The Central Government constituted a four-member expert committee on Wednesday 12th October 2022 to probe the World Health Organization (WHO) reports on the deaths of 66 children in the Gambia caused by cough syrups made by Sonipat-based firm Maiden Pharmaceuticals Limited.
According to a report by ANI, the official sources said, “Government is alert and formed a committee. Production of cough syrups by Maiden Pharmaceuticals Ltd has been suspended, and a lab report is awaited. Four-member expert committee has been formed to investigate the report sent by WHO.”
AK Pradhan, JDC(1), CDSCO, Dr. YK Gupta, Vice Chairperson, Standing National Committee on Medicines (chair), Dr. Pragya Yadav, ICMR-NIV, Pune, Dr. Arti Bahl, Division of Epidemiology, NCDC, New Delhi, and Dr. YK Gupta are the members of the committee made up of technical specialists.
Maiden Pharmaceuticals Limited firm in Sonipat has been instructed to cease producing all cough syrups, according to an order from the Haryana government. A show-cause notice for 12 irregularities discovered at the company’s production facility has also been issued.
On 12th October 2022, Haryana health minister Anil Vij said in an interaction with ANI, “The samples of three drugs of the Sonipat-based pharmaceutical company, which were mentioned by WHO, have been sent to Central Drug Laboratory in Kolkata. The report is yet to come. We will take action only after the report comes. After a joint inspection by Central and State officials, 12 violations were found in the manufacturing facility. It has been decided to shut down total production. We have sent a notice in this regard.” The pharmaceutical business has come under scrutiny when 66 children in the Gambia died after ingesting the cough medication.
According to reports, with approval to export medications to the Gambia, Atlanta-based Atlantic Pharmaceuticals Company Ltd. bought bottles of combination syrups from Maiden Pharmaceuticals Limited. It should be noted that the company manufactured and exported the bottles only to the Gambia, and the same was not sold in the Indian market.
The sources said, “From the preliminary inquiry of Central Drugs Standard Control Organisation (CDSCO), it has been made out that Maiden Pharmaceuticals Ltd is a manufacturer licensed by the State Drug Controller for the product’s Promethazine Oral Solution BP, Kofexnalin Baby cough syrup, Makoff Baby Cough Syrup and MaGrip n Cold Syrup under reference, and holds manufacturing permission for these products for export only.”
The sources added, “It is a usual practice that the importing country tests such imported medicines on quality parameters, and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country. In the present case, it is yet not clear whether these medicines were tested in the Gambia before release.”
According to the tentative results received by WHO, Four samples out of the 23 samples of the products in question that were analyzed were found to contain either high amounts of diethylene glycol or ethylene glycol. The officials said, “WHO has not yet made available a certificate of analysis. It has informed that the same will be made available in near future.”
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 are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, all made by Maiden Pharmaceuticals. According to the alert, laboratory analysis of samples of each of the four products confirms 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 may have been made available in other countries through unofficial channels.