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PharmaTutor ISSN: 2347-7881 | Vol 6, Issue 12 64

An A-Z of Pharma Industry Review: Bangladesh Perspective


AK Mohiuddin
Faculty of Pharmacy,
World University of Bangladesh,
Dhaka, Bangladesh
mohiuddin3@pharmacy.wub.edu.bd

ABSTRACT
After liberation, Bangladesh pharma industry was largely dominated by the import dependent MNCs. On or
before 1982 ordinance, 75% of the market was dominated by the MNCs and the rest share was with the other
133 local companies. After NDP formulation and the Drug Control Ordinance, there was a dramatic change of
reverse. By 1994, a few pharma companies achieved a tremendous growth and they reinvest their profit for
faster return. By next decade, Bangladesh is aiming to 30 world class drug manufacturers to establish strong
footstep in global pharma market. Bangladesh, as an LDC got exempted from the obligation of patent and data
protection in this arena until 2033. Interestingly, Bangladesh already passed across the LDC landmark to a
developing country. So, there’s window of opportunity of more than a decade to grow further from that aspect.

Keywords: National Drug Policy (NDP), The Directorate General of Drug Administration (DGDA), Pharmacy
Council of Bangladesh (PCB), Bangladesh Pharmaceutical Society (BPS), Bangladesh Association of
Pharmaceutical Industries (BAPI)

Purpose: Discussion and projection of Bangladesh pharma market in a multi-dimensional approach.

Methodology: Secondary data were used in market, that they have very few ideas. Along with
preparing this study. Research conducted a students, researchers and professionals of different
comprehensive literature search, which included background and disciplines, e.g. Pharmacists,
technical newsletters, newspapers journals, and marketers, finance companies and regulatory
many other sources. Medicine and technical experts authorities have to acquire much from this article.
were interviewed. Projections were based on
estimates such as the history, current market Social Implication: Medicine manufacturers are an
scenario, drug users, dealers, mergers and integral part of Bangladesh health sector. General
acquisitions, new developments and market trends. people pay much interest but having little knowledge
about them. The article should provide them a
Findings: Bangladesh pharma market has broader picture and unleash many unseen facts.
tremendous hope, although going through lots of
anomalies. Reasons behind are economic INTRODUCTION
development, population blast, investment scopes, In Bangladesh, the pharmaceutical sector is now one
FDIs along with many other unexplained matters. of the fastest growing sectors. The history of
Pharmaceuticals industry dates back to 1950s. Over
Research limitations: Market is too big to be the years, the industry has gone through some
explained in a single article. The term “A -Z” doesn’t significant changes. In the early post-independence
reveal all information about Bangladesh pharma period of Bangladesh, multinational companies
market is accomplished, rather 26 letters used in 26 (MNCs) dominated the pharmaceutical sector.
headlines, that means 26 points of this market is According to Bangladesh Tariff Commission, 2010
discussed that surely comprised a greater part of it. eight leading MNCs enjoyed 75% of the total
domestic market. In 1982, a defined guideline for the
Practical Implication: The soul of this article was to development of the industry was created through
introduce students about Bangladesh pharma
How to cite this article: Mohiuddin AK; An A-Z of Pharma Industry Review: Bangladesh Perspective; PharmaTutor; 2018; 6(12);
Vol. 6, Issue 12 | pharmatutorjournal.com
64-78; http://dx.doi.org/10.29161/PT.v6.i12.2018.64
PharmaTutor ISSN: 2347-7881 | Vol 6, Issue 12 65

the formulation of national drug policy (NDP), and licensing, registration, etc. of all kinds of medicine
drug control ordinance. Under the NDP, only local including those of Ayurvedic, Unani, and Herbal and
companies were allowed to produce vitamins, Homoeopathic systems.
enzymes, and cough syrups. This led to the
formation of local pharmaceuticals companies and The Pharmacy Council of Bangladesh (PCB): PCB was
an increase in domestic production. And Bangladesh, established under the Pharmacy Ordinance in 1976
which was once a drug-importing country, became a to control pharmacy practice in Bangladesh.
drug-exporting country by the late 80s. In 2004, it
was estimated that the total size of the The Bangladesh Pharmaceutical Society (BPS) is
pharmaceutical market in Bangladesh was Tk. 28.416 affiliated with international organizations
million. With an annual growth rate of around 10%, International Pharmaceutical Federation and
the Bengali pharmaceutical industry is now moving Commonwealth Pharmaceutical Association. The
towards self-sufficiency to meet local demand. The National Drug Policy (2005) states that the WHO’s
Bangladeshi pharmaceutical industry is the second current Good Manufacturing Practices (GMP) should
largest contributor to the national treasure after be strictly followed and that manufacturing units will
garments, and is the largest sector of intensive be regularly inspected by the DDA. Other key
employment of white-collar workers in the country. features of regulation are restrictions on imported
IMS (2015) report shows that the market size has drugs; a ban on the production in Bangladesh of
reached $ 1.6 billion. This industry serves almost 98% around 1,700 drugs which are considered non-
of demand through local production. The domestic essential or harmful; and strict price controls,
market of pharmaceutical products has shown a affecting some 117 principal medicines.
tremendous growth over the last few years and the
industry recorded 17.6% average growth between Government Incentive
the years 2011-2015. Pharmaceutical industry has This sector has been considered as a thrust sector in
been ranked second in terms of gross value addition the export policy since 2006. Customs duty on 40
for many years after Readymade Garments (RMGs) basic raw materials used in medicine manufacturing
and the sector has the potential to top the list. The were reduced to 5% from 10%-25% rate. Customs
imported medicines mainly include anticancer drugs, duty on 14 items used in anti-cancer medicines have
vaccines against viral diseases, hormones, etc. been withdrawn. (Budget 2014-15). Government has
Indeed, the true growth of local pharmaceutical been facilitating this industry through reducing
industries began after the promulgation of the "Drug customs duty on raw materials. The government
Control Act" in 1982 in Bangladesh to limit the recently gave 200 acres of land for the API Park in
massive import of drugs and encourage local drug Munshiganj. It is also planning to give 10% cash
production. Many multinational companies (MNCs) incentives to boost the pharmaceutical sector.
were dissatisfied with this development. Category of
the generic product prices are competitive, Products of The Pharmaceutical Industry
Bangladesh mainly concentrated this type of product The Directorate General of Drug Administration
about 80% drug because as labor cost is one of the under the Ministry of Health & Family Welfare, Govt.
lowest in the world. Bangladesh’s pharmaceutical of Bangladesh, is the Drug Regulatory Authority of
sector has been growing steadily over the last twenty the country. This Directorate supervises and
years. implements all prevailing Drug Regulations in the
country and regulates all activities related to import
Regulatory regime and procurement of raw and packing materials,
The Directorate General of Drug Administration production and import of finished drugs, export,
(DGDA): DGDA is the drug regulatory authority of sale, pricing, etc. of all kinds of medicine including
Bangladesh, which is under the Ministry of Health those of Ayurvedic, Unani, Homoeopathic and Herbal
and Family Welfare. DGDA regulates all activities systems (Web DGDA).
related to import and export of raw materials,
packaging materials, production, sale, pricing,

