The Laboratório Nacional de Controlo da Qualidade de Medicamentos (LNCQM), the quality control (QC) arm of the Ministry of Health’s (MoH) Pharmaceutical Department, was formally inaugurated last month at its permanent HQ in Mozambique's capital Maputo.
The lab - which replaces the old national testing facility that closed in 2008 – was developed by the MoH with the support of the US Agency for International Development (USAID) and the United States Pharmacopeial Convention (USP) under their joint ‘Promoting the Quality of Medicines’ (PQM) programme.
Patrick Lukulay, PQM director and vice president of global health impact programs at the USP told in-Pharmatechnologist.com that: “The main day-to-day activities of the LNCQM are the testing of medicines for registration and post-marketing surveillance. Currently, the lab has 4 staff and more will be hired."
He added that the PQM will continue to work with the Mozambique Pharmaceutical Department to build the QC capacity at the LNCQM and help the lab meet international quality standards.
Drug Quality
The current level of oversight of drug quality in Mozambique is hard to assess.
While a 2005 assessment of the national health plan - of the Plano Estratégico do Sector de Saúde - indicated the "availability of high quality medicines in all provinces," the World Health Organisation's (WHO) cites the lack of a "distinct national regulatory authority" as one of the key challenges facing the country's healthcare services.
The PQM has worked with the MoH since the closure of the original lab to both support on-going drug QA/QC assessments – which were carried out at several regional testing sites in the interim period – and to guide development of a replacement national facility.
In 2011 – after conducting a pilot study in Mozambique’s Gaza and Maputo provinces - PQM concluded that additional testing equipment and staff training was needed to help the country develop an effective monitoring system, prompting the creation of the new LNCQM.
The Ministry of Health did not respond to a request for additional comment ahead of publication.
USP in Africa
Mozambique is not the only African country to have been supported by the USP. In February last year, the organisation extended its technical assistance programme (TAP) to include Ethiopia, Ghana, Kenya, Senegal and Sierra Leone.
In December the Maryland, US-headquartered organisation supported the Ethiopian Government’s s efforts to gain ISO accreditation for its national drug quality control and testing laboratory.
More recently the USP announced it would spend $1.5m to set up a lab in Ghana, West Africa, to provide QC services and offer training.