Recent reports indicate that the important committees in Bangladesh, which are meant to approve new medicines, haven’t convened for more than a year. As a result, decisions are pending on 617 requests for new drugs. including 15 costly biologic treatments. This is a critical event because these panels are essential for ensuring timely access to affordable medicine, especially at a moment when the country is preparing to graduate from Least Developed Country status. As local pharmaceutical firms currently benefit from TRIPS waivers, they can bring patented drugs to market at significantly reduced cost. When the country achieves developing nation status in November 2026, that exemption will conclude, leading to a potential surge in prices. With committee inactivity continuing, vital regulatory review has stalled, leaving patients without access to new therapies and manufacturers without guidance. Experts note that local prices for biologic drugs are up to 30–40 percent lower than global market levels, and a cancer immunotherapy syringe might cost as little as Tk 7,000–8,000 locally compared to Tk 85,000–95,000 for imported versions. That price gap plays a life‑saving role for many families amid already high out‑of‑pocket medical spending. Observers warn that a projected 25–30 percent hike in essential drug prices after graduation could push even more patients into poverty. Stakeholders express concern that the government needs to act quickly to either reassemble or gather the inactive sub-committee under the Directorate General of Drug Administration (DGDA), as well as the Drug Control Committee that gives final approval for new products. Without these bodies functioning properly, the industry lacks necessary clearance to continue producing affordable medicines while it still can. Sources highlight that over two years have passed without a meeting of the Drug Control Committee, and over a year since the sub‑committee last convened, effectively blocking progress on all pending registrations. Restoring efficient drug approval mechanisms would help pharmaceutical companies accelerate production under patent exemptions, protect public health access, and prepare the sector for the post‑graduation phase. Government support is critical, as regulatory gaps may otherwise hurt the domestic pharmaceutical industry’s ability to innovate and compete globally. A revived and active drug approval system could help secure timely approvals, support local manufacturing, safeguard patient access to essential medicines, and bolster the country’s health resilience. In light of the impending TRIPS transition, stakeholders emphasize that swift attention is needed now. The health ministry has a clear public health mandate and should urgently restore these regulatory bodies so that the nation’s drug approval infrastructure is fit for purpose both now and in the years ahead.
