Spokesperson of Drug Regulatory Authority of Pakistan (DRAP) Sajid Hussain Shah has said that Registration Board of DRAP has suspended registration of three drug products as these do not qualify criteria of safety, efficacy and quality (SEQ). These drug products include painkiller tablets of Diclofenac Potassium in strengths of 75 & 100 mg, 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.
DRAP advises healthcare professionals, patients, and their attendants on not prescribing or using these drug products as there is very less data on quality, safety, and efficacy of these drugs. After detailed deliberations on results of benefit-risk evaluation and affording an opportunity of personal hearing to manufactures holding registrations of these drugs, statutory board of DRAP to register, suspend or cancel registration of drugs decided to suspend all registrations of these drugs.
Registration Board of DRAP assessed the profiles of these drug products on criteria of quality, safety, and efficacy as per The Drugs Act, 1976. The Board, which is composed of experts from practice of medicine, pharmaceutics, and pharmacology, took its decision to suspend the products based on the reports of various reference regulatory authorities of the Board that include United States Food and Drug Administration (USFDA), Medicine and Health Product Regulatory Authority (MHRA), United Kingdom, Health Canada and Swiss Medic, Switzerland. Moreover, no pharmacovigilance (PV) data is available regarding adverse drug reactions (ADRs) of these formulations.
