New rules fail to resolve counterfeit medicine crisis

RYAN CHIGOCHE

Zimbabwe has been hit by trafficking of counterfeit medicines despite the drug regulator putting in place new distribution and storage rules, Business Times can report.

The Medicines Control Authority of Zimbabwe (MCAZ) Association of Zimbabwe (MCAZ)  and the Pharmaceutical  Society of Zimbabwe said the new rules have failed to meaningfully resolve the crisis.

They said more tighter controls are needed to be put in place.

“The increase in the illicit trade of pharmaceuticals has more public health concerns than the effect on the local manufacturers. It should be noted that the influx of these ‘medicines’ through unregulated processes opens up the consumer to consumption of products of questionable quality and effectiveness and even authenticity as no one can vouch for the contents of the pill or portion thereby exposing the public,” the Pharmaceutical Society of Zimbabwe president Portifa Mwendera told Business Times .

He said counterfeit medicines including cough syrups and ARVs have flooded the local market putting the lives of thousands of people at risk.

Counterfeit medicines may not have the correct active ingredient or may have too much of it, increasing the risk of overdose.

Mwendera said some may not have any active ingredient at all, hence do not have any curative effect.

MCAZ acting director general Richard Rukwata said there was need to put up more measures to supplement the new rules.

‘’..We are in the process of educating players in the supply chain to adhere to those guidelines and hopefully the result will be tighter controls on the market. It is however a slow and arduous process and other measures will still need to be implemented to aid the effectiveness of those  new guidelines,” Rukwata told Business Times.

In October last year, the MCAZ amended its drug guidelines focusing on the distribution and storage practices .

The expectation was that the new rules would resolve the crisis.

According to the amended guidelines by MCAZ, all parties involved in the supply chain of medical products such as pharmaceutical manufacturers and pharmaceutical distributors as well the logistics providers they outsource like transporters, clearing agents should have a comprehensively designed, documented, and correctly implemented quality system that incorporates Good Storage Practices  (GSP) and Good Distribution Practices (GDP)  principles of quality risk management and management review in place.

According to the MCAZ, the GSP and GDP quality system should ensure that the quality of medical products is maintained throughout their shelf-life in the supply chain; and medical products are appropriately procured, stored, distributed, and delivered to premises by the authority.

They should also ensure operations are clearly specified in written procedures; responsibilities are clearly specified in job descriptions; all risks are identified and necessary, effective controls are implemented and that processes are in place to assure the management of outsourced

The amended regulations also stipulate that personnel involved in the supply chain of medical products should be trained and qualified in the requirements of GDP, as applicable.

But, the situation has deteriorated as  the influx of substandard and falsified medicinal products  have hit the country.