DCGI said India has committed to closely monitor its drugs. (Represent)
New Delhi:
India’s drug regulator has told global health authorities that the WHO had made a link early on between the deaths of children in the Gambia and the four Indian-made cough syrups that affected it. bad for the image of the country’s pharmaceutical products globally.
In a latest letter to Dr. Rogerio Gaspar, Director (Regulation and Prequalification) at WHO, Directorate General of Drug Control of India (DCGI), Dr. VG Somani said in a statement issued by the health authority. released in October after the deaths “unfortunately were exaggerated by the global media leading to an internationally constructed narrative aimed at the quality of pharmaceutical products India”.
DCGI says Gambia has informed, according to media reports, that no direct cause-and-effect relationship has yet been established between cough syrup consumption and deaths, and that some children death did not use the syrup mentioned.
In the letter, Mr. Somani said samples of four types of cough syrup made in India linked to the deaths of 66 children in the Gambia tested in a government laboratory here were found to be: compliant with specifications and free from DEG or EG contamination according to test reports.
These reports were made available to a technical committee of experts formed to examine and analyze the details of reports and adverse events received from WHO. DCGI reiterated its full cooperation and collaboration with WHO and said that the Central Drug Standards Control Organization (CDSCO) shared the detailed information available with WHO on a regular basis.
He said that before the committee assumed this role, CDSCO asked WHO on 4 and 10 October, for details of the causal relationship that WHO, on 10 October announced that the group of they in the Gambia are perfecting cause-and-effect relationships. Then, in a letter dated October 13, WHO announced that it had yet to receive any further information on the matter and that several partners were working on it.
“The above-mentioned technical committee has met several times. Each time the committee has asked WHO to provide specific information on other details necessary to establish causality. Contact information has been sent to WHO. on October 15, October 20, and October 29, 2022. WHO has confirmed each time that it is communicating with its team handling the case assessment and will get back to you at the earliest, or that partners Their ground partners are working on it. But so far, WHO has not communicated anything with CDSCO,” Somani said in the letter dated December 13.
DCGI said India has committed to close monitoring and supervision to ensure that the highest production standards are maintained in the quality control of medicines and cosmetics.
After receiving a warning from WHO about incidents in Gambia, an independent inspection was conducted at the facility of Maiden Pharmaceuticals, the company in question.
A notice of cause for display has been given to the company under the terms of the Pharmaceutical and Cosmetic Act of India for violating various Good Manufacturing Practices (GMP) and for failing to export Complete production and testing records in accordance with applicable regulations.
“In current communications, WHO has stated its mandate to ‘identify only global public health risks’ and has stated that it is responsible for ‘establishing causality of cases’. deaths” belong to the countries mentioned.
“This is a position that is in contrast to the position adopted in previous communications when WHO confirmed its commitment to provide details of the case regarding causality. “DCGI mentioned in the letter.
Furthermore, it will be interesting to note that all warnings and communications received since the beginning of the unfortunate event in The Gambia are related to the deaths of children and have been elaborated upon. suggested that the consumption of cough syrup was the primary cause of death, the letter said.
“In fact, as your own email pointed out, the previous communication on September 29, 2022 saying “…cause of death or significant contributing factor, is suspected to be” due to drug use may have been contaminated with Diethylene Glycol or Ethylene glycol.”
Mr. Somani said: “It is clear that perhaps too early inferences were drawn on September 29 about the cause of death. Any subsequent warnings or announcements from WHO appear to be merely a re-affirmation of this inference. without waiting for independent verification”.
The statement issued by the WHO in October was unfortunately amplified by the global media, he said, leading to an internationally constructed narrative targeting the quality of pharmaceutical products. of India.
“This in turn has adversely affected the image of India’s pharmaceutical products globally and caused irreparable damage to the pharmaceutical products supply chain, as well as the reputation of the framework.” national legislation against a presumption that has not been proven by WHO or its partners on the ground,” said DCGI.
(Except for the title, this story has not been edited by NDTV staff and is published from an aggregated feed.)
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