DRAP Proposes Amendments to Labelling & Packing Rules

1. DRAP Proposed Amendment: A Turning Point for Pakistan’s Pharmaceutical Sector The Drug Regulatory Authority of Pakistan (DRAP) has recently introduced a proposed amendment that has sparked nationwide conversation within the pharmaceutical industry. As a key stakeholder, the Pakistan Pharmaceutical Manufacturers Association (PPMA) recognizes the significance of this proposal — and believes it could reshape the future of drug regulation in the country. In this blog, we explore what this amendment includes, what PPMA’s position is, and how it may impact pharmaceutical companies, exports, and healthcare quality.

2. What Is the DRAP Proposed Amendment? The proposed amendment aims to update and streamline Pakistan’s existing drug regulatory laws. It focuses on three major areas: ● Faster approval timelines for essential and innovative medicines ● Stricter quality control standards for local and imported drugs ● Modernized licensing procedures for manufacturing and distribution DRAP’s goal is to ensure that Pakistan’s regulations align more closely with international best practices. PPMA’s Response to the Amendment The Pakistan Pharmaceutical Manufacturers Association (PPMA) has welcomed the amendment but with cautious optimism. PPMA believes that reforms are necessary, but they must be inclusive, transparent, and practical for implementation across the industry. PPMA emphasizes that: ● Regulations should encourage local production rather than increase dependency on imports ● Policies must balance public health safety and industrial growth ● There should be stakeholder consultations before implementation to avoid confusion and delays Why This Amendment Matters Pharmaceutical manufacturing in Pakistan is growing, yet it faces challenges due to outdated procedures and long drug approval timelines. This amendment can: ● Speed up Pakistan pharmaceutical exports ● Improve access to essential medicines ● Build international confidence in ppma Pakistan and its regulatory framework

3. ● Enhance the role of Pakistan pharmaceutical manufacturers globally If executed effectively, this reform could help elevate the quality and reputation of Pakistan’s pharma sector. Key Concerns Raised by PPMA While PPMA supports modernization, it has raised the following points: ● Implementation timelines must be realistic ● Clear guidelines are needed to prevent legal ambiguity ● Local industry should not face excessive compliance burdens ● Regulatory decisions should involve public-private dialogue The Path Forward For any amendment to succeed, open communication between regulators and industry leaders is crucial. PPMA has offered its full cooperation to DRAP for technical discussions, industry insights, and collaborative solutions. PPMA also urges the government to: ● Provide training sessions for manufacturers on new rules ● Offer transition support to avoid disruption in medicine supply ● Recognize the efforts of Pakistan pharmaceutical manufacturers association members list in sustaining national healthcare Conclusion The DRAP proposed amendment marks a pivotal moment for Pakistan’s pharmaceutical future. It offers a chance to reform, rebuild trust, and promote better health outcomes. With PPMA’s active engagement, this regulatory shift can strengthen both the industry and public healthcare systems.

4. If managed wisely, this amendment will not only benefit local manufacturers but also raise the global standing of PPMA Pakistan and its member companies.