New Delhi : While the central government proposed cancellation of the license of Tamil Nadu-based Sresan Pharmaceuticals in the wake of the death of over 20 children due to contaminated cough syrup, it is up to the state drug regulator to take the final decision, according to Health Ministry sources on Wednesday. This situation has sparked a significant cough syrup row regarding accountability and responsibility.
Coldrif, a cough syrup made by Sresan Pharmaceuticals in Kancheepuram, Tamil Nadu, has killed more than 20 children in Madhya Pradesh and Rajasthan, intensifying the ongoing controversy over cough syrup safety.
On October 2, the Tamil Nadu drug control authorities declared that their tests found the Coldrif syrup sample to be adulterated. The sample contained diethylene glycol (48.6 percent w/v), a poisonous substance “which may render the contents injurious to health”, the report said. Such findings contribute to the broader cough syrup debate.
Following the reports, several states, including Tamil Nadu, Kerala, Madhya Pradesh, Punjab, and Arunachal Pradesh, have banned the sale of Coldrif cough syrups. Others, such as Telangana, Karnataka, and Maharashtra, have issued an alert. This has fueled the growing row regarding appropriate cough syrup use and regulation.
Sources from the Health Ministry said that CDSCO has already recommended that the Tamil Nadu FDA cancel the license of the faulty drug maker, as the controversy over cough syrup oversight intensifies.
“State drug controllers issue Form 25, a license to manufacture common formulation allopathic drugs, and they govern its use. The state drug controller also has the authority to cancel the license,” the sources said. This highlights another angle of the cough syrup licensing controversy.
The report added that CDSCO has already recommended that the Tamil Nadu FDA cancel the firm’s license after officials confirmed the presence of DEG in Coldrif. This confirmation further complicates the ongoing cough syrup row.
Diethylene Glycol (DEG), a toxic substance linked to kidney injury, raises additional safety concerns across multiple regions, intensifying the controversy over cough syrup use.
Inspection by the CDSCO found unbilled containers of DEG at Srisan Pharma’s factory. The company was reportedly adding 46-48 percent of DEG to cough syrup against the permitted limit of only 0.1 percent. This revelation magnifies the misuse concerns in the ongoing cough syrup row.
Meanwhile, in an advisory issued to all states and union Territories, the Director General of Health Services (DGHS) Dr. Sunita Sharma urged the rational use of cough syrups in the pediatric population, aligning with the central themes of the current cough syrup controversy.
Health experts recommend that doctors and pharmacists avoid prescribing or dispensing cough and cold medications to children under 2 years, amid ongoing discussions around their use in the cough syrup row.
Sharma explained that most acute cough illnesses in children resolve on their own without pharmacological intervention. He added that doctors generally do not recommend cough and cold medications for children below 5 years, reflecting growing concerns from the cough syrup debate.
He emphasized that healthcare providers should use these medications only after careful clinical evaluation, under close supervision, adhering to appropriate dosing, limiting the duration to the shortest effective period, and avoiding multiple drug combinations. This approach forms the core of current discussions on safe cough syrup use.
–IANS
