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Ahammed Jubaer Chowdhury, ID LLB 06209609
Ahammed Jubaer Chowdhury, ID LLB 06209609
Ahammed Jubaer Chowdhury, ID LLB 06209609
LEGAL PERSPECTIVE
By
Ahammed Jubaer Chowdhury
ID: LLB 06209609
A Thesis Submitted in Partial Fulfillment of the Requirements for the Degree of LL.B.
(Honours)
Supervised by
Afrin Jessin Jenny
Assistant Professor
December 2020
DEPARTMENT OF LAW
By
Ahammed Jubaer Chowdhury
ID: LLB 06209609
A Thesis Submitted in Partial Fulfillment of the Requirements for the Degree of LL.B.
(Honours)
Supervised by
Afrin Jessin Jenny
Assistant Professor
December 2020
LETTER OF TRANSMITTAL
To
Dear Madam,
It is a great pleasure to submit my thesis on ‘Antibiotic Abuse in Bangladesh: A
Research on Legal Perspective’ I have giver best efforts to finish the thesis with
relevant information that I have collected from various sources. I have collected
from various sources. I have concentrated my efforts to achieve to objectives of the
work and hope that my endeavor will serve the purpose. I shall be grateful and
obliged if you kindly accept may thesis and evaluate it.
Sincerely yours,
-------------------------------------
-------------------------------
I Ahammed Jubaer Chowdhury, the student of Law, batch-62 A, bearing ID: LL.B
06209609 ‘Antibiotic Abuse in Bangladesh: A Research on Legal
Perspective’ from Stamford University Bangladesh would like to declare here, the
declaration on the dissertation report on ‘Antibiotic Abuse in Bangladesh: A
Research on Legal Perspective’, which I have not submitted for any other degree
before. The work I have presented dose not breach any copyright.
I further undertake to indemnify the university against any loss or damage
arising from breach of the foregoing obligations.
-------------------------------------
At first, I present my due rewards to all mighty, who have provided me with the
valuable opportunity to build and compete this report successfully with
Sincere and sound mind.
I would like to express my gratitude to my supervisor A Afrin
Jessin Jenny, Department of Law for her guidance during the dissertation program.
Her suggestions and comments were really a great source of spirit to make the
report a good one.
Finally, I would like to thanks my parents from the bottom of my heart for
their endless support and encouragement.
ABSTRACT
Chapter 1
INTRODUCTION 1
Chapter 2
CONCEPT OF ANTIBIOTIC ABUSE
2.1 What is Antibiotic 3
2.2 Antibiotic Abuse 3
2.3 What is Antibiotic Resistance: 3
2.4 Reasons for Developing Antibiotic Resistance: 4
2.5 The Cnsequences of Antibiotic Overuse in Dhaka 4
2.6 Concluding Remark 4
Chapter 3
CURRENT CONDITIONS OF ANTIBIOTIC ABUSE IN BANGLADESH
AND EXISTING LAWS ABOUT ANTIBIOTIC USE
3.1 Current Conditions of Antibiotic Abuse in Banglaesh 6
3.2 Bangladesh Drug Policy, Regulations, Ordinacne and Strategies 7
3.3 Drug Act in Bangladesh: 9
3.4 Import of Drug Act 9
3.5 Export of Drugs Act 9
3.6 Manufacture, Sale and Distribution of Drugs 10
3.7 National Medicine Policy, 2016 11
3.8 Policy and Legislation 11
3.9 Helath Rights Protection 12
8
3.10 Concluding Remark 12
Chapter 4
LEGAL FRAMEWORK RELANTING TO ANTIBIOTIC RESISTANCE
IN VARIOUS COUNTRIES
4.1 Legal Framework and Laws That Enact by India 13
4.2 Legal Framework Made by EU 14
Chapter 5
NECESSARY STEPS CAN BE TAKEN 17
Chapter 6
CONCLUSION
6.1 Recommendations 20
6.2 Conclusion 21
REFERENCES 22
9
Chapter 1
INTRODUCTION
1
[https://www.slideshare.net/chewmeyellow/antibiotic-abuse-and-misuse?qid=12ccc72d-
6a6f- 4fe5-8923-a3d2278132d2&v=&b=&from_search=2, last visited on 25.08.2020].
