VIEW POINT

NATIONAL DRUG POLICY OF BANGLADESH: SOME

PITFALLS IN IMPLEMENTATION
Fazle Rabbi Chowdhury, H.A.M.Nazmul Ahasan and M.Mizanur Rahman*

A BSTRACT
Drug development, manufacturing and marketing have become one of the most important sectors throughout the world for various
reasons. Realizing its importance, the World Health Organization (WHO) has stressed the need of a formulated drug policy in
every country of the world.1 Bangladesh responded very early to this. Experiences over the decades have shown that the said
policy could not fulfill in toto the declared objectives. Our aim is to describe some of the lacunae for which total implementation
of drug policy is still struggling. For this purpose, we meticulously analysed our Drugs Control Ordinance1982 (with an
amendment brought in1994) and upcoming National Drug Policy. We mainly focussed on three factors pointed out by WHO,
which are crucial of a drug policy, which include price limitation, quality and rational use.
We found great variations in price which need to be controlled. Regarding quality, safety and efficacy, we have to be more
cautious. Rational use of drugs is also an area to be focussed on. Every physician should prescribe proper drug with due indication
and in rational way. This pitfall of implementation might happen in many countries of the world and it needs a global discussion
so that the future policy makers can mitigate the demand of the nation.
KEY WORDS:

Drugs. Drug policy. lmplementation. Bangladesh.

INTRODUCTION
Medicinal drugs have a crucial role in disease treatment and
prevention. As such medicines development, manufacture
and marketing have become one of the most important area
throughout the world for various reason. The tremendous
increase in pharmaceutical sector results in development and
marketing of agents of spurious or of only little value thus
creating the so-called therapeutic jungle- from where drugs
relevant to the health needs of the people need to be sorted
out. This concept was developed and elaborated by World
Health Organization (WHO) experts during mid seventies
and came to be known as Essential drug concept.1 Besides,
WHO pointed out the need of a formulated policy
development incorporating the concept of Essential drug
for every nation of the world. Bangladesh was one of the only
14 countries throughout the world to respond properly and to
develop a National Drug Policy in 1982.2
This well formulated policy produces some tremendous effect
on rapid development of the local pharmaceutical industries
as well as makes an overall improvement in the drug sector of
Bangladesh. Some examples are given below:(a) The number of pharmaceutical companies has increased
from 177 in 1982 to 300 in 2004.3
(b) The essential medicine also become available with the
increase in the volume of local production. The monetary

Department of Medicine, Khulna Medical College Hospital, Khulna, Bangladesh.

*Department of Surgery, Khulna
Medical College Hospital, Khulna. Bangladesh.
Correspondence: Dr. Fazle Rabbi Chowdhury, Flat No 4/D, Ruby Tower 49, Dilu
Road, New Eskaton, Dhaka, Bangladesh. E-mail: shakilrabbi@yahoo.com
Received September 13, 2005; accepted: April 16, 2006.

368

value of which grew from taka 1,730 million in 1981 to

about taka 41,000 million in 2002.3
(c) In most of the cases drug prices stabilized, including
(practically a drop in price in real term) by only 20%
compared to an increase of 179% in the consumer price
index.3
(d) Less dependency on imports and prioritization of useful
drugs saved the country approximately U.S. $600 million.3
In spite of these improvement the said policy could not fulfill
in toto the declared objective of providing essential drugs to
all those who need them, about which the future policy
makers should be cautious. In this paper some of those
lacunae are discussed and we think this will help all the health
personnel of the world who are in close touch with all aspects
of health related policy-making and its implementation.

THE

OBJECTIVES OF A NATIONAL DRUG

POLICY
World Health Organization (WHO) points out three objectives
as crucial of a national drug policy.1 These are:
1. Access: equitable availability and affordability of
essential medicine including traditional medicines.1
2. Quality: the quality, safety and efficacy of all medicines.1
3. Rational use: implies promotion of therapeutically sound
and cost-effective use of medicine by health professionals
and consumers.1
This paper discusses these objectives from Bangladesh
perspective.
(A) P RICE LIMITATION : In our 1982 drug policy, 150 drugs were
selected as essentials. 2 According to existing drug
policy, maximum retail price (M.R.P) of every essential
drug will be fixed by the Directorate, Drug
Administration, an Administrative Authority under the
JCPSP 2006, Vol. 16 (5): 368-370

