Centre Holds High-Level Meeting After Cough Syrup Deaths

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 in the wake of multiple child deaths linked to contaminated cough syrup. 

The review followed the deaths of at least 14 children in Madhya Pradesh and Rajasthan after consuming a locally made cough syrup branded Coldrif, which was found to contain the toxic chemical diethylene glycol (DEG).

Officials said the meeting focused on enforcing tighter oversight of cough syrup manufacturing, ensuring rational prescription practices, and expanding surveillance systems to prevent future tragedies.

The ministry underscored that all drug manufacturers must strictly comply with the Revised Schedule M, which includes the Good Manufacturing Practices (GMP) regulation for pharmaceutical units. Non-compliant manufacturing units were warned that their licences would face cancellation.

States were also exhorted to ensure rational prescribing of cough syrups, particularly among children, pointing out that most childhood coughs are self-limiting and do not require pharmacological treatment.

Authorities were further directed to institute enhanced surveillance, ensure timely reporting of adverse events from all health facilities, and expand awareness of the community reporting tool under the Integrated Health Information Platform (IDSP-IHIP).

The ministry also emphasised strengthened inter-state coordination for early detection, reporting, and joint action against potential drug safety breaches.

Expert Warns Of "Criminal Negligence"

Dr YK Gupta, National Scientific Advisor to the Pharmacovigilance Programme of India and former Head of Pharmacology at AIIMS, Delhi, described the discovery of DEG contamination as an act of "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," Dr Gupta said.

Explaining how such contamination could occur, he said, "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 also cautioned that "these cough syrups should not be prescribed for anyone, especially children under the age of two," and urged regulators to continue rigorous testing. "If batches in Madhya Pradesh are found clear, re-sampling should still be done to confirm there is no contamination," Dr Gupta said.

Investigative Findings

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

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

Preliminary findings, officials confirmed, "ruled out common infectious diseases except for one positive case of leptospirosis."

Nineteen medicine samples consumed by the affected children were collected from private practitioners and local retail pharmacies. Of the ten samples analysed so far, "nine meet quality standards," but one - Coldrif cough syrup - "contains DEG beyond permissible limit," the report stated.

Subsequently, regulatory action was taken by the Tamil Nadu FDA on the unit, which is located in Kancheepuram. Cancellation of the manufacturing license has been recommended by CDSCO based on inspection findings. Criminal proceedings have also been initiated.

Central Agencies Mobilised

Dr Rajiv Bahl, Director-General of the Indian Council of Medical Research (ICMR), advised that "children should not be prescribed cough syrups or any combination of drugs to prevent any side-effects."

He said that "the National Joint Outbreak Response Team is already functional, ensuring effective coordination between different Central organizations like NCDC, ICMR, etc., which can assist states in need."

Dr Bahl also urged States to "strengthen coordination between their agencies for rapid response to any calamity."

Director General of Health Services (DGHS), Dr Sunita Sharma, highlighted the dangers of indiscriminate use of cough syrups in paediatric 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," Dr Sharma said.

She also "underlined the need for checking all medications to avoid combined overdose and checking the concentration of drugs."

Dr Sharma further announced that "guidelines in this regard will also be formulated shortly for parents, pharmacists, and doctors and shared with the states."

Drug Controller General of India, Dr Rajeev Raghuvanshi, reiterated the need for all manufacturing units to adhere to the updated GMP requirements.

He reiterated the need for drug manufacturing units to strictly comply with the Revised Schedule M for Good Manufacturing Practices (GMP). He noted that certain firms which applied for the government's infrastructure upgradation scheme have been given an extension till December 2025 and urged states to strictly implement the revised GMP norms.

The Department of Pharmaceuticals informed that "a number of manufacturing units have started availing of the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) for GMP upgradation."

State-level Updates

From Rajasthan, the Principal Secretary (Health) said that the state's inquiry had not directly linked the four deaths reported there to the quality of the cough syrup.

"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 said.

Maharashtra's Secretary of Medical Education reported that "the children admitted in various medical institutions in Nagpur are being treated with the best possible health care."