The DCGI said the Gambia has informed, according to media, that there has been no direct causal relation established yet between the cough syrup consumption and the deaths, and that certain children who had died had not consumed the syrup in question.
The WHO drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country’s pharmaceutical products across the globe, India’s drug regulator has told the global health body.
"I have full faith in Indian regulatory and judiciary processes. I have not done anything wrong," Maiden Managing Director Naresh Kumar Goyal told Reuters, adding, "We will now try to request the authorities to reopen the factory. But I don't know when that will happen. We are still waiting."
In the latest letter to Dr Rogerio Gaspar, Director (Regulation and Prequalification) at WHO, Drugs Controller General of India (DCGI) Dr V G Somani said a statement issued by the global health body in October in the wake of the deaths “was unfortunately amplified by the global media which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products”. The DCGI said the Gambia has informed, according to media, that there has been no direct causal relation established yet between the cough syrup consumption and the deaths, and that certain children who had died had not consumed the syrup in question.
In the letter, Somani said the samples of four made-in-India cough syrups linked to the deaths of 66 children in Gambia which were tested in a government laboratory here were found to be complying with specifications and not to have been contaminated with DEG or EG according to the test reports.
These reports have been made available to the technical committee of experts constituted to examine and analyse the details of the reports and adverse events received from WHO. The DCGI reiterated full cooperation and collaboration with WHO and said Central Drugs Standard Control Organisation(CDSCO) has already shared available details with WHO regularly. He said prior to the committee taking over this role, CDSCO had requested WHO on October 4 and 10, for details on causality relationship to which WHO, on October 10 communicated that its team in Gambia is finalising the causal relations. Thereafter, in a mail dated October, 13 WHO communicated that it is yet to receive any further information in this regard and several partners on the ground are working on it.
“The technical committee mentioned above, has met several times. Each time the committee had requested for specific information from WHO on further details essential to establish the causality. Communications were sent to the WHO on 15th October, 20th October and on 29th October, 2022. Every time 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 WHO with CDSCO,” Somani stated in the letter written on December 13.
The DCGI said 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 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. “In the present communication 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 WHO had affirmed its commitment to provide granular details of the incident on causal relation. It is also a departure from the inflections expressed in the statements issued earlier by the WHO,” the DCGI mentioned in the letter.
Further, it would be interesting to note that 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, the letter said. “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 premature deduction was drawn on September 29th 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,” Somani said.
The statement issued by the WHO in October was unfortunately amplified by the global media which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products, he said.
“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,” the DCGI said.
(with PTI inputs)