PRODUCTION OF ESSENTIAL DRUGS IN BANGLADESH:

OPPORTUNITY AND CHALLENGES

INTRODUCTION
Essential drugs are the foundation for nearly every public health programme aimed at reducing
morbidity and mortality in Bangladesh as well as in the developing world. But about one third of
the worlds population lacks regular access to medicines of a suitable quantity and quality. In
poorer areas of Asia and Africa this figure may be as high as one-half. As a result, millions of
children and adults die or suffer needlessly, although their diseases could have been prevented or
treated with cost-effective and inexpensive essential medicines and the high disease burden in
developing countries such as in Bangladesh is slowing economic growth and worsening poverty
levels.
Irregular access to high-quality essential medicines is an important issue in many countries. The
major cause is either because these are not available or are too expensive, or there are no
adequate facilities or trained professionals to prescribe them; or this may be due to inefficient
pharmaceuticals policy and management systems, poor selection, bad distribution and use,
geographical barriers, lack of resource funding, especially in the public sector, or to a
combination of these.
Although a well-documented Drug Policy and a Drug Administration system including pricing of
drugs are available in Bangladesh, there are pricing differentials of drugs and, availability and
use of essential drugs are very often lacking even at different levels of health care facilities .
There is also limited awareness among related government officials about the impact of relevant
trade agreements (TRIPS: Trade- Related Aspects of Intellectual Property Rights) and
globalization on access to essential drug.
The pharmaceutical sector of Bangladesh is expanding rapidly and some companies have already
certified by different international regulatory authorities like UK-MHRA, Australia-TGA, EU,
etc. for quality management and quality products manufacturing. Moreover, few companies are
on the road to achieve US-FDA approval. According to the information of the Director General

of Drug Administration of Bangladesh (DGDA), there are 263 Allopathic drug manufacturing
companies in Bangladesh; 209 of which are functional, 29 companies are non-functional and 25
companies are suspended in status., Pharma sector has become the 2nd largest potential sector in
Bangladesh to earn foreign currency. At present, about 30 pharmaceutical companies have started
their export activities.
In this report the current scenario of essential drug production of Bangladesh has been presented
along with an analysis of its opportunity and challenges.

Global Pharmaceutical Market

The global pharmaceutical market is highly competitive and entry is difficult due to a
combination of strict regulations and the need for extensive research and development, involving
time-consuming clinical trials. In addition, high research and development costs, lengthy clinical
trial processes, expiring patents and difficulty in gaining product approval from the appropriate
regulatory bodies all mean that companies must produce blockbuster drugs and continue to do so
to remain in good standing.
Spending on generic drugs is driving most of the growth in the leading emerging markets, which
will contribute to the increase in the share of generic spending. Branded products accounted for
nearly two-thirds of global pharmaceutical spending in 2011.

Top Global Pharmaceutical Companies

With the advent of modern technologies, innovative and latest methods are adopted for the
production of best drugs and therefore pharmaceutical industry is also expanding day by day,
with a great competition every company is struggling very hard to prove itself best. Here is the
list of top 10 best pharmaceutical companies in 2014 that are renowned for their work in all over
the world.
Top 10 best pharmaceutical companies in 2014:
i. Pfizer ii. Novartis iii. Hoffmann-La Roche iv. Johnson & Johnson v. Merck & Co vi.
GlaxoSmithKline vii. Sanofi viii. Eli Lilly ix. AstraZeneca x. Abbott Laboratories

An Overview Of The Pharmaceutical Sector In Bangladesh

The pharmaceutical market in Bangladesh remains tiny compared to the population size because
of the lack of spending power of the population. Pharmaceutical spending is also amongst the
lowest in the world in per capita terms. Healthcare expenditures consist of only 3.4% of GDP.
However, the increased awareness of healthcare and the governments increased expenditure in
this sector is causing the demand to increase in this sector.
Surprisingly, the pharmaceutical sector, which is widely regarded as a hi-tech industry, is the
most developed among the manufacturing industries in Bangladesh. Roughly 250 companies are
operating in the market. According to IMS, a US-based market research firm, the retail market
size is estimated to be around BDT 55 billion, which grew by 16.8% in 2009. The market size in
2008 was BDT 47 billion with a growth of 6.9%.The retail market is about 90% of the total
market. In that respect, the total market size is more than BDT 60 billion.

