Dual Regulatory Compliance and Corporate Governance Challenges for Foreign IVD Companies under SECP and DRAP Frameworks in Pakistan: A content Analysis

Abstract

Pakistan’s clinical -requirements are overwhelmingly met by imported in -vitro diagnostic (IVD) -technologies however before a single product reach -a laboratory bench. The foreign -companies that supply these technologies must satisfy- two largely independent -regulatory regimes. The Securities and Exchange Commission -of Pakistan (SECP)- regulates the existence, governance, and financial conduct- of the firm under the -Companies Act 2017. Drug Regulatory Authority of Pakistan- (DRAP) regulates- the safety, quality, and lifecycle of the diagnostic product under -the DRAP Act 2012 -and the Medical Devices Rules 2017. This study examines -the phenomenon of dual -regulatory compliance the obligation of a single foreign diagnostic -enterprise to navigate -two parallel frameworks that overlap procedurally yet -diverge institutionally. The study -maps the statutory and procedural requirements -of both regimes and -identifies points of overlap, conflict, and ambiguity, and -analyses the corporate governance -consequences of operating across them using a -doctrinal and qualitative- case study methodology. Drawing on the theory of- regulatory dualism, institutional -economics, and responsive regulation. It develops -a conceptual framework- linking procedural interdependence, governance and liability -gaps and enforcement -disconnection to the observable outcomes of delayed- market entry, elevated compliance -costs, legal uncertainty, and constrained patient- access. The empirical component- synthesized anonymized case studies- of foreign in vitro diagnostic firms -and stakeholder consultations. The central finding is -that the friction confronting foreign -IVD companies is not a product of excessive regulation- as such but of uncoordinated -regulation timing misalignment between the two- regimes, duplicative -documentation, fragmented enforcement, and unallocated- product liability combine -to extend market entry timelines to between- eighteen and thirty months and to -deter smaller manufacturers entirely. A single-window- digital interface, reliance on -recognized international certifications, mutual data -sharing, statutory liability -clarification, and a publicly accessible register of approved -devices are all components of -the study argument for harmonization rather than -deregulation. These reforms- calibrated to Pakistan’s institutional capacity would- reduce friction while preserving- the public-health and accountability objectives that- justify regulation in the- first place.