Friday | 19 June 2026 | Reg No- 06
বাংলা
Bangla | Friday | 19 June 2026 | Epaper

Dhaka must upgrade API policy as LDC graduation imminent

Published : Saturday, 29 November, 2025 at 12:00 AM  Count : 910
The global pharmaceutical market was valued at approximately USD 1.64 trillion in 2024 and is projected to reach USD 2.1-2.3 trillion by 2030, covering prescription drugs, generics, biologics, vaccines, and over the counter (OTC) products. Global pharmaceutical exports currently stand around USD 825-900billion. Bangladesh's export share is about 0.02-0.03%, compared with 3-4% for China and 2-3% for India.

Bangladesh now maintains strong domestic pharmaceutical performance meeting 98% of national demand and exporting medicines to more than 150 countries. Export earnings, however, remain modest: USD 175 million in FY2022-23 (?7% YoY), USD 205 million in FY2023-24 (+17.1% YoY) and USD 213 million in FY2024-25 (+4% YoY). The top five export destinations of Bangladesh are the USA (24.8%), Germany (16.1%), the UK (9.7%), France (8.3%), and the Netherlands (8.1%). Exports to China and India remain insignificant.

Active Pharmaceutical Ingredients (APIs)is the main ingredients of Pharmaceuticals. It account for 30-55% of drug costs, and Bangladesh imports about USD 1.3 billion annually. A fully operational park could cut raw-material costs by up to 70% and significantly reduce imports, while continued delays risk higher production costs and export declines of around 6.9%.The long-delayed Gazaria API Park approved in 2008 remains the main bottleneck. Authority not yet arranged gas supply at the park. One API industry built a factory and now day paying Tk20 lac bank interest, but the factory is not operational due to lac of gas. A fully operational park could cut raw-material costs by up to 70% and significantly reduce imports, while continued delays risk higher production costs and export declines of around 6.9%.

China's rise as the world's leading API producer is the result of coordinated state policy, large-scale industrial planning, and long-term investment. Key drivers include: (i)Strong state support through industrial policy, export incentives, and long-term sectoral planning, (ii)Large, dedicated API and chemical industrial zones with integrated supply chains and shared infrastructure, (iii) High and sustained R&D investment in process innovation, biotechnology, and cost-efficient manufacturing, (iv)Competitive utility and logistics costs, supported by scale advantages and efficient clustering, (v)Industrial-scale capacity in fermentation, chemical synthesis, and intermediates, enabling global export dominance, (vi)Strict cost-control ecosystems and backward integration into raw materials and intermediates. (vii)Proactive environmental and quality compliance reforms to meet global regulatory standards after 2015.

India often called the "Pharmacy of the World" strengthened its API sector through a mix of industrial policy, incentives, and regulatory reforms. Key initiatives include: (i) Production-Linked Incentive (PLI) schemes to boost domestic API manufacturing and reduce dependence on imports, (ii)API Parks & Bulk Drug Parks with shared utilities, effluent treatment, and common facilities to lower production costs, (iii) Subsidized capital support and viability gap funding for fermentation-based and complex APIs, (iv)Fast-track regulatory approvals and predictable quality-compliance frameworks through CDSCO, (v)Public-private partnerships and state-level incentives in major pharma clusters (Hyderabad, Gujarat, Maharashtra), (vi)R&D strengthening via dedicated biotech funds, innovation councils, and industry-academia collaboration, (vii)Export facilitation through SEZs, logistics support, and global regulatory harmonization.

Bangladesh's Policy Context and Global Position is reflected in the National API and Laboratory Reagents Production and Export Policy, 2018 (valid until 31 December 2032). It remains the central framework for API sector development. A research organization, SANEM's 2022 Assessment: Key Findings on the API Policy: (1)The API Policy is conceptually strong, (2)Implementation progress has been significantly delayed, (3)The Gazaria API Park (approved 2008) remains incomplete, (4)Bangladesh still imports 90% of APIs, (5)A severe human capital gap persists, (6)Only ~40 API molecules (11%) are produced locally versus a target of 360, (7)Global demand and export opportunities are expanding, (8)Bangladesh's TRIPS flexibility effectively ends in November 2026(Due to LDC graduation) , despite the general waiver lasting until July 2033.

The Path Forward for Bangladesh are: (1)Secure a Pharmaceutical TRIPS Extension. With TRIPS exemptions ending in November 2026, the Ministry of Commerce must lead early diplomatic engagement ahead of MC14 (26-29 March 2026, Cameroon). Bangladesh should pursue a sector-specific pharmaceutical extension, follow the Maldives precedent and frame the request around medicine security and public health, (2)Establish a High-Powered National API Implementation and Development Council. The Council should include Government, industry, academia, and other stakeholders. It must centrally monitor progress, coordinate DGDA-NBR-MoC actions, and remove regulatory bottlenecks. Its immediate mandate should be to assess implementation gaps in the 2018 Policy and design a practical, time-bound action plan. Monthly meetings and legal authority to overcome inter-agency obstacles are essential. The Council should also adopt, at minimum, the good practices of China and India, enabling full implementation of the API Policy within the next five years.

With Bangladesh set to graduate in November 2026, its TRIPS exemptions will expire, making early diplomatic engagement crucial. The Ministry of Commerce must lead preparations ahead of MC14 (26-29 March 2026, Cameroon) to secure a sector-specific pharmaceutical TRIPS extension, drawing on the Maldives precedent and framing the request around national medicine security and public-health needs.

Bangladesh should establish a high-powered National API Implementation and Development Council comprising representatives from the Government, pharmaceutical industry, academia, and other key stakeholders. This Council would centrally monitor progress, coordinate DGDA-NBR-MoC actions, and remove regulatory bottlenecks. Its immediate mandate should be to identify the implementation gaps in the 2018 API Policy and prepare a new time-bound action plan. The Council should meet monthly and be legally empowered to resolve inter-agency obstacles. It should also draw on the best at minimum, the good practices of China and India so that Bangladesh can achieve full and effective implementation of the National API and Laboratory Reagents Production and Export Policy, 2018 within the next five years.

The choice for Bangladesh is clear. It may go ahead with decisive reforms, Bangladesh can achieve pharmaceutical self-reliance, expand exports, and secure a stronger global position. Without timely action, the sector faces rising costs, increased vulnerability, and a potential erosion of competitiveness. The window of opportunity is narrow, but still open (November,2026) urgent, coordinated, and time-bound action is imperative for securing Bangladesh's pharmaceutical future.

The writer is CEO, Bangla Chemical





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