A joint inspection team, comprising senior drug inspectors of the central and Haryana governments, will on Thursday again inspect the Sonepat-based pharmaceutical company that is at the centre of a raging controversy over the supply of four syrups linked to the death of 66 children in The Gambia, a west African nation.
The World Health Organisation had on Wednesday issued a medical product alert over the four cough and cold syrups made by Maiden Pharmaceuticals, Sonepat, warning they could be linked to acute kidney injuries and deaths of the 66 children.
Haryana health minister Anil Vij said that samples of the four paediatric cough syrups from the pharmaceutical company were collected jointly by a team of the Drug Controller General of India under the Union health ministry and the Haryana food and drug administration on October 1 and 3 and sent to the Central Drugs Laboratory in Kolkata for examination.
Samples being indigenously tested in Kolkata: Haryana health minister
“It has been decided by the central and state governments that we should first get these cough syrup samples tested indigenously before arriving at a conclusion. Further action will be taken subsequently,” the health minister said.
Vij clarified that all four cough syrups in question were manufactured for export only and not marketed in India.
“The probe into the matter is underway since last Saturday. The company in question is a small-scale unit and during the joint inspection and as per the standard operating procedure all necessary samples and documents were collected,” a Haryana government official said, requesting anonymity.
The official said that documents, including the company’s reports of stability studies of the product and the vendors list, were being scrutinised. “The probe is at a preliminary stage,” the official said.
Unacceptable amounts of diethylene glycol, ethylene glycol
According to reports quoting the WHO, the laboratory analysis of the samples of the four products confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol as containments.
“There is an urgent need to put tough regulatory systems in place to prevent such tragedies,” said a former Haryana State Drug Controller, pointing out that earlier also similar cases were reported involving paediatric syrup manufactured in Haryana.