DRUG REGULATORY AUTHORITY OF PAKISTAN
The Drug Regulatory Authority of Pakistan (DRAP) operates under the Ministry of National Health Services, Regulations & Coordination, and is headquartered at the PM National Health Complex in Islamabad. DRAP is tasked with ensuring the safety, efficacy, and quality of drugs and healthcare products in Pakistan. It oversees the registration of pharmaceuticals, regulates their manufacturing and distribution, and enforces compliance with health regulations. The authority aims to protect public health by facilitating access to safe and effective medications while also promoting a robust regulatory framework. Additionally, DRAP is involved in various health initiatives, policy development, and capacity building within the healthcare sector, working to enhance the overall healthcare landscape in the country.
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Government of Pakistan
DRUG REGULATORY AUTHORITY OF PAKISTAN
Ministry of National Health Services, Regulations & Coordination
PM National Health Complex, Park Road, Islamabad
JOB OPPORTUNITIES
Advertisement No. 01/2024
The Drug Regulatory Authority of Pakistan (DRAP) is seeking applications from eligible Pakistani citizens for various positions. Below are the details regarding qualifications, experience, age limits, and quotas.
1. Assistant Director (RO-12)
- Total Positions: 89
- Pay Scale: Technical
- Maximum Age: 35 Years
- Quotas: 7-Merit, 23-Punjab, 6-Punjab (Women), 4-Punjab (Minorities), 3-Sindh (Rural), 2-Sindh (Rural, Women), 1-Sindh (Rural, Minorities), 4-Sindh (Urban), 1-Sindh (Urban, Women), 1-Sindh (Urban, Minorities), 3-KPK, 2-KPK (Women), 1-KPK (Minorities), 3-Balochistan, 1-Balochistan (Women), 3-KPK (EX-FATA), 1-AJK
2. Technical Specialist - Chemist
- Total Positions: 5
- Pay Scale: Technical
- Maximum Age: 35 Years
- Quotas: 1-Merit, 2-Punjab, 1-Sindh (Rural), 1-KPK
3. Technical Specialist - Microbiologist
- Total Positions: 2
- Pay Scale: Technical
- Maximum Age: 35 Years
- Quotas: 2-Punjab, 1-Sindh (Rural), 1-KPK
4. Technical Specialist - Biomedical Engineer
- Total Positions: 3
- Pay Scale: Technical
- Maximum Age: 35 Years
- Quotas: 1-Punjab, 1-Sindh (Rural), 1-KPK
5. Technical Specialist - Biotechnologist
- Total Positions: 1
- Pay Scale: Management
- Maximum Age: 35 Years
- Quotas: 1-Merit
6. Budget & Account
- Total Positions: 2
- Pay Scale: Management
- Maximum Age: 35 Years
- Quotas: 1-Merit, 1-Sindh (Urban)
7. Costing & Pricing
- Total Positions: 1
- Pay Scale: Management
- Maximum Age: 35 Years
- Quotas: 1-Merit
8. Legal Affairs
- Total Positions: 7
- Pay Scale: Legal
- Maximum Age: 35 Years
- Quotas: 1-Merit, 3-Punjab, 1-Punjab (Women), 1-Sindh (Urban), 1-Balochistan
Qualifications and Experience Required
- Assistant Director: PharmD or B. Pharmacy; relevant pharmaceutical experience preferred.
- Technical Specialist - Chemist: Minimum 16 years of education in organic, analytical, or pharmaceutical chemistry; relevant experience preferred.
- Technical Specialist - Microbiologist: Minimum 16 years of education in microbiology; relevant experience preferred.
- Technical Specialist - Biomedical Engineer: Minimum 16 years of education in biomedical engineering; relevant experience preferred.
- Technical Specialist - Biotechnologist: Minimum 16 years of education in biotechnology; relevant experience preferred.
- Management Positions: Master’s degree in a relevant field; specific experience required.
- Legal Affairs: LLB with membership in the Bar Association and at least 3 years of relevant experience.
Important Instructions
- Candidates who meet the minimum qualifications and experience will be allowed to appear for the tests.
- No travel allowance or daily allowance will be provided for attending the test.
- Employees in public sector organizations must present a No Objection Certificate (NOC) at the interview.
- Appointments will not be made for individuals with financial or professional conflicts of interest.
- Age limits are calculated from the closing date of applications, with a general relaxation of 5 years included.
- Compensation and terms of service will follow the DRAP Employees Service Regulations.
- DRAP reserves the right to withdraw any or all positions during the recruitment process.
- Submission of an application does not guarantee an appointment.
- Verification of character and educational credentials will be conducted.
- Selected candidates must undergo a medical examination by a Federal Government medical board.
- Closing date for applications: November 11, 2024. Ensure timely online submission and fee payment.
Registration Process
- To register, visit: http://etc.hec.gov.pk.
- For assistance, refer to [HEC Help](online help.hec.gov.pk) or contact HEC regional offices.
- Complete the two-step application process: fill out your profile and submit your application.
Payment of Test Fee
- Pay the fee via 1 Link 1 Bill Invoice through participating banks or mobile services.
- Verify your payment on the ETC Dashboard.
- Bring your roll number slip and original CNIC or Passport to the examination.
For further information, please contact:
Rabnawaz Khan
Deputy Director (HR/Officers)
Phone: 051-9255953
Apply Online using the link available on the official webpage.
Overview of the Drug Regulatory Authority of Pakistan (DRAP)
Introduction
The Drug Regulatory Authority of Pakistan (DRAP) is a pivotal institution responsible for the regulation of pharmaceuticals and healthcare products in the country. Established in 2012 under the Drug Regulatory Authority of Pakistan Act, DRAP operates under the Ministry of National Health Services, Regulations & Coordination. Its primary mission is to ensure that all medicinal products are safe, effective, and of high quality for the public.
