Drug Control Policy of Bangladesh

Drug Control Policy-2005

Introduction:

Many poor people destitute of food are dying untimely deaths after suffering a lot just

for not getting the least proportion of medicine. They are so poor that they cannot

subdue their pain and therefore, cannot afford to buy the drugs. This truth strikes the

hardest on the third world countries like ours. That is why, each year, the statistics on

deaths occurred for the lack of medicine and treatment shows an increment. Health

problem is one of the main problems of Bangladesh. Though we have reached in the 21st

century, we cannot assure better health for our people. The only reason behind this is

there was no such "drug policy to apply. Considering the critical situation an ordinance

was passed which was named as "National Drug Ordinancc·1982"

Being healthy is an earned right of the citizen Bangladesh have gone through a lot of

conspiracy and bureaucratic complexities for many years just because of the lack of a

drug policy. Certain profiteering multinational companies are responsible for this havoc.

That’s why public opinions bean to develop which afterwards resulted in a fruitful drug

policy. The Drug Control Policy is a very important milestone in Bangladesh

development.

1 Drug Control Policy -2005

Definition of Drugs:

Drugs are biologically active products measured out in doses made from one or several

substances and subsidiary ingredients. They have a standard composition, unchangeable

brand names, necessary drug form, dosage form and design. Drugs are intended for

human and animal treatment, diagnostics, prophylactics, anesthesia, and contraception;

they have an influence on the functions of the organism.

Definition Essential Drugs:

Essential drugs are those that satisfy the priority health care needs of the majority of the

population. They should be available at all times, in adequate amounts and in

appropriate dosage forms with assured quality and adequate information, and at a price

the individual and the community can afford. They are selected with due regard to

public health relevance, evidence on efficacy and safety, and comparative ’cost-

effectiveness. The implementation of the concept of essential medicines is intended to

be flexible and adaptable to many different situations; exactly which medicines are

regarded as essential remains a national responsibility.


Historical Background of Drug Policy:

Before the announcement of the 1982 Drug Policy, there prevailed a drug ordinance

prepared by the British rulers in 1940. But this ordinance was only for the benefits of the

foreign imperialist companies who were hungry for profit. The general mass had nothing

good from it. Observing all this, a decision was taken to compile a drug rule for

Bangladesh in the advisory meeting of the chief martial administrator on 24th April 1982.

On 27th April 1982, an all time specialist committee of eight members was assigned to

submit a report within two weeks. The specialist committee submitted their report to

the heath advisor Major General M. Shamsul Haque on 12th May 1982. The Chief Martial

administrator approved the report. On the 12th June 1982 the drug Control Policy was

prepared and declared. This announcement was effective from 17th June 1982.

We owe a lot to Dr. Zafrullah Chowdhury for the implementation of the National Drug

Policy. He is regarded as the father of the Drug Policy, which pioneered an affordable

health strategy based in part on the local manufacture of a relatively small number of

essential drugs. He was made a member of a national policy expert committee for drug

policy.


Objectives / Aims of Drug Control Policy:

The Drug Policy was compiled to eliminate many unforeseen social hazards. For the

betterment of public health, efficient drug marketing and overall development was one

of the basic objectives. The following are the aims of the Drug Control Policy -1982.

1. For general peoples’ sake:

The main objective of the drug policy is to provide medicine to the people in times of

extreme need. The policy also insists on the medicine’s quality, common and effective

medicinal usage, being economic and safe. It gives priority for drugs that meet the real

health needs of the majority of the population

2. Affordability:

The drug policy makes sure that the prices of the medicines could well afford by the

general mass. To keep the price under purchasing power of the public this policy's aim

would be to take necessary steps to reduce increased price and keep it stable.

3. Termination of unnecessary medicines:

The medicines that are declared unnecessary for treatment purpose and also proved to

have no therapeutic value at all should be stopped from being supplied in the market.

Again if a medicine is very expensive but can be replaced by a suitable and less costly

drug then the supply of the former can gradually be called off.


4. Giving preference to the local medicine industry:

The drug policy emphasizes on helping the rural medicine producers (drug industry) to

achieve self-sufficiency in producing the very important essential drugs.

5. Termination of harmful drugs:

One of the important aims of the drug policy is to completely terminate the import,

manufacturing and selling of drugs that are declared to be harmful for human health or

proved to have severe or fatal side effects.

6. Taking measure to clear confusing propaganda:

Often the people are confused by the advertisement, festoons, posters etc declared be

the medicine marketers just for commercial purpose. The drug control policy is aimed at

divulging the confusions by regulating the marketers to advertise true, informative

advertisements. The policy also controls aggressive promotional activities.

7. Easy passage for import business:

Government control is needed to get the imported raw materials and medicines easily.

It also must be checked that the price should not increase for packaging of the medicine

containers.

8. Splitting the suppliers:

The responsibility of manufacturing the medicine can be given to those local companies

who supply and manufacture sufficient medicine. Then according to the efficiency, the

foreign companies will have the responsibility to produce high quality medicines.