Bangladeshs pharmaceutical industry contributes almost 1% of GDP. It is the third largest tax
paying industry in the country. Bangladeshi pharmaceutical firms focus primarily on branded
generic final formulations using imported APIs (Active Pharmaceutical Ingredients). About 80%
of the drugs sold in Bangladesh are generics and 20% are patented drugs. The country
manufactures about 450 generic drugs for 5,300 registered brands which have 8,300 different
forms of dosages and strengths.

Market Players
Domestically, Bangladeshi companies including the locally based MNCs produce 95%-97% of
the drugs and the rest are imported. Although about 250 pharmaceutical companies are registered
in Bangladesh, less than 100 are actively producing drugs.
The domestic market is highly concentrated and competitive. However, the local manufacturers
dominate the industry as they enjoy approximately 87% of market share, while multinationals
hold a 13% share. Another notable feature of this sector is the concentration of sales among a
very small number of top companies. The top 10 players control around two-third of the market
share while the top 15 companies cover 77% of the market. Square Pharmaceuticals is the stand out
market leader with a market share of 19.3% which posted domestic revenue of BDT 11.2 billion in the
last four quarters (Apr 09 - Mar 10). Their nearest competitors are Incepta Pharmaceuticals and Beximco

Pharmaceuticals with market shares of 8.5% and 7.6% respectively. Incepta and Beximco had BDT 4.9
billion and BDT 4.4 billion in domestic sales for the last four quarters. Although a number of MNCs are
operational in Bangladesh market, no MNCs are in the top ten in terms of domestic sales.
Figure : Market share concentration

Source BAPI and newspaper reports:

Table : Domestic market share of companies

Current Drug Market

The Therapeutic Groups
The most important therapeutic group in the Bangladeshi market are Systemic Antibiotics. They
account for almost 30% of the market. The second therapeutic group, Anti-acids, are much less
relevant in terms of market, as well as from a public health perspective. Vitamins, Analgesics,
Mineral supplements, Cough and Cold preparations and muscle relaxants also figure
prominently.

API Manufacturing
In most cases, APIs have to be imported from abroad.The leading manufacturers are therefore
going into API manufacturing, focusing mainly on Antibiotics, but also other drugs, such as anticancer drugs.

Distribution Channels
Basically, there are three distribution channel systems in Bangladesh: public hospitals, private
hospitals and private pharmacies. Public hospitals source mainly from the state-owned Essential
Drugs Company Limited (EDCL), whereas private hospitals and pharmacies source from the
private sector. However, public hospitals can also source from private pharmaceuticals through
tender bids.
Retail-sales of drugs in Bangladesh are allowed only under direct supervision of a pharmacist
registered with the Pharmacy Council of Bangladesh. The licenses for retail pharmacies and for
wholesalers are also being controlled by the Drug Administration of Bangladesh. There are close
to 76,000 licensed retail pharmacies in the country, and an estimated 125,000 unregistered retail
pharmacies. In addition, drugs like antibiotics can also be found in village shops etc. without
proper supervision. Whereas the law foresees no OTC drugs, requiring all drugs to be dispensed
through a prescription, in fact all medicines are available without any prescription.
Bangladeshs drug distribution marketplace is composed of small independent pharmacies.
Pharmaceutical firms can sell their products to private sector pharmacies, the government and its

public health care facilities, or to international organizations operating in Bangladesh (e.g.,

UNICEF).
Although there are approximately over 200,000 private pharmacies in Bangladesh, the
government lists officially around 76,000 pharmacies. The rest are illegal, without a license or a
licensed pharmacist on staff. Several brands of each drug, with variable quality levels, are on the
market.
The top twenty pharmaceutical manufacturing firms have established extensive sales and
distribution networks. Most pharmacies have 10-50 pharmaceutical firms supplying their
medicines daily. Hundreds of medical representatives of top pharmaceutical companies visit
pharmacies daily to take drug orders. On an average, a company incurs 10-15% of their total
costs in this process.

