The World Health Organization (WHO) still stands by the alert it has raised on Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup—the four Indian cough syrups.
Around 70 children in the African country of Gambia have died due to acute kidney injury, which is potentially linked to the consumption of India-made cough syrups by Maiden Pharmaceuticals Limited. WHO has issued a global alert about the possible risks of the respective cough syrups and has advised the regulators to stop their sales.
The intergovernmental health body issued the alert regarding the cough syrups in October, and it was in late July when the medical authorities in The Gambia detected an increase in cases of acute kidney injury among children under the age of five. The four accused cough syrups are licensed to Maiden Pharmaceuticals Limited for export purposes only.
Latest Letter by DCGI
On December 13, 2022, a letter was written by the Drugs Controller General of India (DCGI), VG Somani, to Dr. Rogerio Gaspar, the Director of Regulation and Prequalification at the World Health Organization. The letter said that the samples of the same medicines that were exported to the Gambia were kept here for quality control purposes and didn’t contain ethylene glycol or diethylene glycol.
Somani said that, according to the media, Gambia stated that there hasn’t been any direct relationship between the consumption of cough syrups and the deaths.
The test results are being examined by a panel of experts in India. According to the Indian officials, WHO has jumped to the conclusion, spoiling the Indian image. The panel has asked WHO to confirm the accusations made by providing specific details regarding this issue.
The letter further hints that WHO’s statement has targeted Indian-quality drugs on an international level. The accusations made against the drugs by Maiden Pharmaceuticals Limited have adversely impacted the image of India’s products across the globe, creating irreparable damage to the supply of Indian pharma items.
The response on Friday from WHO says that tests were done in organization-contracted laboratories in Ghana and Switzerland, and the suspected Indian cough syrups from Gambia have shown excessive levels of ethylene glycol and diethylene glycol, which are very dangerous and should not be in any medicine ever. They are toxic to humans and could be fatal if consumed.
The response was immediately shared with Gambia, India, and especially the accused, Maiden Pharmaceuticals. Also, Maiden Pharmaceuticals has been ordered to stop production at its main factory in the northern state of Haryana.
After the Indian governmental authorities found nothing wrong with the syrups, the managing director of Maiden Pharmaceuticals, Naresh Kumar Goyal, said that they will now try to request that the authorities reopen the factory. He said that he has not done anything wrong and has complete faith in Indian regulatory and judicial processes.