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The Pharmaceutical Export Promotion Council (Pharmexcil) suspended the member of Maiden Pharmaceuticals, the exporter of ‘substandard’ paediatric cough syrups to the Gambia.
“We have sought a response from the company seeking details of the licensees to whom the company had supplied the drugs mentioned in the alert, importers details, manufacturing license and product permissions and also advised it to investigate the reasons of the Serious Adverse Events at your end and update us with the findings,’‘ R Uday Bhaskar, Director - General, Pharmexcil told businessline on Saturday.
“However, as the Council is not in receipt of any inputs/report on the adverse events we have suspended the membership of Maiden Pharmaceuticals with immediate effect,’‘ Bhaskar said.
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The suspension of Registration Cum Membership Certificate (RCMC) by the Council will deprive Maiden of access to any market access schemes and other benefits generally extended to the exporters.
In a recent alert, the World Health Organisation (WHO) identified four products - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup - as ‘substandard’ in the Gambia, that were exported by Delhi -based Maiden Pharma, which operates a plant in Haryana.
The laboratory tests of these products contained unacceptable levels of diethylene glycol and ethylene glycol as contaminants, WHO said, adding that these products have been ‘potentially linked’ with acute kidney injuries and 66 deaths among children.
“At a time when India is being hailed as ‘Pharmacy of the World’ this kind of incident will hit the brand image of Indian pharma exports. We will also write to the Director General of Foreign Trade (DGFT) to suspend the Import-Export Code of Maiden to stop further exports till the investigation is complete,’‘ the Pharmexcil DG said.
The Health Ministry also ordered a probe into the matter.
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