Professional Documents
Culture Documents
Introduction:
Pharmaceuticals industry is the core of healthcare sector of Bangladesh. Being part of healthcare
sector, its performance is related to demographic variables like population growth as well as
economic growth and healthcare policy. In our country, with improving demographic
characteristics, recent economic growth and favorable policy, the industry has seen good growth.
It is one of Bangladeshs success stories and one of the most technologically advanced sectors
currently in existence. This industry is matter of substantial pride to the country. Skillful
attitudes, knowledge and innovative ideas from the professionals are the key reasons why this
industry grew in the way it did.
A brief history
The history of Pharmaceuticals industry dates back to 1950s. Over the years, the industry has
gone through some significant changes. In the early post-independence period of Bangladesh,
multinational companies (MNCs) dominated the pharmaceutical sector. Eight leading
multinational companies enjoyed 75% of the total domestic market (Bangladesh Tariff
Commission 2010). In 1982, a defined guideline for the development of the industry was created
through the formulation of national drug policy (NDP), and drug control ordinance. Under the
NDP, only local companies were allowed to produce vitamins, enzymes, and cough syrups. This
led to the formation of local pharmaceuticals companies and an increase in domestic production.
And Bangladesh, which was once a drug-importing country, became a drug-exporting country by
the late 80s.
Current Status:
Local Market Overview
The Bangladesh pharmaceutical marketplace is predominantly a branded generic marketplace.
Pharmaceutical firms in Bangladesh can either sell to the private sector pharmacies, to the
government and its public health care facilities, or to international organizations operating in
Bangladesh (e.g. UNICEF).
Number of Firms:
About 300 pharmaceutical companies are operating at the moment. Only 3% of the drugs are
imported, the remaining 97% come from local companies. Positive developments in the
pharmaceutical sector have enabled Bangladesh to export medicine to global markets. By
overcoming the underlying obstacles this sector can develop more and can be an effective
exporting sector of Bangladesh
Industry Structure
The industry has some distinct features compared to other countries. First, R&D activity is
virtually nil in Bangladesh pharmaceutical industry it is a branded generic market. Companies
basically manufacture finished formulation by assembling known generic and patented (in some
cases) product combination. Some firms have been engaged in producing APIs, the core of
pharmaceutical products, but these productions are limited to synthesis stage (final stage) only.
Degree of concentration
The primary layer is R&D Activities. This is often a very costly and hish risk business,
and for many of global Pharmaceutical firms, represent the majority of costs. However, in
Bangladesh, this activity is nil, and all the firms are producers of known and established drugs.
The second layer is manufacture of ingredients for finished formulations. These
activities cover production of Active Pharmaceuticals Ingredients (API), Excipients, and
Solvents etc. that are used as raw material in producing the final drug formulations. Historically,
Bangladesh has been dependent on imports for APIs and other ingredients. The pharmaceutical
manufacturers in Bangladesh procure raw materials from various countries namely UK, France,
Germany, Japan, Holland, Italy, Denmark, China, Switzerland, Austria, Hungary, India, Ireland
etc.
In Bangladesh, companies have only recently entered API business. At present, there are
21 companies in Bangladesh manufacturing 41 APIs. Industry participants claim already
becoming self-sufficient in some APIs, namely, Penicillin, Cephalexin, NSAID and Anti-Pyretic.
The production of APIs is confined to the last stage of Synthesis. Presently, Local APIs take a
20% share in domestic production. The rest 80% is imported. These imported APIs represent
majority of raw materials import by Bangladesh, approximately 70%. But the overall production is
very low compared to total demand.
The final layer concerns producing final products, finished formulations. In this layer,
there are both patented and generic products. However, in Bangladesh, only generic products are
produced. Formulations represent the mainstream business in pharmaceuticals industry of
Bangladesh. Presently, the market consists of approximately 8000 generic products and 258
firms with manufacturing capability, along with some imported patented products. (Source:IDLC
Research)
Regulatory environment
The industry is regulated by Directorate General of Drug Administration (DGDA)
Pricing:
Under the present regulatory structure, government fixes the maximum retail prices (MRP) of
209 essential drug chemical substances. Other drugs, listed as non-essential, are priced through
an indicative price system. For imported finished products, whether they fall in the category of
vital or non-vital drugs, a fixed percentage of markups are applied to the C&F price to obtain the
MRP. For local distribution, all drugs must be registered with DRA. However, this price
determination is only for the local producer companies and still now the multinational
organizations are determining. (SOURCE: National Drug policy 2004) Prices of Bangladeshi
generics are amongst the lowest in the world (Forbes Asia, 2013).
