Drug Regulatory Authority of Pakistan

Drug Regulatory Authority of Pakistan

Government Administration

Drug Regulatory Authority of Pakistan (DRAP) established under the DRAP Act 2012, is mandated regulate therapeutic goods

About us

DRAP was established under the Drug Regulatory Authority of Pakistan Act, 2012, with a mandate to provide effective coordination and enforcement of The Drugs Act, 1976, and to bring harmony to inter-provincial trade and commerce of therapeutic goods. Therapeutic goods regulated by the DRAP include drugs, biological, medical devices, alternative medicines & health products. The regulatory structure of DRAP comprises 13 Divisions under Section 4 of the DRAP Act 2012, performing various regulatory functions as entrusted under Section 7 of DRAP Act 2012 across the country. DRAP has set up its headquarters in Islamabad along with provincial chapters as field offices in Lahore, Karachi, Peshawar, and Quetta. DRAP has also established two Quality Control Laboratories, namely Central Drug Testing Laboratory (CDL) at Karachi and National Control Laboratory for Biologicals (NCLB) at Islamabad. DRAP in collaboration with the drug regulatory structures of all federating units, is responsible for ensuring that therapeutic goods approved and available in the market meet prescribed standards of quality, safety, and efficacy. Its regulatory operations include Registration and Marketing Authorization, Market Surveillance and Control, Licensing Establishments, Regulatory Inspection, Laboratory Testing, Clinical Trials Oversight, Pharmacovigilance, and Lot Release of Biologicals.

Website
https://www.dra.gov.pk/
Industry
Government Administration
Company size
501-1,000 employees
Headquarters
Islamabad
Type
Government Agency
Founded
2012
Specialties
Regulation and Medicine Quality

Locations

  • Primary

    Drug Regulatory Authority of Pakistan

    Islamabad, 54000, PK

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Employees at Drug Regulatory Authority of Pakistan

Updates

  • Drug Regulatory Authority of Pakistan reposted this

    Message from Dr Hanan Balkhy, Regional Director for the Eastern Mediterranean on the occasion of World AMR Awareness Week -------------------------------------------------- Antimicrobial resistance (AMR) is undermining our ability to treat infections. It is a major threat to human, animal and environmental health. The overuse of antibiotics is a key driver of AMR and the Eastern Mediterranean Region has the highest rate of antibiotic consumption in the world. We must act now. We need to improve responsible antibiotics use, in line with the WHO AWaRe antibiotic book. And we need to ensure equitable access to quality medicines and diagnostics across the Region – including in lower-income countries and areas affected by conflict. To stop the development and spread of infections, we need to strengthen infection prevention and control (IPC). The best and most cost-effective interventions include vaccination and water, sanitation and hygiene (WASH) measures in hospitals and communities. In our Region, we face additional challenges from conflicts and other emergencies. Implementing IPC in overcrowded and damaged health facilities is difficult. WASH infrastructure is severely impacted. And ensuring continuous access to essential medicines is often challenging. To advance antimicrobial stewardship, IPC and WASH, we need commitment and action from all stakeholders: – Strong political leadership at all levels to integrate AMR into national plans, budgets and governance mechanisms. – A well-equipped and trained health workforce – including empowered IPC and antimicrobial stewardship experts. – An engaged, informed public practicing responsible antibiotic use and basic IPC measures at home and in schools and workplaces. This year, Member States made strong commitments at the UN General Assembly, the WHO Regional Committee and the fourth Ministerial Conference on AMR to step up efforts to address this major health threat. AMR knows no boundaries. If we do not act, it will kill up to 39 million people globally by 2050. Every government, every partner, every sector, every stakeholder needs to take action. As we mark World AMR Awareness Week, let us “educate, advocate and act now” to combat AMR.

  • 🌟 DRAP Newsletter-Nov 2024 🌟 The Drug Regulatory Authority of Pakistan (DRAP) has just released its latest quarterly newsletter, showcasing key initiatives and developments that enhance our pharmaceutical landscape. 🔍 The newsletter highlights efforts to improve regulatory oversight of clinical trials, the establishment of a stakeholder queries management system, and enhanced interprovincial coordination for the Institutional Development Plan, in line with WHO recommendations. 💊 DRAP is committed to promoting public health and safety through increased surveillance and proactive regulatory measures to ensure the quality and safety of therapeutic goods. Enjoy the read.. #DRAP #PublicHealth #Pharmaceuticals #RegulatoryUpdates #ClinicalTrials

