WHO made early link between Gambian child deaths and Indian cough syrups: Drugs Regulator

New Delhi:

The WHO made a premature link between the deaths of children in The Gambia and the four Indian-made cough syrups that negatively affected the image of the country’s pharmaceuticals around the world, India’s medicines regulator told the health body. world.

In a more recent letter to Dr. Rogerio Gaspar, WHO Director (Regulation and Prequalification), the Comptroller General of Medicines of India (DCGI), Dr. VG Somani, said that a statement issued by the world health body in October in the wake of the deaths “was unfortunately amplified by the global media, leading to the construction of an international narrative targeting the quality of Indian pharmaceuticals.”

The DCGI said the Gambia has reported, according to the media, that a direct causal relationship between the consumption of the cough syrup and the deaths has not yet been established, and that certain children who died had not consumed the syrup in question.

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

These reports have been made available to the technical expert committee set up to review and analyze the details of the reports and adverse events received from WHO. The DCGI reiterated full cooperation and collaboration with the WHO and said that the Central Drug Standards Control Organization (CDSCO) has already shared available details with the WHO on a regular basis.

He said that before the committee took over this role, CDSCO had asked WHO on October 4 and 10 for details on the causal relationship, to which WHO reported on October 10 that its team in The Gambia is finalizing the relationships. causal. Subsequently, in an email on October 13, the WHO reported that it has not yet received more information about it and that several partners on the ground are working on it.

“The technical committee mentioned above has met several times. Each time the committee requested specific information from WHO on more essential details to establish causality. Communications were sent to WHO on October 15, October 20, and October 29. October 2022. “Every time WHO has maintained that it is in contact with its team that deals with the evaluation of the case and that it would communicate as soon as possible or that its field partners were working on it. But so far, WHO has not exchanged information with CDSCO,” Mr. Somani stated in the letter written on December 13.

The DCGI said that India has committed to rigorous monitoring and supervision to ensure that the highest manufacturing standards in quality control of medicines and cosmetics are upheld.

Following the alerts received from the WHO about the incidents in The Gambia, an independent inspection was carried out at the facilities of Maiden Pharmaceuticals, the firm in question.

A notice of justification has been issued to the company under the provisions of the Indian Medicines and Cosmetics Act for violating several Good Manufacturing Practices (GMPs) and for failing to produce the complete manufacturing and testing records as per the rules existing.

“In this communication, WHO has stated that its mandate is to ‘identify only global public health risks’ and has announced that the responsibility for ‘establishing causation of deaths’ rests with the countries concerned.

“This is a strangely contrary position to that taken in previous communications where the WHO had affirmed its commitment to provide granular details of the incident on the causal relationship. It is also a departure from the inflections expressed in previously issued statements by the WHO,” , the DCGI mentioned in the letter.

Furthermore, it would be interesting to note that all the alerts and communications received since the start of the unfortunate event in The Gambia contained references to the deaths of the children and were phrased in such a way as to imply that the consumption of cough syrup was the main cause of the deaths. mortality, the letter said.

“Indeed, as your own email indicates, the above communication dated September 29, 2022 contains “…whose cause of death, or significant contributing factor, was suspected to be the use of medications that may have been contaminated with diethylene glycol or ethylene glycol.”

“It is clear that perhaps a premature deduction was made on September 29 regarding the cause of death. Each subsequent WHO alert or publication only appears to be a reaffirmation of this deduction, without waiting for independent verification,” Somani said.

Unfortunately, the statement issued by the WHO in October was amplified by the global media, leading to an international narrative being built targeting the quality of Indian pharmaceuticals, he said.

“This, in turn, has negatively affected the image of Indian Pharmaceuticals across the globe and caused irreparable damage to the Pharmaceutical supply chain as well as the reputation of the national regulatory framework by an assumption that has not yet been corroborated by the WHO or its partners on the ground,” DCGI said.

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