For imported drugs, GMP validation, bioavailability and bio-equivalency are important
registration criteria
Firms are required to upgrade their productive facilities to ensure cGMP is followed.
Foreign and MNCs are allowed to manufacture drugs in Bangladesh only if at least three
of their original research drug products are registered in at least two of the following
countries: USA, UK, Switzerland, Germany, France, Japan, and Australia.
Drugs not in BP, USP, IP, INN or BPC will not be allowed to manufacture.
Foreign firms can produce drugs in Bangladesh under licensing agreement following
certain conditions.
2. There are significant numbers in technician and similar roles, particularly in large
companies.
3. There are significant numbers of chemists and pharmacists, particularly in the large and
the medium company, reflecting the fact that a range of types of high level work are done
by these professions.
4. There are very large numbers of sales and (in the case of the small company) marketing
workers. This reflects mainly the emphasis on direct sales to retail pharmacies in
Bangladesh.
Export of Pharmaceuticals
Bangladesh is exporting their pharmaceuticals products to Vietnam, Singapore, Myanmar,
Bhutan, Nepal, Sri Lanka, Pakistan, Yemen, Oman, Thailand, and some countries of Central
Asia and Africa. It also has a large market in European countries.
The pharmaceutical sector as a highest priority sector in Bangladesh is entitled to income tax
exemption for export earnings, export credit at reduced rates, assistance in marketing in overseas
market through participating in export fairs, and so on. In addition, the government reduced or
exempted duties on some capital machinery and raw materials imported for the use of
pharmaceutical production. The sector also enjoys a tax holiday and duty drawback scheme. The
export policy of 201215 doubled the value of samples allowed to be sent by the pharmaceutical
industry to overseas buyers to US$60,000 a year.
Import of Pharmaceuticals
Bangladesh is importing the medicinal products from different countries, especially from India.
Different organizations of this country are related to import the pharmaceuticals products and
raw materials of pharmaceutical industries. Novo and Medintis are importing maximum amount
of these types of products. Other organizations are engaging to import the pharmaceuticals
products. They are- Sanofi, Aventis, Glaxo Smithkline, Sandoz, Novartis, Roche, Unimed,
Servier etc.
Import Policy
Pharmaceutical firms are subject to a special low-tariff regime for both outputs and inputs. This
is because of the special dispensation under the Drug Policy (the Drug Control Act of 1982
restricted imports and capped prices) to keep domestic prices low but with strong controls on
competing imports. The effective rate of protection (ERP) in the pharmaceutical sector is
apparently very low, ranging from 0.5percentto about 20percent, provided that the output tariff
of 0 to 5percent is the one actually levied. However, once the tariff equivalence of import
controls is taken into account, ERPs could be much higher
The import regime consists of banned items, restricted items and freely importable items. The
procedures for importation are facilitated by creating a block list of imports for each
recognized pharmaceutical company approved by the Director of the DGDA. Companies
importing raw materials have to present an import invoice and analysis report of the quality,
value, and quantity for each import. The analysis report of the raw materials must be certified by
the DGDA or be prepared by a government-approved preshipment inspection agent (Ministry of
Commerce 2012).
Competitive Position
Pharmaceutical industry is facing competitive market domestically. Square, Beximco, Incepta,
Acme, SK-F, Drug International, AristoPharma, ACI, are the competitors of one another in
medicine market. To purchase the medicinal product is not depending on the customer choice.
For this reason, the primary survey over the customer and the actual condition is different. From
the above chart, this can be said that no organization can capture the maximum market share in
medicine marketing. There is a tough competition among Square, Beximco, and Incepta.
Foreign Competitions
At the beginning the foreign pharmaceuticals were dominating the market in our country. Still
now, Pharmaceuticals industries are facing foreign competition. But our industry is not afraid of
this foreign competition. There are many multinational pharmaceutical organizations which have
established their plants in Bangladesh and importing their raw materials from abroad. Among
these competitors, Roche, Glaxo SmithKline, Novartis are leading. In export market, the
Novartis is playing the dominant role.
Prospects of Foreign Competition
i. Foreign competitions made the country firms more eligible to face challenges that arose after
the year 2005.
ii. Pharmaceuticals industries will become more efficient in producing medicine which may save
our lives.
iii. The local firms will not face any rigorous problem in foreign countries as they are
accustomed in competition with foreign firms.
