DRAP clears its image by reflecting on achievements

The Drug Regulatory Authority of Pakistan (DRAP) -- an organisation that remains mired in controversies and scandals -- Sunday issued a press release to highlight some of its key achievements since the year 2012, when the authority was established. The Ministry of Health’s commitment to uplift DRAP on fast track is also reflected in the press release, which appears more like a rejoinder to the barrage of allegations that continue to be leveled against DRAP.
“DRAP has implemented more than ten new laws to regulate therapeutic goods while six more drafts are in the pipeline to further align the regulatory system with world best practices. DRAP has taken major steps to bring unregulated fields of herbals, alternative medicines and medical devices under the umbrella of regulation. A uniform policy for drug pricing was developed and new amendments in the law have been made to impose strict punishment on overcharging and black marketing of drugs. Pending cases for price fixation have been disposed. DRAP has provided a policy to facilitate export of pharmaceuticals from Pakistan, while allowing import of quality products only,” the press release states.
Major initiatives have been taken to promote quality of drugs including specifications for source of active pharmaceuticals ingredients and primary packaging materials. Drug registration process has been made stringent by ensuring authenticity of drug registration data through onsite product specific inspection of pharmaceutical firms by a panel of expert. WHO standardized format, Common Technical Document (CTD) has been introduced at par with international best practices. Another milestone achievement is the implementation of 2D barcoding on packaging of drugs for eradication of spurious, counterfeit and unregistered drugs through a scientific system, the press release further adds.
Other achievements listed in the press release include monitoring of adverse drug reactions from marketed drugs through a legislative mechanism of pharmacovigilance. A national Pharmacovigilance centre will also be established for monitoring and vigilance of marketed drugs for patient safety. Similarly, rules for conduction of clinical trials and research on new drugs in Pakistan has been recommended by the Authority for approval and is now under consideration of the federal government. National essential medicine list has been developed in 2016 to help procurement of drugs by provincial governments, hospitals and public institutes, the press release states.
DRAP has granted 84 new licenses for manufacturing of pharma drugs while 620 manufacturers and importers have been enlisted for alternative medicines and health and OTC products. The Registration Board has processed more than 13,000 cases for drug new registration in last four years. A national registry for cardiac stents has been developed to monitor utilization of cardiac stents, the press release adds.
DRAP has started upgrading of its drugs testing labs and Central Drug Lab Karachi is being completely revamped for accreditation as WHO pre-qualified lab.