Quality Control Report of Drugs Analyzed in the Drug Analysis and Research Unit During the Period 2016-2020

Kennedy O Abuga; Dennis B Ongarora; Peter M Njogu; Beatrice K Amugune; Alex O Okaru; Stanley N Ndwigah; Isaac O Kibwage

Kennedy O Abuga Drug Analysis and Research Unit, Department of Pharmaceutical Chemistry, Pharmaceutics & Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O. Box 19676-00202, Nairobi, Kenya.
Dennis B Ongarora Drug Analysis and Research Unit, Department of Pharmaceutical Chemistry, Pharmaceutics & Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O. Box 19676-00202, Nairobi, Kenya.
Peter M Njogu Drug Analysis and Research Unit, Department of Pharmaceutical Chemistry, Pharmaceutics & Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O. Box 19676-00202, Nairobi, Kenya.
Beatrice K Amugune Drug Analysis and Research Unit, Department of Pharmaceutical Chemistry, Pharmaceutics & Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O. Box 19676-00202, Nairobi, Kenya.
Alex O Okaru Drug Analysis and Research Unit, Department of Pharmaceutical Chemistry, Pharmaceutics & Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O. Box 19676-00202, Nairobi, Kenya.
Stanley N Ndwigah Drug Analysis and Research Unit, Department of Pharmaceutical Chemistry, Pharmaceutics & Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O. Box 19676-00202, Nairobi, Kenya.
Isaac O Kibwage Drug Analysis and Research Unit, Department of Pharmaceutical Chemistry, Pharmaceutics & Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O. Box 19676-00202, Nairobi, Kenya.

Keywords: DARU, specifications, drug class, market authorization, adulteration, substandard and falsified medicine

Abstract

During the five-year period covering 2016-2020, the Drug Analysis and Research Unit (DARU) received and processed 326 drug samples. Of these samples, 32.5% were locally manufactured, 65.7% imported and 1.8% of undeclared origin. Samples were analyzed according to compendial and/or in-house specifications. The overall non-compliance rate was 1.8% (0.6% locally manufactured, 0.9% imported and 0.3% drugs of undeclared origin). Full analytical compliance was recorded with anti-emetics. spasmolytics, antihypertensives, ophthalmics, anti-infectives, analgesics, anti-inflammatory agents, anti-epileptics, nootropics, anaesthetics, respiratory drugs, genitourinary drugs, anticancers, dermatologicals, immunomodulatory drugs, vaccines and excipients. However, one sample each of anti-ulcers, hypoglycemics, opioids and herbals as well as two samples of antiseptics did not comply with specifications. This represents the lowest failure rate of samples analyzed in DARU and presented as pentad reports since the year 1991.