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Major initiatives to uplift DRA to continue on fast track: Spokes Person

Islamabad: Drugs Regulatory Authority (DRAP) has implemented more than ten new laws with prior approval of Federal Government to regulate the therapeutic goods across the country, since 2012, its inception. Currently, six more such drafts are in pipeline to further align our 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 by making rules for these products. A uniform policy for drug pricing was developed while taking stakeholder on board. Drug Pricing Policy, 2015 is a milestone achievement which provide reference based rational mechanism for price fixation of drugs products. New amendments in law have been made to impose strict punishment on overcharging and black marketing of drugs. Similarly, new guidelines were introduced to provide new drugs generic version like Sovaldie, Daclatasvir, etc, to provide economic drugs to hepatitis patients, and now quality drugs with economic prices are available in the country. Pending cases for price fixation has been disposed. DRAP has provided a policy to facilitate export of pharmaceuticals of Pakistan, while only quality products are allowed to be import in the country.
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 standardize format, Common Technical Document (CTD) has been introduced at par with international best practices. Another milestone achievement is the implementation of 2D bar-coding on packaging of drugs, which is one of the leading step among developing countries. This will help for eradication of spurious, counterfeit and unregistered drugs through a scientific system.
DRAP has also started monitoring of adverse drug reaction from the marketed drugs through a legislative mechanism of Pharmacovigilance. Healthcare professionals, Doctors, Pharmacist and nurses are being encouraged to report the ADRs by online reporting system through DRAP website. More than 80 companies are monthly reporting the ADRs from their products. A National level Pharmacovigilance centre will be also establish for continuous monitoring and vigilance of marketed drugsfor patient safety. Similarly, rules for conduction of clinical trials and research on new drugs in Pakistan have been recommended by the Authority for approval and are now under consideration of federal government. National essential medicine list has been developed in 2016 to help procurement of drugs by provincial governments, hospitals and public institutes.
DRAP has granted 84 new licenses for Drug Manufacturing of Pharma drugs while 620 manufacturers / importers has been enlisted for alternative medicines and health & OTC products. Registration Board has processed more than 13,000 cases for drug new registration in last four years. Medical Devices manufacturers are importers have also started their registration with the Authority and DRAP has provided an online system for enlistment of manufacturers and importers of medical devices and for their products. A national registry for cardiac stents has been developed in collaboration with cath lab association to monitor the utilization of cardiac stents.
DRAP has started upgradation of its drugs testing labs and Central Drug Lab Karachi is being completely revamp for accreditation as WHO pre-qualified lab. A reference drug standard bank at CDL, Karachi is being established and in first phase 150 reference standards have been acquired from United States Pharmacopia, U.S.A for ensuring quality and safety of drugs compared against international standards. Each pharma industry is twice in a year inspected.

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