A month after the Indian government set up an expert committee to probe reports about children’s death in Gambia, allegedly caused due to cough syrup produced by a Sonipat-based company, the investigation had come to a halt over dilly-dallying by the World Health Organisation (WHO). It is pertinent to note that the Medical Control Agency of Gambia had recently admitted that there was no link between cough syrup and the reported deaths of children.
As per an exclusive report by The Economic Times, the specialised agency of the United Nations (UN) has failed to provide the documents, to the Indian authorities, which are required to further the investigation into the deaths of 70 deceased children in Gambia.
The Central Drugs Standard Control Organisation(CDSCO), the drug regulator in India, has written thrice to the World Health Organisation but to no avail. It has so far received no response from WHO.
Citing a source, The Economic Times reported, “We have so far not got anything from the WHO to take a step forward into the investigation,” said a person in the know. On November 3, the English-daily also sent an email to the World Health Organisation but did not receive any response.
It must be mentioned that the Indian government had formed a 4-member expert committee under pharmacologist YK Gupta to probe claims of deaths in Nambia due to cough syrup, produced by Sonipat-based Maiden Pharmaceuticals.
The committee met on three occasions so far but has not made any progress.
The Background of the Case
In July this year, Gambia witnessed a sudden rise in the death of children below the age of 5. Parents of the deceased children claimed that their toddlers fell ill 3-5 days after taking a syrup.
By October, the number of deaths stood at 66, with most developing acute kidney injury. On October 5, the WHO issued a medical alert saying that four substandard products made by the Indian firm were responsible for the death of 66 children in the African nation.
The four products were Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, all made by Maiden Pharmaceuticals.
Take note, share, RT 📢📢📢📢📢📢📢📢
— Dr. Catherine Kyobutungi (@CKyobutungi) October 6, 2022
These cough syrups, all manufactured by MAIDEN Pharmaceuticals, have been associated with more than 60 deaths of young children in the Gambia
PROMETHAZINE Oral Solution
KOFEXMALIN Baby Cough Syrup
MAKOFF Baby Cough Syrup
MAGRIP Cold Syrup pic.twitter.com/0WsB2qXYMn
According to the alert received, laboratory analysis of samples of each of the four products allegedly confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
Although the products were distributed only in Gambia, according to WHO, they might have been made available in other countries through unofficial channels.
We’re not selling anything in domestic market. We’ve been obtaining raw materials from certified & reputed companies. CDSCO officials have taken samples & we are awaiting the results: Maiden Pharmaceuticals Ltd on deaths of 66 children in Gambia allegedly due to their cough syrup pic.twitter.com/HFEJbx1POx
— ANI (@ANI) October 8, 2022
On October 8, Maiden Pharmaceuticals issued a statement, clarifying that it is not selling any of its products in the domestic market. “We’ve been obtaining raw materials from certified & reputed companies. CDSCO officials have taken samples & we are awaiting the results,” it said.
Later on October 12, the Indian government formed a 4-member expert committee to probe the matter. AK Pradhan, Dr YK Gupta, Dr Pragya Yadav, and Dr Arti Bahlare the members of the committee.
“The public in India must be made aware that the licence for this drug was for export only…Medicines produced in India now are known for their quality in the international market, it’s wrong to question the quality of Indian medicines because of one incident. Our regulatory body is strong & we have zero tolerance for such things,” Dr Gupta told ANI.
Medicines produced in India now are known for their quality in int’l market, it’s wrong to question quality of Indian medicines because of one incident. Our regulatory body is strong & we’ve zero tolerance for such things: Dr YK Gupta, Vice-Chairman, Standing National Committee
— ANI (@ANI) October 8, 2022
On October 31, the Medicine Control Agency of Gambia informed that they did not find any link between the deaths of 70 children and the cough syrups manufactured by the Indian firm.