No substandard ARVs in Uganda
Dec 28, 2008
EDITOR—Reference is made to two press articles: “Africa consuming sub-standard ARVs†and “Resistance to ARVs rising among patients†published on december 9. The articles wrongly concluded that there are inadequate controls on quality of ARVs used in developing countries with the potential
EDITOR—Reference is made to two press articles: “Africa consuming sub-standard ARVs†and “Resistance to ARVs rising among patients†published on december 9. The articles wrongly concluded that there are inadequate controls on quality of ARVs used in developing countries with the potential for causing drug resistance in antiretroviral therapy.
The authors of the two articles may have caused much public alarm about the quality of generic antiretrovirals (ARVs) manufactured in India and other developing countries for use in Africa, Uganda inclusive. As the statutory body mandated to regulate medicines consumed in Uganda, the National Drug Authority (NDA) would like to assure the public that it has got in place adequate quality assurance measures to ascertain that only medicines of acceptable quality, safety and efficacy are available in Uganda whether manufactured locally or imported.
Since the NDA started testing ARVs in its Drug Quality Assurance Laboratory from 2004 to date only two samples have failed the test. The failed samples were discovered in 2004.
For any medicine to be authorised for use in Uganda, it is a prerequisite that its manufacturer’s facilities are inspected for consistent production according to acceptable quality standards.
In addition, documentary evidence on quality, safety and efficacy must be availed for independent evaluation by the NDA before the medicine is entered onto the National Drug Register of Uganda which is the list of medicines authorised to be used in Uganda.
The NDA remains committed to ensuring that only safe, efficacious and quality medicines are available for use in Uganda.
Apollo Muhairwe
Executive Secretary/Registrar
National Drug Authority
The authors of the two articles may have caused much public alarm about the quality of generic antiretrovirals (ARVs) manufactured in India and other developing countries for use in Africa, Uganda inclusive. As the statutory body mandated to regulate medicines consumed in Uganda, the National Drug Authority (NDA) would like to assure the public that it has got in place adequate quality assurance measures to ascertain that only medicines of acceptable quality, safety and efficacy are available in Uganda whether manufactured locally or imported.
Since the NDA started testing ARVs in its Drug Quality Assurance Laboratory from 2004 to date only two samples have failed the test. The failed samples were discovered in 2004.
For any medicine to be authorised for use in Uganda, it is a prerequisite that its manufacturer’s facilities are inspected for consistent production according to acceptable quality standards.
In addition, documentary evidence on quality, safety and efficacy must be availed for independent evaluation by the NDA before the medicine is entered onto the National Drug Register of Uganda which is the list of medicines authorised to be used in Uganda.
The NDA remains committed to ensuring that only safe, efficacious and quality medicines are available for use in Uganda.
Apollo Muhairwe
Executive Secretary/Registrar
National Drug Authority