Gambia death case: Drug regulator finds no contamination in syrup, calls out WHO's deduction "premature"

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India's drug regulator claimed that the samples of Maiden Pharma's cough syrups which caused the deaths of children in Gambia were not contaminated with diethylene glycol (DEG) and ethylene glycol (EG) and also called World Health Organization (WHO) for "prematurely" blaming an Indian company for the deaths without verification.

In the letter to World Health Organization's director of regulation and prequalification Rogerio Gaspar, Drugs Controller General VG Somani said that a technical committee constituted by the Government of India found that "the products have been found not to have been contaminated with DEG or EG as per the test reports."

A four-members subject experts' technical committee was formed, chaired by Dr Y K Gupta, Vice Chairperson, Standing National Committee on Medicines 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.

Also Read: WHO alert for four Indian cough syrups as 66 children die in Gambia

"India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacture are maintained in quality control of drugs and cosmetics. In the aftermath of the alerts received from WHO regarding the incidents in Gambia, an independent inspection was conducted on the premises of Maiden Pharmaceuticals, the firm in question. A show cause notice was issued to the firm under provisions of India's Drugs and Cosmetics Act for violation of various Good Manufacturing Practices (GMP), and for not producing the complete records of manufacturing and testing as per the extant rules. Considering the observations made during the inspection, the manufacturing activities of the firm were stopped forthwith in the public interest CDSCO has already Informed WHO in this regard. It is to emphasize that the above action was taken exclusively for GMP violations by the firm," the letter reads.

"Further, WHO had been informed that the samples of these 04 products in question were drawn and sent for testing to Government Laboratory as per extant rules. As per the test reports received from the Government laboratory, all the control samples of the 04 products have been found to be complying with specifications," the letter added.

The letter also noted that all the alerts and the communications received from the onset of the Gambia have contained references to the deaths of the children and have been formulated in such a manner as to hint that cough syrup consumption was the primary cause of the mortality.

It further stated that the previous email, dated September 29, 2022, contains "...whose cause of death, or a significant contributing factor was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol or Ethylene glycol."

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

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