Drug
Regulatory Authority said Division of Pharmaceutical
Evaluation & Registration, DRAP completing free the process of digital
listing of all registered drugs and in this aspect a provisional database has
been uploaded on the official website of DRAP. The Authority has 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. The untiring efforts have been made with the aim to maintain
latest updated data regarding drug products having valid registration, for the
information of all stakeholders and healthcare professionals.
Spokesperson said the link available on the
DRAP’s website (www.dra.gov.pk) open a draft list of
registered drugs which is sourced to database that contain information of drugs
registered by Registration Board. This information mainly include Registration
Number, Proprietary / Brand Name, Generics name with composition, name of
manufacturer and /or importer etc. However, as the process of computerization
has been initiated for the first time therefore the record is being under
continuous verification and scrutiny, the Authority has thus mentioned a
disclaimer that clarify that the information cannot be used for any legal
reference or to be used for any other
purpose. It also invites 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 finalizes and declare this information.
Spokesperson said Drug Act 1976 requires
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
process and approves the applications for registration of drugs according to
the procedure laid down in the LRA (Licensing, Registering & Advertising)
Rules 1976. The availability of online database containing updated information
of registered drugs will help federal and provincial regulators to determine
products that are being marketed have been approved from Drug Registration
Board and are with legitimate status. This will ensure quality drugs from
licensed manufactures/ importers, in the market and will also help to address
the problems of drug shortages and availability. Online access to this database
will strengthen regulatory system and monitoring in order to eradicate unregistered,
substandard, spurious, falsified and counterfeit drug products from the
country.
However, it is
pertinent to mention here 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. 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, establishment of pharmacovigilance system,
are worthy efforts of DRAP team to ensure the provision of quality assured
drugs. These steps has put few culprits in trouble and they are trying to malign
the officials of DRAP and Ministry through baseless complaints and thus to
divert public and agencies attention from their misdoings.
