Regulator appeals for help in flagging flawed medication

Wednesday September 28 2022
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Demand for some drugs has gone up in the market leading to a sharp increase in their prices. PHOTO | CYRIL NDEGEYA


Rwanda Food and Drug Authority (FDA) has appealed to drug importers, pharmacies and the public to help with flagging flawed medication to avert public hazards.

This follows the recent recall of Broncalene syrup for children and adults, usually used for treating coughs, after the medications were flagged for being defective by the French drug regulator.

The recall was based on study findings that revealed a potential association of pholcodine (the active ingredient in broncalene) and increased risk of anaphylactic reaction on curares products used during general anaesthesia.

The voluntary recall was initiated by Melisana pharma, a French drug maker from whom Rwandan drug importers had purchased the flagged broncalene batches.

Ntirenganya Lazare, the division manager for pharmacovigilance and safety monitoring at the Food and Drug Authority, said although the regulator conducts quality and safety testing and inspections at different levels of the supply chain, it is not enough.

“We call upon all stakeholders, from importers, wholesalers, pharmacies and members of the public who buy these drugs to be vigilant through reporting anything out of the ordinary about the drugs and side effects of the drugs they use or sell. This has to be a collaborative e ort and roles have to be played at different levels,” he said.


Rwanda established the Food and Drugs Authority in 2018 to protect public health by regulating human and veterinary medicines, vaccines, medical devices, foods, and cosmetics. Recent data shows that about 18.7 percent of essential medicines circulating in Africa are substandard, a direct result of weak regulatory systems that are unable to detect and prevent their use.

FDA normally conducts a post-marketing survey where they monitor the quality of drugs on the market, which helps detect drugs that don’t meet recommended standards. It also follows reports of users, investigates and tests samples of drugs that have been flagged by users.

If found to have a problem, they are recalled. This statutory recall is done according to the drugs batch numbers.

However, the drug agency largely relies on voluntary recalls from drug manufacturers or external regulators, like the ongoing case with bronchalene. For the bronchalene recall, the FDA gave wholesalers and pharmacies up to 15 days to take the drugs off the shelves, and many have responded positively.

Mechanisms for pharmacies to get refunds in times of recalls are built into the purchase agreements, and this will help the drug sellers get credit notes or replacements.


Even consumers who had bought the recalled drug and have not yet opened it can get a refund or replacement, Ntirenganya says.

“We have already taken the flagged drugs off the shelves. We had just stocked it. We hadn’t yet sold it to any customer, that’s the good thing” said Uwase Joselyne, from Kagophar in Musanze.

She called on the FDA to get a sample from every batch for testing to help avert hazards. But the FDA says it is not possible to test every batch of drugs imported.

“We don’t have the capacity to test every batch of drug that comes into the country. I doubt there is any country that has such capability, but we test at import entry,” said Ntirenganya.

In July the Rwanda FDA recalled over 20 herbal medicines from the market over safety concerns. The regulator said an inspection of samples in the laboratory showed that many products did not meet minimum safety and quality standards. It also put on hold the activities of seven water companies after an inspection revealed they were producing unsafe drinking water.