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1,500 drugs could be delisted

Friday October 18 2019
Medics

Some of the drugs likely to go off the shelves include Asthma drugs. PHOTO | Cyril NDEGEYA

By MOSES K. GAHIGI

You may soon fail to find some essential medicines at your nearest pharmacy, if manufacturers do not register their products by January next year in compliance with a government directive.

Some 1,500 drugs, including life-saving medicines for critical conditions such as asthma, could be struck off a list of approved medicines when the mandatory registration window closes.

The government through the Ministry of Health is developing a database for medicines in line with
requirements by the World Health Organisation to ensure quality and avoid flooding the market with unnecessary and substandard drugs.

Consequently, importers are expected to clear their drugs before they can enter the country. While the deadline was initially set for July this year, industry players including importers complained the notice was too short.

But even after the government pushed the dates forward to January 2020, drug makers or their representatives say they are unlikely to meet the new deadline due to the rigorous registration process which involves a lot of paper work containing information on each drug.

Once submitted, the information, which includes details of the manufacturer, composition of the drug and side effects is then verified before the drug is approved.

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Drug makers say they need at least two years from the date the law was enacted in 2018 to put their paperwork in order and register the drugs. Dr Abel Dushimimana, the chairman of the Drug Importers Association said that the agency is developing a list of the affected drugs.

“We are coming up with a conclusive list of drugs that may have to be removed from the market. We are also going to identify those that have been registered,” he said. Charles Karangwa, the Director General of Food and Drug Authority told this paper that the agency will not extend the deadline, and has asked manufacturers and importers who are running late to present a plan detailing when their products will be registered.

“Some drugs that enter the country don’t even have a physical address listed anywhere; some are made in garages and just inscribed with ‘made in France;’ we have to visit them and investigate to weed out those that do not meet the standards,” said Dr Karangwa.

He said around 30 per cent of the drugs that enter the market are fakes or counterfeits. According to Dr Karangwa, the lack of stringent regulatory measures has seen drugs like misoprostol, which was used to stop bleeding during child birth end up on hospital shelves, yet it caused some women to bleed to death.

By the time it was banned, distribution across the country was at 40 per cent, he said.

"We want to combat fake drugs by hook or crook” said Dr Karangwa. Kenyan firms recently experienced a standoff with the government over new guidelines that required drugs to be
inspected both in the country of import and at home.

Now there are fears that Rwanda may soon find itself in a similar bind that could see a sharp shortage in drugs because it is still too early to know which ones are about to be delisted, meaning dealers cannot plan ahead and stock up.

The local pharmaceutical market has faced a number of challenges in recent times. For example, the move by insurance companies to only pay for generic drugs has left chemists who had stocked up brand-name drugs facing losses as the medicines sell-by dates fast approach.

Insurance companies in Rwanda used to only pay for brand-name drugs, but switched to cheaper generic medicine a few years back, most of which are manufactured in Kenya and India.

However, brand-name medicines which do not have generic versions are still needed.

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