Drug Regulation
The Directorate of Drug Administration (DDA), the national drug regulative authority, regulates
drug manufacturing, import and quality control of drugs in Bangladesh. It belongs to the
Ministry of Health and Family Welfare.
The Directorate issues licenses for import of raw materials for different drugs and packed drugs
from a selected list to pharmaceutical companies and importers. It also monitors quality control
parameters of marketed drugs through an agency called the Drug Testing Laboratory.
DDA also administers vaccines and the indigenous systems of medicine called Ayurvedic and
Unani systems. The Homeopathic system of medicine is not, however, under the regulatory
control of the Directorate. Prevailing laws regarding drug regulations are as follows:
National Drug Policy 1940
Drug Act 1940
Drug Control Ordinance 1982
Drug Control Ordinance 2004
National Drug Policy 1982

Drug Act 1940

The Drugs Act, 1940 is a law that regulates the import, export, manufacture, distribution, and
sale of drugs in the country. It was originally enacted by the Government of India in 1940 and
adopted by the Pakistan Government in 1957 in its modified form. It was adopted in Bangladesh
in 1974. This Act seeks to regulate the import of drugs into the country, the manufacture of
drugs, as well as sale and distribution of drugs.
The Drugs Act permits the import of certain classes of drugs only under the licenses or permits
issued by the relevant authority appointed by Government. In contrast to the control of the drugs
manufactured in the country, quality requirements on imported drugs are very strictly controlled,
thus successfully preventing Indian manufacturers, who could serve the Bangladeshi market at
competitive prices, from entering the market. Licenses are also required for the manufacture and
for the sale or distribution of drugs in the country. Regular control over manufacturing and sales
is exercised by periodic inspection of licensed premises by drug inspectors who are specially
appointed under the Act. Surveillance over the standards of drugs is maintained by taking
samples from drugs, manufactured or offered for sale, and by testing in the Central Drugs
Laboratory.

Drug Control Ordinance 1982

The Drug Control Ordinance 1982 is an Ordinance which controls the manufacture, import,
distribution, and sale of drugs in Bangladesh. It was promulgated in 1982 as additional to the
Drug Act 1940.
Under this Ordinance, (i) no medicine of any kind can be manufactured for sale or be imported,
distributed or sold unless it is registered with the licensing authority; (ii) no drug or
pharmaceutical raw material can be imported into the country except with the prior approval of
the licensing authority; (iii) the licensing authority cannot register a medicine unless such
registration is recommended by the Drug Control Committee; (iv) the licensing authority may
cancel the registration of any medicine if such cancellation is recommended by the Drug Control
Committee on finding that such a medicine is not safe, efficacious or useful; (v) the licensing
authority is also empowered to temporarily suspend the registration of any medicine if it is

satisfied that such a medicine is substandard; (vi) the government may, by notification in the
official gazette, fix the maximum price at which any medicine may be sold and at which any
pharmaceutical raw material may be imported or sold; (vii) no person is allowed to manufacture
any drug except under the personal supervision of a pharmacist registered in the Pharmacy
Council of Bangladesh; (viii) no person, being a retailer, is allowed to sell any drug without the
personal supervision of a pharmacist registered in any Register of the Pharmacy Council of
Bangladesh; and (ix) the government may, by notification in the official Gazette, establish Drug
Courts as and when it considers necessary.