National drug policy of Bangladesh

Ministry of Health and Family Welfare, Government of

Peoples Republic of Bangladesh.2 At present in
Bangladesh there are one hundred and seventeen (117)
essential medicines, the prices of which are fixed by the
drug administration.2 In case of others, company price is
endorsed by the administration.
However, the real situation does not reflect the principle of
price fixation. One or two example is enough to prove this.
Ciprofloxacin is a life saving antibiotic and vastly used for
many diseases. Even at present, cost of Ciprofloxacin extends
from Tks 5 to 14, a price variation of 180%.4 It is very difficult
to explain this variation in price. Whether the cheaper one is
made at low cost sacrificing the quality and its reverse is also
true. Policy makers throughout the world should be cautious
and need to address the problem and formulate effective line
of action to control all these illogical price variation.
The drug administration should check this abnormality
regarding price and quality. The government should take
immediate action about it and every body in the country
should know its fate. This sort of things might happen in any
county of the world.
(B) Q UALITY, SAFETY AND EFFICACY: Still there is no adequate
drug testing facility in Bangladesh. Presently, drug
administration has a laboratory but it is quite inadequate
for the total demand. We know that as a developing
country, we have many limitations. The government
should try to take immediate initiative to establish at least
6 well equipped drug testing laboratories in the divisional
cities as well as to enact a legislation that every company
have to cross this testing hurdle before marketing a drug,
and have to pay for it.
Another important thing is, in relation to the formation of
Technical Committee that addresses technical aspects (quality,
safety and usefulness) of a drug approval for marketing
registration. Most of the members of this committee are not
specifically related to this sector. On the other hand, every
practitioner should be cautious in prescribing a new drug. The
example of cox-2 inhibitor is enough to prove it. Since 1999
celecoxib, rofecoxib, valdecoxib etc. are being widely used all
over the world including Bangladesh in a wide range of
various arthritis and pain syndromes.5 But within 4 years (in
September, 2004) rofecoxib was withdrawn from the market.6
Before withdrawal, the combined yearly sales of cox-2
inhibitor exceeded $5 billion.6 Three randomized, placebocontrolled trials provided new evidence about the
cardiovascular risks of rofecoxib, celecoxib and valdecoxib.7
From this example, the integrity of the American Drug Safety
System has been questioned. How did such problem arise and
how can they be prevented in the future?8 Steven Galson,
acting director of the center for Drug Evaluation and Research,
United States, said: our current drug approval system has
demonstrated that we dont always understand the full
magnitude of drug risks prior to approval of drug products.8
According to a September 2001 report by USA Today, 55% of
all FDA advisory panelists had financial interests in the drugs
they reviewed. A transcript of the most recent arthritis
advisory panel meeting in June 2004 showed that seven of the
14 panelists, including the panels chairperson received
waivers for financial conflict of interest.9 If this is the picture
of United States Federal Drug Administration (FDA) about

