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.

The registration applications cover critical medicines – from cancer drugs to biosimilars used in treating rheumatoid arthritis, diabetes, and autoimmune disorders.

Infograph: TBS

Pharma industry leaders warn that Bangladesh will have to fully comply with TRIPS obligations ahead of LDC graduation in November 2026. Unless the pending drugs are registered by November 2025, Bangladesh may lose the scope to bring them under the waiver facility.

Costs of life-saving drugs will rise as Bangladesh's patent waiver ends. A study by the Geneva-based South Centre estimates that insulin prices in Bangladesh could rise by up to eight times without the waiver.

"Bangladesh will officially graduate from LDC status on 24 November 2026. However, due to obligations under other international agreements, the TRIPS agreement will come fully into effect after November this year. This means that any new drugs entering the market after that time will have to bear patent protection and royalty costs. We have very little time. These drug registrations are being sought for the future," said Mohammad Zakir Hossain, secretary general of the Bangladesh Association of Pharmaceutical Industries (Bapi) and MD of Delta Pharma Ltd.

He told TBS, "At the next meeting, the DGDA may decide on the applications we submitted in 2024. In the meantime, nearly 700 new products have received registration in various countries. We have prepared these as well and submitted them. Our suggestion is that if the Technical Committee and Drug Control Committee hold one or two more meetings within the next three months, the products approved by the US FDA by June or July 2025 will also receive Bangladesh registration."

Zakir said, "Each drug can receive patent protection for 12, 15, or 18 years. If registration is secured now, we will be able to produce these drugs without patents even after Bangladesh graduates from LDC status. Over the next 10–15 years, our capacity will also increase, and there will be no problem then."

Before the recent 26 August meeting, no Drug Control Committee meeting had been held since March 2024, which is why so many new drug applications have piled up.

Kaiser Kabir, CEO and MD of Renata Ltd, told TBS, "In the Drug Control Committee meetings, the government checks each drug name and approves or rejects it. We are urging the authorities to approve the pending applications."

He added, "These drugs will not hit the market immediately after registration. We are requesting this cooperation from the government. Later, they can call another meeting to decide which drugs will get marketing authorisation. If not, drug prices will rise significantly afterwards, as only patented molecules will be available."

Kaiser further said, "All 1,000 pending applications are for serious drugs, not trivial ones. Renata has selected 43 molecules, all related to cancer. This period is extremely important. If we miss this opportunity, we will have to pay royalties to patent holders."

What the DGDA says

The Drug Control Committee held a meeting on 26 August after nearly two and a half years. However, no decision was made regarding the registration of new drugs during this meeting. 

DGDA Director Md Shafiqul Islam told TBS that another meeting will be held soon to make a decision.