Table 1 Comparison of pre and post DRAP scenario of pharmaceutical regulations in Pakistan

Name

Drug Control Organization

Drug Regulatory Authority

Established

1976

2012

Administrative status

Under MoH

Autonomous (financial, technically and administrative)

Human resource (Total No. of technical staff)

36

185 technical personnel, including predominantly pharmacists, pharmacologists, physicians, chemists, and microbiologists

Financial system

Dependent on MoH for budgetary allocation and funding

Self-sustained system with minimal dependence on the external funding through federal government resulting in a stronger independent position and autonomous structure

Organizational structure

• Two divisions including premises licensing, Quality Assurance, and drug registration (market authorization)

• Two drug controllers reporting to Director

• 13 divisions, five thereof related to non-technical areas

• Financial and administrative autonomy with secretary health as chair to policy board and Chief Executive Officer of DRAP as secretary policy board

Infrastructure

• Four provincial offices run by deputy director general, (DDGs), Federal Drugs inspectors (FIDs), and Assistant Drug Controllers (ADC)

• Limited staff and authorities with most of the decisions referred back to central offices in Islamabad

• Other infrastructure includes two central Drug testing Laboratories (DTLs) and a National Biological Control Laboratory

• A Federal Drug Surveillance Laboratory (FSDSL) was shifted to health ministry outside the sphere DCO earlier to the establishment of DRAP

• The current provincial offices are run under additional directors with the team of twenty-five FIDs, Assistant Director Quality Assurance, and Deputy Director Quality Assurance

• A higher number of technical staff with more autonomy and powers results in swift decision making

• Provincial level issuance of import/export permissions, API/raw material import, sampling, inspection

• assistance in customs release

• With respect to working CDL has shifted to full compendial testing with the exception of a few tests including impurity testing

• FDSL is reverted to its status as component of DRAP and now steps are being taken for its functional role.

Market authorization procedures

• Drug registration applications were placed in a meeting of the product registration board without any structured evaluation procedure (e.g. at times, the agenda distribution used to take place merely an hour before the meeting)

• All applications are submitted as Common technical Document (CTD) as per internationally accepted format which are subjected to a comprehensive evaluation and review procedure [40, 41] implemented through a discrete evaluation cell

• Facilitation of USP-PQM in capacity building

Capacity building opportunities and their outcome and liaison with international agencies

• No formal liaison with international agencies was established.

• Hands-on support by the United States Pharmacopoeia (USP) and USAID since inception of DRAP

• The liaison was a driver to implementation of CTDs [40, 41], GMP standards, Quality Management Systems (QMS), membership to Pharmaceutical Inspection Corporation Scheme (PICS), pharmacovigilance and achieving of global bench marking (GBM)

• Two phases of QMS have already been completed by the end of 2017 [42]

PV status with respect to International Drug Monitoring

No status

Observer status to full Member

WHO’s National Regulatory System Global benchmarking Tool (GBT) grading on Maturity Level (ML) 1–4 [43]

No assessment

• Maturity Level status with “Reactive approach” was documented in the initial assessment done in 2014 which was shifted to “Proactive approach” in the second assessment (2017)

• A third assessment is planned in 2019 for attainment of Maturity Level 3 (Stable Formal System approach) compliance certification [44]

• NRAs with ML3 and ML4 compliance status are regarded as WHO listed authorities (WLAs) [43]

CRF liquidation and research initiatives

Only a meagre amount has been used and no concrete research priorities, policies or plans were present

The area is still unaddressed