Pakistan’s pharmaceutical industry is on the brink of transformation, with key regulatory amendments and policy changes in progress. A recent high-level meeting addressed crucial aspects, including drug law amendments, lab upgrades, harmonization of regulations, and export policy revisions. These reforms aim to align Pakistan’s pharmaceutical sector with international best practices and enhance its global competitiveness.
Drug Law Amendment: Ensuring Global Compliance
The Pakistan Pharmaceutical Manufacturers Association (PPMA) proposed amendments to the Drugs Law, which were discussed during the 57th Policy Board meeting on October 17, 2024. However, PPMA later requested to halt the process for further deliberation with the Drug Regulatory Authority of Pakistan (DRAP). The meeting concluded that any amendments should align with international best practices, with a focus on models from successful pharmaceutical-exporting nations. The Ministry of National Health Services, Regulations & Coordination (MNHSR&C) and DRAP have been tasked with consulting stakeholders before presenting the amendment for approval in the Council of Common Interests (CCI).
Upgrading Drug Testing Laboratories (DTLs)
Efforts to modernize provincial Drug Testing Laboratories (DTLs) are underway. DRAP conducted a gap assessment of DTLs in Balochistan, KPK, Sindh, and Gilgit-Baltistan between November 2024 and January 2025. Punjab has committed to completing its lab upgradation by February 21, 2025. To ensure all provinces, including GB and AJK, attain WHO Prequalification (PQ) certification by June 30, 2025, a Working Group (WG) meeting will be held with all relevant stakeholders.
Harmonizing DRAP and Drug Act Regulations
The harmonization of rules across federal and provincial levels is a priority. Model Therapeutic Goods Sale Rules have been drafted and shared with provinces. While consensus has been reached on most issues, Punjab and Sindh require further discussions. A final consultation round is scheduled for February 2025, with full harmonization expected by March 30, 2025. Additionally, the Ministry of Health aims to ensure Pakistan’s membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S) by June 30, 2026.
Regulating Baby Milk and Related Products
The classification of baby milk and related products as food rather than medicine remains a topic of debate. DRAP has proposed amendments to the DRAP Act, 2012, including Alternative Medicines and Health Products (Enlistment) Rules, 2014. However, the Ministry of Law & Justice clarified that without a resolution, the bill would only apply to Islamabad Capital Territory (ICT). A joint Working Group meeting between MNHSR&C and the Law Ministry will determine the best approach for legislative approval through the CCI.
Expanding Scope of Genetic Disorder Prevention Policy
The meeting also reviewed preventive measures for genetic disorders and Thalassemia. It was agreed that the scope should expand to include all genetic disorders, leading to a policy name change to “Genetic Disorder and Genetic Health.” A draft legislation on preventive measures, including genetic health, will be finalized by February 2025 after consultation with provincial stakeholders.
Boosting Pharma Exports and Retention Rates
The Ministry of Commerce is actively working to enhance Pakistan’s pharmaceutical export potential. Discussions with stakeholders are ongoing to establish a Pharma Council. PPMA has requested an additional month to finalize its proposal. Additionally, the government is considering increasing the pharma export retention rate from 15% to 35%, with PPMA directed to submit a proposal justifying the increase. DRAP emphasizes the need for pharmaceutical manufacturers to open up to international audits to boost exports effectively.
Conclusion
Pakistan’s pharmaceutical industry stands at a pivotal moment, with regulatory reforms paving the way for greater international integration and competitiveness. By upgrading labs, harmonizing regulations, and refining drug laws, the government aims to create a robust framework that supports both local growth and global expansion. As these initiatives take shape, collaboration between policymakers, industry leaders, and regulatory bodies will be crucial in ensuring sustainable progress.
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