U.K. regulators uncover data integrity issues at Bangladesh drugmaker

A Bangladeshi company that would like to sell an antibiotic in the U.K. has been stopped before it started after regulators denied it a manufacturing certificate.

 

The Acme Laboratories had applied to manufacture metronidazole for the U.K., but when inspectors visited its plant in Dhulivita, Dhamrai, Dhaka, they uncovered reasons to doubt the accuracy of documents the company had supplied to prove product integrity, a report from the U.K.’s Medicines and Healthcare products Regulatory Agency says.

The agency, under current practices, shared its info with other European Union members so they would know not to permit Acme to ship products into their countries.

RELATED: Bangladesh's drug industry meets nearly all domestic demand, eyes exports

According to a 2015 report, Bangladesh drugmakers handle more than 95% of that country’s demand for pharmaceuticals and some of those producers are exporting to the West. But the country has a long way to go in that regard.

Some western drugmakers are looking at selling there. Denmark’s Novo Nordisk, through a joint venture, started selling domestically produced insulin in Bangladesh in 2012.