The Drug Regulatory Authority of Pakistan (DRAP) on Saturday suspended the registration of three drugs for not qualifying the criteria of safety, efficacy, and quality (SEQ).
According to the spokesperson of DRAP, the Registration Board of DRAP has suspended the registration over safety concerns from painkillers and acidity medicine in irrational strength and dosage gets suspended by DRAP due to no safety data.
These drug products included painkiller tablets of Diclofenac Potassium in strengths of 75 and 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, he added.
The DRAP further advised the healthcare professionals, patients, and their attendants not to prescribe or use these drug products as there is very less data on the quality, safety, and efficacy of these drugs.
After detailed deliberations on the results of the benefit-risk evaluation and affording an opportunity of personal hearing to manufacturers holding registrations of these drugs, the statutory board of DRAP to register, suspend or cancel the registration of drugs decided to suspend all registrations of these drugs.
He said that the 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 the 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 including the 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, the spokesperson added.