Historical Context
Prior to the establishment of DRAP, drug regulation in Pakistan was fragmented and managed by various entities. The lack of a centralized authority led to inconsistencies in drug quality, safety standards, and regulatory enforcement. Recognizing the need for a dedicated agency, the Government of Pakistan enacted the DRAP Act in 2012, creating a centralized body to oversee drug regulation.
Mandate and Responsibilities
DRAP’s mandate encompasses a broad range of responsibilities aimed at safeguarding public health. Key functions include:
Drug Registration: DRAP is responsible for the registration of all pharmaceuticals and therapeutic goods before they can be marketed in Pakistan. This process ensures that products meet the required safety and efficacy standards.
Quality Control: The authority conducts inspections and testing of drug manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP). Regular monitoring helps maintain the quality of drugs in circulation.
Pharmacovigilance: DRAP monitors the safety of drugs post-marketing through adverse event reporting systems. This includes analyzing data related to drug side effects and taking necessary actions to mitigate risks.
Regulation of Clinical Trials: The authority oversees the conduct of clinical trials in Pakistan to ensure that they adhere to ethical standards and regulatory requirements.
Pricing Regulation: DRAP regulates the pricing of essential medicines to ensure affordability and accessibility for the public. This includes establishing a framework for the fair pricing of pharmaceuticals.
Public Awareness and Education: The authority conducts awareness campaigns to educate healthcare professionals and the public about safe medication practices, proper use of medicines, and the risks associated with counterfeit drugs.
Coordination with International Bodies: DRAP collaborates with international regulatory agencies, such as the World Health Organization (WHO) and the International Pharmaceutical Regulators Forum (IPRF), to align its practices with global standards.
Organizational Structure
DRAP operates through a structured hierarchy that includes various departments and divisions, each focusing on specific regulatory functions:
- Drug Registration and Licensing: This division handles the application and approval process for new drugs and monitors existing ones.
- Quality Control and Testing: Responsible for laboratory testing and ensuring compliance with quality standards.
- Pharmacovigilance: Manages the reporting and analysis of adverse drug reactions.
- Legal Affairs: Addresses legal issues related to drug regulation and provides legal support to the authority.
- Public Relations and Communication: Handles communication strategies, public awareness campaigns, and stakeholder engagement.
The authority is governed by a board comprising experts from various fields, including healthcare, pharmacy, and law, ensuring that a wide range of perspectives informs its decisions.
Regulatory Framework
The regulatory framework established by DRAP is designed to ensure that all drugs and health products available in Pakistan meet rigorous safety and efficacy standards. This framework includes:
- Drug Regulatory Authority of Pakistan Act, 2012: The foundational legislation that outlines DRAP’s powers, responsibilities, and operational guidelines.
- Good Manufacturing Practices (GMP): Standards that pharmaceutical manufacturers must adhere to, ensuring that products are consistently produced and controlled according to quality standards.
- Good Clinical Practices (GCP): Guidelines governing the conduct of clinical trials to protect the rights and welfare of trial participants.
- National Essential Medicines List (NEML): A list that identifies the most essential medicines for a health system, guiding procurement and availability.
Challenges and Issues
Despite its critical role, DRAP faces several challenges in effectively regulating the pharmaceutical sector:
Counterfeit Drugs: The proliferation of counterfeit and substandard medicines poses a significant threat to public health. DRAP is actively working to combat this issue through enforcement and public awareness.
Resource Limitations: Limited human and financial resources can hinder the authority's ability to conduct thorough inspections and regulatory activities.
Public Awareness: There is a general lack of awareness among the public regarding the importance of drug regulation, which can lead to the misuse of medicines.
Coordination with Provincial Authorities: Pakistan’s federal structure means that coordination between DRAP and provincial health departments can sometimes be challenging, impacting the overall regulatory framework.
Rapidly Evolving Pharmaceutical Landscape: Advances in biotechnology and changes in global health dynamics require DRAP to continuously adapt its regulatory practices and guidelines.
Recent Initiatives
In response to the evolving landscape, DRAP has undertaken several initiatives:
Digital Transformation: DRAP has initiated efforts to digitize its processes, including online drug registration and licensing, to improve efficiency and transparency.
Strengthening Pharmacovigilance: The authority is enhancing its pharmacovigilance systems to better monitor drug safety and respond promptly to adverse events.
Capacity Building: Training programs for regulatory staff and stakeholders are being implemented to improve knowledge and skills related to pharmaceutical regulation.
Collaboration with Industry: DRAP is engaging with pharmaceutical companies to foster a collaborative approach to regulation, ensuring that industry insights are considered in policy-making.
Public Awareness Campaigns: Increased efforts are being made to educate the public about safe medication practices and the importance of using regulated medicines.
Future Directions
Looking ahead, DRAP aims to strengthen its regulatory framework by:
- Enhancing Collaboration: Building stronger partnerships with international regulatory bodies to adopt best practices and improve local standards.
- Expanding Research and Development: Supporting local pharmaceutical research and development initiatives to foster innovation and self-sufficiency.
- Improving Access to Medicines: Ensuring that essential medicines are accessible and affordable, particularly for marginalized communities.
- Adapting to New Technologies: Embracing advancements in technology, such as artificial intelligence and data analytics, to enhance regulatory processes.
Conclusion
The Drug Regulatory Authority of Pakistan plays a crucial role in safeguarding public health through the regulation of pharmaceuticals and healthcare products. Despite facing numerous challenges, DRAP continues to adapt and evolve in response to the dynamic healthcare landscape. By fostering collaboration, enhancing public awareness, and implementing robust regulatory practices, DRAP aims to ensure that the people of Pakistan have access to safe, effective, and high-quality medicines.
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