Pharma sector needs urgent reforms

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 with many low and middle-income countries, Bangladesh has struck 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 period, the industry maintained annual growth of 15-25 percent. This expansion was fuelled by supportive government policies and the entrepreneurial drive of local firms. During and after the pandemic, however, the sector faced mounting challenges. Global shortages of raw materials, rising input and freight costs, depreciation of the taka against the US dollar, and higher fuel prices pushed up production and distribution expenses.

At the same time, limited flexibility in price adjustments and delays in drug registration intensified operational pressure. Maintaining profitability while ensuring an uninterrupted supply has therefore become increasingly difficult.

In this context, the new government has an opportunity to introduce timely and pragmatic reforms to protect both industry sustainability and public access to medicines. A key priority is to accelerate and modernise 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. New products also improve treatment protocols and broaden therapeutic options. Despite efforts by regulators, the approval process remains slow, as expert committee meetings are held only a few times a year.

Increasing the frequency of meetings, enabling virtual consultations, and establishing multiple committees based on therapeutic classes could improve efficiency. Full digitalisation through an online registration portal would further enhance transparency and reduce processing times.

Another area requiring 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 risk creating inefficiencies and market distortions. Facilitating the import of raw materials and laboratory chemicals is equally important. Pharmaceutical production and quality control depend on timely imports, yet multiple approval requirements often cause delays. As many inputs have limited shelf lives, prolonged clearance reduces usability and raises costs.

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

At the policy level, Bangladesh’s graduation from LDC status presents both opportunity and risk. Under the TRIPS agreement of the WTO, Bangladesh currently benefits from flexibility in producing and distributing patented medicines. This has enabled access to high-cost and biologic drugs at affordable prices.

These flexibilities will expire after graduation, potentially increasing medicine costs due to patent protections and royalty obligations. As innovation capacity for new molecules remains limited, diplomatic efforts to extend the transition period or secure alternative policy space will be crucial to maintaining affordable healthcare. Finally, Bangladesh can 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. With timely reforms and strategic policy adjustments, Bangladesh can unlock a new phase of growth in its pharmaceutical sector while safeguarding access to affordable medicines for all.

The writer is deputy general manager at UniMed UniHealth Pharmaceuticals