February 28, 2019

Drug Importers Unhappy with Government Deadline to Register all Medicines

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Inside this ‘Pharmecie Conseil’, like thousands across Rwanda, there are thousands of medicines which the authorities want to keep track

A government deadline to have all medicines in the country registered before July 2019 has been dismissed as unrealistic and will cause shortages of essential medicines.

The Ministry of Health, in implementing a World Health Organization requirement to keep sophisticated database for medication, has asked all importers to have all their medicines cleared before they are brought.

The WHO for years has been pushing all member states to have this database. It enables countries to avoid importation of unnecessary drugs, that not only flood the market, but also overshadow what is actually needed.

In the east African region, only Rwanda and Burundi have not implemented the WHO database. Uganda started keeping it in 2013, Kenya in 1982 and Tanzania in 1999.

Drug importers and distributors in Rwanda, that are private companies, are resisting the deadline citing various concerns.  

“Registering medicine is fine but the deadline is very close,” said Dr Abed Dushimiyimana, chair of the drug importers association in Rwanda. “I think some of the medicines will not have been registered which will cause shortages on the market.”

What exactly is this registration process. Currently, a drug or equipment importer who wants to bring any medicine, works with the health ministry’s Medical Procurement and Production Division.

The agency also advises private importers on which medical materials are necessary.

However, in recent years, there has been rapid explosion of drug makers from North America and Europe, to India and China.

Combined with aggressive marketing, millions of medicines find their way to drug shelves in Rwanda and elsewhere. There have also been reports over the years that drug makers maintain special offers for doctors so they prescribe their products.

A Rwandan patient visiting a doctor finds themselves in this complicated web of interests. You have no idea what lies behind the medicine prescribed for you.

It is this sea of confusion that the WHO and member governments decided needs to be regulated.

For the case of Rwanda, the health ministry is in charge of the new database.

For all medicines currently in the country already, the importers or representatives of drug companies will file loads of documents on each.

Approving a medicine is not automatic. A long list of complicated details are reviewed such as it’s maker, composition and side effects.

The government of Rwanda has given the program up until July to have been completed. It means that going forward after July, no single medicine will enter Rwanda without going through that rigorous approval.

“Registering a single drug can take more than 2 years because many files will be submitted on each medicine. All that information must be verified,” says Dr Dushimiyimana, from the importers’ association.

He says the health ministry has a very small number of staff handling this database, adding: “Besides, new drugs are discovered everyday from now till July.”

The establishment of a national drug database has been going on for some time, according to the ministry and importers. It should have been completed by now, adds the ministry, but some companies have been “sleeping”.

The Chronicles has been told that medicines which were rejected are still on the market and have not been incinerated as par the regulation requiring such drugs to be destroyed. We have not independently verified this information.

Kipharma SARL is one such medical materials importer. Sales and marketing manager Lambert Kadende wonders how the process can be completed in the remaining the four months.

“A company may not be able to register a given drug by the deadline. In case the drug may be essential, there will be obvious shortages on the market,” said Kadende.

Meanwhile, importers are holding urgent meeting this Friday to decide how to handle the government deadline.

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