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UNANI: At present, there are 295 Unani companies raw material in producing the final drug
operating in Bangladesh. formulations. Historically, Bangladesh has been
AYURVEDIC: At present, there are 201 Ayurvedic dependent on imports for APIs and other
companies operating in Bangladesh. ingredients. The pharmaceutical manufacturers in
HERBAL: At present, there are 15 Herbal companies Bangladesh procure raw materials from various
operating in Bangladesh. countries namely UK, France, Germany, Japan,
HOMEOPATHIC: At present, there are 79 Holland, Italy, Denmark, China, Switzerland, Austria,
Homeopathic companies operating in Bangladesh. Hungary, India, Ireland etc.
ALLOPATHIC: At present, there are 258 Allopathic III. The final layer concerns producing final products,
companies operating in Bangladesh. finished formulations. In this layer, there are both
patented and generic products. However, in
INDUSTRY SCENARIO Bangladesh, only generic products are produced.
A. Local Market Overview: The Bangladesh Formulations represent the mainstream business in
pharmaceutical marketplace is predominantly a pharmaceuticals industry of Bangladesh. Presently,
branded generic marketplace. Pharmaceutical firms the market consists of approximately 8000 generic
in Bangladesh can either sell to the private sector products and 258 firms with manufacturing
pharmacies, to the government and its public health capability, along with some imported patented
care facilities, or to international organizations products. (The Daily Star March 07, 2016)
operating in Bangladesh (e.g. UNICEF). The top two
domestic manufacturers, namely Square and Incepta D. Business nature:
Pharma are having a combined market share of near 1. High-End products (Anti-Cancer, Insulin, Vaccines
30% of the total pharmaceutical market of the etc.)
country. Bangladesh Association of Pharmaceutical These are essentially products specific to market
Industries (BAPI) was instituted in 1972, since then niches, i.e. Anti-cancer, Diabatic products, Vaccines
BAPI playing a pivotal role in shaping up the industry etc. these products are usually high priced and
(Janet et.al 2007). represent a small portion of the market. Profit
margin in such products is very high. Recently,
B. Industry Structure: The industry has some distinct domestic firms have been entering into this field,
features compared to other countries. First, R&D and competition is expected to drive prices and
activity is virtually nil in Bangladesh pharmaceutical import dependency down.
industry – it is a branded generic market. Companies 2. Branded generics (Anti-Gastric, Anti-Biotic etc.)
basically manufacture finished formulation by This represents broadest segment of the market,
assembling known generic and patented (in some comprising products with relatively stable margin
cases) product combination. Some firms have been and Brand orientation. This segment is dominated by
engaged in producing APIs, the core of local manufacturers, and due to high brand loyalty
pharmaceutical products, but these productions are observed in our market, market share of
limited to synthesis stage (final stage) only. manufacturers is usually moving rarely.
3. Low End generics
C. Segmentation: This segment is small, often for products with low
I. The primary layer is R&D Activities. This is often a branding possibility, and price war is most evident
very costly and high-risk business, and for many of here. The number of competitors is very high, and
global Pharmaceutical firms, represent the majority market share of each competitor depends on success
of costs. However, in Bangladesh, this activity is nil, of marketing strategy (Ramesh S, Economitimes
and all the firms are producers of known and India).
established drugs. 4. Contract manufacturing (domestic and export)
II. The second layer is manufacture of ingredients for Locally, this segment is small as almost every firm
finished formulations. These activities cover manufactures its own products. The business usually
production of Active Pharmaceuticals Ingredients comes from Health organizations like SMC (Social
(API), Excipients, and Solvents etc. that are used as

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Marketing Company), UNICEF etc. to provide SmithKline, Novartis are leading. In export market,
products such as saline, contraceptives etc. the Novartis is playing the dominant role.

Presently, a number of top firms engage in contract H. Dumping: Some Indian medicines are sold in the
manufacturing. Competition is very low, as each firm country market at a lower price than Bangladeshi
engages based on foreign counterpart relations. medicines but the medicine of developed countries
Manufacturing technologies and accreditations play and their origin country are sold in a competitive
a vital role in developing contract manufacturing price, even in higher price. This creates the barrier to
capability. capture the market share by Bangladeshi
pharmaceutical industries. Owners of the
E. Export: Export of pharmaceutical products of pharmaceutical companies think that the
Bangladesh is still in infancy. But the rate of government should take actions to stop this practice
establishment of pharmaceuticals industries in (Ahsan et.al 2011).
private sector is increasing and they have already
entered the export market with their finished I. Problems of Marketing:
products. In 2000, Bangladesh imported • Because of having no sufficient incentives in
US$84,000,000 worth of medicinal and comparison with their effort, the turnover rate of
pharmaceutical products and had negligible exports medical representatives is very high.
and some recent statements by industry • Most of the time costs of marketing hardly affect
representatives suggest that exports will increase in the price of the medicine.
the near future. Bangladesh is exporting their • Professionalism in marketing is not achieved yet in
pharmaceuticals products to Vietnam, Singapore, Bangladesh like other developing countries.
Myanmar, Bhutan, Nepal, Sri Lanka, Pakistan, • Lack of proper governmental laws and this
Yemen, Oman, Thailand, and some countries of implementation the law by the drug administration.
Central Asia and Africa. It also has a large market in • Unstable political situation and different types of
European countries. violence.
• Effect of globalization that has increased the
F. Import: Bangladesh is importing the medicinal competition.
products from different countries, especially from • Smuggled production counterfeit, that’s coming
India and China. Different organizations of this from the neighbor countries.
country are related to import the pharmaceuticals
products and raw materials of pharmaceutical J. Five important JOB SCOPES in Pharmaceutical
industries. Novo and Medintis are importing industries
maximum amount of these types of products. Other 1. Pharmaceutical industries (Finished medicines,
organizations are engaging to import the Active Pharmaceutical Ingredients/APIs, and
pharmaceuticals products. They are- Sanofi, Aventis, Excipients Manufacturing industries): In Production,
GSK (now closing operation), Sandoz, Novartis, Quality Control (QC), Quality Assurance (QA),
Roche, Unimed, Servier etc. Product Development (PD), cGMP Training,
Warehouse, Drug Research and Invention, and
G. Foreign Competitions: At the beginning the Technical Services Department (TSD).
foreign pharmaceuticals were dominating the 2. Pharmaceutical Marketing: Product Management
market in our country. Still now, Pharmaceuticals Department (PMD), Medical Services Department
industries are facing foreign competition. But our (MSD), Sales Promotion/Medical Promotion, Clinical
industry is not afraid of this foreign competition. Services, Training for field forces, and International
There are many multinational pharmaceutical Marketing (IM) departments.
organizations which have established their plants in 3. Drug Testing Laboratories (Dhaka and Chittagong)
Bangladesh and importing their raw materials from 4. Research & Development in Pharma industries,
abroad. Among these competitors, Roche, Glaxo educational and research institutes (Research for

