Pharmexcil suspends its membership of Maiden Pharma

The Pharmaceutical Export Promotion Council (Pharmexcil) has suspended the member of Maiden Pharmaceuticals, the exporter of ‘substandard’ pediatric cough syrups to The Gambia.

“We requested a response from the company requesting details of license holders to whom the company had supplied the drugs mentioned in the alert, details of importers, manufacturing license and product authorizations and also advised them to investigate the reasons for the serious adverse events at your end and let us know the results,” said R Uday Bhaskar, Managing Director of Pharmexcil activity area Saturday.

“However, as the Board received no input/adverse event reports, we have suspended Maiden Pharmaceuticals’ membership with immediate effect,” Bhaskar said.

Suspension of Registration and Membership Certificate (RCMC) by the Council will deprive Maiden of access to all market access programs and other benefits generally granted to exporters.

In a recent alert, the World Health Organization (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, which have been exported by Delhi Maiden Pharma, which operates a factory in Haryana.

Laboratory tests of these products contained unacceptable levels of diethylene glycol and ethylene glycol as contaminants, the WHO said, adding that these products have been “potentially linked” to acute kidney injury and 66 deaths in children.

“At a time when India is hailed as the ‘Pharmacy of the World’, this type of incident will damage the image of Indian pharmaceutical exports. We will also write to the Director General of Foreign Trade (DGFT) to suspend Maiden’s import-export code to stop further exports until the investigation is complete,’ DG Pharmexcil said.

The Ministry of Health has also ordered an investigation into the case.

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