Harare, 22 Sept. 2014 -  Zimbabweans stand to gain access to better medicines after WHO’s approval of its medicines quality control laboratory in Harare.  The approval, which follows a thorough assessment by WHO, means that the laboratory operates in compliance with international standards and can carry out quality tests on medicines purchased by the Global Fund to Fight AIDS, TB and Malaria as well as by other large purchasers of medicines for developing countries, like UNICEF.  It also sends a strong message to local and importing manufacturers that their medicines will be tested according to international standards, thereby potentially improving the quality of their products and patient treatments.

“‘This is important work WHO does to improve the functioning of health services, preparing countries to cater to their populations’ health needs, and face crises such as the current Ebola outbreak more effectively, can only be done by bolstering the capacity of health professionals and the functioning of public health structures.’ said Dr Kees De Joncheere, Director of Essential Medicines at WHO/HQ. 

The laboratory, which is part of the Medicines Control Authority of Zimbabwe (MCAZ), the national body regulating medicines in the country, is the 6th  quality control outfit to receive WHO prequalification in Sub-Saharan Africa.  As with the other five, the MCAZ lab benefited from expert assistance from WHO, including guidance and training to raise its performance to the level of international standards, making the lab eligible for prequalification.

‘We are proud of this achievement,’ said Dr David Okello, WHO Representative in Zimbabwe.  ‘In essence it means that when the Global Fund buys millions of dollars’ worth of medicines for Southern African countries, it can rely on the Zimbabwean laboratory to assist in ensuring the medicines are safe and effective.  Without this kind of service, lives would be placed at risk and precious donor funds could be wasted.’

Ensuring the quality of a medicine is a thorough process that starts with the right choice of active ingredients, continues with correct dosage forms and good manufacturing practices and goes all the way through to quality testing of the finished product once it arrives at its destination.  While WHO approval of medicines already gives a strong validation of a product’s quality, it cannot guarantee that the specific batches of medicines purchased have adhered to the manufacturing procedure that achieved prequalification.

As well as increasing countries’ capacity to test medicines locally, the prequalification of quality control laboratories scheme provides a second step in the quality assurance services offered by WHO.  If quality problems arise with batches of prequalified products once they reach the country of destination, the local prequalified laboratories are alerted and check the product; if non-compliance is found, they can facilitate corrective measures and thus avert possible risks to patients.