**Executive Summary**
This document is the response to Unstarred Question No. 1286 in Lok Sabha concerning the contamination of cough syrup, specifically the death of 25 children in Madhya Pradesh allegedly due to Coldrif cough syrup containing Diethylene Glycol (DEG). The response details actions taken by the Government of India, including investigations, recalls, and strengthening pharmaceutical regulations, with key dates in October 2025 regarding advisories and directives. Actions include amending the Indian Pharmacopoeia (IP) 2022 to require testing for DEG and Ethylene Glycol (EG).
**Key Points / Main Content**
* **Investigation and Findings:**
* A Central team investigated deaths in Chhindwara and Nagpur, coordinating with Madhya Pradesh authorities.
* Out of 19 drug samples, 4 were "Not of Standard Quality (NSQ)".
* One sample of Syrup Coldrif (B.No. SR-13) manufactured by M/s Sresan Pharmaceuticals contained 46.28% w/v of Diethylene Glycol (DEG).
* **Actions Against Manufacturer:**
* M/s Sresan Pharmaceuticals had GMP violations, including unhygienic storage conditions.
* The State Drugs Controller, Tamil Nadu cancelled the manufacturing license of M/s Sresan Pharmaceuticals.
* The State of Madhya Pradesh registered a criminal case with arrest of persons involved.
* Madhya Pradesh, Tamil Nadu, Odisha and Puducherry banned and recalled specific cough syrup batches.
* **Regulatory Measures:**
* An advisory was issued on 03.10.2025 to State/UT Health Departments for rational use of paediatric cough syrups.
* The Drugs Controller (India) directed State/UT Drug Controllers on 07.10.2025 to ensure strict compliance with testing requirements under the Drugs Rules, 1945.
* On 27.10.2025, State/UT Drug Controllers instructed to maintain heightened vigilance against spurious and substandard drugs.
* More than 1100 cough syrup manufacturers have been subjected to intense audit.
* Increased market surveillance sampling of syrup formulations has been conducted.
* Indian Pharmacopoeia Commission amended IP 2022 to mandate testing for DEG and EG in oral liquids before market release.
* **CAG Report:**
* CDSCO has not received any Comptroller and Auditor General (CAG) Report, 2024, highlighting serious shortfalls in drug inspections, quality control and pharmaceutical monitoring in the country.
**Impact Analysis**
**Stakeholder: Central and State Governments**
**Impact**
Need to enforce stricter drug regulations and testing protocols, conduct thorough investigations, and coordinate actions related to drug safety.
**Action Required**
Implement advisory issued on 03.10.2025, ensure strict compliance with testing requirements under the Drugs Rules, 1945 (07.10.2025), maintain heightened vigilance against spurious and substandard drugs (27.10.2025), and conduct intense audits of cough syrup manufacturers.
**Stakeholder: Pharmaceutical Manufacturers**
**Impact**
Subject to increased scrutiny and audits. Need to comply with stricter regulations and ensure the use of pharmaceutical-grade raw materials.
**Action Required**
Adhere to revised GMP guidelines, comply with increased testing requirements for raw materials and finished products, and ensure thorough quality control measures.
**Stakeholder: Healthcare Facilities and Professionals**
**Impact**
Need to ensure rational use of paediatric cough syrups and vigilance for adverse drug reactions.
**Action Required**
Implement the advisory issued on 03.10.2025, carefully monitor patients taking cough syrups, and report any adverse events to the appropriate authorities.
**Stakeholder: Indian Pharmacopoeia Commission**
**Impact**
Issued an amendment to Indian Pharmacopoeia (IP) 2022.
**Action Required**
Mandate the testing for DEG and Ethylene Glycol (EG) in oral liquids at finished product stage before market release.
Key Entities Referenced
Ministry of Health and Family Welfare: The primary government body responsible for addressing the issue of contaminated cough syrup and implementing relevant policies.
Central Drugs Standard Control Organisation (CDSCO): The national regulatory body for pharmaceuticals, involved in investigating the incident, coordinating with state governments, and taking action against the manufacturer.
Drugs & Cosmetics Act, 1940: The main act governing the regulation of drugs and cosmetics in India, used for taking action against substandard drugs.
Madhya Pradesh: The state where the child deaths occurred due to the contaminated cough syrup, triggering the investigation.
Tamil Nadu: The state where the pharmaceutical company that manufactured the contaminated cough syrup is located, and where the manufacturing license was canceled.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 1286
TO BE ANSWERED ON06THFEBRUARY, 2026
CONTAMINATEDCOUGH SYRUP
1286.SHRIDURAI VAIKO:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(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 highlytoxic industrial chemicalandif so, the detailsthereof;
(b) whether similar incidents have been reported from other States leading to bans and
investigationsbyState GovernmentsincludingPunjab,Kerala,Tamil Nadu, Madhya Pradesh,
Uttar PradeshandJharkhand andif so, the detailsthereof,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 coughsyrup;
(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 andpharmaceutical monitoringinthe countryandif 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
andpreventthe recurrence of such incidentsinfuture?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SHRIPRATAPRAO 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
childrenwas found tobe 46.28% w/v.
The premises of M/s SresanPharmaceuticalswas inspected.Severalcriticalandmajor
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
actionhasbeentakenincluding 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 monitoringinthe 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 allState/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 andtake prompt action underthe 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
formulationsbyCentral andState drugs regulatorshasalso beendone.
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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