After WHO's Alert For India-Made Cough Syrups, CDSCO Initiates Probe: Report

Preliminary investigation reveals that Maiden Pharmaceutical Limited, is a Haryana based manufacturer licensed by the State Drug Controller for the products.

After the World Health Organisation (WHO) on Wednesday announced that cough syrups made by Maiden Pharmaceuticals Limited had diethylene glycol and ethylene glycol, which are toxic to human beings, the Central Drugs Standard Control Organisation (CDSCO) has taken up an urgent investigation in this regard, reported news agency ANI.

"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," ANI reported, citing sources.

WHO issued a medical product alert for four India-made cough and cold syrups after 66 deaths of children in The Gambia.

"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)," said the ANI source.

The CDSCO responded to WHO within 1.5 hours after it alerted India about 4 cough syrups suspected to be one of the contributing factors behind the death of children in The Gambia. A detailed investigation has been launched to ascertain facts in the matter.

"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), reported ANI, citing its source.

Preliminary investigation reveals that Maiden Pharmaceutical Limited, is a Haryana based manufacturer licensed by the State Drug Controller for the products, and also holds manufacturing permission. The company has manufactured and exported these products only to The Gambia so far.

Meanwhile, the World Health Organisation is yet to provide the exact "one to one causal relation of death" in the cough syrup case, according to the ANI report.

"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," the source told ANI.