There need not be worry over ARV drugs
Jul 09, 2004
SIR— I wish to comment on the article, “Patients worried of AIDS drugs†which appeared in the <i>Monitor</i> last Monday.
SIR— I wish to comment on the article, “Patients worried of AIDS drugs†which appeared in the Monitor last Monday.
The Ministry of Health wishes to re-assure the general public especially patients who are taking anti-retroviral (ARV) drugs that there is no cause whatsoever to be alarmed. Those on ARV treatment should continue taking their ARVs as usual.
The World Health Organisation’s decision to withdraw two products, Lamivudine 150mg and Lamivudine 150mg + ,i>Zidovudine 300mg tablets by Cipla Ltd, from the WHO list of pre-qualified products does not affect the national access to the ARV programme as none of the those two Products were imported for distribution and use to the different ART treatment centres.
This decision does not affect other pre-qualified HIV/AIDS medicines produced by Cipla Ltd or other HIV/AIDS drugs made by other manufacturers.
Secondly, the National Drug Authority (NDA) performs mandatory analyses and tests to confirm the quality of all ARV drugs imported into Uganda before they are released for use in the country.
Therefore, ARVs used in the country conform to the international norms and standard and are safe and effective for use in the treatment of HIV/AIDS.
WHO withdrew the two products from the list because it had no evidence that the products are bio-equivalent with the respective originator products, i.e. that they conform to with quality standards and good practice.
What is missing is proof of bio-equivalence. WHO will consider listing them again once bio-equivalence has been demonstrated by Cipla, evaluated by WHO assessors and found to be meeting their international standard.
The full statement by WHO on removal of the two AIDS medicines can be found on their website at http: www.who.int/mediacentre/statements/2004/statementaidsprequal/en/
The Ministry of Health reiterates its cardinal duty to ensure that people get high quality ARV drugs and other medicines.
There is no cause for alarm or interruption of treatment by those already
on ARV drugs.
Dr Sam Zaramba
Ag. Director General Health Services
The Ministry of Health wishes to re-assure the general public especially patients who are taking anti-retroviral (ARV) drugs that there is no cause whatsoever to be alarmed. Those on ARV treatment should continue taking their ARVs as usual.
The World Health Organisation’s decision to withdraw two products, Lamivudine 150mg and Lamivudine 150mg + ,i>Zidovudine 300mg tablets by Cipla Ltd, from the WHO list of pre-qualified products does not affect the national access to the ARV programme as none of the those two Products were imported for distribution and use to the different ART treatment centres.
This decision does not affect other pre-qualified HIV/AIDS medicines produced by Cipla Ltd or other HIV/AIDS drugs made by other manufacturers.
Secondly, the National Drug Authority (NDA) performs mandatory analyses and tests to confirm the quality of all ARV drugs imported into Uganda before they are released for use in the country.
Therefore, ARVs used in the country conform to the international norms and standard and are safe and effective for use in the treatment of HIV/AIDS.
WHO withdrew the two products from the list because it had no evidence that the products are bio-equivalent with the respective originator products, i.e. that they conform to with quality standards and good practice.
What is missing is proof of bio-equivalence. WHO will consider listing them again once bio-equivalence has been demonstrated by Cipla, evaluated by WHO assessors and found to be meeting their international standard.
The full statement by WHO on removal of the two AIDS medicines can be found on their website at http: www.who.int/mediacentre/statements/2004/statementaidsprequal/en/
The Ministry of Health reiterates its cardinal duty to ensure that people get high quality ARV drugs and other medicines.
There is no cause for alarm or interruption of treatment by those already
on ARV drugs.
Dr Sam Zaramba
Ag. Director General Health Services