Spurious drugs: 41K bottles of syrups recalled in Gambia
Bhartesh Singh Thakur
Chandigarh, October 16
Sonepat-based Maiden Pharmaceuticals had exported 50,000 units of four cough syrups to Gambia, of which 41,000 have been recalled so far. However, over 8,000 units are still unaccounted for.
The four syrups banned in Gambia
- Promethazine oral solution BP
- Kofexmalin Baby Cough Syrup
- MaKOFF BABY Cough Syrup
- MaGrip n Cold Syrup
Kids’ toll rises to 70
- The Gambian authorities have revised the number of children’s deaths due to cough syrups to 70
- A cabinet meeting under President Adama Barrow has set up a Commission of Inquiry into the kids’ deaths
The four cough syrups — Promethazine oral solution BP, Kofexmalin Baby Cough Syrup, MaKOFF BABY Cough Syrup and MaGrip n Cold Syrup — are banned in Gambia and the WHO also issued an alert on October 5 after laboratory tests revealed the presence of diethylene glycol and ethylene glycol. These syrups are suspected to be linked to the death of over 66 children in Gambia.
Promethazine oral solution BP was granted permission for export in 2019. According to a show-cause notice issued to Maiden Pharmaceuticals on October 7, the batch which was exported to Gambia had a commencement date in the Batch Manufacturing Record (BMR), which is a record of manufacturing of a product step by step, of February 27, 2022, and completion on March 1, 2022. However, the date of manufacturing on the label was December 2021. As many as 10,000 bottles of the product were exported.
Kofexmalin Baby Cough Syrup was granted export permission on February 24, 2022. The commencement date of the product mentioned in the BMR was February 26, 2022, and the completion was on March 1, 2022, but on the label, the date of manufacturing was mentioned as December 2021. As many as 10,000 bottles of the syrup were exported.
For MaKOFF BABY Cough Syrup, the product permission for export was granted in 2019. Here too, in the BMR, the commencement date was mentioned as February 22, 2022, and the date of completion as February 23, 2022, but on the label, the manufacturing date was mentioned as December 2021. Its 15,000 bottles were exported.
MaGrip n Cold Syrup got permission for export on February 24, 2022. In the BMR, the date of commencement was mentioned as February 24, 2022, and completion on February 26, 2022, whereas on the label, the date of manufacturing was mentioned as December 2021. Its 15,000 bottles were exported.
The show-cause notice mentioned that there were discrepancies with respect to the date of manufacturing as per the product label, the date of manufacturing as per the BMR and product permission dates.
It was Atlantic Pharmaceuticals Company Limited that imported the syrups into Gambia in June this year. Soon, children’s deaths started getting reported.
Meanwhile, the Gambian authorities have revised the number of deaths due to syrups to 70 as on October 13.
A cabinet meeting under President Adama Barrow on October 14 set up a broad-based Commission of Inquiry into the children’s deaths, whose terms of reference and composition will be gazetted shortly, according to a release from the office of the Gambia President. The WHO, and the Centre for Disease Control (CDC) of the US and Africa are looking into the medical causes of acute kidney injury deaths among children and related medical matters, added the release.