Intellectual Property Legislation

Bangladesh is a signatory of the GATT Uruguay Round and World Trade Organization (WTO)
agreements, including the Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS). It is also a least developed country (LDC) and thereby is exempted by the Doha
declaration from implementing patent protection for pharmaceutical patents until 2016. This only
holds for countries that have not yet implemented a legislation that provides for such patent
protection, though. It is therefore necessary to look at the Bangladeshi law.
The Bangladeshi patent law dates from 1911 and was amended in 1985. The responsible
government institution is the Ministry of Industries, Department of Patents, Designs and Trade
Marks.

The Industry After 1982

Bangladesh formulated its National Drug Policy (NDP) and established the Drugs Control
Ordinance in 1982, to ensure availability, affordability and safety of essential drugs. The Drugs
Control ordinance bans certain types of drugs from the market, limits the marketing rights of
foreign companies and establishes a price control for both finished drugs and their raw materials:
Bans: Combination drugs are only allowed in cases where single drugs are not available or not
cost-effective; Sale and manufacturing of drugs with limited therapeutic usefulness (e.g. cough
mixtures, throat lozenges) or with abuse potential are prohibited.
Foreign Companies: foreign brands are not allowed to be manufactured under license in
Bangladesh if similar products are being manufactured in the country. Multinational companies

that do not have an own production facility in Bangladesh are not allowed to market their
products.
Price Control: 150 drugs were defined as essential drugs. For those, level prices are fixed for
the finished drugs as well as for their corresponding raw materials. No manufacturer can set
maximum retail prices for their goods beyond that limit. However, currently there are 209 drugs
on the essential drugs list. For drugs that do not fall into this Controlled Category, the
manufacturer can set their own price, which must, however, be approved by the Drug Control
Committee.

Opportunity and Challenge Of Essential Drug Production

Opportunity:
Global export market
Due to cost pressures, MNCs increasingly seek to manufacture pharmaceuticals in developing
countries. Pharmaceutical contract manufacturing and research services is a large and growing
business. Worldwide revenues totaled $100 billion in 2004. With a predicted average annual
growth rate of 10.8%, revenues are estimated to reach $168 billion by 2009. Pharmaceutical
firms in Bangladesh exported approximately $45.67 million (approximately 0.03% of the
estimated global pharmaceutical market revenue) in products to 73 countries during 2008-09.
Bangladeshs exports are growing rapidly, as shown in the table below.

Table:Pharmaceutical Exports from Bangladesh

Bangladeshi firms are trying export to the following markets:

Regulated: Square Pharmaceuticals, the only Bangladeshi pharmaceutical firm accredited in a
regulated market, received the UKs regulatory approval in May 2007. The largest barriers to
regulated markets are modern manufacturing facilities which come at a cost of at least $50
million, and know-how.
Moderately Regulated: Some markets, such as Pakistan, Sri Lanka, Tanzania and Malaysia, are
moderately regulated. While countries do not always require stringent certification, a
certification from a regulated market signifies quality and provides a firm with a competitive
advantage.
Unregulated: Most Bangladeshi pharmaceuticals are exported to less than fully regulated
markets such as Bhutan, Nepal, Vietnam, Myanmar and African countries such as Ivory Coast,
Male, etc.

Major Exporters
The majority of Bangladeshs pharmaceutical exports are from MNCs such as Sandoz. Sandoz,
an MNC operating in Bangladesh, has approximately 25 manufacturing sites globally.
Bangladesh is one of its smaller sites. The Bangladeshi manufacturing site is an EU certified
plant which produces about 500 million tablets a year and generates about USD 35-40 million in
sales. It has been growing rapidly15-18% per yearand is responsible for a significant portion
of Bangladeshs pharmaceutical export growth. It imports APIs, acquires packaging
domestically, and manufactures final formulations in Bangladesh for export of USD 12 million
or for sale to the domestic market ranging from USD 23-28 million.
Most pharmaceutical firms in Bangladesh are family owned. While many have the capacity to
export, some do not have the in-house expertise. As a result, only sixteen firms export products.
There are no majority exporters, e.g., companies that sell more than 50% of their output in
export markets. Beximco, for example, is one of the leading exporters. Its 2009 exports were
about USD 4.0 million or 5.9% of total sales. The export situation is evolving. For example,
Square Pharmaceuticals increased exports by 58% from 2007-08 to 2008-09.

