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Title Pharmaceutical Sector in Bangladesh - 20250415 - 012124 - 0000

The pharmaceutical sector in Bangladesh has rapidly expanded, becoming self-sufficient and meeting over 97% of local demand while also emerging as a competitive exporter of generic medicines. The 1982 Drug Policy catalyzed this growth by prioritizing local manufacturing and enhancing regulatory oversight, leading to significant contributions to the national economy. Despite challenges such as reliance on imported raw materials and regulatory bottlenecks, the industry has immense potential for future growth, particularly in exports and innovation.
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0% found this document useful (0 votes)
19 views24 pages

Title Pharmaceutical Sector in Bangladesh - 20250415 - 012124 - 0000

The pharmaceutical sector in Bangladesh has rapidly expanded, becoming self-sufficient and meeting over 97% of local demand while also emerging as a competitive exporter of generic medicines. The 1982 Drug Policy catalyzed this growth by prioritizing local manufacturing and enhancing regulatory oversight, leading to significant contributions to the national economy. Despite challenges such as reliance on imported raw materials and regulatory bottlenecks, the industry has immense potential for future growth, particularly in exports and innovation.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Pharmaceutical Sector in Bangladesh

(Growth, Challenges and Future Prospects)

Submitted by : Anindya Debnath


Session : 2023 - 2024
Roll : 1437
Department : Department of Pharmacy
Institution : Jahangirnagar University
Savar, Dhaka - 1342, Bangladesh

Submitted to : Bidduth Kumar Sarkar


Lecturer, Department of Pharmacy
Jahangirnagar University
Savar, Dhaka - 1342, Bangladesh

Submission Date : 16.04.2025


Introduction

The pharmaceutical industry in Bangladesh is one of the most dynamic and rapidly expanding sectors of the country. It
plays a crucial role in ensuring affordable access to essential medicines for the population, while also contributing
significantly to national economic growth. With a market that meets over 97% of the local demand, Bangladesh has
emerged as a self-sufficient producer of pharmaceuticals. Furthermore, it has positioned itself as a competitive exporter
in global markets, particularly in the area of generic medicine. The industry has created thousands of jobs, strengthened
public health infrastructure, and boosted Bangladesh’s reputation in the global health community.
Historical Background
Before the 1980s, Bangladesh was heavily reliant on imported medicines, with multinational pharmaceutical companies
dominating the market. Local manufacturing was limited, and the country lacked a strong regulatory framework to
control drug quality and pricing. As a result, harmful, substandard, and overpriced drugs were widely circulated. This
posed serious risks to public health and hindered the development of a sustainable domestic pharmaceutical industry.
The lack of investment, research facilities, and skilled workforce further compounded the issue, leaving the healthcare
system vulnerable to external shocks and supply chain disruptions.

There were 166 medicine makers in Bangladesh in the early 1980s. Of them, eight were foreign companies, which
controlled 70 percent of the market. There were 25 medium sized national companies who manufactured another 15% of
the product. The remaining 15% was produced by 133 small local companies who were capable of producing only simple
liquid formulations. All the pharmaceutical companies were mainly engaged in formulation. They produced there raw
materials by import, involving an annual expenditure of tk 60 cores in foreign exchange.
While talking about the history, we should address the man who was the pioneer of “1982 drug policy.”
“Dr. Zafrullah Chowdhury”

Zafrullah Chowdhury (27 December 1941 – 11 April 2023) was a


Bangladeshi public health activist.

He was the founder of Gonoshasthaya Kendra, a rural healthcare


organisation. He was known more for his work in formulating the
Bangladesh National Drug Policy in 1982.

Chowdhury's work in population control earned him the inaugural


Independence Day Award, the highest civilian award in Bangladesh, in
1977.[2] Among other awards, he was given Ramon Magsaysay Award in
1985 and the Right Livelihood Award in 1992 for his work in the public
health sector.
1982 Drug Policy
The introduction of the Drug (Control) Ordinance in 1982 marked a revolutionary change in Bangladesh’s
pharmaceutical landscape. The policy banned over 1,700 harmful or unnecessary medicines and limited the dominance
of multinational corporations. It prioritized local manufacturing, introduced pricing controls to make medicines
affordable, and enhanced government oversight through the Directorate General of Drug Administration (DGDA). This
policy gave local companies the space to grow and laid the foundation for the industry’s future success. It also reflected a
broader public health objective: to make quality drugs accessible to the general population at reasonable prices.

