Drug Regulatory Authority of Pakistan Drug Regulatory Authority of Pakistan was established under the Drug Regulatory Authority of Pakistan Act, 2012, is the main constitutional body to regulate therapeutic goods in the country. Therapeutic goods regulated by the DRAP include drugs, biological, medical devices, alternative medicines & health products. Previously, scope was limited to Drugs and Biologicals, however, it was extended to other categories after enactment of the Drugs Regulatory Authority of Pakistan Act, 2012. Drug Regulatory Authority of Pakistan (DRAP) is mandated to provide for effective coordination and enforcement of The Drugs Act, 1976 (XXXI of 1976) and to bring harmony in inter-provincial trade and commerce of therapeutic goods. DRAP is responsible for ensuring that therapeutic goods approved and available in market meet prescribed standards of quality, safety and efficacy and are sold at reasonable prices. This includes registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight, pharmacovigilance and lot release of biologicals. The
Drug Regulatory Authority of Pakistan was established in 2012 and is the largest department in the Ministry of National Health Services, Regulation and Coordination, with its headquarters in
Islamabad and regional offices in the provincial capitals of
Karachi,
Lahore,
Peshawar and
Quetta. DRAP has been established by the Federal Government, and its General direction, Administration and monitoring of the Authority vests with Policy Board of DRAP. The Authority comprises a Chief Executive Officer (CEO), appointed by the Federal Government and thirteen Directors, leading each Division of DRAP which perform various functions as mandated under the DRAP Act, 2012. These Divisions are majorly divided into two types, those performing regulatory activities as follows: • Division of Pharmaceutical Evaluations & Registration • Division of Drug Licensing • Division of Health and OTC Products (non-drugs) • Division of Medical Devices and Medicated Cosmetics • Division of Pharmacy Services • Division of Quality Assurance and Laboratory Testing • Division of Biological Evaluation and Research • Division of Controlled Drugs • Division of Costing and Pricing While supportive Divisions are; • Division of Management Information Services • Division of Budget and Accounts • Division of Legal Affairs • Division of Administration, HR and Logistics
Tobacco Control Cell A separate cell was created in 2007. The rationale for the creation of the Cell stemmed from Pakistan’s international obligation. Pakistan is a signatory to
WHO Framework Convention on Tobacco Control. The aim of Tobacco Control Cell is to enhance tobacco control efforts in Pakistan.
National Institute of Population Studies National Institute of Population Studies (NIPS) is the research organization established by the
government since 1986. The NIPS has been mandated to act as a technical arm of the Government for undertaking high quality research and to produce evidence-based data, information for utilization by the Public sector and others agencies for policy formulation, strategic planning and making reference in the spheres of demography, population & development and health.
Directorate of Malaria Control Directorate of Malaria Control is a separate cell in ministry to co-ordinate country-wide efforts for implementation of Roll Back Malaria initiative for 50% reduction in the malaria burden in Pakistan by the year 2010. By the year 2015 >70% of the high risk population of Pakistan having access and using effective malaria prevention and treatment. ==Programs==