See Full Document Text
GOVERNMENT OF INDIA
MINISTRY OF AYUSH
LOK SABHA
UNSTARRED QUESTION NO. 5643
TO BE ANSWERED ON 27th MARCH 2026
Raid on Unlicensed Ayurvedic Clinic
5643. Shri Tanuj Punia:
Will the Minister of AYUSH be pleased to state:
(a) whether the Government has received a report of the raid on an unlicensed Ayurvedic clinic
and manufacturing unit in Dehradun in February 2026 and if so, the details thereof along with
the action taken against the persons involved;
(b) the number of unlicensed Ayurvedic clinics or manufacturing units identified, since 2023 and
the number of prosecutions or licence cancellations initiated, State/UT-wise and year-wise;
(c) whether any review of inspection and pharmacovigilance mechanisms has been undertaken
following such incidents and if so, the details thereof; and
(d) the measures proposed to strengthen regulatory oversight in this regard?
ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH
(SHRI PRATAPRAO JADHAV)
(a) Yes, as per the information received from the State Government of Uttarakhand, the
Government is aware of the raid conducted in the matter. During the raid, the unlicensed medicines
were seized and taken into custody by the Drug Inspectors and further action has been taken as per
the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder.
(b) As per the information received from State/UT Governments, the number of unlicensed
Ayurvedic clinics or manufacturing units identified, since 2023 and the number of prosecutions or
licence cancellations initiated are attached at Annexure I.
(c) & (d) The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory
provisions for Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homoeopathy drugs. Provisions
relating to Ayurveda, Siddha, Sowa-Rigpa 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
1mandatory for the manufacturers to adhere to the prescribed requirements for licensing of
manufacturing units & medicines including proof of safety & effectiveness, compliance with the
Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of Drugs Rules, 1945
and quality standards of drugs given in the respective pharmacopoeia.
Rule 160 A to J of the Drugs Rules, 1945 provides the regulatory guidelines for approval
of Drug Testing Laboratory for carrying out such tests of identity, purity, quality and strength of
Ayurveda, Siddha, Sowa-Rigpa and Unani drugs and raw materials used in their manufacture on
behalf of licensee for manufacture for sale of Ayurveda, Siddha, Sowa-Rigpa and Unani drugs. As
on date, 108 private laboratories are approved or licensed under the provisions of Drugs Rules,
1945. Further, there are 34 Drug Testing Laboratories of State/UTs for testing quality of Ayurveda,
Siddha, Sowa-Rigpa and Unani drugs and raw materials including legal samples.
As prescribed in Drugs and Cosmetics Act, 1940 and Rules 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/UT Drug
Controllers/ Licensing Authorities appointed by the concerned State/ UT Government.
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 drugs from the market and
appropriate legal actions as per Drugs and Cosmetics Act, 1940 and Rules made thereunder.
Ministry of Ayush has established an Ayush vertical in the Central Drugs Standard Control
Organisation (CDSCO), which includes the posts of 1 Deputy Drugs Controller, 4 Assistant Drugs
Controllers, and 4 Drug Inspectors. Drug Inspectors posted in Ayush vertical, inspect various
manufacturing units including risk-based inspections in coordination with the licensing
authorities/drug inspectors of the respective States/UTs for ensuring safety and quality of Ayush
medicines.
Ministry of Ayush has implemented a Central Sector Scheme-Ayush Oushadhi Gunvatta
evam Uttpadan Samvardhan Yojana (AOGUSY), having one of the component as
Pharmacovigilance for Ayurveda, Siddha, Unani, and Homoeopathy (ASU & H) Drugs with the
objectives to keep vigilance over Ayush drugs, to reduce the instances of misleading
advertisements and report adverse drug reactions. This Pharmacovigilance program has
established a three-tire network of pharmacovigilance centers distributed throughout the country
with one National Pharmacovigilance Coordination Center (NPvCC), 5-Intermediary
Pharmacovigilance Centers (IPvC) & 97 Peripheral Pharmacovigilance Centers (PPvC).
Ministry of Ayush has launched an IT enabled online portal “Ayush Suraksha” to
track the reported Misleading Advertisements (MLAs)/Objectionable Advertisements (OAs) and
2Adverse Drug Reactions (ADRs) on 30th May 2025. The portal features a centralized dashboard
for capturing of MLAs/OAs and tracking of suspected ADRs for prompt regulatory action and
comprehensive data analysis.
*****
3Annexure
As per the information received from State/UT Governments, the details of the number of
unlicensed Ayurvedic clinics or manufacturing units identified, since 2023 and the number of
prosecutions or licence cancellations initiated, State/UT-wise and year-wise are as follows:
S. No. States/UTs Governments Details of the number of The number of
unlicensed Ayurvedic prosecutions or licence
clinics or manufacturing cancelled.
units identified, since
2023.
1. Uttarakhand 03 02
2. Gujarat 03 03
3. Kerala 09 09
4. Tripura Nil Nil
5. Madhya Pradesh Nil Nil
6. Maharashtra Nil Nil
7. Mizoram Nil Nil
8. Assam Nil Nil
9. Himachal Pradesh Nil Nil
10. Delhi Nil Nil
11. Tamilnadu Nil Nil
12. Puducherry Nil Nil
*****
4