Maiden Pharma Cough Syrup Row: Gambian Parliament Seeks Legal Action

The issue of cough syrups manufactured by Maiden Pharmaceuticals allegedly leading to deaths of 70 children in Gambia was raked up again in the African nation.

According to BBC, a parliamentary committee in Gambia has recommended prosecution of “an Indian manufacturer of cough syrups suspected of causing deaths of at least 70 children in the West African country”.

The Union Ministry of Health could not be reached for comment on the matter. Maiden Pharma, too, could not be reached for a comment.

According to the report, after weeks of investigation, the Gambian parliamentary committee decided that authorities should take tough measures, including banning all Maiden Pharmaceutical products in the country, and also take legal action against the firm.

The findings show that the four cough syrups under the scanner — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — were contaminated with diethylene glycol and ethylene glycol.

This is in stark contrast to what the Indian regulator found in its inspection of cough syrup samples from Maiden Pharma’s Sonipat plant. Drugs Control General of India (DCGI) V G Somani had written to WHO, saying samples of Maiden Pharma’s four cough syrups under scanner that were sent to government laboratories for testing have been found to be “complying with specifications”.

DEG and EG were not detected in these products, the Indian regulator had said, and therefore, these were not found to be contaminated. The excipients, specifically propylene glycol, were sourced from Goel Pharma Chem, Delhi, which had imported these from South Korea.

Glycerine was sourced again from Goel Pharma Chem, who had sourced it from Adani Wilmar. Further, samples of excipients found from the manufacturing site of Maiden Pharma were also found to be complying with specifications.

Indian authorities, however, did not decide to re-open the Maiden Pharma plant, saying the shutdown was ordered due to violations in good manufacturing practices (GMP). The Haryana state regulator had said a joint team comprising inspectors from the state FDA and CDSCO will visit the plant for a re-inspection before it can be allowed to be re-opened.

WHO, however, said samples tested in Ghana and Switzerland were found to be contaminated.

A WHO spokesperson told Business Standard: “WHO-contracted laboratories in Ghana and Switzerland tested the suspected cough syrups products from Gambia and confirmed excess levels of ethyleneglycol and diethyleneglycol. These contaminated syrups are dangerous and should not be in any medicine, ever.”

“WHO’s mandate is to issue global alerts about potential risks. WHO stands by the action taken,” the agency said.