Explainer: Why has WHO issued alert on 4 Indian cough syrups

In a release, the WHO has said that the Indian company has not yet provided guarantees on the safety and quality of cough syrups.

Livemint
Updated6 Oct 2022, 09:30 AM IST
WHO also cautioned that the contaminated medications may have been distributed outside of the West African country, with global exposure possible.
WHO also cautioned that the contaminated medications may have been distributed outside of the West African country, with global exposure possible.

The World Health Organization (WHO) on Wednesday issued a medical product alert on four cough and cold syrups made by an Indian company.

The WHO has said that the usage of these four cough syrups have potentially caused acute kidney injuries and 66 deaths among children in Gambia.

The WHO on Wednesday flagged four "contaminated" and "substandard" cough syrups made by Maiden Pharmaceuticals Limited in Haryana, which have been largely used for pediatric use, are believed to contain chemicals that are toxic and potentially fatal.

The four cough and cold syrups are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

In a release, the WHO has said that the Indian company has not yet provided guarantees on the safety and quality of these products.

It also cautioned that the contaminated medications may have been distributed outside of the West African country, with global exposure "possible."

Also Read: WHO issues alert for 4 India-made cough syrup. Check symptoms, other details

The laboratory analysis of samples of each of the four products confirms they contain unacceptable amounts of diethylene glycol and ethylene glycol, both "toxic to humans when consumed and can prove fatal.

India investigating deaths in Gambia

After the WHO's alert, the Central Drugs Standard Control Organisation (CDSCO) has taken this matter under urgent investigation, sources told 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,” they said.

"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," they added.

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 CDSCO took up the matter immediately and further investigation was launched. 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.

Sources further explained that the quality parameter needs to be followed by the country that imports these products.

"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," source said. 

Look out for these symptoms

Medical officers in Gambia raised the alarm in July, after dozens of children began falling ill with kidney problems. The deaths confounded medics before a pattern emerged: dozens of patients younger than five were falling ill three to five days after taking a locally sold paracetamol syrup.

The symptoms include - abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

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First Published:6 Oct 2022, 09:30 AM IST
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