The Directorate General of Drug Administration (DGDA) on Monday denied allegations made by Gonoshasthaya Kendra regarding the directorate’s non-cooperation over the coronavirus testing kits invented by the Kendra.
DGDA rather extended all kinds of cooperation to Gonoshasthaya Kendra in the process, director general of DGDA major general Mahbubur Rahman told a press briefing today.
The DG also accused Gonoshasthaya Kendra of making derogatory remarks about DGDA.
Earlier on Sunday, Gonoshasthaya Kendra founder Zafrullah Chowdhury said DGDA did not receive the coronavirus testing kits made by them.
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Zafrullah at an urgent press conference at Gonoshasthaya Kendra’s Dhanmondi office mentioned that the authorities refused to take the kits as these were not ‘approved’.
Three scientists, including the kit inventor Bijon Kumar Shil, were denied entry to the DGDA, he alleged.
Refusing Zafrullah’s claim, DGDA director general said their meeting with Kendra on Sunday was amicable.
A three-member delegation of Gonoshasthaya Kendra came to our office at around 3:00pm. One of them was asked to stay outside in a bid to maintain social distancing, Mahbubur Rahman said.
The DGDA informed Kendra’s delegation about the process to follow for approval, DGDA DG said.
As per the rules, the manufacturing company needs to have a contract with a Contract Research Organisation (CRO) to create a protocol.
The protocol deals with the matters such as if the kit is effective, how to run a trial and on how many people and how long the trial will take. Also, Bangladesh Medical Research Center (BMRC) conducts an evaluation to assess if the manufacturing process was right.
The DGDA allows marketing of the kits upon reviewing the BMRC’s assessment and papers of trial, the DG said, elaborating the process.
Mahbubur Rahman said the committee which gives approval consists of leading scientists and experts of the subject.
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The DGDA DG also said they suggested that Gonoshasthya Kendra work with ICDDR’B, IEDCR or IPH as CRO.
While the Gonoshasthya Kendra delegates said the ICDDRB is locked down, the DG said they suggested about nine more organisations which can work as CRO.
“The meeting was held in amicable manner and later he (Zafrullah Chowdhury) held an emergency meeting at 4:00pm,” Mahbubur Rahman said.
Refuting Zafrullah’s claim, the DG showed three letters sent by Gonoshasthya Kendra appreciating DGDA’s cooperation.
He said Gonoshasthya Kendra sought permission to import reagent on 18 March, the authorities gave the approval on 20 March. The DGDA on 22 March and 6 April visited the Kendra’s laboratory as part of the approval process.
The DGDA DG said they requested Gonoshasthya Kendra to hand over the kits after approval.
The DG also said he would not make any comment on the quality of kits before the test.
