Maiden Pharmaceuticals Limited, a firm that is under scrutiny for four “substandard” and “contaminated” cough syrups potentially linked to the deaths of 66 children in The Gambia, did not perform quality testing of a raw material used in the manufacture of one of the medicines, according to a notice sent after an official inspection.
Propylene glycol, which is used to manufacture drugs, can contain contaminants diethylene glycol and ethylene glycol – the two toxic chemicals have been named by the World Health Organization (WHO) as possible causes for the deaths – and strict quality control needs to be ensured, according to experts.
According to an October 7 show-cause notice issued by the Haryana drug authorities to Maiden Pharmaceuticals after a joint inspection with the Central Drugs Standard Control Organisation (CDSCO), “The firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol.” The pharma company has to reply to the notice by October 14, failing which action may be taken against it.
According to the notice, a batch of propylene glycol received and analysed in March 2022 was shown to be the same one that was used to manufacture a batch of MaGrip n Cold Syrup in December 2021, which indicates that it was not likely tested for quality and the paperwork was not in order, people aware of the matter said.
