Top sources in the Union health ministry have said that the World Health Organization (WHO) has been noncommittal about sharing a causality assessment report on Gambian deaths due to cough syrups supplied by Haryana-based Maiden Pharmaceuticals.
Authorities indicated that this report may be crucial to conclusively establish that the kids died due to toxic contaminants in four different cold and cough paediatric syrups supplied to the West African country.
Causality assessment essentially means finding a causal association or relationship between a drug and a drug reaction. It is an evaluation of the likelihood that a particular treatment is the cause of an observed adverse event
Senior officials in the ministry on October 12 stated that the exact one-to-one causal relation of death has not yet been provided by the WHO to the CDSCO although the Indian regulator has requested the information twice.
Experts, however, said that the detection of contaminants diethylene glycol and ethylene glycol in the flagged cough syrups by the WHO and Indian authorities themselves is strong enough evidence against the poor and unsafe quality of the cough syrups, confirming through spot investigations that a key excipient in the cough syrups was not tested for these contaminants.
“In addition, DEG poisoning has certain characteristics such as acute kidney injury, and in most of the 66 kids reported dead in The Gambia due to the adulterated drug, this may be a common thread,” said pharmaceutical expert CM Gulhati.
Buying time?
The WHO, in its alert issued on October 5, had said that “laboratory analysis of samples of each of the four products confirm that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”.
The products included Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
A show-cause notice issued to the company by the Haryana drug regulator, based on joint spot inspections by central and state regulatory authorities and before orders were issued to stop all production at its Sonepat unit, mentions that the firm had failed to produce in-process testing reports of the products in question.
“The firm has not performed the quality testing of Proylene Glycol for Diethylene Glycol and Ethylene Glycol,” said the notice.
Also read I Gambian cough syrup deaths: Health ministry forms four member panel
When the contraventions are so stark, argued S Srinivasan, who is attached to the All India Drug Action Network, stressing that the WHO causality assessment report (is not being made available) may just be a “time buying tactic.”
“The government has put the ball in the WHO’s court and may be trying to show that the culprit may not be identifiable in the absence of the report, which is not the case,” he said.
It is clear that there were gross violations in the drug production, which may have led to fatal impurities going undetected, Srinivasan said, adding that symptoms of DEG poisoning were clear in the children who died in The Gambia.
Moneycontrol wrote to the WHO on Monday seeking details on the causality assessment report but has not heard back from the agency so far. This copy will be updated when it responds.
Calls made to Union health secretary Rajesh Bhushan to seek the government’s official response were also not answered.
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