Indirect Benefits Of Export

Bangladeshi firms that export are slightly more productive than non-exporting firms. Some
possible reasons for this advantage may be due to:
1. Technological lessons learned from foreign buyers.
2. Exporters improved their own technological capabilities to exploit profitable opportunities in
export markets. For example, exporters need to adopt stringent technical standards to satisfy
more sophisticated consumers, and/or they are under more pressure to fill orders in a timely
fashion and to ensure product quality for export markets which are more competitive than
domestic market.
3. Better firms self-selected to enter export markets for the prestige rather than the effects of
exporting necessarily improving the firms.

Contract Manufacturing
Contract manufacturing is a good business opportunity for Bangladeshi firms, and if well done, it
can enable technology transfers to domestic firms. Square Pharmaceuticals, one of Bangladeshs
largest pharmaceutical firms, attributes much of its success to what it learned by working with an
MNC.
Bangladeshi pharmaceutical firms can make several types of contract manufacturing
arrangements with MNCs, including:
Contract manufacturing with the product intended for export to a regulated market. The current
National Drug Policy (NDP) permits this. Contract manufacturing for export is a significant
financial opportunity, but challenging. Square Pharmaceuticals is one of the very few
Bangladeshi firms with a qualified facility. It is currently initiating a contract manufacturing
arrangement with a British firm.
Contract manufacturing with the product intended for the domestic market. The Drug Control
Ordinance (DCO) prohibits foreign firms from selling products in Bangladesh unless they have a
manufacturing presence in the country. Thus, Bangladeshi firms can only contract manufacture
for domestic distribution with MNCs that already have a presence in Bangladesh. An example of

this arrangement is Beximco contract manufactures Ventolin, which is an inhaler for

GlaxoSmithKline.

Demand For Essential Drugs

Bangladesh has a strong pharmaceutical industry represented by private enterprises and the stateowned EDCL. Bangladesh is largely self-sufficient with regard to drugs and has no significant
drug availability problem. Due to widespread vaccination schemes, successful eradication of
leprosy and widespread use of oral rehydration for diarrhea, many of the traditional health
problems are minimized and life expectancy has risen to around 65 years .The most important
health issues in Bangladesh today are related to maternal health and malnutrition, vitamin and
iron deficiency. AIDS, Malaria and TBC are potential health threats. Other important causes of
death are cardiovascular diseases, diabetes and cancer. Mental disorders are an important reason
for disability. Thus, in line with the statement that there is no significant drug availability
problem in Bangladesh, the therapeutic groups do largely reflect the major health issues in the
country.

The Health Care System

Bangladesh is a signatory to the Alma Ata Declaration on Primary Health Care (PHC) in 1978. In
1988, the Bangladeshi Government adopted the PHC approach as a guiding principle to the
health systems development in Bangladesh. Due to resource limitations, introduction of PHC
was started in selective districts. In 2004, an estimated 48 million out of Bangladeshs 140
million population is covered by PHC.
The public health expenditure, totaling 3.4% of GDP in 2001, comparing to 4.1% in India, 4.2 in
Sri Lanka and 2.7% in Pakistan. Public health expenditure accounts for roughly 33.6% of the
total health expenditure. There are around 43,000 registered physicians and 40,000 nurses and
midwives, resulting in about only 3 physician and 3 nurses and midwives per 10,000 population.

Price And Price Sensitivity

For those drugs that are not subject to a fixed price, there is considerable price sensitivity in
Bangladesh, which is explained by the very high variation in quality with significant incidents of
health-damaging spurious drugs and fake drugs that contain no active ingredient.
Thus, it is not uncommon for the high quality branded generics of the leading manufacturers to
have a 100% price premium over their competitors. In some cases the premium is even higher.