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new drug molecules, Novel Drug Delivery Systems, APIs. Industry participants claim already becoming
Improved Healthcare, Clinical aspects, etc.) self-sufficient in some APIs, namely, Penicillin,
5. Hospital Pharmacy Cephalexin, NSAID and Anti-Pyretic. The production
of APIs is confined to the last stage of Synthesis.
K. Key points of National Drug Policy of 1982 Presently, Local APIs take a 20% share in domestic
• To provide administrative and legislative support production. The rest 80% is imported. These
for ensuring quality of essential drugs which are imported APIs represent majority of raw materials
relevant to the national health need. import by Bangladesh, approximately 70%. But the
• To reduce the price of medicine by ensuring the overall production is very low compared to total
lowest competitive price. demand. While the industry is achieving self-
• To eliminate non-essential medicine from the sufficiency, it yet procures 90% of raw materials from
market. 98 indenters around the world as only one company
• To promote production of local drug and raw (Active Fine Chemicals) produces raw materials
materials. independently. There are 3000 valid sources of raw
• To develop proper drug monitoring and materials including countries like China, India, Korea
information system to prevent wasteful misuse and & Italy. API consists a significant percent of total cost
to ensure the in medicine which can run up to 30-40%. At present,
proper utilization of the drugs. only a few companies – Square, Beximco,
• To ensure GMP and qualified pharmacist in Ganasastha Pharmaceuticals, Globe and Active Fine –
manufacturing companies. are manufacturing raw materials for drugs like
paracetamol, amoxicillin, flucloxacillin, ampicillin and
L. Some major characteristics of BD drug marketing metformin, on a limited scale. Ganashastha
sector: Pharmaceuticals Limited (GPL) alone accounts for
• Their distributional channel includes invoice about 60% of the raw materials manufactured in
system, own distribution channel. Bangladesh. Bangladesh is trying to establish an
• Medical representatives are the key persons in industrial park for pharmaceutical production. One
marketing. such park in Munshiganj near Dhaka is nearing
• For promotion, the groups such as doctors, completion and it might result in a big jump in the
surgeons are targeted. income from pharmaceutical exports. A National
• Major promotional strategies include printed Control Laboratory Project is taken by the govt. for
promotional materials, physical sample, and clinical facilitating the pharmaceutical sector. The proposed
materials. API technology Park in Munshiganj, which was
• Special incentives are given to the doctors. For scheduled to be completed by July 2012, is delayed
example, the doctors are given honeymoon with the cost of the project now increasing by 55%.
packages, the cost of which is borne by the This delay has been a major hurdle for the
pharmaceuticals. pharmaceutical industry to gain better control over
• The field level executives are playing the the inputs and improve operational efficiencies.
imperative role for marketing division. Basically, they India, the major generic drug player, has more than
have taken the responsibility to market the products 3500 Drug Master File (DMF) approval for APIs
of their companies. So, the success of a whereas we have none (Pratik 2015).
pharmaceutical industry intensively depends on the
efficiency and effectiveness of the medical N. Access to essential drugs: Although official
representatives. If an organization wants efficient documents indicate that 80 per cent of the
employees in this section, he should to satisfy these population has access to affordable essential drugs,
representatives. (Ahsan et.al 2011) there is plenty of evidence of a scarcity of essential
drugs in government healthcare facilities. One study
M. API Business: In Bangladesh, companies have conducted in four district hospitals and one medical
only recently entered API business. At present, there college hospital showed that only eight per cent of
are 21 companies in Bangladesh manufacturing 41 patients received the prescribed medicines from

