ISLAMAABAD: September 27, 2022: In a major positive development, the Drug Regulatory Authority of Pakistan (DRAP) has allowed import of medicines for an individual patient.
Under the revised DRAP regulations, any person can import medicines from any destination for a patient subject to availability of a prescription of a medical practitioner. Earlier, only licensed importers were allowed to import medicines and sell in the market. It mostly resulted in availability of medicines for serious patients like cancer and other complicated diseases.
The new regulation allows any patient or his/her guardian to apply on line on the DRAP website with details of the patient and seek permission for import of any medicine from any destination for a particular patient.
DRAP has also changed the evaluation criteria for drug manufacturers outside Pakistan and allowed virtual inspections of the manufacturing facilities across the globe.
Earlier, DRAP used to conduct physical verification of drug manufacturing facilities in other countries and its officials who were assigned task to evaluate manufacturing units in any country were officially allowed to charge TA/DA @ $ 100 from the manufacturer whose facility was to be inspected abroad. The permission of charging TA/DA from the manufacturers or his representative in Pakistan was an open- ended procedure to corrupt the DRAP officials.
.DRAP in its notification issued here on September 27, 2022 said “ DRAP will conduct remote virtual inspection for verification of GMP compliances for overseas manufacturing facilities . The remote virtual inspection (RVI) programme will utilize risk based approach based on the complexity of each product. The applicant will ensure adequate communications/ tools , both for the desktop review of the information and video inspection of the site”.
The authority has also notified methodology adopted for virtual inspection of the drug manufacturing facilities and recommended adaptation of US FDA –Remote Interactive evaluation of drug manufacturing and bioresearch monitoring facilities.
Noor Mahar, president Pakistan Pharmacists Lawyers Association (PPLA) , appreciated DRAP measure to allow direct import of medicines for an individual patient. He also appreciated DRAP for changing evaluation criteria and have virtual inspections of manufacturing facilities abroad. He claimed that virtual verification of manufacturing units will weed out corruption that was booming in physical verification system.