Post-Policy Growth
Following the 1982 policy, Bangladesh saw exponential growth in its pharmaceutical sector. Domestic companies began
to expand their operations and invest in infrastructure, technology, and human resources. The industry evolved from
simply packaging and marketing imported drugs to manufacturing high-quality generics across a wide range of
therapeutic categories. Leading companies like Square, Beximco, and Incepta emerged, supported by government
incentives and improved regulatory oversight. This growth transformed the pharmaceutical sector into one of the most
important industrial areas in the country.
Here is a bar chart illustrating the growth of the pharmaceutical industry in Bangladesh from 1982 to 2023, showing how
the market size increased significantly over the years.
Current Market Size
Today, the pharmaceutical market in Bangladesh is valued at over USD 3 billion and continues to grow at an average
annual rate of 12–15%. It contributes significantly to the national GDP and employs hundreds of thousands of people
directly and indirectly. The domestic market is dominated by local firms, with foreign companies holding a minimal
share. This growth is driven by rising healthcare awareness, increased investment, urbanization, and the expansion of
private hospitals and clinics. The pharmaceutical industry is now one of the top three sectors in Bangladesh in terms of
revenue generation and growth potential. The sector is now significant in many aspects like-

Revenue Generation: While specific recent data placing pharmaceuticals definitively within the top three revenue-
generating broad sectors is not explicitly available in the immediate search results, the information strongly indicates
its growing significance within the industrial sector and its substantial contribution to the national economy.

Increasing Domestic Demand: A growing population, rising life expectancy, and increasing per capita income are
boosting local demand for medicines.

Export Potential: Bangladesh's pharmaceutical exports are expanding to over 150 countries, indicating a strong
international presence and potential for further growth. The industry benefits from a patent waiver for LDCs,
allowing the production of generic drugs.
Self-Sufficiency: The local pharmaceutical industry meets about 97-
98% of the domestic demand for medicines, reducing reliance on
imports.

Government Support: The government recognizes the potential of this


sector and is providing support, including the establishment of API
(Active Pharmaceutical Ingredient) industrial parks and export
incentives.

Cost Competitiveness: Production costs in Bangladesh are relatively


lower compared to some other major generic drug producers, giving it
a competitive edge in the global market.

Skilled Workforce: Bangladesh has a growing skilled workforce in the


pharmaceutical manufacturing sector.
Major Pharmaceutical Companies
Several key companies dominate the pharmaceutical
landscape in Bangladesh. Square Pharmaceuticals, the
largest and most established, leads the market in terms
of production volume and revenue. Beximco
Pharmaceuticals is notable for its international
certifications and exports, including to the US and
Europe. Incepta Pharmaceuticals is known for its
innovation in vaccine development and high-tech
manufacturing. Renata Limited and Eskayef
Pharmaceuticals also play significant roles, particularly
in producing specialized and export-grade drugs. These
companies are not only shaping the domestic market but
are also expanding into international territories,
contributing to Bangladesh’s reputation as a reliable
medicine producer.
Production Capacity & Self-Sufficiency
Bangladesh’s pharmaceutical industry meets over 97% of the country’s domestic demand for medicines, including
antibiotics, antihypertensives, anti-diabetics, and even some cancer treatments. More than 300 pharmaceutical
companies are currently operating, with many having modern facilities equipped with advanced machinery and
cleanroom environments. However, the industry still depends heavily on imported raw materials, especially active
pharmaceutical ingredients (APIs). To address this, the government has established an API Industrial Park in
Munshiganj, which is expected to reduce import dependency and ensure a more sustainable supply chain in the coming
years. Currently we are manufacturing several types of drugs. Let’s focus on the table below.
Export Performance
Bangladeshi pharmaceuticals are now exported to over 150 countries across Asia, Africa, the Middle East, Latin
America, and even developed markets such as the USA, UK, and Australia. Export earnings have surpassed USD 200
million annually, with potential for rapid growth in the near future. The export portfolio includes tablets, capsules,
injectables, syrups, ointments, and increasingly, high-tech products such as biosimilars and insulin. The reputation for
quality, competitive pricing, and favorable TRIPS exemptions has given Bangladeshi pharmaceuticals an edge in the
international market.
Export Highlights of Bangladesh’s Pharmaceutical Industry-
International Certifications
To meet international demand, several Bangladeshi companies have obtained prestigious certifications such as US FDA
approval, UK MHRA authorization, and European Union GMP compliance. These certifications validate that the
manufacturing processes, quality control systems, and facilities adhere to global standards. Such approvals not only open
doors to regulated markets but also elevate the reputation of the entire sector. More companies are now investing in
upgrading their facilities and adopting digital quality assurance systems to comply with international benchmarks.

