Pharma exporters body suspends membership of Maiden Pharmaceuticals
Pharma exporters body suspends membership of Maiden Pharmaceuticals
Pharma exporters body Pharmexcil has suspended the membership of Maiden Pharmaceuticals, the Delhi-based drugmaker facing a probe after the World Health Organization red-flagged four products following the death of 66 children in the West African country of Gambia.
Pharmaceuticals Export Promotion Council of India Director General Ravi Udaya Bhaskar said that the membership of Maiden Pharmaceuticals is being suspended with immediate effect as the Council hadnot received any input or report on the adverse events from the company.
On October 6, Pharmexcil had sought details of licensees and importers to whom the drugs were supplied as well as the manufacturing licence copies and product permissions of the products from Maiden. Failure to provide the information will result in the company’s registration cum membership certificate (RCMC) getting suspended without further notice, it had said, setting October 7 as deadline for the responses.
Additionally, the exporters body under the Union Commerce Ministry had advised the firm to investigate reasons of the serious adverse events and update with findings “at the earliest to take necessary further action.”
Close on the heels of the WHO medical product alert, the Central Drugs Standard Control Organisation (CDSCO) launched an investigation. It also sought more information from the WHO, which named the firm as manufacturer of the four cold and cough syrup formulations potentially linked to acute kidney injury and death of the children.
CDSCO took up the matter immediately with Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden is located. A detailed investigation was launched to ascertain facts/ details in the matter in collaboration with the State Drugs Controller, Haryana, the Union Health Ministry had said.
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