1
diarrhoea are becoming resistant to most of the medicines available in the market.
The government has failed to take timely action against the deadly
resistance. However, as later is better than never, few initiatives have been taken
in recent times. But the steps need scaling up. Besides, irrational use of
antibiotics in humans, little awareness among people and drug sellers, a
weak surveillance process, and dearth of information about the health
situation of the country are also contributing to the spread of antimicrobial
resistance (AMR) in Bangladesh. People always have a misconception that once
they start taking antibiotics, they are cured, hence, most often do not take
doses regularly. Irrational use of antibiotics in animal feeds, especially in
poultry farms, have scaled up the fear of AMR spreading in the country.
This research s important because antibiotic resistance in very dangerous and
in future it will become the question of our existence. The few steps taken
by government are use in judging reality. It will show us about our
situation and depth of the matter.
The research consists of five main Chapter : first one is Introduction, where
initial discussions have taken place, second one is Concept of Antibiotic
Abuse where the idea of antibiotic abuse, antibiotic resistance and reasons for
developing antibiotic resistance has been given, third one is Current Condition of
Antibiotic Abuse in Bangladesh and existing laws about antibiotic use where
I will try to present the reality of Bangladesh about using antibiotic and try to find
out saying of law about control their situation, fourth one is Legal Framework
Relanting To Antibiotic Resistance In Various Countries where we will try to find out
which steps they have taken to deal with this matter, fifth one is Necessary
Steps can be Taken, where I tried to highlights that what kind of steps can
be taken by the outhority. In the final part Recommendation and Conclusion are
done.
Chapter 2
CONCEPT OF ANTIBIOTIC ABUSE
2
[https://www.slideshare.net/chewmeyellow/antibiotic-abuse-and-misuse?qid=12ccc72d-
6a6f- 4fe5-8923-a3d2278132d2&v=&b=&from_search=2, last visited on 25.08.2020].
germs are not killed and continue to grow. We can also say that antibiotic
resistance means loss effectiveness of antibiotics or antimicrobial agent.
3
Dr. Asfaque, “Antimicrobial Resistance & Infection Control”, Journal of Antimicrobial
Resistance & Infection Control.Vol. No. 6 (2015), p.5
4
2.6 Concluding Remark
That is the reasons why antibiotic resistance develops, such as over prescription of
antibiotics, inappropriate prescribing, over-use of antibiotics in livestock and fish
farming using of antibiotics. But these are happening due to human negligence. It
is very important to have strict and effective laws to control these, so that these
issues do not happen in any way. Those involved in these issues should ensure the
proper use of antibiotics to protect the interests of ordinary people. But it is seen
that it is not possible due to these negligence Due to which, on the one hand, our
human rights are being violated and on the other hand, public health is
being threatened. Which is why I think there needs to be strict and effective
legislation.
Chapter 3
CURRENT CONDITIONS OF ANTIBIOTIC ABUSE IN BANGLADESH
AND EXISTING LAWS ABOUT ANTIBIOTIC USE
4
MA. Faiz Rahman ‘MR. Rational antimicrobial Use’, Journal of Chittagong Medical College
Teacher Association, Vol.15 No.1-2, ( 2004), pp.1-3.
5
J. Roy ‘Health Status, Treatment and Drug Use in Rural Bangladesh: A Case Study of
a
Village’ Australian Journal of Rural Health, Vol.5 No.2, (1997), p.70 – 75.
