'Compliant with norms': India to WHO on cough syrups and Gambia kids' deaths

All four cough syrup samples of Maiden Pharmaceuticals tested by the government have been found compliant with norms, the national drugs controller said in a recent letter to the World Health Organization (WHO) representative in Geneva, and reiterated India was yet to receive data to establish deaths in The Gambia, where the products were linked to fatalities in children.

Four cough syrups manufactured by Indian drug maker Maiden Pharmaceuticals were said to be linked to at least 66 deaths of children in The Gambia.

In a briefing on October 5, WHO issued a medical product alert over four cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — manufactured and exported by Maiden Pharma.

Also read | No confirmation yet on cough syrups causing deaths: Gambia body

WHO said in its alert that two toxic contaminants, diethylene glycol and ethylene glycol, were found in the four cough syrups.

“… WHO had been informed that the samples of these 4 products in question were drawn and sent for testing to the government laboratory as per extant rules. As per the test reports received from the government laboratory, all the control samples of the 4 products have been found to be complying with specifications,” said the drugs controller general of India, VG Somani, in his letter addressed to Rogerio Gaspar, director, Regulation and Prequalification, WHO, on Tuesday.

HT has seen a copy of the letter.

READ | Samples from pharma firm linked to Gambia deaths within guidelines: India to WHO

“Further, DEG and EG were not found to be detected in these products and the products have been found not to have been contaminated with DEG or EG a s per the test repots. These reports have been made available to the government technical committee which is examining them.”

Propylene glycol, which is used to manufacture drugs, can contain contaminants diethylene glycol and ethylene glycol – the two toxic chemicals were named by WHO as possible causes for the deaths – and strict quality control needs to be ensured, according to experts.

“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,” said Somani in the letter.

In the aftermath of the alerts received from WHO regarding the incidents in The Gambia, an independent inspection was conducted in the premises of Haryana based Maiden Pharmaceuticals.

READ | No confirmation yet on cough syrups causing deaths: Gambia body

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 rules.

Regarding the establishment of causality, Somani pointed out that WHO seemed to have shifted its stance, even as The Gambia itself announced there didn’t seem yet any causal relationship between the deaths and syrup consumption.