Pune, India – In the wake of alarming reports linking cough syrups to child deaths in neighboring states, the Maharashtra Food and Drug Administration (FDA) has intensified its crackdown on potentially unsafe medications. A recent raid on a Pune-based pharmaceutical unit resulted in the seizure of cough syrup stock worth ₹13 lakh.
The FDA's action follows tragic incidents in Madhya Pradesh and Rajasthan, where at least 19 children died after consuming contaminated cough syrups. Preliminary investigations revealed the presence of hazardous levels of Diethylene Glycol (DEG), a poisonous industrial chemical, in some of the syrups.
The Pune raid targeted Rednex Pharmaceutical Pvt. Ltd., the manufacturer of the cough syrup 'RespiFresh TR'. Authorities initiated the inspection following directives from the Central Government, with initial suspicions suggesting the syrup may be unsafe for consumption. Samples were collected from the manufacturing unit and sent for laboratory testing to ascertain their safety and compliance with quality standards.
Girish Hukre, Joint Commissioner of the FDA, stated that the department is tracking whether cough syrups from manufacturers involved in the incidents in other states are being sold within their jurisdiction. He clarified that while the specific syrups linked to deaths in Madhya Pradesh and Rajasthan are not known to be available in Maharashtra, the FDA is taking precautionary measures by thoroughly testing samples.
The Central Government has also responded to the crisis by issuing an advisory cautioning against administering cough syrups to children under two years of age. The advisory further stated that such syrups are not entirely safe even for children under five years old. In 2023, the central government had already mandated that pharma companies include warnings on labels and package inserts stating that fixed-dose combinations of chlorpheniramine maleate and phenylephrine should not be used in children below four years of age.
The World Health Organization (WHO) has requested clarification from Indian authorities regarding whether the cough syrup in question was exported to other countries. The WHO may issue a "Global Medical Products Alert" on the cough syrup, Coldrif, pending official confirmation from authorities.
These events have triggered public concern over drug safety and quality control in the state. The Maharashtra FDA has urged citizens, retailers, wholesalers, and hospitals to cease the circulation of the implicated syrup, secure existing stock, and immediately notify local drug control authorities. Doctors and pharmacists have also been urged to stay alert and advised against stocking products from unverified sources. Health officials have stressed the importance of consulting a doctor before giving any cough syrup to young children and to avoid self-medication.
The incident has brought to light the necessity of stringent oversight in cough syrup manufacturing, rational prescription practices, and expanded surveillance systems. The Union Health Ministry has emphasized that all drug manufacturers must strictly comply with the Revised Schedule M, which includes Good Manufacturing Practices (GMP) for pharmaceutical units.
This is not an isolated incident. There have been several cough syrup related deaths in India over the past three decades. In light of these incidents, there have been calls for reforms such as a unified regulatory authority, equal standards for all markets, and laboratory upgrades.
