A total of 69 children lost their lives from kidney injury linked to contaminated India-made cough syrups, Gambia’s Health Minister Ahmadou Lamin Samateh told journalists in Banjul Saturday.
Experts had said that Propylene glycol, which is used to manufacture drugs, can contain contaminants like diethylene glycol and ethylene glycol. These two chemicals have been named by the World Health Organization (WHO) as possible causes of the deaths of children in The Gambia.
The show-cause notice was issued by the Haryana drug authorities to Maiden Pharma after a joint inspection with the Central Drugs Standard Control Organisation (CDSCO) on October 7, according to The Hindustan Times.
"The firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol," the notice read, adding that the pharma company has to reply to the notice by October 14, failing which action may be taken against it.
According to the notice, Propylene glycol (batch number E009844) having a manufacturing date of September 2021 and expiry date of September 2023 was used in the manufacturing of Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, and MaGrip n cold syrup having a product expiry of November 2024, which indicates that the shelf life of the drugs was fixed to be longer than the expiry period of the raw material.
The four cough syrups linked to the deaths in the West African nation are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
Experts, as quoted by HT, said that quality tests should have been performed on the stock of propylene glycol to check for contamination because it is expensive which may lead to mixing.
Recently, the WHO issued an alert stating that laboratory analysis of samples of each of the four products confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol.
During the inspection, the Haryana drug controller also said that the batch of chemicals in question was not mentioned in the certificate of the analysis report.
In the notice, the state drug controller said, "The pharma firm has not performed process validation and analytical method validation for the drug products in question."
The show-cause notice was issued to the Maiden pharma company under Section 85 (2) of the Drugs and Cosmetics Rules which pertains to the cancellation and suspension of the license of the firms.
