Islamabad, July 04, 2018 (PPI-OT): Federal Minister, National Health Services, Muhammad Yusuf Shaikh was briefed by the Chief Executive Officer, Drug Regulatory Authority of Pakistan(DRAP), Dr. Sheikh Akhter Hussain regarding various functions and working of DRAP on 4th July.2018. Captain (R) Zahid Saeed, Federal Secretary for NHSR and C was also present during briefing. It was briefed that DRAP Act 2012 was promulgated by the parliament to provide effective coordination and enforcement of the Drugs Act 1976 and to bring harmony in interprovincial trade and commerce of therapeutic goods.
Therapeutic goods include Allopathic drugs, Biologicals, Medical devices, Alternate medicines, Health and OTC products and Medicated cosmetics, etc. Vision of DRAP is consistent with the Pakistan Vision 2025 and mission of DRAP is to ensure access to safe quality and efficacious medicines and therapeutic goods at affordable prices. The working of 13 DRAP’s Division were presented. 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.
Interprovincial coordination has improved for enforcement actions and an ongoing campaign has been launched through National Task Force upon the direction of honourable Supreme Court of Pakistan for eradication of spurious drugs, unregistered drugs, falsified and counterfeit drugs. Task force conducted 2176 inspections / surveillance visits, during which about 2500 regulatory actions were taken, while at the same time about 61 FIR has been launched against the culprits involved in manufacturing and selling of unregistered and spurious drugs. DRAP has initiated the process of International Accreditation, WHO self-assessment of National Regulatory Authority and WHO prequalification of its central Drug Laboratory, Karachi.
Quality Management System is being established, automation of DRAP functions and processes on a single online platform of integrated Regulatory Management Information System (IRMIS)is also in process of its completion. It was informed that drug registration dossier submission format has been revised as per international harmonized pattern of WHO / ICH Common Technical Document (CTD) has been implemented through SRO 713 (I)/2018 dated 9th June,2018.
Drug Pricing Policy has also been revised in 2018 through consultative meetings with stakeholders in light with direction of Supreme Court of Pakistan in HRC 2858/2006. National Essential Medicine List of Pakistan is being revised in 2018 in collaboration with WHO and USAID Project and shall be published in July. DRAP has also signed in 2018 an agreement with WHO, Geneva for collaborative registration procedures for prequalified finished pharmaceutical products.
The progress made in Medical Devices, Licensing, Registration, Controlled Drugs, Alternative Medicines and Health OTC products was also presented. The Honorable Federal Minster appreciated the comprehensive briefing by CEO DRAP and emphasized to provide quality medicines at affordable prices to the masses. Later on, a detail briefing on pricing mechanism for drugs was given to the Honorable Secretary by the CEO, DRAP, explaining the new Drug Pricing Policy and resolution of pricing cases in Supreme Court.
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