The Rwanda Food and Drugs Authority (Rwanda FDA) has banned Misoprostol tablets (200 mcg), produced by Angel Biogenic Private Ltd, an Indian pharmaceutical company. The drug is commonly used in Rwandan hospitals to induce uterine contraction. This prohibition extends to all batches of the product and effectively ceases the importation of these tablets into Rwanda. The announcement, on Monday, October 9, follows an official statement signed by Emille Bienvenu, the Director General of Rwanda FDA on X (formerly Twitter), issued on October 7. The decision to ban Misoprostol tablets comes after an extensive investigation into the product's quality conducted by the Rwanda FDA. The findings confirmed that the tested tablets of this medication failed to meet established quality standards, as outlined in the statement. ALSO READ: Rwanda FDA warns about illegal family planning medicines Misoprostol is widely recognized for its role in reducing the risk of stomach ulcers in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin. According to the Mayo Clinic, a renowned medical center based in the United States, Misoprostol assists in safeguarding the stomach against acid damage and reduces the production of stomach acid. Recall of all batches and stop of the importation of Misoprostol tablet 200 mcg manufactured by Angel Biogenic Private Ltd / India: pic.twitter.com/IgIPYWS9N9 — Rwanda Food and Drugs Authority (@RwandaFDA) October 9, 2023 In response to this ban, the Rwanda FDA has issued directives to all pharmacies and healthcare providers involved in the distribution or importation of the aforementioned drug, emphasizing strict compliance with the imposed measures. To ensure patient safety, consumers and healthcare providers are urged to scrutinize the product's origin and authenticity carefully. The immediate imposition of this ban stems from concerns regarding the drug's therapeutic ineffectiveness, primarily attributed to an unacceptable lower level of the active pharmaceutical ingredient (API), as indicated by failed identification tests and essays, as stated in the press release. ALSO READ: Rwanda FDA explains ban on over 100 cosmetics Additionally, the Rwanda FDA has directed all importers, central medical stores, wholesalers, branches of Rwanda Medical Suppliers, retailers, and both public and private health facilities to halt the distribution and dispensing of the said drug. These entities are instructed to return the products to their respective suppliers for proper management. Furthermore, importers and suppliers of the questioned medicine are requested to promptly report to the Agency within three days of the recall's publication, detailing quantities imported, quantities distributed, quantities returned, and their final stock on hand.
