Islamabad - The pharmaceutical evaluation and registration division of Drug Regulatory Authority of Pakistan continued working on digital listing of all registered drugs to facilitate the stakeholders and healthcare professionals, an official said.
According to the DRAP official, the facility would ensure presence of quality drugs from licensed manufactures or importers in the market and would also help address the problem of drug shortage. He added that online access to the database would strengthen regulatory system and monitoring in order to eradicate unregistered, substandard, spurious, falsified and counterfeit drug products from the country.
The official further said that the DRAP had initiated the process for computerisation of decades-old manual drug registration record since 1976.
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 includes registration number, proprietary or brand name, generic name with composition, name of manufacturer or importer. However, as the process of computerisation has been initiated for the first time, therefore; the record is being under continuous verification and scrutiny, he added.
He further said that the authority had also invited stakeholders to review information related to their products and are 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 finalises and declare this information.
He said that Drug Act 1976 required pharmaceutical companies that manufacturing and import or export of drugs for commercial use to be registered prior to availability in market. Drug Registration Board approves applications for registration of drugs according to the procedure laid down in the LRA (Licensing, Registering and Advertising) Rules 1976, he said.
The official also said that availability of online database containing updated information of registered drugs would help the federal and provincial regulators to determine that the products that are being marketed are approved from the board and are with legitimate status.
He said that computerisation of drug registration record has disturbed the miscreants and they are spreading disinformation. As per the present policy for transparency and open access, divisions of DRAP regularly upload minutes of meetings of their respective bodies including registration and central licensing boards and enlistment evaluation committee on DRAP’s website to ensure transparency, fair practices across the board and data integrity.
He said that new initiatives of DRAP regarding modernisation of drug registration to international practices including WHO-CTD format for drug registration dossier, 2D bar coding on pharmaceutical labelling, mandatory GMP certified source of raw materials and establishment of pharmaco-vigilance system. He said that these steps which would ensure 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.