The Central Drugs Standard Control Organization (CDSCO) has launched an urgent inquiry into four India-made cough and cold syrups used for paediatric groups after the World Health Organization (WHO) issued an alert.
“Urgent investigation in the matter has been already taken up by CDSCO with the State Regulatory Authorities immediately after receiving communication from WHO based on the available information. While all required steps will be taken in the matter, as a robust National Regulatory Authority, WHO has been requested to share at the earliest with CDSCO the report on the establishment of causal relation to death with the medical products in question, photographs of Labels/ products etc. which is awaited,” Sources told ANI.
WHO on Wednesday issued an alert over four India-made cough and cold syrups which are made by Maiden Pharmaceuticals in India. WHO has also notified that the same cough and cold syrups could be linked to the deaths of 66 children in The Gambia.
According to the sources, “WHO on September 29, 2022, informed DCGI, the National Drug Regulator of India, that it is currently providing technical assistance and advice to the Gambia, where children were suspected to have died where a significant contributing factor, is suspected to be the use of medicines which may have been contaminated with Diethylene glycol or Ethylene glycol (this has been confirmed in some of the samples by further analysis conducted by WHO).”
The Central Drugs Standard Control Organisation(CDSCO) took up the matter immediately and further investigation was launched, “CDSCO while responding to WHO within an hour and a half, took up the matter immediately thereafter with the concerned State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located. Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana (the concerned State Drug Control Authority), said sources.
From the preliminary enquiry, it has been made out that Maiden Pharmaceutical Limited, Sonipat, Haryana is a manufacturer licensed by the State Drug Controller for the products under reference, and holds manufacturing permission for these products. The company has manufactured and exported these products only to The Gambia so far.
“It is a practice that the importing country tests these products on quality parameters, and satisfies itself as to the quality of the products before their release for usage in the country,” said a source and explained the quality parameter needs to be followed by the country that imports these products
“As per the tentative results received by WHO out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated. It has also been informed by WHO that the certificate of analysis will be made available to WHO in near future and WHO will share it with India. At the same time, the exact one-to-one causal relation of death has not yet been provided by WHO, nor have the details of Labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products,” they said.