Unmet Demand
The demand for essential drugs in Bangladesh is largely covered. In accordance with the above,
in many cases the cheap availability of essential drugs without adequate health care
infrastructure is not without problems.
The global need for essential drugs is huge in theory and the actual demand depends to a large
extent on financing possibilities and mechanisms, which are difficult to foresee in detail, but the
creation and dedication of funds and institutions like e.g. the Global Fund to combat AIDS,
Malaria and Tuberculosis, justify a significant growth expectation for the actual demand. It is
also to be expected that wherever donor funds are directly used to purchase drugs (as e. g. the
Global Fund or the Gates Foundation), the demand will come with such quality requirements that
would put a country like Bangladesh with a good track record and a lot of experience at
advantage over African LDCs that are only just entering the business of pharma manufacturing.

Investors And Sources Of Capital

In Bangladesh, there are several national investors interested in building up pharmaceutical
manufacturing: many of the existing pharmaceutical corporations, like Square and Beximco,
belong to large conglomerates that have proven the commercial opportunities to invest in
pharmaceutical manufacturing plants.
When investing in pharmaceutical manufacturing plants, the equity rate used by Bangladeshi
investors is significantly higher than the usual equity rate in transnational pharmaceutical
companies. The reason lies partly in the comparatively high cost of capital and also in the
necessity to group together different banks for financing a large credit sum, since the sum each
bank is allowed to lend is usually not sufficient to finance a large drug manufacturing plant. As a

result, there is a large number of very small scale manufacturer present in the industry. These
manufacturers focus mostly on a handful of basic and essential drugs.

Challenges:
Access To Essential Drugs
Although official documents indicate that 80 per cent of the population has access to affordable
essential drugs . there is plenty of evidence of a scarcity of essential drugs in government
healthcare facilities. One study conducted in four district hospitals and one medical college
hospital showed that only eight per cent of patients received the prescribed medicines from these
facilities.In another report, two major hospitals in the capital city of Dhaka were operating
without essential medicines for eight consecutive weeks.

Quality Of Available Drugs

Of the 300 pharmaceutical companies in Bangladesh, only the 20 to 25 top ones produce drugs
of standard quality. Reports show that numerous small companies market substandard drugs in
the country. Fake or substandard medicines, including lifesaving ones, with an estimated worth
of US$ 150 million per year, are flooding the domestic market. In its annual testing in 2004, the
government laboratory detected 300 counterfeit or very poor quality drugs out of 5,000 drug
samples. A recent assay involving 15 brands of ciprofloxacin showed that 47 per cent of samples
contained less than the specified amounts of the active ingredient. Another report noted that 69
per cent of paracetamol tablets and 80 per cent of ampicillin capsules produced by small
companies were of substandard quality .

Lack Of Control Over Drug Prices

In Bangladesh the maximum retail price (MRP) of every essential drug is fixed by the
Directorate of Drug Administration (DDA); for all other drugs the DDA endorses the companies
quoted prices . Drug prices are quite high in Bangladesh in comparison to neighbouring
countries. The drugs control authority is apparently reluctant to negotiate with the companies to
fix prices . The regulatory authorities have virtually no control over drug prices in Bangladesh.
Indiscriminate pricing can be observed in all therapeutic classes of drugs. For example, prices of
various ciprofloxacin brands range from Taka (Tk) 5 to 14 (US$ 0.07 to 0.20) per unit. The price

of dexamethasone eyedrops extends from Tk 24 to 90 (US$ 0.34 to1.29) per 5ml, and diclofenac
eye drops are available at a price range from Tk 40 to 200 (US$ 0.57 to 2.86) per unit (6). These
are a few of the existing price discrepancies in the country.