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these facilities. In another report, two major Administration (DDA); for all other drugs the DDA
hospitals in the capital city of Dhaka were operating endorses the companies’ quoted prices. Drug prices
without essential medicines for eight consecutive are quite high in Bangladesh in comparison to
weeks. There are countless such incidents relating to neighboring countries. The drugs control authority is
the supply of essential medicines in Bangladesh. In apparently reluctant to negotiate with the
most such cases, government officials and health companies to fix prices. The regulatory authorities
professionals are responsible for the shortage as have virtually no control over drug prices in
they often sell government-supplied drugs to local Bangladesh. Indiscriminate pricing can be observed
drug stores instead of dispensing them to poor in all therapeutic classes of drugs. For example,
patients. The government must be cognizant of this prices of various ciprofloxacin brands range from
fact, but rarely takes any action. Taka (Tk) 5 to 14 (US$ 0.07 to 0.20) per unit. The
price of dexamethasone eyedrops extends from Tk
O. Quality of available drugs: Of the 300 24 to 90 (US$ 0.34 to1.29) per 5ml, and diclofenac
pharmaceutical companies in Bangladesh, only the eye drops are available at a price range from Tk 40 to
20 to 25 top ones produce drugs of standard quality. 200 (US$ 0.57 to 2.86) per unit. These are a few of
Reports show that numerous small companies’ the existing price discrepancies in the country. Easy
market substandard drugs in the country. Fake or excessive profits made pharma companies reckless
substandard medicines, including lifesaving ones, and making misleading statements implicating of
with an estimated worth of US$ 150 million per year, Dollar Taka conversion rate as a reason for increase
are flooding the domestic market. In its annual price. As a counter misinformation, continuously
testing in 2004, the government laboratory detected propagating that pharma exports will soon overtake
300 counterfeit or very poor-quality drugs out of garment export. Present pharma export is not even 1
5,000 drug samples. A recent assay involving 15 percent of total national export.
brands of ciprofloxacin showed that 47 per cent of
samples contained less than the specified amounts Q. Patterns of drug use: To ensure rational and
of the active ingredient. Another report noted that appropriate use of drugs in Bangladesh was another
69 per cent of paracetamol tablets and 80 per cent prime concern of the NDP. But there has been no
of ampicillin capsules produced by small companies drug use study in the country. Clinically
were of substandard quality. Good manufacturing inappropriate and inefficient use of medicines is a
practice (GMP) is a major criterion to maintain serious problem. More than half the medicines in
standard quality in drugs, and it was one of the Bangladesh are inappropriately prescribed,
principal objectives of the NDP to ensure standard dispensed or sold. Despite legal prohibitions,
manufacturing practices for drug manufacturers. But numerous drugs with similar or no significant
there are some 265 pharmaceutical companies in benefits are available in the market. As a specific
Bangladesh that do not follow or comply with GMP. example, there are seven members of the
It is widely alleged that adulteration flourishes in the angiotensin-converting enzyme (ACE) inhibitors
country because of poor government vigilance and available in the country. The efficacies and chemical
supervision over drug manufacturers and sellers. structures of these molecules are more or less
Unfortunately, a section of corrupt physicians and similar, but their price vary significantly. The drug
government officials is involved in these underhand policy clearly prohibits the production of multi-
dealings. The government states that it has limited ingredient preparations of vitamins and minerals
manpower and facilities to cope with the country’s with the exception of B-complex vitamins. But a
fast expanding pharmaceuticals sector. In fact, the mixture of 32 vitamins and minerals including
regulatory authorizes have given scant attention to selenium, vanadium, molybdenum, tin and many
quality matters in Bangladesh. other unnecessary ingredients has been marketed in
the country for a few years, violating the principles
P. Lack of control over drug prices: In Bangladesh of the NDP. The need for these trace elements in
the maximum retail price (MRP) of every essential Bangladesh is not established whereas nutritional
drug is fixed by the Directorate of Drug deficiencies are mainly related to vitamins A and B-

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complex, iron, calcium, iodine and zinc. Irrational pharmacies visited had one person with a year’s
prescription and use of antibiotics are rampant training and several untrained coworkers, all of
throughout the country, with an estimated half of all whom were working as pharmacists. Rural
antibiotics being sold without prescriptions. Self- pharmacies may have pharmacists with high school
medication is widespread, and all types of medicines education and approximately two weeks training.
can be purchased without a prescription. There are The Bangladesh Pharmacist Society is currently
about 30,000 illegal and 80,000 unlicensed drug implementing the first phase of a three-phased
stores operating in the country. It is alleged that program to improve skills of pharmacists. The
both legal and illegal drug dealers are engaged in program should be completed in seven to eight
selling fake, smuggled and adulterated medicines in years. Most pharmacies are individual shops, though
the country (Mohammad 2008). some chains are starting to develop, especially in
urban areas. Large pharmacies visited reported
R. Domestic drug distribution: Bangladesh’s drug buying medicines according to sales trends, e.g.,
distribution marketplace is composed of small what sells the most. The medium and small
independent pharmacies. This structure combined pharmacies visited reported linkages with a medical
with an under-regulated industry, few firms doctor. Their sales were therefore usually skewed
manufacturing pharmaceuticals, and companies towards that medical professional’s preferences.
competing to sell branded generics based on brand Several brands of each drug, with variable quality
names provides ample opportunity for the sale of levels, are on the market. In urban areas, the visited
low-quality drugs at higher prices. And this partly pharmacies tended to sell higher quality brands,
explains why the quality of drugs available for sale whereas in more rural areas, pharmacies visited
varies significantly in Bangladesh. Pharmaceutical tended to sell lower quality, lower cost brands. This
firms can sell their products to private sector may be due to a district’s political sway influencing
pharmacies, the government and its public health brand selection. The pharmacies visited tended to
care facilities, or to international organizations have brands associated with people who held power
operating in Bangladesh (e.g., UNICEF). Government in that district. Those more distant from the city
sales are not as profitable as private sector sales center also had increasingly more ayurvedic and
because the government pays less, on consignment, herbal medicines. The top 20 pharmaceutical
and at times, after considerable delay. manufacturing firms have established extensive sales
Pharmaceutical firms nevertheless still target pubic and distribution networks. Each pharmacy visited has
facilities because doctors become acquainted with 10-50 pharmaceutical firms supplying their
the firms’ drugs and then prescribe them in their medicines daily. For example, Beximco
private practices. And, because drugs are not readily Pharmaceuticals has 1,200 representatives visiting
available at public facilities, patients receiving pharmacies daily to take drug orders. Each pharmacy
treatment there may still go to a private pharmacy to receives approximately 12- 15 Beximco shipments
procure the required drugs. Without these public per month. Acme Pharmaceuticals has 1,100
sector connections, many firms would turn more representatives and Square Pharmaceuticals has 950
attention to the private sector. Although there are representatives visiting pharmacies. None of the
approximately 200,000 private pharmacies in pharmacies visited restock any medicine that does
Bangladesh, the government lists officially only not sell well. The small pharmacies report only
76,000 pharmacies. The rest are illegal, without a keeping a medicine for a maximum of six months. A
license or a licensed pharmacist on staff. Pharmacists significant number of drug consumers obtain drugs
have varying education levels and many lacks without a prescription. When consumers lacks a
adequate training. For example, a visit to four prescription, they will usually either ask a pharmacist
pharmacies in Dhaka and ten pharmacies in the for a specific drug or describe their ailment to a
bordering Gazipur, Narayanganj, Keranigonj and pharmacist who diagnoses the problem and
Manikgonj Districts revealed that each had one recommends a drug on the spot. Popular products
professional pharmacist, who had four years of include a variety of antibiotics, painkillers, and
coursework; while the two medium-sized gastric remedies. Consumers purchase one to ten

