700 Cough Syrup Units Audited as Govt Acts on Child Deaths, Substandard Drugs: MoS
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New Delhi: Multiple regulatory actions have been initiated following inspections that uncovered substandard drugs, including a toxic cough syrup linked to child deaths in Madhya Pradesh, with 700 cough syrup manufacturing units audited nationwide as part of an intensified crackdown, the Parliament was informed.
During a recent Lok Sabha session various concerns were raised including the safety of life-saving medicines, the names of such drugs found substandard during inspections, the action taken against the manufacturers involved, details of the reported child deaths in Rajasthan and Madhya Pradesh due to contaminated cough syrup, and whether the implicated medicines met quality standards.
In response to the same, Minister of State for Health and Family Welfare Anupriya Patel informed that the Central Drugs Standard Control Organisation (CDSCO) and State Drug Authorities routinely draw samples across the supply chain for testing. Drugs declared Not of Standard Quality (NSQ), Spurious, Misbranded, or Adulterated are published under the Drug Alert section on the CDSCO website, and action is taken as per the Drugs and Cosmetics Act, 1940.
The Minister further informed that 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 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 ofStandard 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 Patel added.
On the enforcement action taken against the manufacturers, the MoS confirmed that 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.
To prevent recurrence of such incidents, the Minister highlighted several regulatory steps, such as an advisory 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.
In addition, the Patel stated, "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."
Strengthening quality safeguards further, the Indian Pharmacopoeia Commission (IPC) has amended the Indian Pharmacopoeia 2022 to mandate testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in all oral liquid formulations at the finished-product stage, in addition to raw material testing before market release.