  • The Drug Regulatory Authority of Pakistan organized an advanced training for GMP Inspectors and Regulatory Staff to strengthen the Inspectorate competence based on the PIC/s GMP Guide. The training session were conducted by Bob Tribe , former PIC/s Chair and Chief GMP Inspector at TGA Australia, who is supporting DRAP on its roadmap towards PIC/s Accession. Training modules covers various inspection techniques, Report Writing skills, Risk assessment and categorization of GMP deficiencies in both sterile and non sterile manufacturing facilities. DRAP is committed to strengthen Regulatory Inspection and Post Marketing Surveillance System of Pakistan in line with PIC/s GMP Standards to ensure enhanced access to safe, quality assured and efficacious therapeutic goods to the people of Pakistan and beyond. #DRAP #GMP #PublicHealth #MedicineQuality #RegulatorySystem #Health #PIC/s

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  • Drug Regulatory Authority of Pakistan reposted this

    View profile for Akhtar Abbas Khan, PhD, graphic

    Drug Regulatory Authority Pakistan | Pharmaceutical Policy | Pharmacovigilance | medicine Safety Communication | Social Media Campaign | Podcast | QMS

    As Medicine Safety Week comes to an end, we want to extend our heartfelt gratitude to all the healthcare professionals who joined us in raising awareness about medicine safety. The idea of sharing video messages in both national and local languages has received an incredible response, and we couldn’t be more thankful. Remember, if you suspect you’re experiencing a side effect from any medicine, speak with your healthcare professional and submit a report to your provincial Pharmacovigilance center or DRAP. Thank you for your commitment to making healthcare safer for everyone. #MedSafetyWeek

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  • As #MedSafetyWeek draws to a close, the safety of medicines and patients everywhere remains a top priority. Many side effects can be prevented by taking medicines as instructed. Remember to take your medicines in the right dose, at the right time, and in the right way. If you suspect that you’re experiencing a side effect from a medicine, be sure to talk to your healthcare professional and submit a report via https://lnkd.in/dHnWxDP4. By submitting detailed reports, you can help us improve #PatientSafety and make medicines safer for all! ✅

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  • Drug Regulatory Authority of Pakistan reposted this

    View profile for Akhtar Abbas Khan, PhD, graphic

    Drug Regulatory Authority Pakistan | Pharmaceutical Policy | Pharmacovigilance | medicine Safety Communication | Social Media Campaign | Podcast | QMS

    #Punjabi is native language of majority of Pakistanis and spoken by 150 million people worldwide. #DRAP officer, Ahsan Ul Haq Athar is here to emphasize the importance of medicine safety. We are committed to reaching you through every possible way to ensure your safety. Video credit SALATEEN WASEEM PHILIP #medsafetyweek #medicinesafetyweek #communication #reportADR

  • Drug Regulatory Authority of Pakistan reposted this

    View profile for Akhtar Abbas Khan, PhD, graphic

    Drug Regulatory Authority Pakistan | Pharmaceutical Policy | Pharmacovigilance | medicine Safety Communication | Social Media Campaign | Podcast | QMS

    This Medicine Safety Week, we’re highlighting the importance of sharing safety information in our national languages. When people receive medicine safety messages in their own language, they can understand and act on this critical information more effectively. Communicating in familiar languages helps ensure that everyone, regardless of background, can use medicines safely, avoid potential side effects, and know when to report any issues. Let’s work together to make medicine safety accessible to all. #Medsafetyweek #Pharmacovigilance #Medicinesafety #communication #DRAP #drugsafety #reportsideeffects

  • Drug Regulatory Authority of Pakistan reposted this

    View profile for Akhtar Abbas Khan, PhD, graphic

    Drug Regulatory Authority Pakistan | Pharmaceutical Policy | Pharmacovigilance | medicine Safety Communication | Social Media Campaign | Podcast | QMS

    Pashtu, one of Pakistan’s national languages, is spoken by over 50 million people worldwide. Our colleague Adnan Shahidullah has shared an important message on medicine safety in his native language. The goal is to reach every Pakistani and others who understand Pashtu to promote awareness. Video courtesy SALATEEN WASEEM PHILIP #medicinesafety #medicinesafetyweek #pharmacovigilance #ReportSideEffects #MedSafetyWeek #Communication #drap #AdverseDrugReaction

  • Drug Regulatory Authority of Pakistan reposted this

    View profile for Akhtar Abbas Khan, PhD, graphic

    Drug Regulatory Authority Pakistan | Pharmaceutical Policy | Pharmacovigilance | medicine Safety Communication | Social Media Campaign | Podcast | QMS

    #Sindhi is a language with roots tracing back to the Indus Valley Civilization, evolving over thousands of years. It is spoken by over 32 million people in Pakistan. The medicine safety message from our colleague,Farman Ali Bozdar is well worth listening to. Video credit SALATEEN WASEEM PHILIP #medsafetyweek #medicinesafetyweek #communication #reportADR

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