Bhartesh Singh Thakur
Chandigarh, November 26
As no action has been initiated against Maiden Pharmaceuticals in India over the four “contaminated” baby syrups due to a delay in the lab test reports, the Ministry of Health, Gambia, has put out an acute kidney injury (AKI) update, specifying that there were 82 confirmed cases, of which 70 kids died.
No action, only notice issued
- Of the 82 children, 75 were aged between 1 and 3, while seven were in the four to seven age group
- Haryana has so far only issued a notice to Maiden Pharma on the cancellation/suspension of the licence
Of the 82 children, 75 were aged between 1 and 3, while seven were in the four to seven age group. There were 50 males and 32 females.
In a tweet on November 13, Gambia’s Health Ministry cautioned parents and caregivers not to give the “contaminated” baby syrups manufactured by Sonepat-based Maiden Pharmaceuticals that included Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The pictures of the syrups have also been posted.
In another tweet by the WHO, Gambia, on November 17, it was informed that both Gambia’s Health Ministry and the WHO were engaging religious leaders around the country to sensitise people to the AKI situation and how the community could support in reporting and controlling such incidences in future.
Back home, the Haryana Government has so far only issued a notice to Maiden Pharmaceuticals on the cancellation/suspension of the licence. The production at the unit has been halted.
For further action, the laboratory test report is awaited from the Central Drugs Standard Control Organisation for the past two months.
Throwing light on testing of the control samples taken from the unit, former State Drug Controller, Haryana, GL Singhal said, “The control samples for any batch of medicine help a firm withdraw its stock if issues related to the quality of a drug arise. Legally, the control samples have to be kept for a particular period. However, a manufacturer can change the control samples to prevent a drug from failing the test. So, the regulatory authority has to seize the control samples as soon as it gets information about the quality or toxicity of drugs like in the case of the syrups of Maiden Pharmaceuticals.”
The notice issued to Maiden Pharmaceuticals on October 7 points out that the “firm has submitted the 6-month real-time and accelerated stability data of the drugs (syrups exported to Gambia) in question. However at the time of the investigation, none of drugs were found charged in the stability chamber”.
“It implies that the data may have been cooked,” said Singhal. Another expert, who did not want to be named, said control samples were subject to manipulation.
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