Samples taken from Maiden Pharma co linked to Gambia deaths not contaminated, India tells WHO

Tribune News Service

New Delhi, December 15

India on Thursday said the World Health Organisation drew a premature deduction in linking cold and cough syrup products of an Indian firm to the death of 66 Gambian children in late September this year, and said that control samples of the four products in question tested domestically were not found to contain contaminants— Diethylene glycol (DEG) and ethylene glycol (EG).

“It is clear that perhaps - premature deduction was drawn on September 29 itself regarding the cause of death of children. Every subsequent alert or publication from the WHO only seems to be a reaffirmation of the deduction without waiting for independent verification,” India’s drug regulator VG Somani said on Thursday in a letter to the WHO, which had issued a global medical alert in respect of four cold and cough syrups manufactured by Sonepat-based maiden pharma on October 5, potentially linking the deaths of over 66 Gambian children with allegedly contaminated products from India.

Somani in the letter to WHO said that as per the test reports received from government laboratory in India, all the control samples of the four products in question have been found to be complying with specifications.

“Further, DEG and EG were not found to be detected in these products and the products have been found not to have been contaminated with DEG and EG as per the test reports,” Somani said.

The Indian drug regulator also said that another ingredient propylene glycol in the said products was sourced from Goyal Pharma Chen Delhi which is recorded to have been imported from a firm in South Korea.

Noting that the statement issued by the WHO in October this year was unfortunately amplified which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products, Somani said,

“This in turn has adversely impacted the image of Indian pharmaceutical products across the globe 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 yet not been substantiated by the WHO or its partners on ground.”

The Indian drug regulator added thatall the alerts and the communications received from the onset of the unfortunate event in Gambia contained references to deaths of children and were “formulated in such a manner as to hint that cough syrup Consumption what is the primary cause of death even though Gambia has itself said that not all children who died consumed the products in question.”

Hoping that the WHO would now allow the expert technical committee constituted by India to look into the matter, the national drug regulator also reiterated his previous communications to the global body seeking further information necessary to establish the alleged causal link, as stated by the WHO in its medical alert.

Somani also said in his letter that following WHO’s initial alert a show cause notice was issued to Maiden Pharma under the provisions of the Drugs and Cosmetics Act for violating various good manufacturing practices and for not producing the complete records of manufacturing and testing as per rules.

“CDSCO has already informed the WHO that the above action was taken exclusively for good manufacturing practices violations by the firm,”

Somani said terming it strange that the WHO in fresh communication to India has said that establishment of causality of death rests with the countries in question.

“A strangely contrary position to the one adopted in the earlier communications where WHO had affirmed its commitment to provide granular details of the incident or causal relation. It is also a departure from the infections expressed in the statements issued earlier by the WHO,” said Somani.

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