Challenges in the Pharmaceutical Industry: How Can Regulators Support High-Quality Production?

According to Dr. Maryam Habibi, CEO of Rasta Imen Darou, the imposition of fixed drug pricing has led to a range of consequences in the pharmaceutical industry.

Speaking to Pharmondays, she stated:
"The enforcement of price controls on pharmaceuticals has had multiple repercussions—not only a decline in drug quality, but also broader crises and challenges within the country’s pharmaceutical sector."

She added that one of the key issues is a reduction in drug production. "In the case of certain drugs where there is no profit margin for manufacturers, and fixed pricing further restricts them, producers simply lose interest in manufacturing those medicines. This ultimately results in production halts, market shortages, and a lack of access for patients to essential medications."

According to Dr. Habibi, the shortage of domestically produced drugs often compels the Food and Drug Administration to turn to imports, which is not a sustainable solution. "Either higher costs are incurred for imports, or to maintain lower prices, drugs are sourced from lower-quality suppliers," she warned.

She continued: "Decreased revenues among pharmaceutical companies—caused by low or nonexistent profit margins—creates a double-edged threat to the sector. On the one hand, companies lack the ability to invest in R&D or develop new drugs; on the other, to cut costs, they may resort to lower-quality raw materials."

Dr. Habibi emphasized that one of the key drivers of competitive product quality is the presence of international pharmaceutical companies. "The growing trend of licensed production has several advantages. It draws attention to high-quality, approved sources of raw materials and excipients, enhances GMP standards through international inspections, and fosters a production culture aligned with acceptable European standards. All of this contributes significantly to improving drug quality and manufacturing standards."

As a board member of the Health Investment Tamin Holding, Dr. Habibi also discussed how regulatory bodies can support producers committed to high-quality pharmaceuticals.

She suggested implementing incentive-based policies that encourage the presence and consistency of quality products in the market. "These could include segmenting manufacturers based on GMP compliance—evaluated both at product release and during post-market quality studies—and then offering benefits accordingly. For instance, companies with higher scores might be granted higher pricing approvals, prioritized pipeline positioning, or exclusivity rights for newly launched products."