Islamabad, April 27, 2019 (PPI-OT): Minister of State for Health Dr. Zafar Mirza in his maiden visit to Drug Regulatory Authority of Pakistan Headquarters after assuming office issued directions to end business as usual approach and take concrete and immediate measures towards transforming the organization to conform to global standards. He was accompanied by Secretary Health Capt. ® Zahid Saeed. The Minister said it would be his personal mission to uplift the organization to come up to the expectations of the people as a truly efficient world class regulatory body.
To this end every possible technical support will be sought from international bodies to make it a model regulatory authority in the region. Dr. Zafar Mirza said we must make a long term investment in improving the quality and capacity of professionals in the area of health regulation. I would soon invite all stakeholders to chart a course for making the field a truly professional one by introducing postgraduate level programs of Health Regulatory Sciences in universities. Concrete steps are afoot to strengthening the Pharmaceutical sector We will provide enabling environment to facilitate responsible growth of the Pharma industry and take concrete steps to this end, the minister said.
Ensuring provision of quality affordable drugs to the masses is our responsibility and both the regulator and industry must be mindful of their responsibility to the society, the minister added. Dr. Zafar Mirza said there will be zero tolerance for wrongdoing and stern action will be taken in case an iota of malpractice is discovered. Ensuring good governance and highly transparent and efficient conduct of business at DRAP was his mission the minister said. A reward and punishment system will be instituted to allow career growth of high performers in DRAP.
Specialized training programs will be introduced to build capacity of both assessors and inspector, said the minister. Earlier, the Minister was briefed by Asim Rauf, Chief Executive Officer, DRAP on authority’s scope, functioning and progress on various steps taken to improve efficiency of the Authority. It was informed that various regulations were in process of introduction to improve the functionalization of therapeutic goods regulation in the country.
DRAP is focused on automation of its processes. In this context, Integrated Regulatory Information Management System (IRIMS) has been deployed which is in its pilot testing phase for registration of pharmaceutical drugs and licensing of pharmaceutical manufacturing units. DRAP has involved 10 pharmaceutical manufacturers in testing phase for smooth running for the online system.
Similarly, DRAP is adopting international best practices in order to harmonize its regulations and functions with global regulatory regimes to further ensure quality and improve safety and efficacy of therapeutic goods. Such steps will increase the acceptance of DRAP’s registered products all over the world. CEO DRAP also informed that digitization and archiving of DRAP record has been started which will be completed in 6 months. He maintained that it is essential to upgrade the resources and capacities of DRAP to meet the requirements of enforcement in true letter and spirit.
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