Multinational Collaborative Study
Study on Counterfeit Medicines
LMCS has, along with LEF, been promoting a comparative study on the medicines quality which contain artesunato, cotrimoxazol and zidovudine active substances, available in the African countries, the most affected by the counterfeited products.
This study, “Quality assessment of drug products distributed through the authorized channels in developing countries”, constitutes an effective mean to gather information on the quality of medicines, allowing, therefore, to assess the performance of the local quality assurance systems and their capacity to make available medicines with the necessary quality to the population.This study will, additionally, detect possible cases of medicines falsification, a rising concern amongst all countries.
Objectives of the study
Study’s main purposes are making a comparative assessment of medicines quality containing active substances with great therapeutic value in the countries singled out by the study (Angola, Mozambique, Cape Verde, Guinea-Bissau, S. Tome and Prince and Brazil) and detect possible cases of counterfeited medicines.
The substances (artesunato – an antimalarial –, cotrimoxazole – an antibiotic – and zidovudine – an antiretroviral) have a high therapeutic value and are of great importance to public health in these countries.
LMCS SAMPLING and TESTING programme on counterfeit medicines
The section has been promoting meetings in African countries where the quality of medicines is a rising concern. This was the theme of the Spring Meeting that took place this year in Cabo Verde.
Angola and Mozambique have already sent some products for the study and medicines from Green Cape and Ghana are on the way. We have received not only products from the mentioned substances but also products containing other substances.
Until now the section has received for analysis the following products:
|
Active ingredient
|
Dosage
|
Quantity
|
|
Amoxiciline (capsules, tablets and powder for oral solution) |
500 mg 250 mg 125 mg |
12 products |
|
Furosemide (tablets) |
40 mg |
5 products |
|
Atenolol (tablets) |
100 mg 50 mg |
5 products |
|
Paracetamol (tablets) |
500 mg |
6 products |
|
Ciprofloxacin (tablets) |
500 mg |
6 products |
|
Bromexin (oral solutions) |
8 mg 4 mg |
7 products |
|
Chloroquine (tablets, oral solutions and injectable) |
300 mg 250 mg 50 mg |
11 products |
|
Quinine (tablets and injectable) |
500 mg |
4 products |
|
Dihidroartemisinina
(tablets) |
|
1 product |
|
Diazepam (tablets) |
10 mg |
2 products |
|
Artesunate (tablets) |
|
2 products |
The costs concerning the acquisition of the products will be reimbursed to the participants. The laboratory’s work will be done on LEF.
The study results will not be presented in the FIP Congress has the expected, but we believe to conclude the study until the end of 2006.
