It is alarming that a sub-committee under the Directorate General of Drug Administration (DGDA) tasked with reviewing new drug registration applications has not met in over a year. Furthermore, the Drug Control Committee, responsible for final approvals, has not convened in two years. This has resulted in 617 applications for new medicines, including 15 biologic drugs, being left pending, as reported by a local publication.
The lack of movement in these bureaucratic processes could have significant consequences, particularly as pharmaceutical companies in Bangladesh work against the clock. Being classified as a Least Developed Country (LDC) grants Bangladesh an exemption under the World Trade Organisation’s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, allowing the country to manufacture patented pharmaceuticals without facing patent enforcement. This enables local companies to produce essential drugs at a fraction of the international cost, improving access to life-saving treatments.
For instance, a cancer patient can purchase a locally made immunity-boosting drug for Tk 7,000-8,000 per pre-filled syringe, significantly less than the Tk 85,000-95,000 price tag of the imported version. Experts observe that Bangladeshi companies have managed to keep biologic drug prices 30-40 percent below the global average. However, this advantage will be lost once Bangladesh transitions from an LDC to a developing country in November 2026. Post-graduation, pharmaceutical firms will need to pay substantial royalties or make significant investments to secure patent rights, leading to increased costs for patients.
Bangladesh already faces one of the highest out-of-pocket health expenditure burdens globally, with a significant portion allocated to purchasing medications. The escalating medical costs frequently drive families into poverty. An anticipated 25-30 percent surge in essential drug prices could further restrict access to affordable healthcare for many individuals.
Given the circumstances, pharmaceutical companies must maximize the remaining time to produce biologic drugs without royalty obligations. The government should provide robust support to the industry during this critical period. Regrettably, almost a year after the political transition, there is still indifference observed in the relevant authorities. There is no justification for the delay in reconstituting or reactivating these vital committees. The Ministry of Health, already facing scrutiny for ongoing irregularities in public healthcare, must take prompt action. It is imperative for the ministry to ensure public health protection by streamlining the drug approval process and implementing measures to assist the pharmaceutical sector in addressing the forthcoming challenges associated with LDC graduation.