Samples found complying with specifications: Health Ministry to WHO on Gambian deaths

India’s Health Ministry on Thursday has told global health body WHO that all four products in connection with the deaths in Africa’s Gambia have been found to be complying with specifications.

“The WHO had been informed that the samples of these 4 products in question were drawn and sent for testing to a government laboratory as per extant rules. As per the test reports received from government laboratory, all the control samples of the 4 products have been found to be complying with specifications,” Drugs Controller General of India, Central Drug Standard Control Organisation, Dr V.G Somani, said in a letter to the WHO’s Director, Regulation and Pre-qualification, Dr Rogerio Gasper.

It also said that the technical committee to examine and analyse the details of the reports has met several times and had requested specific information from the WHO on further details essential to establish the causality. Communications were sent to the WHO on October 15, 20 and 29 this year. Every time, the WHO has maintained that they are in contact with their team handling the case assessment and would get back at the earliest or that their ground partners were working on it. But no information so far has been exchanged by the WHO with the CDSCO, he added in the letter.

“In the present communication, the WHO has declared its mandate to be of ‘identification of global public health risks alone’ and has announced that the responsibility of ‘establishment of causality of deaths’ rests with the countries in question.

“This is a strangely contrary position to the one adopted in the earlier communications where the WHO had affirmed its commitment to provide granular details of the incident on causal relations. It is also a departure from the inflections expressed in the statements issued earlier by the WHO,” the ministry said.

The letter reads that in the aftermath of the alerts received from the WHO regarding the incidents in Gambia, an independent inspection was conducted in 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 public interest.

The excipients (substances other than the medicine’s active ingredient), specifically propylene glycol, available at the manufacturing site at the time of inspection was also sampled and tested and was found to be complying with USP and propylene glycol was not found contaminated with DEG (diethylene glycol) and EG (ethylene glycol). Further the sample of glycerine has also been found to be complying with IP specifications, it said.

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 or EG as per the test reports. These reports have been made available to the technical committee which is examining them, said the ministry.

“All the alerts and the communications received from the onset of the unfortunate event in Gambia have contained references to the deaths of the children and have been formulated in such a manner as to hint that the cough syrup consumption was the primary cause of the mortality. In fact as your email itself indicates, the earlier communication dated September 29, 2022 contains ‘.. .. whose cause of death, or 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 29th itself regarding the cause of death,” added the ministry.

The ministry has said that the statement issued by the WHO in October 2022 was unfortunately amplified by the global media, which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products. This, in turn, has adversely impacted the image of India’s 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.

“We believe that WHO would now allow the technical committee of subject experts constituted by Government of India to arrive at the conclusion based on all the facts and evidence available. We would be more than willing to consider permitting WHO representatives to interact with this technical committee,” the ministry has told the WHO.

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