Lagatar24 Desk
New Delhi, Dec 16: In a recent letter to the World Health Organization (WHO) representative in Geneva, the national drugs controller stated that all four Maiden Pharmaceuticals cough syrup samples that had been tested by the government had been found to be in compliance with standards. He also emphasised that India had not yet received data to establish deaths in The Gambia, where the products had been linked to child fatalities.
According to reports, four cough syrups produced by the Indian pharmaceutical company Maiden Pharmaceuticals are responsible for at least 66 child fatalities in The Gambia.
In a briefing on October 5, WHO issued a medical product alert on four cough syrups made and exported by Maiden Pharma: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
WHO said in its alert that two toxic contaminants, diethylene glycol and ethylene glycol, were found in the four cough syrups.
“… WHO had been informed that the samples of these 4 products in question were drawn and sent for testing to the government laboratory as per extant rules. As per the test reports received from the government laboratory, all the control samples of the 4 products have been found to be complying with specifications,” said the drugs controller general of India, VG Somani on Tuesday in his letter addressed to Rogerio Gaspar, director, Regulation and Prequalification, WHO.
Drug Controller of India writes to WHO over the premature conclusion linking Indian-made cough syrups to deaths in Gambia. pic.twitter.com/ytyYdhrJOp
— ANI (@ANI) December 16, 2022
“All control samples of 4 cough and cold syrups manufactured by Maiden Pharmaceutical were sent for testing to Government Laboratory as per extant rules and all the 4 products have been found to be of standard quality,” the letter reads.
An independent inspection was carried out on the premises of Maiden Pharmaceuticals, which has its headquarters in Haryana, as a result of the WHO alerts concerning the incidents in The Gambia.
In accordance with the regulations of India’s Drugs and Cosmetics Act, a show-cause notice was given to the company for violating various Good Manufacturing Practices (GMP) and failing to provide complete records of manufacturing and testing as required.
Somani emphasised that the WHO appeared to have changed its position with regard to establishing causation, despite The Gambia’s own announcement that there didn’t yet appear to be a causative association between the deaths and syrup intake.
