PPMA Leadership, led by key executive members, held a productive meeting with DRAP Additional Director Dr. Obaid Ali to discuss regulatory reforms, industry challenges, and future collaboration to uplift Pakistanโs pharmaceutical sector.
This strategic meeting marks a significant development in the ongoing efforts to strengthen regulatory coordination in the pharma industry of Pakistan. With the presence of Pakistan Pharmaceutical Manufacturers Association (PPMA) officials and the Drug Regulatory Authority of Pakistan (DRAP), the dialogue focused on sustainable practices, consistent compliance standards, and smoother regulatory approvals.
The pharmaceutical sector in Pakistan plays a critical role in ensuring public health and economic stability. Recognizing this, PPMA emphasized the need for closer engagement with DRAP to overcome operational bottlenecks and foster a more conducive business environment for local and multinational manufacturers.
Dr. Obaid Ali, appointed as Additional Director for DRAPโs South Office in Karachi, shared his vision of developing a more responsive and transparent regulatory system. He stressed the importance of regular dialogue between stakeholders to align on policy changes, registration timelines, and pharmacovigilance practices.
During the session, PPMA members addressed common industry concerns such as:
- Delays in product registration and market authorization.
- Lack of standardized pricing policy implementation.
- Challenges in the drug approval process for new molecules.
- Need for improved digital integration between PPMA and DRAP systems.
This collaboration aims to modernize the Pakistan pharma industry by implementing innovative regulatory frameworks that are internationally aligned and locally adaptive.
PPMA leadership also proposed a joint task force to streamline future engagements between the industry and DRAP. This task force will be tasked with quarterly reviews, tracking policy impact, and ensuring mutual accountability.
Moreover, both parties acknowledged the need for:
- Training workshops for regulatory teams.
- Guidelines for pharmacovigilance and bioequivalence studies.
- Enhanced transparency in inspection protocols.
By reinforcing regulatory efficiency and industry trust, this initiative sets the groundwork for elevating quality and competitiveness across medicine companies in Pakistan. The anticipated outcomes include faster time-to-market, improved patient access to medications, and increased export readiness.
Recent Industry Data Supporting Reforms
According to the Ministry of National Health Services, the pharmaceutical market in Pakistan surpassed Rs. 600 billion in 2023, with a projected annual growth rate of 10-12%. A report by IQVIA noted that streamlined regulation could boost exports from $300 million to over $1 billion by 2028.
These figures underscore the urgency of reform. A harmonized regulatory mechanism will not only ensure public safety but also foster investment and innovation across the pharma industry of Pakistan.
PPMA reaffirmed its commitment to supporting DRAPโs ongoing digitization and capacity-building initiatives. As part of its agenda, PPMA also recommended pilot projects for electronic submissions, risk-based inspections, and international regulatory benchmarking.
Looking ahead, this meeting signifies a turning point in public-private collaboration. It sets the tone for a future where regulatory agility meets industrial ambition. It also ensures that patients across Pakistan will benefit from high-quality, affordable, and timely healthcare solutions.
In conclusion, this engagement between Pakistan Pharmaceutical Manufacturer Association and DRAP is a positive stride toward building a robust pharmaceutical regulatory landscape. With the right follow-up mechanisms in place, this cooperation could redefine industry standards and pave the way for global competitiveness in the Pakistan pharma industry.