This week, Rwanda Food and Drugs Authority appealed to frontline stakeholders like drug importers, pharmacies and the general public to be vigilant in helping with flagging and detection of flawed medicine to ensure it doesn't reach the public.
This follows the body's recent recalling of Broncalene syrup for children and adults, after the drug products were deemed defective by the French drug regulator. The recall was based on study findings that revealed a potential association of pholcodine (active ingredient of broncalene) and increased risk of anaphylactic reaction on curares products used during general anesthesia.
Prior to the establishment of Rwanda FDA in February 2018, there was insufficient infrastructure and human resources to implement and operate an autonomous regulatory institution for foods and pharmaceuticals. This contributed to inadequate assurance of quality, safety, effectiveness of medicines and food products in the country.
Figures by the World Health Organization (WHO) show as of February 2021, Rwanda FDA has licensed 17 pharmaceutical manufacturing companies — four large and 13 small-scale — more than 700 retail and wholesale pharmacies, and has approved more than 4,000 human and veterinary medicines.
In recent years, Rwanda FDA has recalled various products from the market, including drugs. However, the Authority still largely relies on international drug manufacturers to recall some medicines that cause concern.
This is partly because large pharmaceutical companies are reluctant to recall their products due to the reputation risk. By the time the manufacturer recalls a product, the damage is already done.
As the case against Johnson & Johnson baby powder in the US has shown, companies will spare no cost to protect their reputation. Despite widespread allegations of the powder being linked to cancer, only recently did the company announce that it will end global sales in 2023.
However, the company which is facing over 40,000 lawsuits in the US alleging that baby powder contaminated with asbestos caused ovarian cancer or mesothelioma, vehemently denied the claims, insisting that the decision to stop its manufacturing is a “commercial decision” that “will help simplify our product offerings, deliver sustainable innovation, and meet the needs of our consumers, customers, and evolving global trends.
“Our position on the safety of our cosmetic talc remains unchanged,” the statement continued.
“We stand firmly behind the decades of independent scientific analysis by medical experts around the world,” the company said.
The challenge for Rwanda FDA now is to step up its due diligence and independently test drugs manufactured by big pharma. To wait for manufacturers to recall their products increases the risk of more unsuspecting users being exposed to harmful products.