As a result of a project developed by Instituto de Tecnologia em Fármacos (Farmanguinhos/Fiocruz), supported by Fiotec, Sociedade Moçambicana de Medicamentos – SMM (Mozambique Drug Company) – a manufacturing site for antiretrovirals and other drugs – started operating last Saturday (July 21st). Established in Maputo capital, the manufacturing site is the first public institution in the pharmaceutical field in Africa. This initiative is part of a cooperation deal between Brazil and Mozambique, and will benefit around 2.7 million people with HIV/Aids in Mozambique.
In this first phase, 3,255 vials of Nevirapine 200 mg will be labeled, equivalent to 195,300 pharmaceutical units. Initially, three antiretrovirals will be produced: Lamivudine+Zidovudine, Nevirapine, and Ribavirin – with a total of 226 million pharmaceutical units per year. In the future, other five drugs will be included on the list. The technology used for developing and producing these drugs will be gradually transferred by Farmanguinhos.
In addition to antiretrovirals, the site is foreseen to manufacture 21 different types of drugs, including antibiotics, antianemics, antihypertensives, anti-inflammatories, hypoglycemics, diuretics, antiparasitics and corticosteroids. The site production is estimated in around 371 million pharmaceutical units per year, including antiretrovirals and other drugs.
Michel Temer, Brazilian Vice-President; Paulo Gadelha, Fiocruz President; Jorge Bermudez, Fiocruz Vice-President for Production and Health Innovation; and Hayne Felipe, Director of Farmanguinhos attended the event held on Saturday. From Mozambique, Alexandre Manguele, Health Minister; Apolínio Panguene, President of the Board of Directors of the Management Institute of State Participations (Igepe); Alcino Ndeve, SMM President; and Noémia Muissa, SMM Executive Director also participated in the event.
According to the Social Communication Division of Fiocruz (CCS), Paulo Gadelha said, during his speech, that in addition to making the manufacturing site feasible, there will be field-specific human resource qualification, which is unprecedented in Mozambique. Fiocruz will also help the country build a regulatory system in the health area. Thus, the manufacturing site will have the chance to be internationally certified by the World Health Organization (WHO), and provide drugs to the entire Sub Saharan Africa.
Brazilian Support
The support of the Brazilian government, estimated in around US$ 23 million, covers all steps of implementation, including feasibility studies, equipment acquisition, technology transfer, technical qualification, validation and registration, and submission of national and international certificates. The support also covers the preparation of a business plan and guidance related to the sustainability issues of the organization.
Epidemic
With approximately 24 million habitants, Mozambique suffers from a disease epidemic that threatens 11.3% of the population, according to data from the National HIV/Aids Council (CNCS) of the country. Still according to CNCS, 15% of the pregnant women in Mozambique, aged 15 to 49 years old, have HIV.
The epidemic is heterogeneous in geographical, social demographical, and social economic terms: women, urban residents, and residents from the south and center regions are the most affected by HIV and Aids. The main transmission route among adults continues to be heterosexual in around 90% of the cases.
Source: Social Communication Division of Fiocruz (CCS).
