Over 1,000 Drug Applications Pending Ahead of Bangladesh’s LDC Graduation

More than 1,000 applications for generic and biosimilar drugs have been awaiting approval from the Directorate General of Drug Administration (DGDA) for nearly two and a half years, raising concerns among industry experts. They warn that Bangladesh’s upcoming graduation from Least Developed Country (LDC) status could end its pharmaceutical patent waiver under the TRIPS agreement.

TRIPS and LDC Benefits
TRIPS (Trade-Related Aspects of Intellectual Property Rights) is a global agreement under the World Trade Organization (WTO) that sets standards for intellectual property protection. Bangladesh, as an LDC, currently enjoys transitional flexibilities, including patent exemptions for pharmaceuticals.

Although the DGDA’s Drug Control Committee finally convened on 26 August, no decisions were made on the pending applications. These include crucial medicines such as cancer treatments, biosimilars for rheumatoid arthritis, diabetes, and autoimmune disorders.

Urgency Ahead of Graduation
Bangladesh is set to officially graduate from LDC status on 24 November 2026, but TRIPS obligations are expected to fully apply after November 2025. Experts warn that unless pending drug registrations are completed by then, the country could lose the opportunity to produce these medicines under patent waivers, potentially driving up costs of life-saving drugs.

A study by the Geneva-based South Centre estimates that insulin prices in Bangladesh could increase up to eightfold without the waiver.

Industry Perspective
Mohammad Zakir Hossain, Secretary General of the Bangladesh Association of Pharmaceutical Industries (Bapi), stressed the urgency: “If these drugs are registered now, we can manufacture them without patent restrictions even after LDC graduation, securing supply and stabilizing costs for the next 10–15 years.”

He added that nearly 700 new products approved internationally in 2024 have already been submitted to the DGDA. “If the Technical Committee and Drug Control Committee meet one or two more times over the next three months, drugs approved by the US FDA by mid-2025 could also receive Bangladesh registration,” he said.

Kaiser Kabir, CEO of Renata Ltd, noted that all pending applications involve critical medicines. “For example, Renata has submitted 43 cancer-related molecules. Missing this window would force us to pay royalties to patent holders, significantly raising drug prices.”

Next Steps
DGDA Director Md Shafiqul Islam confirmed that a new meeting will be scheduled soon to make decisions on the backlog. Industry leaders are urging authorities to approve these applications promptly to safeguard public access to essential medicines.