India’s drug regulator has claimed that the samples of Maiden Pharma’s cough syrups which reportedly caused deaths of children in Gambia were not contaminated with diethylene glycol and ethylene glycol, thus giving the company a clean chit. According to Ministry officials in the know, the company is now looking at re-opening its Haryana facility and the process is likely to be initiated soon.

The Drug Controller General of India in a letter to the World Health Organization (WHO) said that the latter has “prematurely” blamed an Indian company for the deaths without verification.

“It is clear that perhaps a premature deduction was drawn on September 29 itself regarding the cause of death. Every subsequent alert or publication seems to be a reaffirmation of this deduction, without waiting for independent verification,” the letter read.

A four-member subject experts’ technical committee was formed, chaired by Dr Y K Gupta, Vice Chairperson, Standing National Committee on Medicines along with experts from the National Institute of Virology-ICMR, Pune, National Centre for Disease Control (NCDC) and CDSCO also in the team.

This committee was formed after the reports of deaths in the Gambia caused by the Indian firm Maiden Pharmaceuticals’ cough syrup came forefront. Till December 15, deaths in Gambia reached 66.

India’s Drug Controller mentioned that samples of all the four products in question– made by Maiden Pharma – were drawn and sent for testing (to a government lab) and all of them were found to be “complying with specifications”.

As per the letter to WHO, the propylene glycol was sourced from Goel Pharma Chem, Delhi, who in-turn imports it from a South Korea. Further, glycerine was sourced by Goel Pharma Chem, which again, was sourced from Adani Wilmar.

Adversely Impacted India’s image

The Drug Controller General in his letter mentioned that a narrative was built “intentionally targeting the quality of Indian pharmaceutical products” which has “adversely affected” the country’s image.

“....and caused irreparable damage to the supply chain of pharmaceutical products as well as repute of the national regulatory framework over an assumption that has not yet been substantiated by WHO or its partners on ground,” the letter mentions.

It further added that Gambia has informed, too, that there has been no direct causal that has been established between the cough and child deaths. Further, there are reports that some of the children who died had not consumed the cough syrup.

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