ISLAMABAD: Drug Regulatory Authority of Pakistan (DRAP) chief executive officer (CEO) Dr Sheikh Akhter Hussain has said that the National Essential Medicine List is being revised in 2018 in collaboration with World Health Organisation (WHO) and USAID that would be published in July.
Speaking at a briefing session on pricing mechanism for drugs for the Ministry of National Health Services and Regulations (NHSRC), the DRAP chief said, the drug pricing policy is also being revised through consultative meetings with stakeholders in light with the direction of Supreme Court of Pakistan in HRC 2858/2006.
NHSRC Federal Secretary Captain (retd) Zahid Saeed was also present during the briefing.
This year DRAP also signed an agreement with WHO, Geneva for collaborative registration procedures for prequalified finished pharmaceutical products, Hussain said.
127 alternative medicines get approval from DRAP
The progress made in medical devices, licensing, registration, controlled drugs, alternative medicines & health OTC products was also presented.
Caretaker Minster Muhammad Yusuf Shaikh appreciated the initiatives by the authority and emphasised on provision of “quality medicines at affordable prices to the masses”.
It was highlighted that the DRAP Act 2012 was promulgated by parliament to provide effective coordination and enforcement of the Drugs Act 1976 and to bring harmony in interprovincial trade and commerce of therapeutic goods.
Vision of DRAP is consistent with the Pakistan Vision 2025, Hussain said, and “Mission of DRAP is to ensure access to safe quality and efficacious medicines and therapeutic goods at affordable prices,” he added.
The main achievement of DRAP were highlighted as restructuring National Regulatory Body, promulgation of alternative medicines and health products rules, medical devices rules, drug pricing policies for uniform prices of molecules, revision of rules in line with international guidelines of WHO and ICH for drug registration, licensing, quality control and post marketing surveillance of drugs.
Hussain explained that interprovincial coordination has improved for enforcement actions and an ongoing campaign has been launched through National Task Force upon the direction of Supreme Court for eradication of spurious and unregistered drugs.
Crackdown: DRAP drive against spurious drugs continues
Sharing the data, he said, the task force conducted 2,176 surveillance visits, during which about 2,500 regulatory actions were taken, while at the same time about 61 FIRs were registered against culprits involved in manufacturing and selling of unregistered and spurious drugs.
He said that DRAP has initiated the process of international accreditation, WHO self-assessment of National Regulatory Authority and WHO prequalification of its central Drug Laboratory, Karachi.
Automation of DRAP functions and processes on a single online platform of integrated Regulatory Management Information System (IRMIS) is also in process of completion, Hussain added.
It was informed that drug registration dossier submission format has been revised as per international harmonised pattern of WHO/ICH Common Technical Document (CTD), which has been implemented through SRO 713 (I)/2018 dated June 9.
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