Amid rising concerns over the safety and quality of certain paediatric cough syrups, several Indian states banned or suspended the sale of Coldrif following the deaths of children in Madhya Pradesh's Chhindwara.
The ban and suspension in several states came after lab tests that confirmed the presence of contaminants in one sample of Coldrif, which contained diethylene glycol (DEG) which was beyond permissible limits.
The syrup is manufactured in Kancheepuram, Tamil Nadu, reports have said, adding that regulatory actions have been initiated against the manufacturer, including potential cancellation of the firm’s licence and criminal proceedings.
States that have banned or suspended Coldrif:
Madhya Pradesh: Sale, distribution, and stock banned after adulteration confirmed.
Tamil Nadu: Sale banned effective October 1; production suspended, stocks removed from market.
Kerala: Sale and distribution have been suspended as a precaution; suppliers and pharmacies have been instructed to halt sales.
Maharashtra: FDA has issued an urgent ban on a specific batch of Coldrif cough syrup due to safety concerns.
Telangana: Public alert issued; retailers, wholesalers, and hospitals ordered to remove existing stocks and stop use.
Rajasthan: Regulatory crackdown underway; drug controllers suspended, stocks frozen, possible ban being considered.
Meanwhile, Union Health Secretary Punya Salila Srivastava chaired a high-level meeting with all states and Union Territories to review compliance with Good Manufacturing Practices under the Revised Schedule M, promote rational use of paediatric cough syrups, and ensure stricter regulation of retail pharmacies. She urged states to enhance surveillance and also noted that most childhood coughs are self-limiting and do not require medication.
According to a press release by the government, risk-based inspections have been initiated across 19 drug manufacturing units in six states to detect systemic lapses in the system. After the coldrif controversy, experts have also cautioned against prescribing cough syrups to children due to limited benefits and potential side effects.
The Health Ministry has reaffirmed its commitment to patient safety and drug quality, directing states and UTs to take “swift, coordinated and sustained action” to prevent such incidents in the future.
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