Here is a detailed list of major Bangladeshi and the international certification they have obtained :

#Square Pharmaceuticals Ltd.


1. WHO GMP
2. US FDA
3. UK MHRA
4. TGA etc.
#Beximco Pharmaceuticals Ltd.
1. WHO GMP
2. US FDA
3. UK MHRA
4. TGA etc.

#Eskayef Pharmaceuticals Ltd.


1. WHO GMP
2. EU GMP
3. ANVISA
4. US FDA etc.

#Incepta Pharmaceuticals Ltd.


1. WHO Prequalification GMP
2. EU GMP
3. UK MHRA etc.
Generic Drug Leadership
Bangladesh has earned global recognition for its robust production of generic medicines. Due to the exemption from the
TRIPS agreement (valid until 2033), Bangladesh is allowed to manufacture patented medicines without needing to pay
licensing fees. This allows domestic firms to produce affordable versions of expensive, life-saving drugs, particularly for
diseases like cancer, HIV, and hepatitis. These generics are not only consumed locally but also exported to low- and
middle-income countries, improving global access to essential medicines while boosting Bangladesh’s economic footprint.

R&D Investment
Research and development (R&D) are becoming central to the pharmaceutical industry’s future in Bangladesh.
Companies are increasingly investing in new formulations, biosimilars, and advanced delivery systems. R&D centers are
being set up in collaboration with academic and foreign institutions. Although the current level of R&D spending is
modest compared to global standards, there is a growing trend toward innovation-driven growth. The success of complex
generics and biopharmaceuticals will largely depend on the strength of R&D in the coming decade.
Role of Academia
Universities and pharmacy colleges in Bangladesh play a
pivotal role in supplying the skilled workforce needed by the
pharmaceutical industry. Institutions such as the University
of Dhaka, Jahangirnagar University, North South University,
and East West University and some more collaborate with
pharmaceutical companies on research projects and internship
programs. This academia-industry link supports drug safety
monitoring, formulation development, and analytical studies.
However, more structured partnerships are needed to foster
innovation and bridge the gap between academic research and
industrial application.
Biotechnology & Vaccines
Biotechnology and vaccine manufacturing are emerging as promising areas for Bangladesh. Companies like Incepta
have already taken major strides in producing vaccines for hepatitis B, tetanus, and other diseases. During the
COVID-19 pandemic, local firms demonstrated their capability to contribute to vaccine importation and potential
local production. With global demand for biologics rising, Bangladesh is positioning itself to enter this high-value
market through strategic investment and international collaboration.
Globe Biotech Limited, a Bangladeshi pharmaceutical company, developed a COVID-19 vaccine candidate named
Bangavax (initially called Bancovid). This vaccine is based on mRNA technology, similar to the Pfizer-BioNTech and
Moderna vaccines.
Key Facts about Bangavax:
Developer: Globe Biotech Limited, a concern of Globe Pharmaceuticals Group of Companies.
Vaccine Type: mRNA-based.
WHO Recognition: Three of Globe Biotech’s COVID-19 vaccine candidates, including Bangavax, were listed in the
World Health Organization’s draft landscape of vaccine candidates.
Clinical Trials: In November 2021, Globe Biotech received ethical clearance from the Bangladesh Medical Research
Council (BMRC) to conduct human trials of Bangavax.
While Globe Biotech was the first Bangladeshi company to develop a COVID-19 vaccine candidate, other companies
like Beximco Pharmaceuticals played significant roles in vaccine distribution. Beximco entered into an agreement with
the Serum Institute of India to import and distribute the Oxford-AstraZeneca vaccine in Bangladesh.
Government Policies
The government of Bangladesh has adopted multiple supportive policies to foster growth in the pharmaceutical sector.
These include tax exemptions on R&D equipment, subsidies for export-oriented firms, and fast-track registration for
WHO-prequalified products. Special Economic Zones and the API Industrial Park have been introduced to facilitate
local raw material production. These policy initiatives are aimed at transforming Bangladesh from a generic drug
producer into a high-value pharmaceutical exporter.

