Bangladesh Pharmaceutical Companies Risk Losing Royalty-Free Access to 15 Biologic Drugs Due to Regulatory Delays
核心洞察
Bangladesh's pharmaceutical companies face losing the opportunity to produce at least 15 costly biologic drugs royalty-free due to regulatory hurdles that have stalled over 600 medicine registration applications for more than a year.
The Drug Control Committee, responsible for final approval of new medicines, has not convened for two years, creating a critical bottleneck as Bangladesh approaches its November 2026 transition from Least Developed Country status.
Local production of biologic medicines has dramatically reduced costs, with Adalimumab prices dropping from Tk 1.65-3.6 lakh to Tk 15,000 and Filgrastim from Tk 85,000-95,000 to Tk 7,000-8,000 per syringe.
Bangladesh's pharmaceutical industry faces a critical deadline as regulatory delays threaten to eliminate royalty-free manufacturing opportunities for at least 15 costly biologic drugs. Around 50 pharmaceutical firms have submitted applications to the Directorate General of Drug Administration (搜索) (DGDA) for registering 617 new medicines, including biologic drugs used for treating cancer (搜索) and chronic diseases, but these applications have remained stalled for over a year.
The urgency stems from Bangladesh's scheduled transition from Least Developed Country (LDC) status to developing nation status on November 24, 2026. This transition will end the country's patent protection waiver under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), forcing companies to pay royalties to patent holders.
"If we can't secure registration soon, we'll miss the opportunity to manufacture these drugs royalty-free once Bangladesh graduates from Least Developed Country [LDC] status next year," said Abdul Muktadir, president of Bangladesh Association of Pharmaceutical Industries (搜索).
Regulatory Bottleneck Threatens Industry
The primary obstacle lies in the Drug Control Committee, which provides final approval for new medicines but has not convened for the past two years. The registration process begins with a technical sub-committee review, chaired by the DGDA director general, before forwarding approved proposals to the health secretary-led Drug Control Committee comprising government officials, experts, and industry representatives. The sub-committee last met in March 2024.
Prof Sayedur Rahman, special assistant to the chief adviser for the health ministry, acknowledged that the previous committees required reconstitution due to their shortcomings. "The committees will be reconstituted soon and hold meetings to decide on pending applications," he told The Daily Star recently. According to DGDA officials, restructuring became necessary due to leadership changes in medical associations and institutions following the July mass uprising, as many committee representatives had affiliations with the former government.
Economic Impact of Patent Window
Patent protection typically lasts 20 years from a drug's development date. With five to 10 years already elapsed since the development of some of the 15 drugs in question, Bangladesh has a remaining 10 to 15-year window for royalty-free production, according to Muktadir.
"This window is critical. If we miss it, we must pay royalties to patent holders, meaning patients will have to shoulder the burden of inflated prices for these life-saving medicines," he explained.
Dramatic Cost Reductions Through Local Production
The stakes are particularly high given the substantial cost savings achieved through local biologic production. Muktadir provided specific examples of price reductions: an imported pre-filled syringe of Adalimumab, prescribed for rheumatoid arthritis (搜索) and psoriasis (搜索), once cost Tk 1.65 lakh to Tk 3.6 lakh, but local production has reduced its price to as low as Tk 15,000.
Similarly, cancer (搜索) patients can now purchase locally produced Filgrastim—used for boosting immunity—for Tk 7,000-8,000 per pre-filled syringe, compared to Tk 85,000-95,000 for imported versions.
Biologic Medicine Transformation
Unlike traditional chemical drugs, biologic medicines are derived from living organisms, including animals, microorganisms such as bacteria and yeast, or other living sources. Monjurul Alam Monju, CEO of Beacon Medicare (搜索), noted that while chemical drugs were once the cornerstone of treatment, biologic medicines are now transforming treatment for cancer (搜索), diabetes (搜索), arthritis, asthma (搜索), obesity (搜索) and high cholesterol, offering more effective and targeted therapies with fewer side effects.
Md Morsaline Billah, professor of Biotechnology and Genetic Engineering at Khulna University, emphasized that Bangladesh's pharmaceutical sector has managed to keep prices of biologic medicines 30-40 percent lower than the global average, providing vital affordability for patients.
Industry Concerns and Future Risks
"But this advantage is at risk. With Bangladesh set to graduate from LDC status in 2026, full compliance with TRIPS will be required. Companies will need to pay high royalties or invest heavily in securing patents—both of which are difficult and costly," Billah warned.
Zahangir Alam, chief financial officer of Square Pharmaceuticals Ltd (搜索), expressed concerns about regulatory complexities, stating, "We believe the approval process could be more rationalised and better aligned with the needs of the pharmaceutical industry."
Billah cautioned that local firms could face lawsuits and trade penalties if they produce these drugs without permission from patent holders. He warned that delays in regulatory approvals and outdated patent laws could undermine years of progress, with drug prices potentially rising 25-30 percent and pushing essential medicines out of reach for many patients.
Recommended Solutions
To address these challenges, Billah suggested that the government negotiate transitional flexibilities with WTO members and reform existing patent law. He emphasized the need for public-private partnerships for technology transfer, stating, "Inaction is not an option… We must act now to protect access, sustain our industry, and seize global market opportunities."