**Executive Summary**
This document summarizes the Indian government's response to the WHO alert regarding contaminated cough syrups linked to child deaths, to be answered on December 5th, 2025. It details actions taken, including investigations, license cancellations, and enhanced monitoring and testing of oral-liquid medicines. A key action item is the implementation of new testing requirements for DEG and EG in oral liquids before market release.
**Key Points / Main Content**
* **Investigation and Initial Response:**
* A Central team investigated child deaths in Chhindwara, Madhya Pradesh, linked to cough syrups.
* 19 drug samples were collected and tested.
* 4 samples were declared Not of Standard Quality (NSQ)
* Syrup Coldrif (B.No. SR-13) manufactured by M/s Sresan Pharmaceutical contained 46.28% w/v of Diethylene Glycol (DEG).
* **Actions Against M/s Sresan Pharmaceutical:**
* M/s Sresan Pharmaceuticals' premises were inspected, revealing GMP violations.
* The State Drugs Controller, Tamil Nadu, cancelled the manufacturing license.
* Criminal case was registered and strict action, including arrests, was taken.
* **Broader Measures and Directives:**
* An advisory was issued on 03.10.2025 to all State/UT Health Departments to ensure 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 and on 27.10.2025 to maintain heightened vigilance against spurious and substandard drugs.
* Immediate ban and recall orders were issued in Madhya Pradesh, Tamil Nadu, Odisha, and Puducherry, where the impugned batches were supplied.
* **Enhanced Monitoring and Testing:**
* Over 700 cough syrup manufacturers are under intense audit.
* Market surveillance sampling of syrup formulations has been increased.
* The Indian Pharmacopoeia Commission amended IP 2022 to mandate testing for DEG and Ethylene Glycol (EG) in oral liquids at the finished product stage before market release.
**Impact Analysis**
**State/UT Health Departments and Healthcare Facilities**
* **Impact:** Required to ensure the rational use of pediatric cough syrups.
* **Action Required:** Adhere to the advisory issued on 03.10.2025 regarding the rational use of cough syrups.
**State/UT Drug Controllers**
* **Impact:** Required to enforce stricter testing and vigilance.
* **Action Required:** Ensure strict compliance with testing requirements under the Drugs Rules, 1945 and maintain heightened vigilance against spurious and substandard drugs as directed on 07.10.2025 and 27.10.2025.
**Cough Syrup Manufacturers**
* **Impact:** Subject to more stringent audits and testing requirements.
* **Action Required:** Undergo audits and comply with the new testing requirements for raw materials, DEG, and Ethylene Glycol (EG) in finished products before market release.
Key Entities Referenced
Central Drugs Standard Control Organization (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India, responsible for overseeing drug manufacturing, import, and sale.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
Drugs & Cosmetics Act, 1940: Indian act regulating import, manufacture, distribution and sale of drugs and cosmetics.
Drugs Rules, 1945: Rules under the Drugs & Cosmetics Act, 1940 governing standards for manufacturing, sale, and distribution of drugs.
Schedule M/Good Manufacturing Practices (GMP): Sets out the good manufacturing practices to be followed by pharmaceutical manufacturers in India.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 1094
TOBE ANSWERED ON05TH DECEMBER, 2025
REGULATORYACTIONS ONCONTAMINATEDMEDICINES
1094.DR. SHASHITHAROOR:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) the immediate actions that have been taken by the Government in response to the World
Health Organization’s alert of 13 October 2025 regarding contaminated cough syrups
manufactured in the country, which were linked to child deaths and found to contain
Diethylene Glycol (DEG) far the above permissible limits;
(b) the current status of regulatory reform for oral-liquid medicines, especially syrups for
children;
(c) whether domestic products requires the same testing standards as exported ones in the
countryandif so, the detailsthereof;
(d) whether the licences of implicated companies have been suspended and if so, the details
thereof;
(e) the number of manufacturing units in India have failed to comply with revised Schedule
M/Good Manufacturing Practices (GMP) standards asof October 2025; and
(f) the enforcement mechanisms like recall, licence cancellation, prosecution are being used
by the Ministry and the Central Drugs Standard Control Organization (CDSCO) to prevent
further public-healthharm?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a)to(f): 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. Chemicalanalysis 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.
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 700 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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