Comparative Analysis of Pharmaceutical Product Recall Guidelines followed by East African Regulatory Authorities

Grace Achieng Otieno; Shital M Maru; Dennis SB Ongarora; Lucy J Tirop

Grace Achieng Otieno Kenya Medical Training College, Nairobi Campus, P.O. Box 30195-00100, Nairobi, Kenya
Shital M Maru School of Pharmacy and Health Sciences, United States International University, P.O. Box 14634-00800, Nairobi, Kenya.
Dennis SB Ongarora Department of Pharmaceutical Chemistry, Pharmaceutics and Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O Box 19676-00202, Nairobi, Kenya
Lucy J Tirop Department of Pharmaceutical Chemistry, Pharmaceutics and Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O Box 19676-00202, Nairobi, Kenya

Keywords: Drug products safety; recall procedures; Pharmacy and Poisons Board; Tanzania Medicines and Medical Devices Authority; Ugandan National Drug Authority

Abstract

Pharmaceutical product recalls are carried out in response to defective products or adverse events occasioned by use of a product. Recalls are necessary to safeguard the health of the consumer, hence they need to be timely and effective. The objective of this study was to compare pharmaceutical product recall procedures and requirements followed by the Pharmacy and Poisons Board (PPB) of Kenya with those followed by the National Drug Authority (NDA) of Uganda and the Tanzania Medicines and Medical Devices Authority (TMDA). This cross-sectional study reviewed and thematically analyzed guidelines for product recall accessed from the websites of the three regulatory bodies. There were similarities in three out of twelve parameters (initial communication and final progress report contents as well as depth of recall) for all three regulators. The PPB and NDA had similar guidelines for two parameters while TMDA and PPB had similar requirements for four parameters. Both the NDA and TMDA lacked specifications for six parameters. Overall, the product recall procedures followed by the PPB, TMDA and NDA were found to be divergent. Adoption of harmonized guidelines will streamline product recall procedures within the East African region which share a political and economic ecosystem.