ISLAMABAD: Drug Regulatory Authority Pakistan (DRAP) has implemented more than 10 new laws, with prior approval of the federal government, to regulate therapeutic goods across the country.
Currently, six more such drafts were in the pipeline to further align the regulatory system with world best practices in the field of medicine.
According to details, DRAP had taken major steps to bring unregulated fields of herbal, alternative medicines and medical devices under the umbrella of the authority by creating new rules for these products. A uniform policy for drug pricing was also developed by taking all stakeholders on-board.
Drug Pricing Policy 2015 was a milestone achievement which provided reference based rational mechanism regarding price fixation of drugs. New amendments in law had been made to impose strict punishment on overcharging and black marketing of drugs.
Similarly, new guidelines were introduced to provide new drugs like Sovaldie and Daclatasvir, to ensure availability of economical drugs to hepatitis patients. Currently, quality drugs were being made available in the country at reasonable prices.
Meanwhile, pending cases for price fixation had been disposed by the authority. DRAP had also provided a policy to facilitate export of pharmaceuticals of Pakistan, while only quality products were allowed to be imported in the country per new regulations.
According to the health ministry spokesman, major initiatives have been taken to promote quality of drugs, including specifications for source of active pharmaceuticals ingredients and primary packaging materials.
He said that drug registration process had been made stringent by ensuring authenticity of drug registration data through onsite product specific inspection of pharmaceutical firms by a panel of experts. World Health Organisation standardise format and Common Technical Document (CTD) had been introduced at par with international best practices, he added.
The spokesman further said that another milestone achievement was the implementation of 2D barcoding on packaging of drugs, which was one of the major steps in regard to drug regulation in the country. This would help in eradication of spurious, counterfeit and unregistered drugs through a scientific system, he added.
DRAP had also started monitoring adverse drug reaction among patients from the marketed drugs through a legislative mechanism known as pharmacovigilance.
The spokesperson further said that healthcare professionals, doctors, pharmacists and nurses were being encouraged to report the ADRs by online reporting system via DRAP website.
A national level pharmacovigilance centre would also be established for continuous monitoring and vigilance of marketed drugs to ensure patient safety. Similarly, rules for conducting clinical trials and research on new drugs in the country had been recommended by the drug authority for approval and was now under consideration of the federal government.
National essential medicine list had been developed in 2016 to help procurement of drugs by provincial governments, hospitals and public institutes.
DRAP had granted 84 new licenses for manufacturing of pharma drugs, while 620 manufacturers/importers had been enlisted for alternative medicines and health and OTC products. The registration board had processed more than 13,000 cases for new drug registration in the last four years.
DRAP had also started upgradation of its drugs testing labs, under which the Karachi Central Drug Lab (CDL) was being completely revamped for accreditation as a WHO pre-qualified lab. A reference drug standard bank at CDL was also being established.
In the first phase, 150 reference standards have been acquired from the United States Pharmacopia for ensuring quality and safety of drugs per international standards. Each pharma industry was also being inspected twice every year by DRAP officials to improve the system of drug registration.
