Official sources here said a panel of experts was formed on Wednesday to examine details and adverse event reports received from the WHO regarding the death of 66 children in The Gambia linked to four cough syrups made in India.
It says the committee will advise and recommend further action to the Drugs Controller General of India (DCGI) after they’ve reviewed and analyzed adverse event reports, causal links, and all related details shared by or to be shared by the World Health Organization.
The development comes on a day when the Haryana government ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceuticals and asked it to explain “many contraventions” found during a recent inspection within a week or risk having its license suspended or revoked.
66 children in the African nation of Gambia died from four cough syrups manufactured at the facility, the World Health Organization (WHO) said two days prior to the production halt order.
The four members of the technical expert committee are Dr. Y. K. Gupta. Dr Pragya D. Yadav, NIV, ICMR, Pune; Dr Arti Bahl, Division of Epidemiology; Vice-Chairperson, Standing National Committee on Medicines. NCDC, New Delhi; and A. K. Pradhan, JDC(I), CDSCO.
It’s official, WHO told CDSCO on September 29 that they were giving Gambia technical help and advice (Promethazine Oral Solution BP, KOFEXNALIN Baby Cough Syrup, MaKOFF Baby Cough Syrup, MaGrip n Cold Syrup, MaGrip n Cold Syrup), where kids died and medicine might’ve played a part (Promethazine Oral Solution BP, KOFEXNALIN Baby Cough Syrup, MaKOFF Baby Cough Syrup, MaGrip n Cold Syrup).
The WHO said they may have been contaminated with Diethylene glycol or Ethylene glycol because they’re made and exported by Maiden Pharmaceuticals Ltd., Sonepat, Haryana.
CDSCO notified Haryana State Regulatory Authority immediately, under whose jurisdiction the drug manufacturing unit is located, and a detailed investigation was launched by CDSCO and Haryana State Drugs Controller.
According to the WHO’s tentative results, four of the 23 samples of the products under reference that were tested by WHO contain Diethylene Glycol/ Ethylene Glycol.
CDSCO had requested WHO to provide a relevant analysis/report that would establish a one-to-one causal relationship between those deaths and the alleged adulteration of said drugs. WHO hasn’t yet provided the same,” a source said.
The WHO shared the Certificate of Analysis (COAS) and summary of adverse events, etc. on October 11 2022, following up on CDSCO’s follow-up with the WHO.
Additionally, according to the memorandum, the WHO says they’re in the process of looking into it.
According to the source, “it has been decided to form a committee made up of technical experts to look at and analyze the reports/adverse events/CoAs that have been received from WHO in this matter.”