Maiden pharma fails to clear quality test in cough syrup: Report

New Delhi, Oct 12: Maiden Pharmaceuticals Limited, the company which has come under scanner for 'sub-standard' and 'contaminated' cough syrups potentially linked to the deaths of 66 children in the Gambia, failed to perform quality testing of a raw material used in the manufacture of one of the medicines, as per a report.

"The firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol," the October 7 notice read, as per a report published in Hindustan Times.

The pharma company has been asked to give a reply to the notice by October 14 and action will be taken if it fails to respond, the report stated.

Gambia's Health Minister Ahmadou Lamin Samateh on Saturday claimed that 69 children died due to kidney damage caused by contaminated cough syrup made in India.

As per the experts, propylene glycol, used to make drugs, can contain contaminants such as diethylene glycol and ethylene glycol and the World Health Organization (WHO) identified these two chemicals as potential causes of child deaths in the Gambia.

The notice states that Propylene glycol (batch number E009844) with a manufacturing date of September 2021 had an expiry date of September 2023, but was used to manufacture four cold syrups having a product expiry of November 2024, the report added.

Last week, the WHO issued a medical product alert for four contaminated medicines made by Maiden Pharmaceuticals in India which is linked with acute kidney injuries and 66 deaths among children.

Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

However, Naresh Goyal, managing director of Maiden Pharmaceuticals, has said that their products had nothing to do with the deaths, The Times of India reported.

"Medicines Control Agency (national medicines regulator of The Gambia) only recalled the products. They never said that they resulted in deaths," he said. "The deaths have been due to paracetamol syrup and not due to our cough syrups," the daily quoted him as saying.