6
SM Ahmed Hossain, ‘Knowledge and Practice of Unqualified and Semi-Qualified
Allopathic Providers in Rural Bangladesh: Implications for the HRH Problem.’ Aritcle
of Health Policy, Vol. No. 84, (2007), pp.332–343.
common among the rural medical practitioners with antibiotics and vitamins
prescribed widely7
Unchecked use of antibiotics in poultry, fish and veterinary feeds are
common in Bangladesh and their unplanned use in treating diseases contribute to
the increase in antibiotic resistance. Antimicrobial resistance threatens
the effective prevention and treatment of an ever increasing range of infections
caused by bacteria, parasites, viruses and fungi.8
Another recent icddr,b study has found rising antibiotic resistance to bacterial
pathogens which cause bloodstream infectionsa condition when bacterial infection
elsewhere in the body enters the bloodstream. Dr Dilruba Ahmed, head of clinical
microbiology and immunology at icddr,b, has studied over 100,000 blood samples
from a period of over ten years and tested them for the presence of pathogens and
the incidence of antibiotic resistance in these pathogens. A high percentage
of these bloodstream pathogens have acquired multidrug resistance.9
7
FR. Chowdhury Rahman, ‘Rationality of Drug Uses: Its Bangladeshi Perspectives’ Journal
of Mymensingh Medical, Vol. 15 No. 2 (2006), p.15
8
[https://www.amr-insights.eu/antibiotic-resistance-crisis-deepens-in-bangladesh/lastvisited
on 11.11.2020].
9
Dr. Asfaque, “Antimicrobial Resistance & Infection Control”, Journal of Antimicrobial
Resistance & Infection Control.Vol. No. 6 (2015), p.5
country. Quality drugs locally produced are now being exported to 113 countries
across the globe, including developed countries. Already, a number of drug
manufacturing companies have been awarded with Good Manufacturing Practice
(GMP) certificates by drug regulatory agencies of developed countries. Due
to attaining required technology, Bangladesh pharmaceutical sector is capable
of producing almost all conventional and high technology based dosage forms.
The pharmaceutical sector is enriched with not only higher technological resources
but also experienced and skilled pharmacists as well as other affiliated
competent manpower. Since 2009, sufficient medicines of required
quality are being supplied in line with expansion of health care
center/facilities.10
The first National Drug Policy was formulated by the Government of
Bangladesh in 1982which was hailed and immensely praised by WHO and other
international organizations. The first National Drug Policy led to ensure the drug
safety, quality and control of drug prices. Reducing Import dependency country
started to become more self-reliance in drugs, foreign dominance on the
drug sector was lessened and local pharmaceutical industries began establishing
large and modern technology based drug manufacturing facilities.
Bangladesh pharmaceutical sector attained a glorious image in the
international arena, transition of Bangladesh from a drug importing country
to a drug exporting country.
Drugs are regard as specialized consumer products and the patients is
considered as an exceptional customer who need professionals advice during any
ailment from the physicians to procure drugs from a the pharmacy, indicating type
its doses route of administration and duration in a particular diseases
condition and to know the side effects of drugs against the potential
benefits. Medical professionals, pharmacists dispensers nurses and other health
staff should have the capacity to make information decisions about all aspects of
drug use for patients in their respective responsibilities. Therefore they need
special training and access
to necessary medical therapeutic information. The production,
distribution,
10
M. Rahman, ‘High Risk Behavior among drug Abusers in Bangladesh,’ 8th ed., (Dhaka
Eastern Publication, 2015), pp. 23-27.
storage and dispensing of drugs also require special knowledge
understanding skill and expertise.11
11
Ibid.
Provided that nothing in this section shall apply to the export, subject to the
prescribed conditions, of small quantities of any drug for the purpose
ofexamination, test or analysis or for personal use.
The Central Government may, alter consultation with the Boardand after previous
publication by notification in the official Gazette, make rulesfor the purpose
of giving effect to the provisions of this Chapter
12
[www.banglapedia.org/httpdocs/HT/D_0286.HTM,last visited on 14 November 2020].