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tablets or capsules at a time. The quantity of drugs causes acute renal failure and death when ingested.
purchased often depends more on the consumer’s Its toxicity became apparent in the 1930s when it
finances of than on the required dose of medicine was used to prepare a sulphanilamide elixir in the
(Janet et.al 2008). United States. The deaths of at least 76 people from
ingestion of this sulphanilamide elixir prompted the
S. Most pharma companies tempt doctors with promulgation of the United States Food, Drugs, and
'gifts': With a view to popularizing their brands, most Cosmetics Act in 1938, which regulates the
of the pharmaceutical companies in the country evaluation and use of new drugs or foods. Diethylene
allegedly practice unethical drug promotion alluring glycol is occasionally identified in medical
doctors with free samples and gifts to prescribe their preparations or foods, though rarely in lethal
medicines. To stop such unethical promotion of concentrations. Drug toxicity due to formulation
drugs, there was no effective implementation of the alteration is very much common. There are a lot of
Drugs (Control) Ordinance, 1982 that regulates examples of this type of malpractices. It gets
manufacture, import, distribution and sale of drugs importance because of some recent incidence. In
in Bangladesh. The Drug Administration, which 2009, 26 children died due to formulation alteration
regulates manufacture, import and quality control of in case of paracetamol syrup, where propylene glycol
drugs in the country, is also inactive to put a stop to was replaced by diethylene glycol as a solvent.
such unethical practices. Pharmaceutical companies Health officials in the country said that so far 26
practice drug promotion to boost sales and earn children aged between 11 months and three years
more profit, although it is clearly unethical. have died after taking paracetamol (acetaminophen)
Bangladeshi pharmaceutical companies produce syrup contaminated with diethylene glycol that was
standard medicines but all companies cannot manufactured by local drug producer Rid
produce quality products. According to the industry Pharmaceutical Co (Arrest warrants issued after DEG
sources, the pharmaceutical companies allocate kills 26 infants in Bangladesh). The trade name of the
huge sums in their annual budget for gifts to be drug was Temset (paracetamol suspension). In
distributed among the medical practitioners. A addition, three hundred thirty-nine (339) deaths
number of representatives of pharmaceutical attributed to paracetamol syrup contaminated with
companies, both local and multinational, said they diethylene glycol in 1990-1992. This incidence shows
often bribe doctors to promote their particular that, the formulation alteration by harmful chemical
drugs. Pharmaceutical companies offer attractive can pose a serious threat to health care system.
gifts to the doctor on various occasions from pens to b) Substandard vitamin A tragedy in Bangladesh:
cash money - as part of their promotional activities. Vitamin A deficiency may be a major threat to the
Sometimes they even undertake decoration of the health and survival of children and mothers. Effects
doctors and also offer sarees for doctors. This gift of vitamin A deficiency extend much beyond
(bribe) culture is reportedly higher in urban areas. blindness alone. Vitamin A deficiency increases the
Bangladesh Legal Aid and Services Trust (BLAST) risk of child deaths from diseases such as measles
stressed full implementation of the Drug Act as well and diarrhea. These infections contribute to over
as effective inspection and monitoring on one-third of deaths among children aged 0-5 years in
manufacturing, marketing and use of drugs. BLAST Bangladesh (UNICEF- Bangladesh media center, 6
also suggested the government to recruit more June 2009). For this reason, the Government of
manpower in the Drug Administration to make it People’s Republic of Bangladesh conducts National
more effective as well as effective monitoring and vitamin A plus campaign every year. In 2013 due to
checking 'Code of Marketing' to prevent unethical ingestion of substandard vitamin A capsule many
practice to save the lives of people (The Daily Star children became sick, and online reports talked
February 12, 2011). about some patients experiencing vomiting
sensation and feeling unwell. Children were reported
T. Necessity of Pharmacovigilance: sick at Chittagong, Cox’s Bazaar and Lakhimpur
a) Diethylene glycol tragedy in Bangladesh: among other places. Rumors of death were also
Diethylene glycol is a highly toxic organic solvent that reported with one report claiming a child had died

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from administration of Vitamin A capsule which were in the market. The system also becomes beneficial to
supplied by Indian source, Olive healthcare (Nusrat those firms that do not have enough manufacturing
et.al 2017). capacity but register increased demand for drugs
c) Doctors are writing more prescriptions for (Sohel 2015).
Nitazoxanide instead of Metronidazole for
amoebiasis and diarrheas; Azithromycin for diarrhea, V. Emerging business of herbal medicines: Herbal
typhoid and PID. Other misused drugs are caffeine medicines are increasingly popular in local and global
with paracetamol, Diclofenacs, Statins, Irrational markets. More than 20 firms seek licenses to come
vitamin preparations with all sorts of mineral which into the sector. Herbal medicines are set to witness
cannot be detected in Government Drug Laboratory; an investment boost as over 20 companies have
Benzodiazepines, sex hormones, steroids, lined up for licenses from the drug administration to
Terbinafine, Butenafine, Crotamiton etc. Promoting manufacture such medicines to exploit business
Directly to Consumers through daily newspaper with potentials in the sector, still almost untapped,
separate advertising sheet on Dukoral (a Swedish industry people said. “A new avenue for herbal
company, Crucell product) for prevention of diarrhea medicine has opened up as many investors are
and cholera tactfully using name of WHO and looking for venturing in making such medicines,” a
ICDDR,B. Aggressive and unethical promotion senior official of Directorate of Drug Administration
increases irrational prescriptions leading to told The Daily Star (Sohel 2009). Officials said the
multiplication of profit of the companies. Counterfeit drug regulator has received nearly two dozen of
version of costly drugs surfacing in progressive order. applications seeking approval to make herbal
More spurious and substandard drugs freely moving medicine. Of the applicants, four got licenses and
into the market (Development dialogue 1995:1). around 20 companies are awaiting approval. The
latest approval was given to Radiant Nutraceuticals
U. Contract manufacturing brings new hope for Ltd, which is set to join the fray with three existing
pharma companies: Pharmaceutical companies are operators -- Square, ACME and Modern -- with
increasingly engaging in toll or contract Square Herbal and Nutraceuticals being the pioneer
manufacturing, a development that allows them to in the segment. Industry insiders said allopathic
utilize unused capacities and reduce the need for pharma market in Bangladesh is worth around Tk
fresh investment. Toll manufacturing, ushered in by 4,000 crore, while the market size for herbal
the government in the National Drug Policy 2005, is medicines including Ayurvedic and Unani stands at
an arrangement in which a company with specialized more than Tk 1,000 crore. Industry people observed
equipment processes raw materials or semi-finished that scopes to exploit the untapped herbal medicine
goods for another company. Around 30 drug makers now lure investors to the segment with majority of
including Renata, Beximco and Popular are currently applications coming from new investors along with
engaged in toll manufacturing for their local allopathic drug makers. Stakeholders said some of
counterparts or even multinational companies, a the well-known allopathic drug makers are gearing
sum which was less than 10 a couple of years ago. up for establishing herbal medicine units. The sector
Currently, some foreign companies make a certain started pulling attention after the government had
portion of their drugs for the domestic market endorsed herbal medicine in the drug policy along
through contract manufacturing, which lowers their with two other traditional branches of medicine --
operating costs. Contract manufacturing is mainly Ayurvedic and Unani. Later the sector received a
used for specialized or high-tech products, the further boost as the government termed herbs and
facilities for which require considerable capital herbal medicine as one of the five priority sectors to
investment. An industry official said that it is diversify the country's export basket. Industry people
unfeasible for a firm to develop facilities to make a observed that Bangladesh has prospect in making
single product. Insiders said the scope for toll footsteps on the global market for medicinal plant
manufacturing has enabled firms, especially the and products as nearly 650 medicinal plant species
newly-established ones, to better utilize their have been identified to be in use in Bangladesh with
capacities as they are yet to create a strong presence around 25 plants having high value. Sector people

