The World Health Organization (WHO) issued a medical product alert after 66 children died in the Gambia, and Maiden Pharmaceuticals was named in that alert. The Pharmaceuticals Export Promotion Council of India (Pharmexcil) suspended Maiden Pharmaceuticals’ membership on Saturday. Due to the suspension, the company’s exports will no longer be eligible for Market Access Initiative Scheme incentives.
The council had previously threatened to suspend the company’s authorization certificate if it did not provide Pharmexcil with information about its licensees and importers by October 7.
In a letter dated October 7 to the company, the council stated, “The council is not in receipt of any inputs/report on the adverse events and hereby states that the membership of Maiden Pharmaceuticals with Pharmexcil is stopped with immediate effect.”
On October 5, the WHO issued a warning instructing governing bodies and the general public to stop using four medicinal items produced by Maiden Pharmaceuticals that had been discovered to be subpar.
On October 6, Pharmexcil requested information about the licensees Maiden Pharmaceuticals provided the pharmaceuticals to, information about the importers, documents of the manufacturing licences, and product permissions for the items in question.
Additionally, it has advised the business to look into the causes of the major bad events and inform the council so that it may take the appropriate further measures.
As certain customers from African countries have expressed worries about the quality of the drugs, the council is also likely to bring up the issue with the Directorate General of Foreign Trade to suspend the pharmaceutical company’s import and export code.
