26 140
6. Madhya Pradesh 2021 148
2022 128
2023 111
2024 127
2025 116
7. Delhi 2021-22 862022-23 105
2023-24 108
2024-25 114
2025-26 110
8. Jharkhand - 75
9. Arunachal Pradesh 2021-22 01
2022-23 01
2023-24 01
2024-25 01
2025-26 01
10. Gujarat 2022- to Till date 485
11. Uttarakhand Last 5 years 300
12 Puducherry 2024 08
2025 13
13. Tripura - Nil
14. Chandigarh - Nil
15. Meghalaya - Nil
*************Annexure-II
As per the information received from State/UT Licensing Authorities, number/percentage of
samples found sub-standard or misbranded in the last five years is as follows:
S. No. State/UT Year Number/percentage of samples found
sub-standard or misbranded
1. Himachal Pradesh 2021-22 31
2022-23 53
2023-24 38
2024-25 108
2025-Upto 05.03.26 36
2. Tripura 2021-22 Nil
2022-23 65
2023-24 07
2024-25 36
2025-Upto 09.03.26 07
3. Odisha 2021-22 329 / 15.87%
2022-23 303 / 18.5%
2023-24 112 / 16.5%
2024-25 07 / 2.7%
2025-26 66 / 14.83%
4. Tamil Nadu 2021 10
2022 07
2023 33
2024 08
2025 35
5. Kerala 2021 21
2022 37
2023 13
2024 14
2025 25
6. Maharashtra 2021-22 15
2022-23 15
2023-24 08
2024-25 30
2025-26 14
7. Madhya Pradesh 2021 06
2022 242023 04
2024 04
2025 61
8. Delhi 2021-22 14
2022-23 14
2023-24 03
2024-25 03
2025-26 01
9. Jharkhand 2021 06
2022 03
2023 00
2024 05
2025 01
10. Arunachal Pradesh - Nil
11. Uttarakhand 2021-22 3.6%
2022-23 6.5%
2023-24 5.2%
2024-25 2.7%
2025-26 2.7%
12. Gujarat 2023 05
2024 25
2025 13
13. Puducherry - Nil
14. Chandigarh - Nil
15. Meghalaya - Nil
************