Country’s drug controller General of India (DCGI) has written a strongly worded letter to Rogerio Gaspar, Director, Regulation and Prequalification, WHO informing that all control samples of the products have been found to be complying with specifications.
“Further, DEG and G 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 aforesaid Technical Committee which is examining them,” VG Somani said in a letter dated December 13.
Somani said that the statement issued by the WHO in October led to a narrative being built internationally targeting the quality of India 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,” it said.
He said that alerts and the communication received from the onset of the event in Gambia have contained references to the deaths of the children and have been presented in such a light as if the cough syrups was the primary cause of mortality.
“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 s e e m s to be a reaffirmation of this deduction, without waiting for independent verification,” it said.
The drug regulator has been writing to the WHO continuously ever since the incident asking them to share the details. However, in the letter he said that 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 letter said.
So far Gambia has also not found any direct causal relation between the cough syrup consumption and the deaths, and that certain children who had died had not consumed the syrup in question.
The drug regulator has asked the WHO to provide details to the technical committee of subject experts constituted by the government 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 letter said.
