India's Health Ministry Responds to Child Deaths from Contaminated Cough Syrup: Urgent Regulatory Actions and Safety Measures

The Union Health Ministry on Sunday held an emergency high-level meeting with health secretaries and drug control officials from all States and Union Territories following multiple child deaths associated with contaminated cough syrup.

The urgent review was prompted by at least 14 children dying in Madhya Pradesh and Rajasthan after consuming a locally manufactured cough syrup called Coldrif, which testing revealed contained toxic diethylene glycol (DEG).

According to officials, the meeting concentrated on implementing stricter oversight of cough syrup manufacturing processes, ensuring responsible prescription practices, and expanding surveillance systems to prevent similar tragedies in the future.

The ministry emphasized that all pharmaceutical manufacturers must adhere strictly to the Revised Schedule M, which incorporates Good Manufacturing Practices (GMP) regulations for pharmaceutical facilities. Manufacturing units failing to comply were warned they would face license cancellation.

States were strongly urged to ensure rational prescribing of cough syrups, particularly for children, noting that most childhood coughs resolve naturally without requiring medication.

Authorities received directions to implement enhanced surveillance systems, ensure prompt reporting of adverse events from all healthcare facilities, and increase awareness of the community reporting tool available through the Integrated Health Information Platform (IDSP-IHIP).

The ministry also stressed the importance of strengthened inter-state coordination for early detection, reporting, and collaborative action against potential drug safety violations.

Dr. YK Gupta, National Scientific Advisor to the Pharmacovigilance Programme of India and former Head of Pharmacology at AIIMS, Delhi, characterized the DEG contamination as "serious and criminal negligence."

"There is no safe permissible limit for these chemicals. Even trace amounts can be harmful. These chemicals should never be present in a pharmaceutical manufacturing unit. Their presence points to a serious and criminal level of negligence," stated Dr. Gupta.

Explaining potential contamination sources, he noted, "Sometimes, for economic reasons, people mistake DEG or EG for safer alternatives like glycerin or propylene glycol and use them in production. This is a grave and unacceptable error."

He further cautioned against prescribing cough syrups to anyone, especially children under two years of age, and advocated for continued rigorous testing by regulators. "If batches in Madhya Pradesh are found clear, re-sampling should still be done to confirm there is no contamination," Dr. Gupta advised.

According to Health Ministry reports, a central expert team—comprising epidemiologists, microbiologists, entomologists, and drug inspectors from the National Centre for Disease Control (NCDC), National Institute of Virology (NIV), and Central Drugs Standard Control Organisation (CDSCO)—visited affected districts in Chhindwara (Madhya Pradesh) and Nagpur (Maharashtra).

Working alongside state authorities, the team collected various clinical, environmental, entomological, and drug samples, which were sent to NIV Pune, the Central Drug Laboratory (CDL) Mumbai, and NEERI Nagpur for comprehensive testing.

Preliminary findings ruled out common infectious diseases, except for one positive leptospirosis case.

Nineteen medicine samples consumed by the affected children were collected from private practitioners and local pharmacies. Of ten samples analyzed, nine met quality standards, but Coldrif cough syrup contained DEG beyond permissible limits.

Following these findings, the Tamil Nadu FDA took regulatory action against the manufacturing unit located in Kancheepuram. CDSCO has recommended cancellation of the manufacturing license based on inspection results, and criminal proceedings have been initiated.

Dr. Rajiv Bahl, Director-General of the Indian Council of Medical Research (ICMR), advised against prescribing cough syrups or drug combinations to children to prevent potential side effects.

He confirmed that the National Joint Outbreak Response Team is already functioning, ensuring effective coordination between central organizations like NCDC and ICMR, which can assist states when needed.

Dr. Bahl also emphasized the importance of states strengthening coordination between their agencies for rapid emergency response.

Director General of Health Services (DGHS), Dr. Sunita Sharma, highlighted the dangers of indiscriminate cough syrup use in pediatric populations.

"She highlighted the need for rational use of cough syrup for pediatric population. She informed that cough medications have minimal proven benefit in children but carry significant risks," the report stated.

Dr. Sharma also stressed the importance of checking all medications to avoid combined overdose and monitoring drug concentrations. She announced that guidelines for parents, pharmacists, and doctors would be formulated shortly and shared with the states.

Drug Controller General of India, Dr. Rajeev Raghuvanshi, reiterated that all manufacturing units must adhere to updated GMP requirements.

He noted that certain firms that applied for the government's infrastructure upgradation scheme have been granted extensions until December 2025 and urged states to strictly implement the revised GMP standards.

The Department of Pharmaceuticals reported that numerous manufacturing units have begun utilizing the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) for GMP upgradation.

Rajasthan's Principal Secretary (Health) stated that their investigation had not directly linked the four reported deaths to cough syrup quality.

"Their investigation so far indicates that the 4 deaths were not linked to quality of the cough syrup and that an awareness generation campaign is being conducted for rational use of paediatric formulation. However, by way of abundant caution various regulatory actions have been undertaken. Further investigations are being conducted," the official reported.

Maharashtra's Secretary of Medical Education confirmed that children admitted to various medical institutions in Nagpur are receiving the best possible healthcare.