Patterns Of Drug Use

There has been no drug use study in the country. Clinically inappropriate and inefficient use of
medicines is a serious problem. More than half the medicines in Bangladesh are inappropriately
prescribed, dispensed or sold . Despite legal prohibitions , numerous drugs with similar or no
significant benefits are available in the market. As a specific example, there are seven members
of the angiotensin-converting enzyme (ACE) inhibitors available in the country. The drug policy
clearly prohibits the production of multi-ingredient preparations of vitamins and minerals with
the exception of B-complex vitamins . But a mixture of 32 vitamins and minerals including
selenium, vanadium, molybdenum, tin and many other unnecessary ingredients has been
marketed in the country for a few years, violating the principles of the NDP. The need for these
trace elements in Bangladesh is not established whereas nutritional deficiencies are mainly
related to vitamins A and B-complex, iron, calcium, iodine and zinc. Irrational prescription and
use of antibiotics are rampant throughout the country, with an estimated half of all antibiotics
being sold without prescriptions. Self medication is widespread, and all types of medicines can
be purchased without a prescription. There are about 30,000 illegal and 80,000 unlicensed drug
stores operating in the country.
More challenges about essential drugs are
Underdeveloped backward linkages particularly API (active pharmaceutical ingredients)
manufacturing.
Lack of investment and knowledge based workforce hindering R&D
Failure to capitalize on TRIPS so far

TRIPS
The WTOs Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)
requires all signatories to legislate twenty-year patent protection for pharmaceutical products into

their domestic law.. While signatory countries must meet its requirements through legislation,
TRIPS provides significant flexibility.
Until 2016, TRIPS provides Bangladesh with domestic, patent-free production rights and limited
exporting advantages. Bangladesh imports approximately 80% of its APIs for domestic
production, 20-25% of which are patented. These API costs will most likely rise as TRIPS phases
in.
Bangladesh enjoys some export advantages from TRIPS. But these advantages are somewhat
offset by the pace and competitiveness of the Indian and Chinese generic markets. In both
markets, companies can produce drugs at highly competitive pricingeven with higher costs
associated with buying patented APIs or paying royalties.

Conclusion
The essential drugs market in Bangladesh is well supplied, and there is no availability problem of
essential drugs. Partly due to the failure of the local authorities to provide credible quality
certifications, and partly due to their aspiration to increasingly target export markets, leading
Bangladeshi manufacturers are already successfully working on obtaining international quality
certification for their products and plants, in some cases bringing in experienced experts from
MNCs or Indian competitors.
The ability of the Bangladeshi drug industry to manufacture drugs for all kinds of needs is
beyond doubt. While some manufacturers are already able to produce world class quality drugs,
others would require considerable assistance to be able to reach that target. However, the
Bangladeshi industry has been largely focused on the domestic market until recently.
In terms of cost, Bangladeshi companies can be expected to compete successfully with African
players, especially if an international quality standard is required. The ability to compete with
Indian and Chinese manufacturers is limited due to the necessity to import machinery and
notably the precursor substances. The ultimate competitiveness of Chinese and Indian
manufacturers depends on the expected rigor of the TRIPS enforcement, the viability of
voluntary or compulsory licensing for Indian and Chinese players, and the amount of license fees
they would have to pay, and the competitiveness of Bangladeshi manufacturers will largely
depend on the pricing of the raw materials. Still, Bangladesh is probably one of the few LDCs

where under the TRIPS agreement new patent protected drugs and APIs can be cost-effectively
produced and at high quality.
Thus, Bangladesh is a natural candidate to supplement or substitute Indian and Chinese providers
to the developing country markets of both finished drugs and APIs, notably in antibiotics, antiulcerants, anti-hypertensives and anti-depressants. However, the domestic market is large enough
to be self-sustaining and lucrative for the domestic players until they become ready to take on the
global pharmaceutical market.
Inadequate supply of essential drugs, substandard quality uncontrolled drug prices and
inappropriate uses of drugs are major problems in Bangladesh. The drugs control authorities
should be better equipped and more vigilant to cope with the situation. Health professionals and
drug manufacturers should be more committed in order to achieve the goals of the NDP.

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