Islamabad: Pakistan has formally taken a major step towards aligning its pharmaceutical regulatory system with leading international standards, as the Drug Regulatory Authority of Pakistan (DRAP) began implementing the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines for Good Manufacturing Practices (GMP).
Senior DRAP officials described the move as a “huge success” for the country’s regulatory regime and a gateway to entry into stringent international markets.
The development follows the issuance of SRO 1587(I)/2025 in August last year, under which DRAP adopted PIC/S GMP Guidelines as the benchmark for regulatory inspections of pharmaceutical manufacturers in Pakistan. After a six-month transition period and extensive consultations with industry stakeholders, the Central Licensing Board (CLB) has now approved a phase-wise implementation plan, with the first chapter of the PIC/S GMP Guide coming into force from February 25, 2026.
“This is a milestone moment for Pakistan’s drug regulatory system. By moving towards PIC/S standards, Pakistan is signalling to the world that its pharmaceutical manufacturing and regulatory oversight are being aligned with globally recognised benchmarks. This will strengthen confidence in Pakistani medicines, both locally and in export markets,” a senior DRAP official told this correspondent.
PIC/S is an international cooperation arrangement between regulatory authorities in Europe, Asia and other regions, aimed at harmonising Good Manufacturing Practices and inspection procedures for medicinal products. Membership and compliance with PIC/S standards is widely seen as a mark of regulatory credibility, facilitating acceptance of pharmaceutical products in highly regulated markets and improving cross-border regulatory cooperation.
Under a circular issued by DRAP’s Division of Drug Licensing on February 24, the CLB approved the implementation of Chapter 4 of the PIC/S GMP Guide, which focuses on documentation requirements. This chapter sets out detailed standards for record-keeping, batch documentation, standard operating procedures and quality records, all of which are central to ensuring traceability, accountability and product quality in pharmaceutical manufacturing.
However, certain technical elements such as the Site Master File and Technical Agreements will be implemented from June 1, 2026, as part of a phased transition to allow manufacturers time to align their systems.
To ensure regulatory continuity during the transition, the CLB has also approved a compliance framework for new pharmaceutical units and manufacturers holding formulation licences. This framework covers requirements related to factory premises, plant and equipment, production and quality control facilities, hygiene and sanitation, as well as the particulars to be recorded in manufacturing records. Other chapters of the PIC/S GMP Guide will be introduced gradually, with some sections temporarily exempted until further orders.
The senior DRAP official said the phased approach was designed to balance reform with operational realities on the ground. “We wanted to move decisively towards PIC/S without disrupting medicine supply or placing unrealistic burdens on manufacturers overnight. The implementation plan was developed in consultation with industry and reflects a practical roadmap for regulatory modernisation.”
The DRAP leadership has also acknowledged the role of the pharmaceutical industry in the transition process. According to officials, Pakistan Pharmaceutical Manufacturers’ Association (PPMA) and sector experts provided technical input during consultations, helping shape a framework that aligns international standards with local manufacturing realities.
CEO DRAP has commended the efforts of DRAP’s technical teams for steering the reform process and engaging with stakeholders over the past six months. Officials said the move reflects growing regulatory maturity and an institutional commitment to quality, transparency and international best practices.
Public health experts say the shift towards PIC/S GMP standards could have long-term benefits for patients and the healthcare system. Stronger documentation, quality systems and inspection practices are expected to improve the consistency and safety of locally manufactured medicines, reduce the risk of substandard products, and enhance Pakistan’s standing with foreign regulators and international procurement agencies.
For Pakistan’s pharmaceutical exporters, the move is being seen as particularly significant. Compliance with PIC/S-aligned GMP standards is often a prerequisite for accessing regulated markets in Europe, parts of Asia and other high-income regions. Industry sources believe that, if implemented effectively, the new framework could help Pakistani manufacturers compete more credibly in international tenders and contract manufacturing arrangements.
DRAP has directed all pharmaceutical manufacturers to comply with the newly notified framework in letter and spirit, warning that inspections and licensing decisions will now increasingly be guided by PIC/S benchmarks. Officials say further phases of the implementation plan will be rolled out after reviewing industry preparedness and regulatory capacity.
“This is not just a technical upgrade. It is about changing the culture of compliance, documentation and quality across the sector,” the senior DRAP official said. “If sustained, this reform can reshape Pakistan’s pharmaceutical landscape and its reputation in global markets.”
Ends