Pharmaceutical Evaluation and Registration Division of Drug Regulatory Authority of Pakistan (DRAP) has continued working on digital listing of all registered drugs to facilitate concerned stakeholders and healthcare professionals.
According to an official of DRAP, this facility would ensure quality drugs from licensed manufactures or importers, in the market and would also help address the problems of drug shortages and availability.
He added online access to this database would strengthen regulatory system and monitoring in order to eradicate unregistered, substandard, spurious, falsified and counterfeit drug products from the country.
He said that the authority had initiated the process early in this year for computerization of decades old manual drug registration record since 1976, the era of defunct Ministry of Health and Drug Control wing.
He said that a provisional database had been uploaded on the official website of DRAP and the link was available on the DRAP’s website, which was sourced to database that contain information of drugs registered by the registration board.
This information mainly included registration number, proprietary or brand name, generics name with composition, name of manufacturer or importer etc.
However, as the process of computerization had been initiated for the first time therefore the record was being under continuous verification and scrutiny, he added.
He said that the authority had also invited stakeholders to review information related to their products and were directed to contact the Division in case of any discrepancy and check for the updates and provide reference for further verification against the DRAP record, before the authority finalizes and declare this information.
He said that Drug Act 1976 required pharmaceutical companies that manufacture, import or export in or out of the country for commercial use to be registered prior to availability in market.
The Drug Registration Board approves the applications for registration of drugs according to the procedure laid down in the LRA (Licensing, Registering and Advertising) Rules 1976.
He said that the availability of online database containing updated information of registered drugs would help federal and provincial regulators to determine products that are being marketed have been approved from Drug Registration Board and are with legitimate status.
He said that computerization of drug registration record has also disturbed the miscreants and they are spreading disinformation. As per the present policy for transparency and open access, Divisions of DRAP regularly uploads the minutes of meetings of their respective bodies including registration board, central licensing board, enlistment evaluation committee etc., on DRAP’s website, to ensure transparency, fair practices across the board and data integrity.
He said that new initiatives of DRAP regarding modernization of drug registration process to international practices including WHO-CTD format for drug registration dossier, 2D barcoding on pharma labelling, mandatory GMP certified source of raw materials and establishment of pharmacovigilance system.
He said that these steps which would ensure the provision of quality assured drugs had put few culprits in trouble and they were trying to malign the officials of DRAP through baseless complaints to divert public attention from their misdoings.
