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GOVERNMENT OF INDIA
MINISTRY OF AYUSH
LOK SABHA
UNSTARRED QUESTION NO. 3671
TO BE ANSWERED ON 13th MARCH 2026
Death due to Ayurvedic Medicines
3671. Shri Khalilur Rahaman:
Will the Minister of AYUSH be pleased to state:
(a) the total number of deaths reported due to consumption of non-standard, non-tested
Ayurvedic medicines during the last five years, State/UT-wise;
(b) the details of the initiatives taken by the Government against agencies supplying
nonstandard AYUSH drugs;
(c) the details of the testing standards in place to ensure a check on such drugs; and
(d) the details of action taken by the Government to ensure that non
tested/spurious/nonstandard Ayurvedic drugs are not be supplied by such agencies?
ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH
(SHRI PRATAPRAO JADHAV)
(a) As per the information received from States/UTs Governments, no death has been reported
due to consumption of non-standard, non-tested Ayurvedic medicines during the last five years.
(b) and (d) 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
Drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union
Territory Government.
Under Chapter IVA of the Drugs and Cosmetics Act, 1940, section 33EEB prohibits
manufacturing for sale of Ayurvedic, Siddha and Unani (ASU) drugs, which are not in
accordance with standards, prescribed in relation to that drug by Pharmacopoeia Commission
for Indian Medicine & Homoeopathy (PCIM&H). Sections 33E, 33EE, and 33EEA of the
Drugs and Cosmetics Act, 1940 define misbranded, adulterated, and spurious ASU drugs,
respectively.Further, Section 33EEC prohibits the manufacture of any misbranded, adulterated, or
spurious ASU drugs. The penalties for manufacturing of misbranded or adulterated or spurious
ASU drugs, or for manufacturing ASU drugs without a valid licence, are provided under
Section 33-I of Drugs and Cosmetics Act 1940.
Section 17, 17A and 17B of the Drugs and Cosmetics Act, 1940 provides definition
of misbranded, adulterated and spurious Homoeopathic drugs. Section 27 of Drugs and
Cosmetics Act 1940 provides penalties for manufacturing of misbranded, adulterated and
spurious Homoeopathic drugs or drugs manufactured, sold, or distributed without a valid
licence.
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.
(c) 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. 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.
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 (ASSU) as may be required under
the provisions of these rules, on behalf of licensee for manufacture of Ayurveda, Siddha, Sowa-
Rigpa and Unani drugs. As on date, 108 private laboratories are approved/licensed for
manufacturers, and 34 State/UT Drug Testing Laboratories are engaged in testing legal samples
and raw materials of ASSU drugs.
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