Lok Sabha Question No. 1286 (UNSTARRED), answered on 2026-02-06
Subject: Contaminated Cough Syrup
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Shri Durai Vaiko

## GOVERNMENTOFINDIA MINISTRYOF HEALTH AND FAMILY WELFARE DEPARTMENTOFHEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 1286 TO BE ANSWERED ON 06 TH FEBRUARY, 2026

## CONTAMINATED COUGH SYRUP

## 1286. SHRI DURAI VAIKO:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether the Government is aware of reports regarding the death of 25 children in Chhindwara district of Madhya Pradesh allegedly after consumption of Coldrif cough syrup supplied by a pharmaceutical unit based in Tamil Nadu, which found to contain Diethylene Glycol (DEG), a highly toxic industrial chemical and if so, the details thereof;
- (b) whether similar incidents have been reported from other States leading to bans and investigations by State Governments including Punjab, Kerala, Tamil Nadu, Madhya Pradesh, Uttar Pradesh and Jharkhand and if so, the details thereof, State-wise;
- (c) whether laboratory tests conducted by Government laboratories have detected 48.6 per cent Diethylene Glycol in a batch of the said cough syrup, far exceeding the permissible limits prescribed in the country and if so, the details thereof along with the action taken against the manufacturer and the suppliers of raw materials involved in the production of the said cough syrup;
- (d) whether the Government has taken note of the findings of the Comptroller and Auditor General (CAG) Report, 2024, highlighting serious shortfalls in drug inspections, quality control and pharmaceutical monitoring in the country and if so, the details thereof; and
- (e) the immediate steps taken or proposed to be taken by the Government to strengthen pharmaceutical regulation, ensure the mandatory use of pharmaceutical-grade raw materials and prevent the recurrence of such incidents in future?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI PRATAPRAO JADHAV)

(a) to (e): Upon receipt of reports of a cluster of child deaths from Chhindwara, Madhya Pradesh, a Central team of experts comprising an epidemiologist, a microbiologist, an entomologist, and drug inspectors from the National Centre for Disease Control (NCDC), National Institute of Virology (NIV), and Central Drugs Standard Control Organisation

(CDSCO), respectively visited Chhindwara and Nagpur and undertook a detailed investigation of the reported cases and deaths in coordination with the Madhya Pradesh State Authorities. A total of 19 drug samples, reportedly consumed by the affected children, were collected from the treating private practitioners and nearby retail stores for testing. Chemical analysis of these 19 samples indicated that 15 samples were of Standard Quality, while 4 samples were declared Not of Standard Quality (NSQ). As per the test report, the content of Diethylene Glycol (DEG) in Syrup Coldrif (B.No. SR-13) manufactured by M/s Sresan Pharmaceutical located in Kancheepuram, Tamil Nadu and consumed by the deceased children was found to be 46.28% w/v.

The premises of M/s Sresan Pharmaceuticals was inspected. Several critical and major Good Manufacturing Practices (GMP) violations including unhygienic storage conditions were observed. The matter regarding the criminal action against the manufacturer was taken up by CDSCO with the State Government of Tamil Nadu. The State Drugs Controller, Tamil Nadu cancelled the manufacturing licence. Further, following the incident, the States of Madhya Pradesh, Tamil Nadu, Odisha and the Union Territory of Puducherry to which the impugned cough syrup batches were supplied, ordered immediate ban and recall of the same. Criminal case has been registered in the matter by the State of Madhya Pradesh and strict action has been taken including the arrest of persons involved.

CDSCO haven't received any such report from Comptroller and Auditor General (CAG) Report, 2024, highlighting serious shortfalls in drug inspections, quality control and pharmaceutical monitoring in the country.

Further, an advisory has been issued on 03.10.2025 to all State/UT Health Departments and healthcare facilities to ensure rational use of paediatric cough syrups. Further, the Drugs Controller (India) directed all State/UT Drug Controllers on 07.10.2025 to ensure strict compliance with testing requirements under the Drugs Rules, 1945, and on 27.10.2025 instructed them to maintain heightened vigilance against spurious and substandard drugs and take prompt action under the Drugs & Cosmetics Act, 1940.

More than 1100 cough syrup manufacturers have been subjected to intense audit in coordination with State authorities. Increased market surveillance sampling of syrup formulations by Central and State drugs regulators has also been done.

In addition to the existing requirements of testing the raw materials, the Indian Pharmacopoeia Commission, Ghaziabad has issued an amendment to Indian Pharmacopoeia (IP) 2022, to also mandate the testing for DEG and Ethylene Glycol (EG) in oral liquids at finished product stage before market release.

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