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said herbal medicine differs from Ayurvedic and impact of 82’ ordinance was dramatic. Total number
Unani medicines due to its unique manufacturing of registered products both locally produced and
process, although all the three branches of medicine imported from 122 foreign companies of 22
depend mainly on medicinal plants. The herbal countries were 4340 of which 1742 were found to be
medicine market, which has been expanding harmful, inappropriately formulated or
gradually since 1980, will exceed Tk 2,500 crore by therapeutically ineffective. Out of 1742 harmful and
2020, herbalists predicted. The sales volume of /or ineffective drugs, 176 were imported and 949
herbal medicines jumped to Tk 1,000 crore in 2010 were manufactured by 156 local manufacturers.
against Tk 1 crore in 1980. The nation's 210 Capitalist countries had exported more ineffective,
Ayurvedic establishments produce 272 types of useless or harmful drugs than that of socialist
medicines (Unb Dhaka 2012). countries. West German and Swiss Companies
ranked very high in mischiefs. However, these
W. MNCs facing a lot of problems: In decisions kept MNCs on fire. The National Drug
pharmaceutical sector, multinational corporations Policy (NDP) in 1982 and 2005 has major impact in
are more concerned about research and the development and growth of the Bangladesh
development than locally owned companies. The pharmaceutical industry. The need for NDP was very
implication is that MNCs will need to find ways to evident. Almost all the multinational companies
increase their R&D productivity, and it also means were producing simple and non-essential drugs in
that Indian and Chinese firms with relatively novel Bangladesh like vitamins mixture or cough syrups.
approaches to product and process development They used to import their raw materials from abroad
may find opportunities opening up for them, at high prices. There was a need for vast quantity of
whether through go-it-alone strategies or through essential, useful and economic drugs in Bangladesh.
co-operative R&D partnerships with MNCs. Right It was essential and important for Bangladesh to
after liberation war three fourth of the introduce a drug policy for the betterment of
pharmaceutical industries was dominated by national health by availing international standard
multinational companies. In view of the caliber of medicine in lower cost to Bangladeshi people.
machinery and technical know-how which lies in Precisely, multinational companies were prevented
their hands for producing important and innovative to reduce their unessential drugs production and
drugs for the country, the task of producing antacids discouraged to import raw material at high process.
and vitamins will lie solely with the national Under the Drug (Control) Ordinance 1982, the
companies, leaving the multinationals free to Government determines Maximum Retail Prices
concentrate their efforts and resources on those (MRP) of 117 essential drug chemical substances.
items not so easily produced by smaller national This price determination is only for the local
companies. Multinationals will, however, be allowed producer companies and still now the multinational
to produce injectable vitamins as single-ingredient organizations are determining their price by their
products (Development dialogue 1995:1 Making own way. Many LDC countries have implemented full
National Drug Policies a Development Priority). No TRIPS patent protection or expanded TRIPS-plus
multinational company without their own factory in patent protection in advance of the 2016 deadline.
Bangladesh will be allowed to market their products Activists say this is due to pressure from
after manufacturing them in another factory in multinational pharmaceutical companies or
Bangladesh on a toll basis. Multinational companies developed country governments while MNCs say
(MNCs) are allowed to manufacture all registered that IP laws are individual to each country and may
drugs except antacid and vitamins provided they reflect other trade and policy priorities. The role of
have their own factories in Bangladesh. However, multinationals in providing medicine for this country
MNCs will be allowed to produce injectable vitamins is acknowledged with appreciation. As NDP 1982
because of higher technology. No foreign brands will implemented, most multinational companies sold
be allowed to be manufactured in Bangladesh under their business to local pharmaceutical. This fueled to
third party license. Imports will not be allowed if the evolution of the local pharmaceutical sectors.
similar products are manufactured locally. The According to the Directorate General of Drug

