WHO: Two months after the World Health Organization (WHO) raised an alert on four India-manufactured syrups, the country’s apex drug regulator has written to the intergovernmental body and stated that it made a “premature deduction…regarding the cause of death” of the children, and that all its further communications were a “reaffirmation of this deduction, without waiting for independent verification”.
In October, the WHO issued a medical alert linking four syrups manufactured by Haryana-based Maiden Pharmaceuticals — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — to the deaths of 70 children in the Gambia due to Acute Kidney Injury.
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Drug Controller General of India (DCGI), Dr V G Somani’s letter
The Drug Controller General of India (DCGI), Dr V G Somani, stated in a letter (dated December 13) to Dr Rogerio Gaspar, Director (Regulation and Prequalification), WHO, that the WHO backtracked on its initial commitment of providing granular details by stating that the responsibility of establishing the causal link between the deaths and syrups lies with the country in question — the Gambia. The letter noted that the statement issued by WHO adversely impacted the image of India’s pharmaceutical products and caused irreparable damage to the supply chain “over an assumption that has not been substantiated by the WHO or its partners on ground”.
According to the letter, the Gambia has stated that no direct causal relationship between the deaths and the cough syrups has been established, with some of the children not even having consumed the syrups in question. “We believe WHO would now allow the technical committee…to arrive at the conclusion based on the facts and evidence available,” the drug controller wrote, despite the fact that neither WHO nor the Gambia had shared any information. Following the alert, the Union Health Ministry formed a four-member expert panel to review the data sent by WHO, which has since sought details on initial signs and symptoms, treatment offered, investigations conducted, and clinical presentation following syrup consumption.
According to the letter, this technical committee has met several times and has requested information from the WHO at least three times, but has never received any data.
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Independent investigation by DCGI found that the control samples did not contain di-ethylene glycol or ethylene glycol
In what appears to be a clean chit for the manufacturer, Somani in the letter stated that an independent investigation by DCGI found that the control samples — samples from the same batch exported to the Gambia maintained by the company for quality control purposes — did not contain di-ethylene glycol or ethylene glycol.
The drug regulator also tested the propylene glycol and glycerine available at the manufacturing facility at the time of the inspection and found that they did not contain di-ethylene glycol or ethylene glycol above the permissible limit, according to the letter. The propylene glycol came from a South Korean company, and the glycerine came from Adani Wilmar through a Delhi-based company. The solvents were thought to be the most likely source of contamination with di-ethylene glycol or ethylene glycol, both of which are known to cause acute kidney injury.
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