The drug administration authority has issued show-cause notices to 15 pharmaceuticals companies, which have previously been identified as manufacturers of substandard drugs, asking them to explain within 15 days why their licences should not be cancelled.
The Directorate General of Drug Administration (DGDA) made the move following a directive from the Health Ministry made on April 20.
Major General Jahangir Hossain Mollick, director general of the DGDA, confirmed the news and said the notices were served to companies identified by a specialised committee, which was formed by the parliamentary body of the ministry in 2010 following the deaths of 24 children allegedly caused by the paracetamol syrup produced by Rid Pharmaceuticals Ltd.
The team of specialists had also previously identified the drugs of 29 pharmaceutical companies as posing “high risk to public health.”
When asked why the DGDA issued notices to only 15 of the 29 companies, Major General Mollick said the 14 other companies had already been suspended by the drug administration. But the suspension orders were later halted by the court after those companies lodged writ petitions against the DGDA. So the show-cause notices could not be served to those companies, the DG added.
The punitive actions against the 15 companies will depend on the replies of the show-cause notices, he said, adding that the highest punishment will be the cancellation of manufacturing licences.
Seeking anonymity, a senior DGDA official told the Dhaka Tribune that most of the companies identified as “risky” had been continuing the manufacturing of large amounts of fake and substandard drugs by securing court orders against their suspension.
Sources at the DGDA said the team of specialists had identified 62 companies as producers of fake medicine in 2010, and revised the number to 73 following a second round of inspections in 2013.
Out of those 73, the team identified 29 companies as posing “high risk to public health.” Three were told to continue production of drugs except penicillin, cephalosporin, antibiotics and steroids while the other 26 were told to continue production in accordance with the specialised team’s instructions, but were also barred from producing penicillin, cephalosporin, antibiotics and steroids.
The report by the specialised team mentioned that the 29 companies did not comply with the World Health Organisation guidelines.
Prof ABM Faruque, a member of the inspection team, told the Dhaka Tribune that the team had visited the companies in 2010 and cautioned them about maintaining standards. Some of those companies had managed to improve their quality, but the rest were still in same conditions.