What rapid reforms the pharma sector needs

Among the knowledge-driven industries that have placed Bangladesh on the global stage, the pharmaceutical sector stands out as one of its most notable success stories. Compared to many low- and middle-income countries, Bangladesh has achieved a strong balance between affordability, quality, and accessibility of medicines.

This progress has strengthened public health security while positioning the country as a reliable global supplier of generic drugs.

From the mid-1980s to the pre-Covid-19 period, the industry maintained impressive annual growth of 15-25 percent.

This expansion was fueled by supportive government policies and the entrepreneurial drive of local firms. However, during and after the Covid-19 pandemic, the sector encountered significant challenges.

Global shortages of raw materials, rising input and freight costs, currency depreciation against the US dollar, and increased fuel prices drove up production and distribution expenses.

At the same time, limited flexibility in price adjustments and delays in drug registrations intensified operational pressures. As a result, maintaining profitability while ensuring uninterrupted supply has become increasingly difficult.

In this context, the new government has a crucial opportunity to introduce timely and pragmatic reforms to protect both industry sustainability and public access to medicines. One key priority is accelerating and modernizing the drug registration process.

The introduction of new molecules is essential for sustaining growth in the generic market, often contributing 15-20 percent of overall expansion. Moreover, new products improve treatment protocols and expand therapeutic options.

Despite the efforts of regulatory authorities, the approval process remains slow, as expert committee meetings are held only a few times each year.

Increasing the frequency of meetings, enabling virtual consultations, and establishing multiple therapeutic class-based committees could significantly enhance efficiency. Full digitalization through an online registration portal would further improve transparency and reduce processing time.

Another critical area for reform is the pricing mechanism. Excessive price controls and complex approval procedures can disrupt supply and discourage investment.

A transparent, evidence-based pricing framework involving all stakeholders would help ensure sustainability for both manufacturers and consumers. Introducing fixed timelines for price approval decisions would improve predictability and strengthen regulatory confidence.

Similarly, recently introduced production quotas for essential medicines may not be feasible for all companies. If national supply is already sufficient, such mandates could create inefficiencies and market distortions.

Facilitating the import of raw materials and laboratory chemicals is also vital. Pharmaceutical production and quality control depend on timely imports, yet multiple approval requirements often cause delays.

Since many inputs have limited shelf lives, prolonged clearance reduces usability and increases costs. Establishing a coordinated one-stop service mechanism for imports would streamline processes and enhance productivity.

The Active Pharmaceutical Ingredient (API) Industrial Park in Gazaria, Munshiganj requires urgent attention as well. Several companies have already invested heavily but are still waiting for essential utilities and infrastructure.

With prompt government intervention, production could begin soon, reducing dependence on imported APIs and transforming the facility into a regional export hub.

At the policy level, Bangladesh’s graduation from Least Developed Country status presents both opportunities and challenges.

Under the TRIPS agreement of the World Trade Organization, Bangladesh currently benefits from flexibility in producing and distributing patented medicines.

This has enabled access to high-cost and biologic drugs at affordable prices. However, these flexibilities will expire after graduation, potentially increasing medicine costs due to patent protections and royalty obligations.

Given that innovation capacity for new molecules remains limited, diplomatic efforts to extend the transition period or secure alternative policy flexibility will be crucial for maintaining affordable healthcare.

Finally, Bangladesh can further strengthen pharmaceutical exports through strategic commercial diplomacy.

Diplomatic missions can support product registration in foreign markets, facilitate regulatory coordination, and promote government-to-government agreements. Such initiatives would significantly enhance the country’s global pharmaceutical presence.

With timely reforms and strategic policy adjustments, Bangladesh has the potential to unlock a new phase of growth in its pharmaceutical sector—ensuring industry sustainability while safeguarding access to affordable medicines for all.

The writer is a pharmacist and deputy general manager at UniMed UniHealth Pharmaceuticals. He can be reached at azs_sohel@yahoo.com