ISLAMABAD, Jul 27 (APP):Federal Minister National Health Services Muhammad Yusuf Shaikh said the importance of strengthening Health in a country cannot be undermined.
He was addressing the Integrated Regulatory Information Management System here on Friday said as a part of social development, Health sector and its allied disciplines need special attention for ensuring timely availability of Health facilities to the fellow citizens.
Yusuf Shaikh said that Government of Pakistan was continuously investing its resources and aimed at providing sufficient health care facilities in the country. The availability of quality and safe medicines is the essential component of this system where Drug Regulatory Authority of Pakistan (DRAP) has been mandated to regulate therapeutic goods and it is essential that such international practices that will enhance its functions.
Minister said the enhancement of its regulatory functions can be achieved more effectively using advanced, state of the art and internationally accepted practices including harmonized information management system. The implementation of this software for integration of all data related to regulatory functions of DRAP in one system will help to improve the access to safe effective and quality medicine, he added.
He said it is also necessary to harmonize the functions of DRAP with stringent regulatory agencies around the globe. It will boost the export volume of quality and safe pharmaceutical products to more regulated markets which will ultimately benefit the foreign exchange resources of the country. The robust systems and ease of business will attract new investments in the field of pharmaceutical manufacturing, he added.
Minister said accordingly, Implementation of Integrated Regulatory Information Management System (IRIMS) is a success of DRAP in updating its systems in accordance with modern technological needs.
He expressed his pleasure that DRAP has adopted such system and is committed to ensure access to affordable quality assured, safe and efficacious medicine to the people. “It is a process of continual improvement and I encourage DRAP to streamline its systems and processes”, he remarked.
Speaking on the occasion Chief Executive Officer (CEO), DRAP said with technological advances and ease of access to information in this age, it has become mandatory to adopt computer assisted programs. The benefits of such computerized programs surpass all other modes of manual functioning. And there is no doubt that in order to meet today’s requirements of efficiency, effectiveness and management of huge amount of information and data, a software based system is necessary, he said.
CEO, DRAP said the regulation of therapeutic goods is based on science and with everyday advancements in the field, new technology, research practices evolve to ensure safety of patients. He said, “It is important to update our regulation and operations accordingly at par with international best practices”. DRAP with its mandate to ensure quality assured safe medicine in the country has started to upgrade its systems along with updating its rules and regulations as a requirement of modern day needs for harmonization, transparency and effectiveness. It is the first time that completely integrated international standard software is being deployed at DRAP which is specific to the functions of the Authority.
CEO said implementation of IRIMS is one of various steps taken for ensuring availability of quality assured, safe and efficacious therapeutic goods in the country. In this spirit, DRAP is committed to enhance its management of regulatory requirements in the country and our target in site is the attainment of World Health Organization level III compliance for a formal stable regulatory system for regulation of medicine, he said.
He said certain things have been achieved in this regard for example updating of rules and regulations as per international requirements, preparation of guidelines, deployment of database, implementation of barcode, and adoption of CTD. WHO certification of CDL is almost near completion and establishment of a Quality Management System at DRAP is in pipeline and extensive work has been done for increasing output of the existing system, he added.