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GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
DEPARTMENT OF HEALTH AND FAMILY WELFARE
RAJYA SABHA
UNSTARRED QUESTION NO. 456
TO BE ANSWERED ON 03RD FEBRUARY, 2026
FAKE RABIES VACCINE
456. SMT. PRIYANKA CHATURVEDI:
Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:
(a) whether Government is aware that Australia, UK and USA issued health advisories warning
their citizens about counterfeit rabies vaccine circulating in India since November 2023;
(b) the total number of counterfeit vaccine batches identified, seizures made, prosecutions
initiated and convictions secured since January 2025;
(c) whether similar counterfeiting detected for other life-saving vaccines, including those under
the Universal Immunisation Programme;
(d) the accountability fixed on pharmaceutical supply chain failures, allowing fake vaccines
market penetration and measures strengthening regulatory oversight; and
(e) whether a national vaccine tracking system with batch-level monitoring will be established
to prevent future counterfeiting?
ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY
WELFARE
(SMT. ANUPRIYA PATEL)
(a) to (e): Based on a complaint received from M/s. Human Biologicals Institute (A
division of Indian Immunologicals Limited), Hyderabad regarding the circulation of batch
specific spurious Rabies Vaccine in India, Central Drugs Standard Control Organization
(CDSCO) alongwith State Licensing Authority has investigated the matter. In this regard, one
person has been arrested.
The manufacture of Spurious/Adulterated/ Not of Standard Quality (NSQ) drugs is a
punishable offence under the provisions of the Drugs and Cosmetics Act, 1940. The Act
empowers the concerned licensing authorities to take necessary legal action in such cases
including cases of manufacture, sale, and distribution of any prohibited or banned drug.
Under National Health Mission (NHM), Ministry of Health and Family Welfare
monitors the availability of the drugs through Drug and Vaccine Distribution Management
System (DVDMS). DVDMS is a web-based Supply Chain Management System that deals in
purchase, supply, distribution and inventory management of various drugs, sutures, surgicaland consumable items. It has an inbuilt provision of monitoring and checking the availability
of medicine at all facilities at district and state level.
CDSCO has issued guidelines on “Recall and Rapid Alert System for Drugs” (including
Biologicals & Vaccines). Further, draft Guidelines on Good Distribution Practices for
Pharmaceutical Products is also published for ensuring quality of Drugs in the supply chain.
These guidelines are available on website of CDSCO (www.cdsco.gov.in).
Further, a proposal for affixing bar code or quick response code on other drug
formulation products was deliberated in the 90th Drugs Technical Advisory Board (DTAB)
meeting held on 25.01.2024. The Board has agreed to the proposal to extend the provision of
QR code to all vaccine products and to all antimicrobials, narcotic & psychotropic substances
in a phase wise manner.
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