WHO alert on cough syrups: Govt forms panel to examine details, adverse event reports
New Delhi: The government on Wednesday formed a four-member panel of experts to examine the details and adverse event reports received from the WHO on the deaths of 66 children in The Gambia being linked potentially to the four made-in-India cough syrups, official sources here said.
They said after examining and analysing the adverse event reports, causal relationship and all related details shared by or to be shared by the World Health Organization, the committee will advise and recommend further course of action to the Drugs Controller General of India (DCGI).
The development comes on a day the Haryana government ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceuticals, and asked it to explain within a week “many contraventions” found during a recent inspection, or face suspension or cancellation of license.
The order to halt production came days after the World Health Organization (WHO) potentially linked four cough syrups manufactured at the facility to the deaths of 66 children in the African nation of Gambia.
The four-member committee of technical experts are: Dr. Y. K Gupta. Vice Chairperson, Standing National Committee on Medicines; Dr Pragya D. Yadav, NIV, ICMR, Pune; Dr Arti Bahl, Division of Epidemiology. NCDC, New Delhi; and A. K. Pradhan, JDC(I), CDSCO.
According to official sources, the WHO on September 29 had informed the Central Drugs Standard Control Organisation (CDSCO) that they were providing technical assistance and advice to Gambia, where children have died and where a contributing factor was suspected to be the use of medicines (Promethazine Oral Solution BP, KOFEXNALIN Baby Cough Syrup, MaKOFF Baby Cough Syrup and MaGrip n Cold Syrup).
There are manufactured and exported by Maiden Pharmaceuticals Ltd, Sonepat, Haryana, and the WHO had informed they may have been contaminated with Diethylene glycol or Ethylene glycol.
The CDSCO took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located, and a detailed investigation was launched by CDSCO in collaboration with the State Drugs Controller, Haryana.
It has also been indicated by the WHO that as per the tentative results received by the WHO, out of the 23 samples of the products under reference which were tested by WHO, four have been found to contain Diethylene Glycol/ Ethylene Glycol.
“The CDSCO had requested WHO to provide relevant analysis / report indicating / establishing one-to-one causal relation of said deaths with the alleged adulteration of the drugs referred to above. The same is yet to be provided by WHO,” a source said.
On further follow up done by CDSCO with the WHO, the Certificate of Analysis (COAS) of the sampled products and the summary of the adverse events etc. were shared by the WHO on October 11 2022.
Further, the WHO has informed they are in the process of taking forward the investigation, the memorandum stated.
“In order to examine and analyse the details of the reports/adverse events/CoAs received to be received from WHO in the instant matter, it has been decided to constitute a committee comprising technical experts,” the source stated.