ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) recently suspended the registration of three drug items for failing to meet safety, efficacy, and quality requirements (SEQ).
Sajid Hussain Shah, the spokesperson of DRAP, has said that the Board of DRAP has suspended the registration of these drug products, including painkiller tablets of Diclofenac Potassium in strengths of 75 & 100 mg, a liquid suspension of anti-ulcer drug Famotidine in strengths of 10mg/ 5ml and 40mg/ 5ml, and a combination drug product containing paracetamol, thioridazine and caffeine over lack of safety data.
Because there is very little data on the quality, safety, and efficacy of these pharmaceutical products, DRAP advised healthcare professionals, patients, and their attendants not to prescribe or use them. The statutory board of DRAP to register, suspend, or cancel drug registrations decided to suspend all registrations of these drugs after an extensive deliberation on the results of the benefit-risk evaluation and providing an opportunity for personal hearing to manufacturers holding registrations of these drugs.
The DRAP Registration Board evaluated the profiles of these drug products based on quality, safety, and efficacy criteria according to The Drugs Act of 1976. The panel, which is made up of experts in medicine, pharmaceutics, and pharmacology, made the decision to suspend the products based on reports from the US Food and Drug Administration (USFDA), the Medicine and Health Product Regulatory Authority (MHRA) in the United Kingdom, Health Canada, and Swiss Medic in Switzerland. Furthermore, no pharmacovigilance (PV) data on these formulations' adverse drug reactions (ADRs) is available.