Along with other LDCs, Bangladesh has an exemption from the World Trade Organization's
(WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement. The
exemption is currently due to expire at the start of 2016. The TRIPs exemption allows
Bangladesh (and other LDCs) not to provide patent protection for drugs that are required by
TRIPs to be protected by patents elsewhere in the world. The government of Bangladesh has
proposed that the exemption should be extended to 2026, but it is not yet clear whether this will
happen. The chief benefit of TRIPs exemption to the sector in Bangladesh is that it allows
companies operating in Bangladesh to develop generic versions of drugs that are under patent
protection elsewhere, and to sell these products. They can be sold on the local market. They can
also be sold in markets where the patent owner has not filed for protection, or to other LDCs or
non-members of the WTO which have not implemented patent protection, which gives the sector
some advantages in export markets. A further benefit is that Bangladesh is now one of very few
countries that can fulfill an export request for a compulsorily licensed pharmaceutical product
originally patented after 2005. Under Article 31 of TRIPs, a government can over-ride a patent to
compulsorily license a pharmaceutical product for public health reasons.
In some cases, Bangladesh companies that are already producing a generic version of a patented
drug may have a head start in exporting it to global markets when it comes off patent protection.
Bangladesh has tariff-free access to the EU, USA and Japan for pharmaceuticals. It has reduced
tariffs for exports to India and China under the South Asian Free Trade Area and the Asia Pacific
Trade Agreement. This favorable market access is not related to TRIPs. The benefits that the
Bangladesh pharmaceutical sector derives from the TRIPs exemption are limited by the fact that
it purchases most of its Active Pharmaceutical Ingredients (APIs) from countries compliant with
TRIPs. Most of the APIs under patent protection that it purchases are therefore licensed by the
patent holder, and this is reflected in prices paid.
The Bangladesh pharmaceutical sector is investing heavily in the capabilities needed to
develop its own APIs. If the TRIPs exemption is extended it is likely that it will be able to
replace many licensed in-patent APIs with its own generic versions, significantly cutting its
costs. Conversely, if the exemption is not extended, some holders of pharmaceutical intellectual
property might use their greater leverage to enter Bangladeshs domestic market, possibly
limiting access by the Bangladesh sector to APIs, or to raise prices for APIs charged to
Bangladesh businesses.
********
The future of pharmaceutical exports from Bangladesh is bright. After the inclusion of
the Doha declaration in WTO / TRIPS Agreement, each and every country belonging to the LDC
Category has the option not to opt for pharma product patent until year 2,016; which means, they
can now legally reverse-engineer patented products and sell in their markets and can export to
other LDCs, too. This generates a huge export opportunities for Bangladesh, as among all 50
LDCs, Bangladesh is the only country which had a strong pharma manufacturing base. Besides
direct export operations, there is also a huge opportunity for the Bangladeshi companies to go for
the Contract Manufacturing and compulsory licensing. The good news is, the leading pharma
exporters of Bangladesh have already started availing these opportunities.
industries
(Finished
medicines,
Active
Pharmaceutical
5. Problems of Marketing
i.
ii.
iii.
Most of the time costs of marketing hardly affect the price of the medicine.
iv.
Lack of proper governmental laws and this implementation the law by the drug
administration.
6. Prospects of Marketing
i.
Marketing system is improving in this sector and proper marketing may help a
firm to achieve the aim.
ii.
For free and fair competitions marketing can play a major role.
iii.
Marketing can be regarded one of the most important weapons to face the
challenges of open market economy
7. Problems of Export
i.
Unstable political situation is one of the vital reasons for not achieving the
expectation in export.
ii.
Problems of port (both sea and air) hinder the timely export.
iii.
iv.
v.
Still now, the products of the pharmaceuticals industries of Bangladesh are not
world class.
8. Prospects of export
i.
ii.
iii.
iv.
Export brings foreign currencies for the country which is helpful for the reserve of
the country.
i.
One main problem is in producing rare drugs foreign companies are ahead of us in
terms of quality, experience and market share.
ii.
Most of the time, to purchase the medicinal products is not depending on the
customer choice. Customers buy their product according to the prescription of
doctors.
i.
ii.
By producing rare drugs at home, the country can save its foreign exchange.
iii.
i.
ii.
iii.
By following all the rules and innovating alternative power supply source, this
sector is entering the competitive market.
ii.
approving market strategies, including pricing strategies, to ensure they are aligned with the
Bangladesh firms interests, and to ensure that the benefits of low factory gate prices do not only
accrue to an agent or distributor.
Clinical trials are important to the future of the sector for two reasons:
1. The large numbers of generic drugs requiring testing for regulatory approval will generate a
substantial demand for bioequivalence testing from the Bangladesh pharmaceutical sector. A
base of local suppliers of bioequivalence laboratory services could supply this service at lower
cost than international competitors.
