WHO by no means supplied any proof that hyperlinks youngster deaths in Gambia to Indian cough syrup, amplified blame: Drug Controller General

On thirteenth December 2022, India’s Drugs Controller General Dr VG Somani wrote a letter to Dr Rogerio Gaspar who’s the Director of Regulation and Prequalification on the World Health Organization. In this letter, Somani asserted that the Indian cough syrups from Maiden Pharma meet the mandatory regulatory requirements and are due to this fact innocent.

He added that the WHO’s assertion blaming Indian cough syrups for the deaths of kids in Gambia has impacted India’s picture on the planet in an opposed method.

Somani’s letter was written in a response to the WHO’s letter dated sixth December 2022.

It is notable that the WHO had blamed India’s Maiden prescribed drugs for the deaths of kids within the Gambia in October. In October 2022, the WHO expressed fears that the youngsters died because of the firm’s cough syrup.

Drug Controller of India writes to WHO over the untimely conclusion linking Indian-made cough syrups to deaths in Gambia. pic.twitter.com/ytyYdhrJOp

— ANI (@ANI) December 16, 2022

The letter reads, “Central Drugs Standard Control Organization (CDSCO) would like to reiterate its full cooperation and collaboration with WHO on the subject. In line with this spirit, CDSCO has already shared available details with WHO regularly. However, it is to reiterate that subsequent to the initial reports received from WHO on the possible causality relationship between drugs manufactured in India and deaths in Gambia, the Government of India constituted a technical committee of subject experts to examine and analyze the details of the reports/ adverse events/ COAS received from WHO.”

“All control samples of 4 cough and cold syrups manufactured by Maiden Pharmaceutical were sent for testing to Government Laboratory as per extant rules and all the 4 products have been found to be of standard quality,” the letter reads

— ANI (@ANI) December 16, 2022

It provides, “India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacturing are maintained in quality control of drugs and cosmetics. In the aftermath of the alerts received from WHO regarding the incidents in Gambia, an independent inspection was conducted in the premises of Maiden Pharmaceuticals, the firm in question.”

“India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacture are maintained in quality control of drugs and cosmetics,” the letter reads additional

— ANI (@ANI) December 16, 2022

The letter asserted, “All control samples of 4 cough and cold syrups manufactured by Maiden Pharmaceutical were sent for testing to Government Laboratory as per extant rules and all the 4 products have been found to be of standard quality.”

Underlining the ailing results of WHO’s statements on India’s picture, Dr VG Somani wrote within the letter, “The statement issued by the WHO in October 2022 was unfortunately amplified by the global media which led to a narrative being built internationally targeting the quality of Indian 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 the repute of the national regulatory framework over an assumption that has yet not been substantiated by the WHO or its partners on the ground.”

Somani’s letter additionally reiterates that the repeated requests by the CDSCO to WHO looking for documentation or any factual info from WHO that fashioned the premise of their preliminary declare blaming the deaths in Gambia on Maiden Pharma’s cough syrups have been met with silence from the WHO to this point. The letter additionally says that the preliminary declare, and subsequent mentions by WHO has solely amplified this allegation with none factual foundation and Maiden Pharma’s cough syrups have been discovered to be containing no dangerous substances.

Dr VG Somani additional wrote on this letter, “It may be emphasized here that the Gambia informed that there has been no direct causal relation established yet between the cough syrup consumption and the deaths, and that certain children who had died had not consumed the syrup in question. We believe that WHO would now allow the technical committee of subject experts constituted by the Government of India 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.”

On Wednesday twelfth October 2022, the Central Government constituted a four-member knowledgeable committee to probe the World Health Organization (WHO) experiences on the deaths of 66 youngsters within the Gambia which was swiftly blamed on cough syrups made by Sonipat-based agency Maiden Pharmaceuticals Limited. Maiden Pharmaceuticals Limited agency in Sonipat was instructed to stop producing all cough syrups, based on an order from the Haryana authorities. A show-cause discover for 12 irregularities found on the firm’s manufacturing facility was additionally issued. The letter written by Dr VG Somani additionally informs the WHO director about this.

In November this yr, an Economic Times report acknowledged that the specialised company of the United Nations (UN) has failed to offer the paperwork, to the Indian authorities, that are required to additional the investigation into the deaths of 70 deceased youngsters in Gambia.

“The Central Drugs Standard Control Organisation(CDSCO), the drug regulator in India, has written thrice to the World Health Organisation but to no avail. It has so far received no response from WHO”, the report had added.