JCPSP 2006, Vol. 16 (5): 368-370

safety and efficacy specially while prescribing new drugs,

then what may be the situation in developing countries e.g.
Bangladesh? Every policy maker should think about that and
build effective mechanism to mitigate the problem.
Conversely every practitioner should be cautious in
prescribing newer drugs regarding their safety and efficacy.
(C) USEFULNESS AND RATIONAL USE: The physicians are the
ultimate judges in this regard. According to our 1982 drug
policy, there is a clear indication that no company can market
a drug of similar benefits as of the existing one with minor
chemical difference. 2 but many companies are not abide by the
act. So the whole society is exposed to unnecessary drug with
potential risk. For an example, in case of cardiovascular
disease, use of angiotensin converting enzyme inhibitor is
very popular. At present, in Bangladesh, there are captopril,
cilazapril, enalapril, fosinopril, lisinopril, perindopril, and
ramipril in use.4 Of course, the efficacy of captopril and the
related progeny is more or less same, but the price varies from
3 taka (approx. 2 Pak. rupees) per tablet to 18 taka (approx.12
Pak. rupees) per tablet is another example of the same class of
agents.4,10 This corresponds to a variation of 500%! So every
physician should use cost-effective drug. But many physicians
are using others instead of captopril, possibly because of
personal illegal interest and unethical, aggressive promotional
activity of the pharmaceutical companies. Recently, different
companies in our market launched a mixture of vitamins and
mineral. But is there any justification of marketing this sort of
drug in a country like Bangladesh? Ask yourself? What are
the deficiency diseases we commonly found in Bangladesh in
our common practice? Most are due to Vitamin A or Bcomplex, iron, calcium, iodine, or zinc deficiency. B-Complex
or multivitamin preparation and/or specific mineral
replacement is enough to treat these cases. There are very
seldom diagnoses of selenium or vanadium deficiency or
molybdenum deficiency, if ever. How many amount of tin are
required for a healthy life? So, there is no point in prescribing
these type of agents to our poor people. Because a single tablet
costs about 6-7 taka (approx. 4-5 Pak. rupees), whereas
common multivitamin takes only 1-1.5 taka (less than 1 Pak.
rupees)/tablet. This type of vitamin-mineral mixture is still
absent in the market of Britain, Australia, New Zealand and
other European countries. British pharmacopoeia clearly
indicates that there is no justification for prescribing multiple
ingredient vitamin preparation.11 Even according to our 1982
drug policy, this is completely unlawful because a mixture of
vitamin and mineral has no proven scientific basis.
Another important issue in the last 4-5 years is the launching
of many new agents by pharmaceutical companies in the
world market including anti-hypertensive, hair tonic, antiimpotency, cholesterol lowering agents, anti-depressant, sleep
regulating, anti-psychotic and anti-obesity agents etc.12 But
there are very few new agents for the medical problems most
common in developing countries like infectious diseases
(examples being malaria, kala-azar, tuberculosis) or the
poisoning antidotes like anti-snake-venom, dimercaprol (for
heavy metal poisoning), naloxane (for narcotic poisoning) etc.
So there should be a clear guidelines regarding this in every
drug policy.

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Fazle Rabbi Chowdhury, H.A.M.Nazmul Ahasan and M.Mizanur Rahman

CONCLUSION

5.

Ahasan HAM. Caution with Cox-2 inhibitors (editorial). BMJ Khulna

2004; 37.2: 27-60.

Last of all, the aim of every physician should be to prescribe

proper medicine with due indication and in a rational way. It
is only possible when there is an effective drug and health
policy. So policy makers of every countries of the world,
particularly developing countries like Bangladesh, Pakistan,
India, Sri-Lanka etc. should pay attention to all these problems
and come forward to make an effective drug policy that
reflects greater interest of the community.

6.

Drazen JM. Cox-2 inhibitors: a lesson in unexpected problems

(editorial). N Engl J Med 2005; 352: 1131-2.

7.

Psaty BM, Furberg CD. Cox-2 inhibitors - lessons in drug safety

(editorial). N Engl J Med 2005; 352: 1133-5.

8.

Tanne JH. FDA will increase postmarketing surveillance of drugs, BMJ

2004; 329: 1203.

9.

Lenzer J. FDA bars own expert from evaluating risks of painkillers. BMJ
2004; 329: 1203.

REFERENCES

10. Edwin KJ. Renin and angiotensin. In: Hardman JG, et al. (edi.)
Goodman & Gilmans the pharmacological basis of therapeutics. 10th
ed. Mc Graw-hill 2001: 809-42.

1.

W.H.O. Policy perspective on medicines - How to develop and

implement a national drug policy 2003;Geneva: 1-6. Available
from:URL : http://www.who.int/medicines.

2.

Ministry of Health and Family Welfare: Drug (control) ordinance, 1982,

enacted by Government of Peoples Republic of Bangladesh: 1-10.

3.

Ministry of Health and Family Welfare: National Drug Policy, 2004 (a

preliminary paper), compiled by the Directorate of Drug Administration,
Government of Peoples Republic of Bangladesh: 2-13.

4.

Islam AFMS, Khan AA, Jahangir MS. Drug Bangladesh. Drug

Information Center 2003.

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11. British National Formulary (BNF). 41st ed.; 2001: 428-33. Available
from: URL: http//www. editor@bnf.rpsgb.org.uk.
12. Sterckx S. The lack of access to essential drugs: the nature and
magnitude of the problem. Drug and Health 2003; 5: 1-8. Available
from: URL: http// www.drugandhealth-bd.org

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