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 the committee will recommend further course of action to the Drugs Controller General of India (DCGI) after examining and analysing the adverse event reports, causal relationship and all related details already shared by or to be shared by the World Health Organization.
The development comes on a day the Haryana government ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceuticals while the state drug regulator has 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 WHO potentially linked four cough syrups manufactured at the facility to the deaths of 66 children in the African nation.
The four-member committee of technical experts is chaired by Dr Y K Gupta, Vice Chairperson, Standing National Committee on Medicines and has Dr Pragya D Yadav, National Institute of Virology-ICMR, Pune; Dr Arti Bahl, Division of Epidemiology. National Centre for Disease Control (NCDC), New Delhi; and A K Pradhan, Joint Drugs Controller(I), CDSCO as members.
The official sources also said they have taken note of media reports that Atlanta-based Atlantic Pharceuticals Company Limited had procured the drugs from Maiden Pharmaceurticals for further export to The Gambia.
They further said the WHO has not yet made available certificate of analysis and has informed it will done in the near future.
“The exact one to one causal relation of death has not yet been provided by WHO to CDSCO although the latter (CDSCO) has requested the WHO twice in this regard,” one source said. Also, it is a usual practice that the importing country tests imported medicines and satisfies itself with the quality of the products before releasing them for usage in their country, the source said. “In the present case, it is not yet clear whether these medicines were tested in The Gambia before release,” he added.
The WHO had on September 29 had informed the Central Drugs Standard Control Organisation (CDSCO) that they were providing technical assistance and advice to The Gambia, where children have died and where a contributing factor was suspected to be the use of four medicines: Promethazine Oral Solution BP, KOFEXNALIN Baby Cough Syrup, MaKOFF Baby Cough Syrup and MaGrip n Cold Syrup.
They 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, 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 sources said.
“The CDSCO had requested the 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 by the 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, he said. Further, the WHO has informed they are in the process of taking forward the investigation, he 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,” he added.
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