The Pharmaceutical Export Promotion Council suspended the membership of Maiden Pharmaceuticals, the Haryana-based drugmaker whose four cough syrups are linked to deaths of 66 children in The Gambia, The Hindu Businessline reported on Saturday.
The World Health Organization had issued an alert about the syrups on Wednesday.
“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 licence and product permissions and also advised it to investigate the reasons for the Serious Adverse Events at your end and update us with the findings,” said R Uday Bhaskar, director of the council, which is also known as Pharmexil.
The suspension cuts off Maiden Pharmaceuticals from the Market Access initiative under which incentives up to Rs 2 crore are given to a company that registers their products with a drug or health regulator abroad, The Hindu Reported.
After suspending the company, Pharmexcil could also urge the directorate general of foreign trade to withdraw the import-export code of the company, making it ineligible to export items, Bhaskar said.
The Union health ministry is also investigating the matter and providing assistance to The Gambia. It said that an inquiry by the Central Drugs Standard Control Organisation has shown that the medicines are manufactured for export purposes only.
The ministry added that samples of the medicines have been sent for testing to the Central Drugs Standard Control Organisation laboratory in Chandigarh and that the results are awaited.
The World Health Organization had said that the medicines were potentially linked with cases of “acute kidney injuries” that resulted in the deaths of children in the west African country. It also cautioned that the medicines may have been distributed to other countries. It has recommended all countries detect and remove the products from circulation to prevent further harm to patients.