13
The Daily Star, ( 14 August 2013), p.6
Chapter 4
LEGAL FRAMEWORK RELATING TO ANTIBIOTIC
RESISTANCE OF VARIOUS COUNTRIES
14
[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6563746/, last visited on 01/12/2020]
15
[https://www.cdc.gov/drugresistance/solutions-initiative/stories/ar-global-threat.html,last
visited on 01/12/2020]
In India, they have a national action plan for antimicrobial resistance. Where it
included, Improve awareness and understanding of AMR through effective
communication, education, and training, Strenghen knowledge and evidence
through surveillance, reduce the incident of infection through effective infection,
prevention and control, optimize the use of antimicrobial agents in all
sectors, promote investment for AMR activities , research and innovation.16
India has few regulations on antibiotic use in food animals. Most existing
laws are concerned with exports and aquaculture. Recommendations have
been made by various bodies to regulate the non-therapeutic use of
antibiotics in animals, including by the National Centre for Disease Control, the
Central Drugs Standard Control Organization and the Directorate General of
Health Services, Ministry of Health & Family WelfareThough, none of these
recommendations have been formalized as regulations or laws.However, they
have taken some effective legal framework
Last year, Union health ministry of India banned the manufacture, sale and
distribution of the antibiotic colisioin and its formation for food producing
animals, poultry, aqua farming animal feed suppliment 17. and they are trying
to take more legal framework like this. There is a laws that regulate antibiotics in
food animals within India. In January 2012, G.S.R. 28(E) required that medicine
for treatment of animals state a withdrawal period 1 in the labeling (Ministry
of Health and Family Welfare, Department of Health 2012). For medicines with no
defined withdrawal period, withdrawal periods in meat/poultry and
marine products should be 28 days and 500 degree-days, respectively.
In 2006, the EU banned all antibiotic growth promoters. Since the ban of
avilamycin, erythromycin, vancomycin, and virginiamycin as antibiotic
growth
16
[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6618210/,last visited on 02/12/2020]
17
[https://www.theweek.in/theweek/cover/2020/01/03/need-more-laws-to-deal-with-
antimicrobial-resistance.html, last visited on 01/12/2020]
14
promoters in Denmark, antibiotic resistance levels in humans have
decreased, suggesting that the agriculture ban has had the desired
effect. For example, following the ban on virginiamycin as a growth promoter in
1998, virginiamycin resistance decreased by one-third by 2000. In Great Britain
the percent of S. typhimurium isolates from calves resistant to tetracycline
dropped from 60 percent to 8 percent in the seven years after banning tetracycline
for growth promotion.
Based on the council regulation established in 1990, (EEC) No. 2377/90, the
commission regulation (EU) 37/2010 outlines maximum levels of antibiotics
in foodstuffs of animal origin. This commission regulation also includesa list
of several antimicrobials that are banned from use in food products because
safe levels have not
been determined. They are chloramphenicol, dapsone, dimetridazole,
metronidazole, nitrofurans (includingfurazolidone), and ronidazole.
In November 2011, the EU put forward a five-year plan to fight against
antimicrobial resistance. The plan included 12 recommendations to
restrict veterinary use of antibiotics, both new antibiotics and antibiotics
that are considered critically important to humans. Other recommendations
focused on the
‘promotion of appropriate use of antimicrobials’ and the strengthening
of
‘regulatory frameworks on veterinary medicines’. In addition, the commission
suggested a new animal health law pertaining to good farming practices to avoid
infections and the reduction of antimicrobials in aquaculture, to be
implemented shortly18.
The World Health Organization Regional Office for Europe also released
a
strategic action plan on antibiotic resistance in 201119.Strategic objectives include
18
[https://www.researchgate.net/publication/45185021_The_European_ban_on_antibiotic_gro
wth_promoters_in_animal_feed_From_challenges_to_opportunities,lastvisitedon
01/12/2020]
19
World Health Organization Regional Office for Europe 2011
the prevention and control of the development and spread of antibiotic resistance in
the veterinary and agricultural sectors20
20
Ibid.
