On 13th December 2022, India’s Drugs Controller General Dr VG Somani wrote a letter to Dr Rogerio Gaspar who is the Director of Regulation and Prequalification at the World Health Organization. In this letter, Somani asserted that the Indian cough syrups from Maiden Pharma meet the necessary regulatory standards and are therefore harmless.
He added that the WHO’s statement blaming Indian cough syrups for the deaths of children in Gambia has impacted India’s image in the world in an adverse manner.
Somani’s letter was written in a response to the WHO’s letter dated 6th December 2022.
It is notable that the WHO had blamed India’s Maiden pharmaceuticals for the deaths of children in the Gambia in October. In October 2022, the WHO expressed fears that the children died due to the company’s cough syrup.
Drug Controller of India writes to WHO over the premature 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 adds, “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 further
— 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 ill effects of WHO’s statements on India’s image, Dr VG Somani wrote in 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 also reiterates that the repeated requests by the CDSCO to WHO seeking documentation or any factual information from WHO that formed the basis of their initial claim blaming the deaths in Gambia on Maiden Pharma’s cough syrups have been met with silence from the WHO so far. The letter also says that the initial claim, and subsequent mentions by WHO has only amplified this allegation without any factual basis and Maiden Pharma’s cough syrups were found to be containing no harmful substances.
Dr VG Somani further wrote in 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 12th October 2022, the Central Government constituted a four-member expert committee to probe the World Health Organization (WHO) reports on the deaths of 66 children in the Gambia which was hastily blamed on cough syrups made by Sonipat-based firm Maiden Pharmaceuticals Limited. Maiden Pharmaceuticals Limited firm in Sonipat was instructed to cease producing all cough syrups, according to an order from the Haryana government. A show-cause notice for 12 irregularities discovered at the company’s production facility was also issued. The letter written by Dr VG Somani also informs the WHO director about this.
In November this year, an Economic Times report stated that the specialised agency of the United Nations (UN) has failed to provide the documents, to the Indian authorities, which are required to further the investigation into the deaths of 70 deceased children 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.