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Administration (DGDA) website, the value of the market and a negative sales growth every year,
locally produced drug was 175 crores in 1981 that earlier faced by GSK Bangladesh as well.
increased to 325 crores by 1985. Many multinational
companies (multinationals) were dissatisfied with X. High Court bans 34 pharmaceutical companies
this development. GSK Bangladesh has convened a from producing medicines: The order by Justices
meeting next month as it seeks shareholders' nod to came after hearing of a rule issued earlier on a
close its unprofitable pharmaceuticals business in petition filed by the Human Rights and Peace for
the country. Meanwhile, nearly 200 employees of Bangladesh (HRPB) to stop production and marketing
the local operations of the British multinational of substandard medicines. The order asked the
pharmaceuticals company have been staging a sit-in Bangladesh drug regulatory authority to regularly
on the factory premises in Chittagong for the last 50 monitor whether these companies continued to
days to protest the closure decision. The produce and market medicines and file a report to
demonstration began after the GSK Bangladesh the High Court after every four months. HRPB
board on July 26 proposed to shut down the plant, counsel informed that the government has already
saying it was making losses. A senior official said its cancelled the license of 7-8 of these 34 companies
product portfolio lacks medicines that sell the most (bdnews24). The High Court has constituted a five-
in the local market. GSK Bangladesh also blamed the member committee to examine fresh application by
gap in the product portfolio for the losses (Ahsan those companies who have not had their license
2018). Earlier, Beximco completes Nuvista (formerly cancelled, if they agreed to abide by existing drug
Organon) acquisition in a first for Bangladesh regulatory parameters. The committee consists of a
pharmaceutical industry (Bdnews24 representative each from World Health Organization,
03.04.2018). Nuvista, formerly Organon Bangladesh Drug Regulatory Authority, Dhaka
(Bangladesh) Ltd, was a subsidiary of the University's Pharmacy department and the Health
Netherlands-based Organon International. It was Ministry. Twenty companies banned from producing
sold out to the current Bangladeshi management in all medicines namely Exim Pharmaceuticals, Avert
2006. Phizer Bangladesh started its operations in Pharma Ltd, Bikalpa Pharmaceuticals Ltd, Dolphin
1972 as Pfizer (Bangladesh) Ltd. In 1993, Pfizer Pharmaceuticals Ltd, Drugland Ltd, Globe
transferred the ownership of its Bangladesh Laboratories Pvt Ltd, Jolpa Laboratories Ltd, Kafma
operations to local shareholders and the name was Pharmaceuticals Ltd, Medico Pharmaceuticals Ltd,
changed to Renata Ltd (Renata LTD. Website). Sales National Drug Pharma Ltd, North Bengal
of SK + F were worth Tk 1 crore in 1990 when it Pharmaceuticals Ltd, Rimo Chemicals Ltd, Rid
started its journey, a successor of Smith, Kline & Pharmaceuticals Ltd, Skylab Pharmaceuticals Ltd,
French in Bangladesh, was acquired by Transcom in Spark Pharmaceuticals Ltd, Star Pharmaceuticals Ltd,
1990. The company was renamed Eskayef Shunipun Pharmaceuticals Ltd, Today
Pharmaceuticals Limited (The Daily Star. 2015-12- Pharmaceuticals Ltd, Tropical Pharmaceuticals Ltd
29). In 1973, the UK based multinational and Universal Pharmaceuticals Ltd. Fourteen
pharmaceutical company, ICI plc, established a companies banned from producing antibiotics Ad-
subsidiary in Dhaka, known as ICI Bangladesh dwin Pharmaceutical Ltd, Alkad Laboratories Ltd,
Manufacturers Limited. In 1992, ICI plc divested its Belsen Pharmaceuticals Ltd, Bengal Drugs and
share to local management, and the company was Chemicals (Pharma) Ltd, Bristol Pharma Ltd, Crystal
renamed Advanced Chemical Industries (ACI) Limited Pharmaceuticals Ltd, Indo-Bangla Pharmaceuticals
(ACI website). As part of the World Cancer Day, Ltd, Millat Pharmaceuticals Ltd, MST Pharma and
Apollo Hospitals Dhaka organized a rally jointly with Healthcare Ltd, Orbit Pharmaceuticals Ltd, Pharmic
Roche Bangladesh Limited and Sanofi Bangladesh Laboratories ltd, Phoenix Chemical Laboratory Ltd,
Limited inside the Bashundhara residential area to Rasa Pharmaceuticals Ltd and Save Pharmaceuticals
increase awareness against the disease in the Ltd (The Daily Star February 14, 2017, The Daily Sun
community (The Daily Star February 11, 2018). Both 13th February, 2017).
of these MNCs are facing potential competition in

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Y. The PCB has revoked the registration The number of pharmacy graduate increasing day by
examination system: The PCB has revoked the day. After that student finishing bachelor degree got
registration examination system for the evaluation of job after the bachelor course. Now a days, number
graduate pharmacists for the issuance of of pharmacy students became so high that even they
Registration for Pharmacy practice. By dint of are not getting job after their master degree.
revoking examination, Pharmacy graduates from any Besides, job sector for the pharmacist also increased
public or private university would be awarded but not sufficient. They are working in Product
professional registration without any qualifying Development, Quality Assurance, Quality Control,
examination. To a new Pharmacy graduate this Production, Marketing, Sales, Training, Regulatory
option may be seemed to be happy news because Affairs, Commercial department etc. Few years ago,
they don’t need to sit for any examination and they many pharmaceutical companies assigned chemist to
can get the certification for Pharmacy practice perform laboratory work but now pharmacist start to
without any qualifying test. But practically this replace chemist from pharmaceutical industry.
option may lead Pharmacy profession to challenge in Pharmacists are also working in veterinary industries.
the long run. The number of graduate Pharmacists Today new job area for Bangladeshi pharmacist is
coming out from private universities is 6 times Hospital Pharmacist and Clinical Pharmacist. Their
greater than that of public universities. Recently, working place is the hospital and deals with the
many intellectuals raised questions about the patients and help the doctors to prescribe medicine.
educational status and quality of some of the private Thus, error in prescribing wrong medicine and miss-
universities although most of the private universities dose also reduced. New opportunity in another
are doing pretty well. Whatever the private or public sector is cosmetic industry. Bangladesh is a land of
universities, the examination systems is maintained medicinal plants. Thus, herbal medicinal industry
in all the developed countries like USA, UK, Canada, also developing day by day. Some giant groups
Australia, Japan, etc. on order to obtain the focusing their concentration in herbal industry. So,
registration for pharmacy practice. So, what is the the demands of pharmacist in herbal industry are
problem in our case? If the pre-qualifying increasing day by day. Though food is one of the
examination is maintained, this will surely ensure the important parts of our daily life, one of the main
quality of Pharmacists suited for the practice of causes of disease development is food habit. But
Pharmacy profession in Bangladesh. The examination pharmacist is not part of this industry. Pharmacist
system would enhance the ability of any graduate should develop their career in food industry. The
Pharmacist whether from private or public pharmaceutical sector of Bangladesh has developed
universities. At least they may learn/study many in the manufacturing of finished pharmaceutical
aspects of Pharmacy profession if they have to products; the API and Excipients based industries
prepare for qualifying examination, that will help have not yet remarkably advanced in this country.
them to practice their profession. Therefore, at least So, Bangladeshi Pharmacists have job scope limited
a minimum evaluation test (that would ensure the to pharmaceutical finished products manufacturing
basic and minimum knowledge of Pharmacy) must industries. At present, industrial jobs also are
be conducted by the Pharmacy Council of saturated or will saturate soon. Therefore, getting
Bangladesh before issuing professional registration entrance of new Pharmacists to Pharmaceutical
for the practice of Pharmacy in Bangladesh. Industries become quite tough or have narrow scope
Obtaining registration after passing pre –qualifying for new Pharmacists and also the problems to be
evaluation will carry the dignity of graduate faced for new pharmacist if having poor training, lack
Pharmacists in their profession; otherwise of in-depth knowledge of fundamental concepts and
registration will not have any evaluation in practical practical skills (Zubair 2013). No person shall
job markets (Mokles academia.edu). manufacture any drug except under the personal
supervision of a pharmacist registered in Register 'A'
Z. Job crisis in the Pharmaceutical industries for the of the Pharmacy Council of Bangladesh: Provided
pharmacists: Few years ago, students of pharmacy that this provision shall not apply to the manufacture
got job during final year of their bachelor degree. of any drug under the ayurvedic, unani, or

