Child Deaths in The Gambia | WHO has made premature link to cough syrups made in India, medicines agency says

A photo shows collected cough syrup in Banjul in The Gambia on October 6, 2022.

A photo shows collected cough syrup in Banjul in Gambia on October 6, 2022. | Photo credit: AFP

WHO has made a hasty link between the deaths of children in The Gambia and the four Indian-made cough syrups that have negatively impacted the image of the country’s pharmaceutical products around the world, the Indian Medicines Agency told the global health agency.

In the recent letter to Dr. Rogerio Gaspar, Director (Regulation and Prequalification) at WHO, said Dr. VG Somani, Drugs Controller General of India (DCGI), a statement issued by the global health agency in October following the deaths was unfortunately amplified by the global media, resulting in a narrative being built internationally that emphasizes the quality of Indian pharmaceutical products”.

Also read | Explained: The Gambian Deaths and the Toxic Cough Syrups That Cause Them

The DCGI said The Gambia had informed media that no direct causal link between cough syrup use and the deaths had yet been established and that certain children who had died had not consumed the syrup in question.

In the letter, Somani said samples of four Indian-made cough syrups linked to the deaths of 66 children in The Gambia, tested at a government laboratory here, met specifications and were not contaminated with DEG or EG, according to the test reports.

These reports were made available to the Technical Expert Committee, which was set up to review and analyze the details of the reports and adverse events received from WHO.

The DCGI reaffirmed its full collaboration and collaboration with the WHO and said the Central Drugs Standard Control Organization (CDSCO) had already regularly shared available details with the WHO.

He said that before the committee took on that role, CDSCO asked WHO on October 4 and 10 for details on the causality relationship, which WHO informed on October 10 that their team in The Gambia was finalizing the causality relationships.

The WHO then announced in an October 13 email that they had not yet received any further information on this and that several local partners were working on it.

“The technical committee mentioned above has met several times. Each time, the committee has requested specific information from WHO for further details essential to establishing causality. Notifications were sent to WHO on October 15, October 20 and October 29, 2022. Each time WHO has claimed they are in contact with their team handling the case assessment and would get back to them at the earliest or that their ground partners are working on it. So far, however, no information has been shared by WHO with CDSCO,” explained Dr Somani in the letter dated 12/13.

According to the DCGI, India is committed to strict monitoring and monitoring to ensure the highest manufacturing standards are maintained in the quality control of pharmaceuticals and cosmetics.

An independent inspection was carried out at the premises of Maiden Pharmaceuticals, the company concerned, following the WHO warnings about the incidents in The Gambia.

The company has been issued with a notice of violation of various Good Manufacturing Practices (GMP) under the provisions of the Indian Drugs and Cosmetics Act and failure to provide full manufacturing and testing records in accordance with applicable regulations. “In the present communication, WHO has stated that its mandate is “to identify solely global public health risks” and has announced that the responsibility for “determining the causality of deaths” lies with the countries concerned. This is a strangely opposite position to that adopted in the previous communications, in which the WHO reaffirmed its commitment to provide granular details of the causal link incident. It is also a departure from the inflections expressed in the WHO’s previous statements,” the DCGI mentioned in the letter.

Additionally, it would be interesting to note that all warnings and notices received in The Gambia since the unfortunate event began contained references to the deaths of the children and were worded in a way that suggested the cough syrup consumption was the primary cause of mortality, the letter says.

“As your email itself indicates, the earlier notice, dated September 29, 2022, “…whose cause of death or significant contributory factor was suspected of using drugs potentially contaminated with diethylene glycol or ethylene glycol.”

“It is clear that an early deduction as to cause of death may have been made on September 29 itself. Any subsequent warning or publication by the WHO appears to be just a reconfirmation of this deduction, without waiting for independent verification,” Somani said.

Unfortunately, the WHO’s October statement was amplified by the global media, resulting in a narrative being built internationally targeting the quality of Indian pharmaceutical products, he said.

“This in turn has negatively affected the image of India’s pharmaceutical products around the world and caused irreparable damage to the pharmaceutical supply chain and the reputation of the national regulatory framework due to an as yet unproven acceptance by the WHO or its local partners,” said the DCGI.

Leave a Reply

Your email address will not be published. Required fields are marked *