Cough syrup deaths: Maharashtra FDA orders inspection of liquid oral formulations

In the wake of the death of 20 children in Madhya Pradesh linked to a contaminated cough syrup, the Maharashtra FDA has launched a special drive to inspect and test liquid oral formulations stocked by hospitals and distributors.

The Food and Drug Administration (FDA) directed all joint commissioners and drug inspectors to immediately submit details of all manufacturers in their jurisdictions and to collect samples from government and semi-government hospitals, private wholesalers, and retailers.

A circular was issued after a video conference chaired by the FDA commissioner on Tuesday.

Officials were directed to immediately report details of all liquid oral formulation manufacturers and ensure suspected batches are recalled from hospitals and distributors.

Drug inspectors and assistant commissioners have been asked to collect samples from government and semi-government hospitals, as well as private wholesalers and retailers, for priority testing, the circular said.

Samples from Mumbai, Konkan, Pune, and Nashik divisions will be sent to a laboratory in Mumbai, while those from Chhatrapati Sambhajinagar, Amravati, and Nagpur divisions will go to the Chhatrapati Sambhajinagar laboratory. Sampling is to be completed by October 9, with daily reports submitted via a dedicated Google Form.

The inspections of all liquid oral manufacturers will be conducted from October 10 to 15 to verify the quality of solvents such as glycerin, sorbitol, and propylene glycol, confirm vendor validation, check testing protocols for DEG and EG, and ensure proper record-keeping, according to the circular.

The FDA warned that manufacturers using suspect solvents or adulterated products will face stringent legal action. The campaign aims to enforce strict quality control and prevent recurrence of such incidents in the state.

On Monday, the FDA in Maharashtra appealed to the public and chemists to immediately stop the sale or use of Coldrif Syrup, urging immediate reporting to the nearest Drugs Control Authority.

Five children from Madhya Pradesh are in a critical condition, while 20 have died due to kidney infections caused by the consumption of the "contaminated" cough syrup, containing toxic substances like Diethylene Glycol and Ethylene Glycol.