CDSCO Probe On WHO’s Complaint For India-Made Cough Syrups

6 October, 2022 | Pranay Lad

CDSCO Top News

CDSCO has launched a probe following the WHO's alarm on four cough and cold syrups developed in India that are utilised for pediatric populations.

The Central Drugs Standard Control Organization (CDSCO) has launched an urgent inquiry into this matter following the World Health Organization’s (WHO) alarm on four cough and cold syrups developed in India that are utilised for pediatric populations.

“After receiving a notification from the WHO, CDSCO promptly began an urgent inquiry into the situation with the State Regulatory Authorities based on the information at hand. While all necessary procedures will be made in the situation, WHO has been asked to provide with CDSCO as soon as possible the report on the establishment of a causal link to mortality with the in question medical items, images of Labels/products, etc “sources informed the media.

The four cough and cold syrups produced by Maiden Pharmaceuticals in India were the subjects of a notice from the WHO on Wednesday. The same cough and cold medications may be responsible for 66 children’s deaths in The Gambia, according to a WHO alert.

Sources claim that “on September 29, 2022, WHO 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 and where a significant contributing factor is suspected to be the use of medicines that 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).”

In response to the WHO within an hour and a half, the Central Drugs Standard Control Organization (CDSCO) immediately took up the issue and launched a further investigation. “CDSCO took up the issue immediately with the concerned State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located,” said CDSCO. According to reports, a thorough investigation was also started to discover the facts and specifics in the case in cooperation with the State Drugs Controller for Haryana (the relevant State Drug Control Authority).

According to preliminary investigation, Maiden Pharmaceutical Limited, Sonipat, Haryana, is a firm authorised by the State Drug Controller to produce the items in question and is in possession of a production permit for them. To date, the firm has only produced and shipped these goods to The Gambia.

A source explained the quality parameter needs to be followed by the country that imports these products and said, “It is a practise 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.”

“Four of the 23 samples tested, according to the preliminary data provided to WHO were found to have the required amounts of diethylene glycol and ethylene glycol. The certificate of analysis will soon be made available to WHO, who would then share it with India, according to information provided by WHO.

However, neither the precise one-to-one causal relationship of mortality nor the specifics of the labels or goods that would have allowed CDSCO to authenticate the identity or source of the products’ production have yet been disclosed by WHO “they said.

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