Paidamoyo Chipunza Senior Reporter
The Medicines Control Authority of Zimbabwe (MCAZ) yesterday said shelf life or expiration of medicines was different from the best before date, normally marked on non-medical products.
Giving oral evidence before a joint Parliamentary Portfolio Committee on Health and Child Care and the Thematic Committee on HIV and Aids over extension of antiretroviral drugs, MCAZ spokesperson Mr Richard Rukwata said; “Every time shelf life is extended, there is usually a reaction from the market largely due to the fact that a lot of our population think that shelf life or expiry is similar to a best before date.
“That is actually not correct. If I buy peanut butter from a supermarket and it says best before a particular date, I can conclude that from that date and beyond the quality of the product begins to deteriorate.
“That is not necessarily the same with medicines.”
Mr Rukwata said in prescribing a shelf life to a product, the manufacturer was asked to bring minimum data upon application for registration.
He said the data, coupled with MCAZ’s own test, is what will then be used to prescribe a shelf life.
Mr Rukwata said according to regulations governing the control of medicines, shelf life refers to a period up to which medicines in that batch will maintain their potency as fixed by the Authority.
“So, for example, the Authority might say a formulation of Tenofovier and Lamivudine has a shelf life of two years, when the manufacturer manufactures a batch of that product in March 2019 they will give an expiry date of March 2021, which is consistent with the shelf life prescribed by the Authority,” he said.
Mr Rukwata said although the Authority usually prescribed a shelf life of two years, there were products that have a shelf life of up to five years.
“For many reasons, manufacturers will only submit minimum required data to support shelf life, this allows them to get on the market fast,” he said.
“The Authority has a certain minimum acceptable for shelf life and for us it is usually two years, which means the manufacturer by the time they are coming for registration they must have data to justify a minimum of two years shelf life, but some products can actually have a shelf life of up to five years.”
Mr Rukwata said shelf life was only extended in emergency cases or when there was a public health need due to shortages, as in the case of ARVs.
This follows the recent extension of the shelf life of some batches of ARVs, a development that did not go down well with stakeholders in the HIV and Aids sector, who then petitioned Parliament to investigate the matter.
In addition to extension of ARVs shelf life, looming shortages were another concern raised by the activists in their petition to Parliament.
MCAZ is mandated with regulating the use of all medicines in Zimbabwe.