WHO Alert Spurs India's Probe Into Deadly Cough Syrup, Licence Cancelled, 700 Plus Units Audited, Parliament Informed

New Delhi: In response to the World Health Organization's alert of 13 October 2025 on contaminated cough syrups linked to child deaths, the Union Minister of State for Health informed the Lok Sabha that a CDSCO-led probe in Madhya Pradesh detected dangerously high levels of Diethylene Glycol in a pediatric syrup, prompting license cancellation, product recalls across multiple States, arrests, and nationwide advisories.

Following the incident, over 700 cough syrup units were audited, surveillance was intensified, and DEG/EG testing was made mandatory at the finished-product stage.

Replying to the question raised by Dr Shashi Tharoor, the Minister of State in the Ministry of Health and Family Welfare, Anupriya Patel, detailed the Government’s immediate steps following the reported cluster of child deaths in Chhindwara, Madhya Pradesh.

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 Sresan Pharmaceutical located in Kancheepuram, Tamil Nadu and consumed by the deceased children was found to be 46.28% w/v.

The premises of 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 an 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.

Updating the current status of regulatory reform for oral-liquid medicines, especially syrups for children, she informed the House that an advisory has been issued on 03.10.2025 to all State/UT Health Departments and healthcare facilities to ensure rational use of pediatric 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.

Further responding to queries on whether domestic products are subject to the same testing standards as export consignments, the suspension of licenses of implicated firms, the number of units failing to comply with revised Schedule M–GMP norms as of October 2025, and the enforcement tools being deployed—such as recalls, licence cancellations and prosecutions—she added more than 700 cough syrup manufacturers have been subjected to intense audits in coordination with State authorities. Increased market surveillance sampling of syrup formulations by Central and State drug 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.