Pharmaceutical companies advocate for rapid approval of up to 1,000 new medications
The pharmaceutical sector in Bangladesh is bracing for significant changes as the country prepares to graduate from the Least Developed Country (LDC) status next year. According to Kaiser Kabir, the CEO and Managing Director of Renata, these changes will have far-reaching economic consequences.
The main issue at hand is the absence of gas supply at the Active Pharmaceutical Ingredient (API) Industrial Park, a hindrance that has prevented the park from reaching its full potential since its launch in 2007. Despite this challenge, policy amendments have been made, and several companies are in the process of setting up factories at the park.
Bangladesh's commitment to the World Trade Organisation's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement means that after November 2025, the country will have to fully comply with its TRIPS obligations. This will require high royalty payments and expensive patent procedures for unregistered drugs, ultimately driving up medicine prices.
The Bangladesh Association of Pharmaceutical Industries (Bapi) is urging the government to fast-track the registration of over 1,000 new medicines that are currently pending with the Directorate General of Drug Administration (DGDA) for more than two years. If these medicines are not registered before the country's LDC graduation in November 2026, the local pharmaceutical industry will lose the opportunity to produce these medicines royalty-free under the current TRIPS waiver.
Failure to register these drugs could have significant financial implications. Companies will need to pay high royalties or negotiate costly licenses with patent holders, significantly increasing production costs and drug prices domestically and for export. This could lead to higher medicine prices for patients and reduced competitiveness of Bangladesh's pharmaceutical exports.
Currently, Bangladesh's pharma companies can manufacture many medicines, including biologic drugs for cancer and chronic diseases, without licensing fees due to the TRIPS waiver applying to LDCs. However, once Bangladesh complies fully with global patent rules post-graduation, any new drug still under patent would require authorization and royalty payments. Missing the registration window means the local industry could lose a critical 10-15 year royalty-free production period for over 600 medicines now awaiting registration approval.
The economic impact includes potential shrinking of domestic manufacturing freedom, increased costs for importing patented medicines at global prices, and legal risks if manufacturing proceeds without licenses. Industry leaders and experts warn this transition will create "substantial pressure" on both domestic markets and exports, with consequences for access to affordable medicines in Bangladesh and other countries relying on these exports.
While some hope for an extension of the TRIPS waiver until 2029 to allow time for industry adjustment, regulatory delays mean many companies risk missing the registration deadline anyway. Strategic plans and international collaboration may mitigate some impacts, but the transition presents a serious financial and legal challenge to Bangladesh's pharma sector if the more than 1,000 new medicines are not registered on time.
In summary, failure to register these medicines before the LDC graduation will:
- Force the industry to pay royalties or face restrictions on producing patented medicines.
- Raise domestic drug prices by an estimated nearly 20%.
- Undermine Bangladesh’s competitive edge in pharmaceutical exports.
- Increase cost burdens on patients and limit access to affordable generic medicines.
[1] The Daily Star
[2] The Financial Express
[5] The Business Standard
- The science and health-and-wellness sector might experience change due to the rise in medicine prices brought by Bangladesh's compliance with the World Trade Organisation's policies, which could impact access to affordable generic medicines.
- In the realm of finance and business, the local pharmaceutical industry could experience substantial pressure as a result of the increased costs associated with producing and importing patented medicines, affecting the competitive edge of its exports.
- The policy-and-legislation and politics spheres may witness negotiations and advocacy efforts as the government and industry leaders work to address the financial and legal challenges brought by the expiring TRIPS waiver, as reported in general-news outlets such as The Daily Star, The Financial Express, and The Business Standard.
