State government revokes license amid growing concerns over drug safety and quality compliance.
The Tamil Nadu government has taken decisive action against Sresan Pharmaceutical Manufacturer by revoking its manufacturing license and shutting down the company. This decision follows the tragic deaths of 22 children over the past month, all linked to the consumption of Coldrif cough syrup produced by the firm, located in Kancheepuram district.
Reports indicate that the fatalities occurred primarily in Madhya Pradesh and Rajasthan, where several children suffering from cold and fever ingested the syrup. The syrup’s consumption resulted in severe side effects, including vomiting and difficulties in urination. The first reported death associated with Coldrif was recorded on September 2, and subsequent investigations revealed serious quality control issues.
On October 2, the Tamil Nadu director of drugs control conducted an examination of Coldrif samples and found them to be substandard. Further investigation on October 5 by officials in Madhya Pradesh revealed that one sample of Coldrif contained a concerning 48.6% of diethylene glycol, a toxic substance. The permissible limit for diethylene glycol as an impurity is only 0.1%, and experts have indicated that its presence is dangerous, even in minimal amounts, highlighting significant compliance issues regarding product safety.
In response to these incidents, authorities in Madhya Pradesh arrested G Ranganathan, the owner of Sresan Pharmaceutical Manufacturer, in Chennai on October 9. Additionally, two drug inspectors from Tamil Nadu faced suspension for failing to perform necessary quality checks on the products manufactured by Sresan Pharmaceutical over the last two years. The situation has prompted a broader crackdown, with the Coldrif formulation being banned in several states, including Tamil Nadu, Madhya Pradesh, Kerala, Karnataka, Punjab, Himachal Pradesh, Uttar Pradesh, Puducherry, West Bengal, and Delhi.
As part of the ongoing investigation, the Enforcement Directorate has conducted searches at seven locations in Tamil Nadu, targeting properties associated with employees of Sresan Pharmaceutical as well as officials from the Tamil Nadu Drugs Control Department. These searches also included the residence of PU Karthikeyan, a former joint director of drugs control. In a prior incident in July 2024, Karthikeyan was caught by the Directorate of Vigilance and Anti-Corruption accepting a bribe of Rs 25,000 from a soap factory owner in exchange for expediting a permit application.
The Tamil Nadu government’s swift measures underscore the urgency of addressing public health concerns related to drug safety. With the alarming rise in incidents linked to tainted medications, authorities are now prioritizing comprehensive inspections of other drug manufacturers across the state to prevent any future occurrences.
