1,000 drug registrations stuck as Bangladesh risks losing TRIPS waiver

Over 1,000 applications for generic and biosimilar drugs have been pending with the drug regulatory authority for nearly two and a half years as industry insiders warn that Bangladesh’s upcoming LDC graduation will end its pharmaceutical patent waiver under TRIPS agreement.

TRIPS (Trade-Related Aspects of Intellectual Property Rights) is an international agreement setting intellectual property standards for World Trade Organization (WTO) members. Bangladesh, a WTO member, currently benefits from transitional flexibilities as an LDC, especially for pharmaceutical patents.

Although the designated drug approval committee – Directorate General of Drug Administration (DGDA) – finally held a meeting last week, no decision on these applications was taken.

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