Srinagar- The World Health Organization has issued an alert for four “contaminated” medicines manufactured by an Indian pharmaceutical company that have been “potentially linked” with acute kidney injuries and 66 deaths among children in The Gambia.
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The manufacturer of these products is Maiden Pharmaceuticals Limited, Haryana, India, and to date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products , WHO said.
The Drugs Controller General of India said Thursday it has launched an investigation with state authorities after WHO informed the regulator of the deaths late last month.
Samples of four cough syrups manufactured by a Sonipat-based firm have been sent to the Central Drugs Laboratory in Kolkata for examination, Haryana’s Health Minister Anil Vij said Thursday, a day after the WHO report hit headlines.
“The samples have been collected by a team of the DCGA and Haryana’s Food and Drugs Administration Department and sent to the CDL, Kolkata for examination,” Vij told PTI over phone on Thursday.
He said a senior official of Centre’s Department of Pharmaceuticals spoke with Haryana’s Additional Chief Secretary (Health). Vij said the cough syrups manufactured by the pharma company were approved for export. “It is not available for sale or marketing in the country.”
“Whatever action has to be taken will be taken once the CDL report comes. Only after the report is in, we can arrive at any conclusion,” Vij said.
When asked about the matter at a news conference here, Haryana Chief Minister Manohar Lal Khattar said the Centre was looking into this issue. “When an international issue is involved, the Government of India deals with it and they are dealing with it,” he said.
However, he added, “So far, we do not have information on whether the deaths actually happened because of these medicines or due to some other reasons.”
Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
Outlining the risks associated with the products, WHO said 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,” it said.
All batches of these products should be considered unsafe until they can be analysed by the relevant National Regulatory Authorities. The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death, it added.