Regulatory Bodies
The Directorate General of Drug Administration (DGDA) is the principal regulatory authority for pharmaceuticals in
Bangladesh. It is responsible for approving new medicines, licensing manufacturing units, inspecting facilities, and
monitoring product safety. The DGDA also collaborates with international bodies like the WHO to align Bangladesh’s
regulatory standards with global best practices. Strengthening the capacity and digital infrastructure of the DGDA is
essential to ensure consistent quality and compliance across the sector.
TRIPS & Patent Waiver
As a Least Developed Country (LDC), Bangladesh is exempt from the WTO’s Trade-Related Aspects of Intellectual
Property Rights (TRIPS) obligations until 2033. This allows local companies to manufacture patented drugs without
legal restrictions, giving them a unique edge in producing and exporting affordable generics. However, after 2033,
Bangladesh will have to comply with global patent laws. The industry must prepare now by building R&D capacity,
securing voluntary licenses, and developing original formulations.
So, several Bangladeshi pharmaceutical companies are actively developing original drug formulations, moving beyond
generic manufacturing to innovate in new chemical entities (NCEs), novel drug delivery systems (NDDS), and
therapeutic vaccines. Here are some notable examples:

Beximco Pharmaceuticals Ltd.


Innovation: Introduced the world’s first generic version of Remdesivir for COVID-19
treatment.
Product Development: Launched Emorivir, a branded generic version of molnupiravir,
an oral antiviral for COVID-19.
Incepta Pharmaceuticals Ltd.
Innovation: Developed and exported semaglutide-based drugs (Fitaro and Orsema), which are alternatives to Novo
Nordisk’s Ozempic.
Market Reach: Exported to multiple countries, leveraging regulatory exemptions for least developed countries.

Globe Biotech Ltd.


Innovation: Developed Bangavax, Bangladesh’s first mRNA-based COVID-19 vaccine candidate.
Recognition: Listed in the World Health Organization’s draft landscape of vaccine candidates.
Clinical Trials: Received ethical clearance for human trials in November 2021.

Drug International Ltd.


Innovation: Pioneered the introduction of soft gelatin capsule formulations in Bangladesh, enhancing drug
absorption and efficacy.
Product Development: Produced GYNOMIX, a soft gelatin capsule vaginal suppository with antibacterial and
antifungal properties.
Challenges Facing the Industry
Despite its success, the pharmaceutical industry in Bangladesh faces several challenges. These include heavy reliance on
imported raw materials, shortages of specialized human resources, weak intellectual property protection, and occasional
lapses in quality control. Regulatory bottlenecks, lack of advanced research infrastructure, and limited access to venture
capital also hinder innovation. To remain competitive, these issues must be addressed through policy reform, investment,
and skill development.

Opportunities & Future Prospects


Bangladesh has immense potential to expand its pharmaceutical exports, especially to under-served markets in Africa,
Latin America, and Southeast Asia. The completion of the API Park will reduce import dependency and lower
production costs. Areas like contract manufacturing, vaccine production, biosimilars, and digital health integration
present major growth opportunities. With consistent policy support, Bangladesh could become a regional
pharmaceutical hub by the 2030s.
Recommendations
To ensure sustainable growth, Bangladesh should focus on increasing investment in local API production and
pharmaceutical R&D. The government must enhance regulatory oversight, simplify drug registration processes, and
improve infrastructure for manufacturing and distribution. Academic institutions should be more closely integrated with
industry through joint research and training programs. Finally, strategic partnerships with global companies can bring
technology transfer and expand market reach.

Conclusion
In conclusion, the pharmaceutical sector in Bangladesh is a remarkable success story of self-reliance, innovation, and
global competitiveness. With strategic policy support, industry-academia collaboration, and a forward-looking approach
to research and quality, the country can further strengthen its position as a major player in the global pharmaceutical
market.
References
Directorate General of Drug Administration (DGDA)
Bangladesh Association of Pharmaceutical Industries (BAPI)
WTO TRIPS Agreement Documents
WHO Guidelines
Annual Reports of Square, Beximco, Incepta, Renata, Eskayef
Ministry of Health and Family Welfare, Bangladesh
Wikipedia

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