Revoke licences of 20 drug firms
An expert committee has recommended revoking licences of 20 drug companies for failing to ensure quality of products.
The companies have repeatedly and grossly failed to comply with the good manufacturing practices (GMP), according to a report prepared by the committee upon inspections.
An evaluation of the GMP of 84 drug makers was done for two years following a decision of the parliamentary standing committee on the health and family welfare ministry in August 2014.
Prof ABM Faruque, who led the team of experts, gave a presentation yesterday on the findings at a meeting of the parliamentary body at the parliament building.
The medicines manufactured without following the GMP will not meet the standards and might inflict damage on health, according to the report.
“The damage could even be fatal and so such drugs should be avoided for the sake of public health,” experts said in the report.
The Daily Star has obtained a copy of it.
The 20 companies that might see their licences revoked are Aexim Pharmaceuticals Ltd, Avert Pharma Ltd, Bikolpo Pharmaceuticals Ltd, Dolphin Pharmaceuticals Ltd, Drugland Ltd, Globe Laboratories (pvt) Ltd, Jalpha Laboratories Ltd, Kafma Pharmaceuticals Ltd, Medico Pharmaceuticals Ltd, National Drug Pharma Ltd, North Bengal Pharmaceuticals Ltd, Remo Chemicals Ltd (Pharma Division), Rid Pharmaceuticals Ltd, Skylab Pharmaceuticals Ltd, Spark Pharmaceuticals Ltd, Star Pharmaceuticals Ltd, Sunipun Pharmaceuticals Ltd, Today Pharmaceuticals Ltd, Tropical Pharmaceuticals Ltd and Universal Pharmaceuticals Ltd.
Many of the inspected factories have upgraded their manufacturing mechanism over the last five to six years while the improvement made by some others was not satisfactory, the experts said.
Many companies had only killed time in the name of improvement, and some factories made no progress at all, rather the quality of their products plummeted.
The expert committee suggested cancelling the licences of 14 companies for manufacturing all types of antibiotics, saying that they had been found incapable of producing quality antibiotics.
It also recommended that the government cancel approvals given to 22 companies for manufacturing antibiotics of penicillin and cephalosporin groups.
These companies have the system in place only to manufacture antibiotics of non-penicillin group, the experts said.
One company was identified as not being capable of producing drugs at all for human body. Therefore, the government should allow it to produce medicines for animals only, according to the report.
It also recommended scrapping the permission that a company had obtained to manufacture antibiotics of penicillin and cephalosporin groups, anti-cancer drugs and hormones in its three factories since they were not following the standard procedure.
Health Minister Mohammed Nasim, State Minister for Health Zahid Malik, and lawmakers AFM Ruhal Haque, Yunus Ali and Selina Begum were present at yesterday's meeting presided over by Sheikh Fazlul Karim Selim, chairman of the parliamentary committee on the health ministry.
Bangladesh Association of Pharmaceutical Industries (BAPI) President Nazmul Hasan Papon was present there at a special invitation of the parliamentary committee.
The pharmaceutical companies that are not members of the BAPI should not be given licences in the first place, the expert committee suggested in a statement.
If they have already obtained licences, those should not be renewed without approvals of the BAPI, the experts said, adding that stern actions should be taken against the companies manufacturing adulterated drugs.