2. Clinical trials represent an enterprise development opportunity in their own right. India has
become a major global player in this part of the pharmaceutical value chain, based on
characteristics (large population, low costs, lack of universal access to high quality medical
services) that are shared with Bangladesh to a significant extent. There may be room for
Bangladesh to become a significant player too. So far, Bangladeshs clinical trials sector is small.
Even if it only to service the need for bioequivalence testing, it will need stronger capabilities.
Laboratory technicians
Production managers
Producing APIs
The main skills associated with each of the main business capabilities associated with APIs are:
Process development: High level skills in chemistry and pharmacy, from bachelor degree
to PhD level, with a need for support from chemistry technicians.
Process scale-up: More high level skills in chemistry and pharmacy, from bachelor
degree to PhD level, plus chemical engineers, again supported by chemistry technicians.
Process plant design and installation: Engineers and technicians from a range of
engineering disciplines, including chemical engineering, mechanical engineering,
electrical engineering, software/electronic/automation engineering and instrumentation
engineering.
Pharmaceuticals in 2013:
According to International Marketing Services (IMS), Bangladesh's domestic pharmaceuticals
market grew nearly 13% to $250m in 2013.
In addition, per the Commerce Ministry's Export Promotion Bureau (EPB), Bangladesh now
exports to about 85 countries including Austria, Denmark, the UK, Germany, France, Singapore,
Indonesia, Vietnam, the Philippines, Brazil, Pakistan, Burma and Yemen.
According to the DGDA, 194 of 275 government-registered pharmaceutical companies regularly
produce items like cough syrup and flu tablets. Square, Incepta, Beximco, Acme, and Eskayef
account for 45% of Bangladesh's total production, manufacturing products for export in state-of
the-art factories. Companies like the UK's GlaxoSmithKline, Switzerland's Novartis and France's
Sanofi have set up plants producing life-saving vaccines, anti-cancer drugs and other high-end
products in Bangladesh. Future forecasting is given as belows:
Pharma exports rose around 24 percent year-on-year to $59.82 million in fiscal 2012-13 thanks
to a growing demand for Bangladeshi medicines in Southeast Asia, Asia Pacific and Africa.
With an annual two-digit growth rate the Bangladesh pharmaceutical industry is now heading
towards self sufficiency in meeting local demand. There are more than 300 small, medium,
large and multinational companies operating in the country producing around 97% of the total
demand. The sector is the second highest contributor to the national ex-chequer after tobacco and
it is the largest white-collar intensive employment sector in Bangladesh.
Recommendations:
International agencies like ITC, UNIDO, WHO, World Bank etc should extend technical
support through educating the local industry representatives on TRIPS and its potential
benefits. International agencies may also extend technical assistance to Bangladesh
pharmaceutical industry sector for setting up world class Drug Testing Laboratory for
testing of medicines. Multilateral financing agencies should provide soft funds to set-up
plants for producing active pharmaceutical ingredients. External financial support may be
explored for combined water treatment plant for waste management of the proposed
API manufacturing plants.
sophisticated documentation, and huge initial capital investment. Actually the export volume
to the highly regulated countries will not be easily feasible; rather we can perform pretty well
and can potentially increase our export if the exporters become more attentive to LDCs.
Among 50 LDCs, only Bangladesh has its strong fundamental and modern manufacturing
base, hence we can easily share the drug market of rest of the LDCs. So, considering the
practical situation, the LDCs should be the targeted markets of our pharmaceuticals, of
course, side by side, moderately regulated and highly regulated
Establishing Export cell by the govt./private Consultancy firms may promote Pharma
export:
Government can establish specialized Export Cell to promote exports of pharmaceuticals to
grab and capitalize the huge export opportunities in LDCs. Some private Consultancy firms
having experience and expertise in drug export professionally can be engaged to assist the
pharmaceutical companies who do not have the technical and expertise know-how to go
through the entire process of export, or have lacking in documentation skills or even do not
have the skilled man power to deal with the drug export. Thus, Consultancy firms can play a
significant role to explore export to maximum countries, accelerate export activities, and to
reduce the overall cost of export. Even some small companies having International Marketing
Department (IMD) can explore the benefits of outsourcing by hiring Export Consultants to
reduce its overhead expenditure and make a comparative study of cost-benefit ration to
justify having IMD.
Power Generation: Pharmaceutical companies may take the initiative to generate the
Advertising cost: It should be reduced and this is necessary to make the marketing
people aware of their profession.