MELBOURNE/NEW DELHI, 18 December 2022: India and World Health Organisation (WHO) lock horns over the Indian cough syrups exported to Gambia, that allegedly killed more than 60 children. While India says the cough syrups were fine, the WHO stands by its international alert against the syrups.
India has informed the World Health Organisation (WHO) that samples taken and analysed from Maiden Pharma, whose cough syrup was linked to deaths of children in Gambia, complied with legal specifications. India says the WHO was “presumptuous” about its opinion on the issue.
But the WHO has said “WHO’s mandate is to issue global alerts about potential risks. WHO stands by the action taken,” an official told the BBC over email. The health body added that the “contaminated syrups are dangerous and should not be in any medicine, ever”. Earlier, the WHO said four cough syrups produced by Maiden Pharma contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”.
In a Medical Product Alert this year the WHO said – ” Ethylene glycol and diethylene glycol are toxic to humans when consumed and can prove fatal. The substandard products referenced in the annex of this Alert are unsafe and their use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.”
The Indian government’s response came in reply to a question in its Parliament. Bhagwant Khuba, India’s central Minister of State for Chemical and Fertiliser in a written reply in the Rajya Sabha (upper house) said, “As per the report of the Government Analyst, the samples have been declared to be of standard quality. The said samples were also found negative for both Diethylene Glycol (DEG) and Ethylene Glycol (EG).”
ANI reports: In the letter to World Health Organization’s director of regulation and prequalification Rogerio Gaspar, Drugs Controller General VG Somani said that a technical committee constituted by the Government of India found that “the products have been found not to have been contaminated with DEG or EG as per the test reports.” A four-members subject experts’ technical committee was formed, chaired by Dr Y K Gupta, Vice Chairperson, Standing National Committee on Medicines with experts from the National Institute of Virology-ICMR, Pune, National Centre for Disease Control (NCDC) and CDSCO also in the team.
This committee was formed after the reports of deaths in the Gambia caused by the Indian firm Maiden Pharmaceuticals’ cough syrup came forefront. Till December 15, deaths in Gambia reached 66.
“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. In the aftermath of the alerts received from WHO regarding the incidents in Gambia, an independent inspection was conducted on the premises of Maiden Pharmaceuticals, the firm in question. A show cause notice was issued to the firm under provisions of India’s Drugs and Cosmetics Act for violation of various Good Manufacturing Practices (GMP), and for not producing the complete records of manufacturing and testing as per the extant rules. Considering the observations made during the inspection, the manufacturing activities of the firm were stopped forthwith in the public interest CDSCO has already Informed WHO in this regard. It is to emphasize that the above action was taken exclusively for GMP violations by the firm,” the letter reads.
“Further, WHO had been informed that the samples of these 04 products in question were drawn and sent for testing to Government Laboratory as per extant rules. As per the test reports received from the Government laboratory, all the control samples of the 04 products have been found to be complying with specifications,” the letter added.
The letter also noted that all the alerts and the communications received from the onset of the Gambia have contained references to the deaths of the children and have been formulated in such a manner as to hint that cough syrup consumption was the primary cause of the mortality.
It further stated that the previous email, dated September 29, 2022, contains “…whose cause of death, or a significant contributing factor was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol or Ethylene glycol.”
It is clear that perhaps or premature deduction was drawn on September 29 itself regarding the cause of death. Every subsequent alert or publication from the WHO only seems to be a reaffirmation of this deduction without waiting for independent verification.”
