According to the ministry, preliminary investigations have revealed that Maiden Pharmaceutical Limited — the manufacturer of the drugs in question, namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup — had permission only for export of these products and that the company had manufactured and exported them only to Gambia.
“It is a usual practice that the importing country tests these products on quality parameters and satisfies itself… before [it]… decides to release such products for usage in the country,” the ministry said in a statement issued on Thursday.
It was followed by a medical product alert from the World Health Organisation (WHO) which said that four cough and cold syrups made by Maiden Pharmaceutical Limited, an Indian firm, were potentially linked with acute kidney injuries and 66 deaths among children in Gambia. The UN body said the drugs in question contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. “To date, these four products have been identified in Gambia, but may have been distributed, through informal markets, to other countries or regions,” the UN health body had said.
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Its effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death. The Union health ministry clarified that the Drug Controller General of India was informed about the issue on September 29.
“CDSCO took up the matter immediately with Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of M/s Maiden Pharmaceutical Limited, Sonepat, is located. Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with the State Drugs Controller, Haryana,” the ministry said.
It added that four out of 23 samples of the products under reference were found to contain diethylene glycol/ethylene glycol — an organic solvent but the certificate of analysis for the same was yet to be shared by the WHO with the CDSCO. According to the ministry, the exact one to one causal relation of death has not yet been provided by WHO to CDSCO either.
“…CDSCO has requested WHO to share at the earliest the report on establishment of causal relation to death with the medical products in question etc,” the ministry said.
Meanwhile, the ministry added controlled samples of the same batch for all the four drugs in question had been taken and sent for testing to Regional Drug Testing Lab, Chandigarh, by CDSCO. “The results of the test will guide further course of action as well as bring clarity on the inputs received/to be received from WHO,” the health ministry explained.
In the past also, incidences of mass deaths due to diethylene glycol and ethylene glycol contamination have been reported. In 1998, for example, 33 children admitted to two hospitals in Delhi died after complaining of abdominal pain and discomfort among others. Detailed investigation suggested the role of diethylene glycol in it.