Case of death of 66 children due to cough syrup: investigation of Sonipat company completed; Drug used without test, notice issued on flaws

Following WHO’s objection, investigation has been completed into the death of 66 children in The Gambia after drinking cough syrup. The team of Food and Drug Administration (FDA) Haryana and Central Drugs Standard Control Organization (CDSCO) North Zone Ghaziabad has found many lapses.

The investigation of Maiden Pharmaceuticals in Sonipat found deficiencies in several accounts of the company. Batch number was not given in them. Also, the manufacturers name, manufacturing date and quality details of propylene glycol were not found in the medicines.

Propylene glycol not tested
In relation to cough syrup, it has been found that the company has not done quality testing of propylene glycol for diethylene glycol and ethylene glycol. Propylene glycol is used as a solvent in pharmaceutical drugs such as syrups. If contaminated with diethylene glycol and ethylene glycol, cough syrup can lead to death of the person drinking it.

What does WHO say
According to the WHO, the effects of adulterant diethylene glycol (DEG) and ethylene glycol poison can be abdominal pain, vomiting, diarrhea, difficulty urinating, headache, mental problems and kidney infection, which can lead to the death of the drinker. .

Error in expiry date
The joint investigation of CDSCO-FDA has also revealed that the company has also erred in the expiry date of the syrup. Investigations have revealed that propylene glycol was used in the syrup with a manufacturing date of September 2021 and a last date of September 2023, but the last date has been given as November 2024.

The company also failed in in-process testing
CDSCO-FDA has also sent a show cause notice to the company after the lapses found in the investigation. It states that the company has also failed to submit in-process testing reports of the products under consideration.

Haryana Health Minister Anil Vij said that we are getting them tested at our level. Strict action will be taken against the company after that.

Requested reply in 7 days
The company will have to reply within seven days to the show cause notice issued for the lapses. In which it is said that this notice has been issued to the company under Rule 85 (2) of the Drugs Rules, 1945. It has been said in the notice that on the basis of the defects found, why the manufacturing license should not be canceled.