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homeopathic or biochemic system of medicine. Also, pharmaceutical scientists. Due to lack of this, our
this act 13 (1) (Employment of Pharmacist) of the drug control authority cannot monitor the quality of
DRUGS (CONTROL) ORDINANCE, 1982 (ORDINANCE drugs manufactured by different pharmaceutical
NO. VIII OF 1982) was abandoned earlier by companies in Bangladesh. Moreover, foreign buyers
government to create job opportunities for non- and regulatory authorities raise question about the
pharmacists. status of our drug testing laboratory, the central
quality monitoring facilities of drug authority of
FUTURE CHALLENGES Bangladesh.
Lack of API Support: API/Raw Material Production
Plant: The major advancement of Bangladesh Regulated Markets: To register pharmaceutical
pharmaceutical sector has been occurred only in the products in regulated markets it requires highly
production of finished products. Manufacturing of standardized documents. There are regulations
pharmaceutical products are vastly dependent on directed by the regulatory authorities of United
imported raw materials, as almost 90% of raw States of America, European Union, Australia and
materials are now being imported. This dependency Japan along with other highly regulated and semi
on imported raw materials is resulting in increased regulated countries. To meet all their requirements
production cost of the finished products. Ultimately sophisticated and accredited manufacturing plant,
the competition to offer export prize is becoming standardized manufacturing process, proper quality
tougher, which is one of the major challenges of control and above all highly skilled professionals are
pharmaceutical sector of Bangladesh. Setting up of a required. It is tough to meet all the requirements by
standardized Active Pharmaceutical Ingredient (API) small pharmaceutical companies of Bangladesh.
plant is very essential. Local production of raw
materials will greatly contribute to pharmaceutical RECOMMENDATIONS
export to extend export volume, and also can The proposed suggestions may help the
potentially contribute to the country’s economy. pharmaceutical industries to reduce the problems in
different areas. These are as follows:
Bioequivalence Test Facility: Bioequivalence study of  The medical representative’s turnover is not
a product is a must for the registration of that adequate and equitable. So, the
product in many of the moderately regulated and organizations can take measures to increase
regulated countries of the world. There is no the salary for the medical representatives.
standard facility for bioequivalence study in  Advertising cost should be reduced and this
Bangladesh. In order to register a product, a is necessary to make the marketing people
pharmaceutical company has to carry out this test in aware of their profession.
foreign country by spending of a huge charge. For  The local pharmaceutical companies should
this reason, many pharmaceutical manufacturers produce quality product by using the
don’t show interest to register their products in updated equipment and raw materials,
foreign countries that require Bioequivalence study. which can help them to acquire the market
It is relevant here to mention that BAPI and share.
pharmaceutical exporters first felt the necessity of  Pharmaceutical companies should produce
having Bioequivalence test facility in our country and world class medicine which may increase the
they proposed and demanded to set up a modern demand for Bangladeshi drug in the world
Bioequivalence test center to the govt. for the market.
promotion of pharmaceutical export.  Industry should make the people aware of
the local products and with that they should
Modern Drug Testing Laboratory: A major limitation ensure the quality medicine to earn
of drug control authority of Bangladesh that also confidence.
affects pharmaceutical export is unavailability of a  The pharmaceutical companies should not
modern, well equipped drug testing laboratory (DTL) violate the law imposed by the government,
with the engagement of sufficient and skilled

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which can hamper the trust of the people of by BAPI. This organization also upheld the
the country. demand and urged to the government and
 Organizations should produce their product other concerning authorities for API Park,
in a hygienic environment and maintain the Bioequivalence test laboratory, Central drug
highest standard. testing laboratory, cash incentives, problems
 Government should take measures or in remit transfer and sample sending etc. But
formulate some clear–cut rules to restrict many issues are yet to resolve.
the foreign pharmaceutical organizations to  In the context of Bangladesh, E-commerce is
practice the concept of dumping in this a new concept. Again, trust and security
country. Backward integration into API is issues can come in the way of its
also very important to reduce import cost. implementation in the pharmaceutical
 Providing cash incentive by the govt. to the sector. That is because both electronic
medicine exporters, like RMG may money transaction and sensitive items like
encourage pharmaceutical exporters. medical equipment and medicines are likely
 International fair arrangement by Export to provoke doubts in the minds of
Promotion Bureau (EPB) is a very effective customers. In this situation, the actually
way to search buyers and to establish renowned pharmaceutical companies can
business in a new country. A lot of initiative have an option of ordering online in the
have been taken by BAPI (Bangladesh already existing websites on a trial basis at
Association of Pharmaceutical Industries) in first stage (Journal of Business Studies, Vol.
different times, such as, high level XXXIV, No. 3, December 2013
pharmaceuticals delegation team visited recommendation).
foreign countries to explore export initiated

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https://defence.pk/pdf/threads/developments-in-bangladesh.184826/page-31
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