Barekat Health & Pharmaceutical Group: Amid years of mounting internal and external economic pressures, Iran’s pharmaceutical sector has been anything but immune to persistent shocks. The discontinuation of subsidized exchange rates, the acute crisis in raw material procurement, energy imbalances, volatile pricing mechanisms, and the influx of counterfeit pharmaceuticals are just a few of the multifaceted challenges currently threatening the pharmaceutical value chain—from production to supply and distribution.
In light of these pressing issues, all eyes are now on the IFDA, the pivotal agency tasked with balancing public health imperatives, industrial sustainability, and national policy frameworks.
In this context, Dr. Mehdi Pirsalehi offers insights into the government’s support mechanisms for pharmaceutical enterprises, strategies to mitigate the impact of currency and energy crises, the fight against counterfeit drugs, and the methodology for assessing and addressing shortages.
Q: In light of the elimination of preferential exchange rates—which has significantly escalated drug prices—and the government’s failure to directly compensate some manufacturing companies (with subsidies redirected to insurance providers), what are the IFDA’s long-term support strategies for the pharmaceutical industry?
A: The IFDA remains committed to implementing support policies aligned with the evolving economic landscape and its ramifications on pharmaceutical pricing. In response to these disruptions, we are proactively collaborating with related institutions to develop and enforce frameworks that shield both the industry and the patient population.
A fundamental priority is the targeted allocation of subsidies directly to pharmaceutical manufacturers, addressing liquidity issues and sustaining the financial viability of the sector. These support measures aim not only to mitigate the broader economic stressors impacting pharmaceutical enterprises but also to ensure production continuity through financial facilitation and resource allocation. Long-term strategies also include safeguarding supply chain stability and preempting production line shutdowns.
Q: Considering the challenges in sourcing raw materials and persistent energy imbalances across all seasons, what supportive measures has the IFDA implemented to prevent production halts and subsequent market shortages?
A: To forestall disruptions in pharmaceutical production, particularly due to raw material shortages and inconsistent energy supply, the IFDA, in coordination with other government entities, has enacted a set of preventative measures.
These include enhancing access to essential energy inputs and critical raw materials, while simultaneously fostering domestic production capabilities. Moreover, for irreplaceable inputs, we are facilitating expedited and prioritized importation. This dual approach—supporting local manufacturing while ensuring flexibility in international procurement—is central to our crisis mitigation strategy.
Q: Given the financial strain on consumers and patients, how does the IFDA structure its pricing policies to both preserve drug accessibility and prevent unchecked price inflation? Do these policies strike a fair balance between industrial viability and patient welfare?
A: Our pricing policies are engineered to strike a careful balance between economic realism and public health equity. In calibrating drug and medical device pricing, the IFDA takes into account macroeconomic pressures while upholding the principles of quality assurance and equitable access.
The policies are designed to inhibit disproportionate price increases, ensuring that pharmaceutical manufacturers can maintain production even under financial duress. By carefully regulating margins and aligning incentives, we strive to establish a sustainable equilibrium between the interests of the producers and the needs of the public.
Q: In recent years, the proliferation of counterfeit drugs and unauthorized health products has alarmed both regulators and the public. What strategies has the IFDA deployed to combat this issue and to raise public awareness?
A: Combating the infiltration of counterfeit pharmaceuticals and unlicensed health products is among the IFDA’s top enforcement and public health priorities. Our response encompasses both regulatory surveillance and public education initiatives.
We have intensified market oversight, augmented penalties for violations, and implemented advanced tracking systems—especially for essential and high-risk medications. In parallel, public education campaigns aim to raise awareness about the risks of illicit drugs and empower consumers to make informed decisions. The use of digital authentication technologies and blockchain-based traceability is also under active consideration to enhance transparency and product integrity.
Q: Economic sanctions—particularly those targeting the importation of pharmaceutical raw materials—have had a significant impact on the industry. As head of the IFDA, what specific measures have you adopted to avert raw material shortages and promote local alternatives? How are these challenges being managed in relation to the availability of essential medicines?
A: Sanctions have undoubtedly intensified the complexity of pharmaceutical supply chains, especially in terms of sourcing active pharmaceutical ingredients (APIs). To counteract these constraints, the IFDA has enacted a comprehensive strategy emphasizing both import diversification and domestic capability expansion.
We are actively fostering domestic production of essential raw materials, providing incentives and regulatory support to local manufacturers, and identifying new, sanction-resilient international suppliers. Our priority is to maintain a stable inventory of essential medicines, with special attention to those critical for vulnerable patient populations.
Q: How does the IFDA define and track drug shortages, and how does this differ from public perception?
A: The IFDA employs a rigorous, evidence-based methodology for identifying drug shortages. From the public’s perspective, a shortage is perceived when a particular medication is unavailable at a few pharmacies. However, our formal definition extends to scenarios where neither the original brand nor any of its generic equivalents are accessible within the regulated distribution system.
Disparities in statistical reporting often stem from this definitional divergence. While the public may sense a shortage, systemic availability in selected pharmacies may still be sufficient under our classification. Nevertheless, even a single shortage of a vital medication is treated with utmost urgency, and we are working to minimize such occurrences. At times, over-importation may paradoxically coincide with poor distribution logistics or societal anxiety, further exacerbating the perceived scarcity.
برای امتیاز به این نوشته کلیک کنید!
