MCAZ Defends ART Shelf Life Extension

THE Medicines Control Authority of Zimbabwe sticks to its guns on why they extended the shelf life of Antiretroviral drugs namely Tenofovir and Lamivudine.

BY Kudakwashe Pembere

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 on Monday, MCAZ spokesperson Mr Richard Rukwata first explained the statutes permitting shelf life extension. He said there was a serious misconception on expiry dates and shelf life extension. According to the Medicines And Allied Substances Control SI 150 of 1991, shelf life in relation to any batch of a medicine means the period up to which a medicine in that batch will retain the potency and properties stated on the label as fixed by the Authority.

This follows a public outrage over this decision to extend the shelf life of ARVs.

“In relation to any batch of a medicine means the date on which the shelf life of such medicine will expire. So how is this shelf life determined?  This is where the science comes into effect. We look at certain parameters as presented by the manufacturer. This is how the product dissolves in water. How much of the active ingredients is still up to the specifications after a certain period of time. How the impurities in that medicine are actually behaving. Are they going down or up? We also look at microbial limits. How well the product stands up to microbial contamination.

“So what then happens honorable chair is when applicants or manufacturers submit their products for registration by the MCAZ, they submit this data and the authority uses this data to prescribe shelf life for a particular medicine. Having the shelf life determined, the manufacturer uses this shelf life to determine the expiry dates.

“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 up to   March 2021, which is consistent with the shelf life prescribed by the Authority,” he said.

He said with regards to shelf life, their policy is that the medicines should  have one lasting two years and do not permit importation of medicines with less than half of that.

“So the authority has policies honourable chair whereby there is a certain minimum acceptable shelf life which means for us its usually two years, so a manufacturer then unless there are special circumstances must make sure that by the time they are coming to the authority asking for registration of their product, they have data to justify a minimum of two years. What then happens honourable chair is that with the passage of time sometimes the manufacturers themselves will initiate what we call shelf life extension.

“This is whereby they submit data beyond the original two year shelf life support data and the authority will look at these data and actually extend the shelf life. So there are certain products honourable chair where shelf life can go as far as five years,” he said adding that while it is restricted they usually issue a six month shelf life in extreme cases of public health need, shortages, a huge national emergency.

He said there haven’t been many shelf life extensions for drugs and for the handful they issued, uproars occur.

“And then when we look at the shelf life extensions approved over the last few years, there are actually not a lot of consignments. In 2015, we had just one consignment of Ritonavir 100mg. In 2016, it was Ethambitol 100MG, this is a antiTB medicine. In 2018 we had an antimalarial product Artemether and Artesunate injection in 2018 as well. In November 2018. We had Tenofovir, Lamivudine. And everytime that shelf life is extended, there is usually a reaction  from the market,” he said.

HE explained that this is on the back of expiry dates of medicines taken as that of non-medical products which use the term Best Before.

“Largely to the fact that I think a lot of our population, members of our population, they believe that shelf life or an expiry date is similar to a best before date. That is actually not correct. If I buy peanut butter in the supermarket and it says best before a particular date I can reasonably expect that at that date and beyond, the quality of this product begins to deteriorate, that is not necessarily the same with medicines. Because as I indicated earlier Honorable chair, it might be that the data are there to support a longer shelf life but the data were never presented,” Mr Rukwata clarified.

Mr Rukwata also stated that as an independent body, the Health Ministry is expected to justify the public health need so there may be shelf life extension.

He also shot down the position by scientists at the antiretroviral medications cannot have their shelf life extended. In line with global practice, shelf life extensions though rare can be issued in the event of the manufacturer initiating it through producing data seeing the medicines tested again by the medicine authorities.



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