21
FDA 2012
22
[https://www.hpnonline.com/infection-prevention/antibiotic-stewardship/
article/21158128/national-action-plan-for-combating-antibioticresistant-bacteria-updated-for-
2020-through
2025#:~:text=The%20National%20Action%20Plan%20for,the%20course%20of%20antibioti
c%20resistance%2C,last visited on 02/12/2020]
these prohibitions and preventive laws, it is also important for Bangladesh to have
punitive laws for violators of prohibitions and preventive laws
Chapter 5
NECESSARY STEPS CAN BE TAKEN
23
Ibid.
That the antibiotics are being prescribed, sold or used in poultry, fish and
veterinary feeds as their own will,There is no authority in our country to supervise
these.So a strong supervisory authority is needed to properly supervise these
matters.This authority may also be given magistrate powers in law.
Also in order to ensure the proper use of these antibiotics, any kind of use,
sales rules are not yet in the form of law in our country.The issue is so important
that it is time to enact a Separatelaw on antibiotics use, sale and on
prescribe.Because of the way this antibiotic is being used in Bangladesh, the
severity of resistance will reach a critical level in the future.And one day
the situation will get out of control.And if that happens, it is beyond
our comprehension what the impact will be in a populous country like ours.So now
it is the time to consider the real situation, and enact a new law
about antibiotic.Although it should have been done much earlier.The existing drug
law does not elaborate on antibiotics that we found in previous chapter 3.
And I left out the words of the people. They may be using these as they
wish without knowing its consequence. But the doctors who have prescribe
antibiotic as his own wish, they must know about the consequence of over use of
antibiotics.Even then they don’t keep it in mind when writing prescriptions.They
prescribe antibiotics on prescription when even its don’t need to prescribe. So these
doctors have to be brought under a law.What rules they will follow when
prescribing antibiotics, how much to prescribe, under what circumstances the
patient may be given antibiotics, etc.They may even be punished for violating this
rules. It could be revocation of medical license or imprisonment or fine
And the pharmacy owner, they are all known that selling these antibiotics
without prescription is unethical.Even then they sell them without a prescription
for their own profit.Although there are still guidelines in this regard, only a few
large pharmacies follow these instructions.And there is no legal obligation to this
instruction. So they are not paying attention to the instructions .So They also have
to be brought under a obligatory law that what rule they have to follow regarding
sale of these antibiotic and conversely, they could face penalties, including
revocation of their drug licenses.
Then those who raise poultry, fish, cows commercially, also know
how bad the use of these antibiotics is for the human body.Even after that
they are using it for their own benefit.Traders in these sectors can also be brought
under a binding lawand conversely, they also could face penalties .including
revocation of their trade licenses.
In the future, this antibiotic resistance will be a threat to our very
existence. So realizing the importance of this, a separate antibiotic law should be
enacted now.Where the production, use, purchase, sale and other relatable matter
of antibiotics will be detailed.Therefore, in addition to enacting these prohibitions
and preventive laws, it is also important for Bangladesh to have punitive laws for
violators of this law.
Chapter 6
CONCLUSION
6.1 Recommendations
The recommendations of this Study are-
i. Government can formedaNational Action Plan For Microbial Resistant,
Which will be included these like Improve awareness and understanding of
AMR through effective communication, education and training among
the people
ii. To assure rational use of antibiotics, a strong supervisory authority is needed
to be formed.This authority may also be given magistrate powers in law.
iii. To assure rational use of antibiotics ,a separate law about antibiotic should be
enacted, where the production, use, purchase, sale and other relatable matter
of antibiotics will be detailed.
iv. At the same time, necessary amendments have to be brought in the
penal code to punish the violators of this law.
v. Doctors have to be brought under a law that what rule they have to follow
while they prescribe antibiotics, how much dose to prescribe and under what
circumstance the patient may be given antibiotics etc.They may even be
punished for violating the rules.It could be revocation of their medical license
or imprisonment or fine
vi. All kind of pharmacies in Bangladesh have to be brought under a obligatory
law that what rules they have to follow regarding sale antibiotics and
violators of these rules can be punished like, revocation of drug license and
imprisonment or fine.
vii. The use of antibiotics in poultry, fisheries and dairy industries should
be stopped by law. The existing situation cannot be controlled with
instructions alone.
viii. To assure rational use of antibiotics all hospitals (governmentand
private) level of the country must have their own ‘Antibiotic user guidelines’
which must be regularly updated and followed during delivery of health
care services.
ix. Drugs and Therapeutic committee should be formed in all public and private
hospitals to ensure rational use of drugs including antibiotics.
6.2 Conculsion
The prevalence of antibiotic abuse is very high in Bangladesh. It is a
thunder signal for us. If such a situation continues, we will be in a very
bad situation within next couple years. And at some point it will become a threat
to our very existence.I have tried to highlight here what kind of legal action we
can take in terms of our reality and the legal framework taken by other
countries in the world.However, this legal step will not be enough.In
addition to these legal measures, the governmenthas to Promote
investments for AMR activities, research, and innovations.
REFERENES
Book
1. M. Rahman, ‘High Risk Behavior among drug Abusers in Bangladesh,’ 8th ed.,
(Dhaka Eastern Publication, 2015).
Journals
1. Dr. Asfaque, “Antimicrobial Resistance & Infection Control”, Journal
of Antimicrobial Resistance & Infection Control.Vol. No. 6 (2015).
2. FR. Chowdhury Rahman, ‘Rationality of Drug Uses: Its Bangladeshi
Perspectives’ Journal of Mymensingh Medical, Vol. 15 No. 2 (2006).
3. J. Roy ‘Health Status, Treatment and Drug Use in Rural Bangladesh: A Case
Study of a Village’ Australian Journal of Rural Health, Vol.5 No.2, (1997).
4. MA. Faiz Rahman ‘MR. Rational antimicrobial Use’, Journal of Chittagong
Medical College Teacher Association, Vol.15 No.1-2, ( 2004).
5. MA. Yusuf, “Prevention of Antimicrobial Resistance: Bangladesh
Perspective,” Journal of Current and Advance Medical Research, Vol. no
5 (2018).
6. SM Ahmed Hossain, ‘Knowledge and Practice of Unqualified and Semi-
Qualified Allopathic Providers in Rural Bangladesh: Implications for the HRH
Problem.’ Journal of Health Policy, Vol. No. 84, (2007).
Report
1. World Health Organization Regional Office for Europe 2011
Statutes
1. The Drugs Act, 1940,s.18.
2. Code of Civil Procedure Act, 1908, s.10.
3. Dangerous Drugs Act, 1930, s.1
News Paper
1. The Daily Star, ( 14 August 2013).
Electronic Data
1. [https://www.slideshare.net/chewmeyellow/antibiotic-abuse-and-
misuse?qid=12ccc72d- 6a6f- 4fe5-8923
a3d2278132d2&v=&b=&from_search=2,
2. [https://www.slideshare.net/chewmeyellow/antibiotic-abuse-and-
misuse?qid=12ccc72d- 6a6f- 4fe5-8923-
a3d2278132d2&v=&b=&from_search=2].
3. [www.banglapedia.org/httpdocs/HT/D_0286.HTM
4. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6563746/]
5. [https://www.cdc.gov/drugresistance/solutions-initiative/stories/ar-global-
threat.html]
6. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6618210/]
7. [https://www.theweek.in/theweek/cover/2020/01/03/need-more-laws-to-deal-
with- antimicrobial-resistance.html]
8. [https://www.researchgate.net/publication/45185021_The_European_ban_on_
antibiotic_gro
wth_promoters_in_animal_feed_From_challenges_to_opportunities]
9. [https://www.hpnonline.com/infection-prevention/antibiotic-stewardship/
article/21158128/national-action-plan-for-combating-antibioticresistant-
bacteria-updated-for- 2020-through
2025#:~:text=The%20National%20Action%20Plan%20for,the%20course%20
of%20antibioti c%20resistance%2C]