9. Compulsory duty:


Responsibilities should be given to the local and foreign companies for producing the

essential and life saving drugs in our country. For that the Govt. can impose

manufacturing companies to produce certain drugs compulsorily.

10. To punish the corrupts:

One of the important aims of the national drugs policy is to discourage the ill marketing

process by legislating certain punishment s for several offences.

11. Practicing the Panel Court:

Rightful "drug court" should be established in order to accelerate provisions for quick,

on the spot justice. The authority of such mobile court will be at least equally powerful

as the session court.

12. Termination of Drug Wastage:

Provision for collecting, storing and distributing medicines, have to be enhanced so that

common people all over the country can get medicines easily and cheaply. Misuse and

wastage of medicines in this way, can be stopped

L3.Generic name:

Consequently, provisions should be made so that the drugs be produced, distributed

and sold with their own generic name. Various multinationals can give the brand names

but the generic names must be specified to the general consumers.

14. Encouraging local Production:


National Drug Policy of Bangladesh encourages the local production of the raw materials

and bulk drugs within the countries and offers the extensive opportunities in this

direction.

It is very nominal to say that the drug policy has to address the issues of quality,

indigenous manufacture, available of essential drugs, review of existing irrational and

hazardous drugs, and affordability of the drugs that are available. The additional

objectives of the Drug policy are as follows:

• Adequate training of all prescribers;

• Access to objective information;

• Real dialogue between patient and prescriber;

• Empowerment of consumers through education and information

• Community involvement and participation

• Development of drugs that meet health needs in the third world and not only those of

the rich countries;

• Responsible manufacture and export;

• Ethical promotion and marketing;

• A stop to "donations" of hazardous and ineffective products.


Success of Drug Policy:

Certain overseas multinational companies have looted millions of Taka as profit from

our country through their imperialist and profiteering hands until the Drug Policy —

1982 was compiled. The multinationals felt threatened and for that conspiracy against

implementing the policy was zero from 1982 to 1996. But against all odds, the policy has

seen some light of success. The observed achievements of the drug policy --1982 are

described below:

1. Production of the essential medicines has increased.

2. Unnecessary and harmful medicines have been banned.

3. The prices of the medicines are well afforded by the general people.

4. Broadening of local pharmaceutical companies was showing a development.

5. Employment is provided to the jobless yet potential youths.

6. Supply of crucial medicines was incremented.

7. Wastage of foreign currency was reduced.

8. Almost 60% of the raw materials are supplied from domestic sources.

9. 305 medicines are declared essential and 1500 medicines are called banned for being

unnecessary and hazardous.

10. Approximately 7000 medicines are produced as different brand names.

The most pleasing success of the drug policy is that it has reduced price. The

multinationals gave excuse that their objective was to ensure good quality. For that they

bought raw material from the profiteering sources. This increased the price of general


and essential drugs. In 1982, our market was just $40 million. Today it is over $900

million. The drug policy restricted them from buying the raw materials from their

choices. The raw materials arc collected from Govt. controlled sources.

Some Policy Matters of Implementing Drug Policy:

For full implementation of the Drug Policy-1982 a meeting was set in the International

Summit Center in 21st June, 1989. The meeting was called jointly by the drug advisory

committee and the drug control committee to discuss the effectiveness of the drug

policy and to prepare a index for the essential drugs. The following decisions are taken

to implement:

1. 305 essential drugs are nominated to keep in the index and the list is not to be

changed in three years. ·

2. The medicines that are not in the list but are registered should be dropped within two

years respectively.

3. The pharmacies, drug shops must not sell steroid anti biotic, narcotic drugs and any

other toxic able medicines.

4. For the time being (1989-1992) the generic name must be avoided.

5. The medicines can be produced in a capsule form but the price must be same.

6. If new entry of a medicine in the list of the 305 medicines, suitable medical trial must

passed. The inclusion must be put in the place of an old one.

7. The medicines that are locally manufactured and distributed but are not included in

the essential drug list must be destroyed.


8. All the medicine distributed in rural areas must be marketed as Vitamin B complex

branded generic except the birth control pills.

9. The media publicity and advertisements must be t developed to raise public

awareness and a balanced price of the drugs.

For publishing a national formulary a committee must be adopted.

The present situation of marketing of medicine:

The institutions that are involved in marketing of medicine skillfully in Bangladesh are

the Producers, Drug administration, Health ministry, the Doctors, the Laboratories, and

the Wholesaler and the Retailer of medicine etc.

The manufacturers of medicine:

The numbers of drug manufacturers in Bangladesh are Allopathic — 262, Unani — 267,

Ayurvedic — 202, Homeopathy — 79, and Herbal— 19. To increase the profit margin the

manufacturers tries their best to demoralize the doctors to prescribe their brands. The

pharmaceutical companies also presented limited information and partial product

quality, On the other hand excess want of profit controls MNC’s business and that is

why they don’t care for the legal aspects. lf any company misrepresents the quality of

the medicine — this is counted as an unforgivable crime. American and Japanese

doctors submitted various report on this matter. Many cases have been made for this. In

spite of this, banned medicines are being marketed fluently.

Ref: Directorate General of Drug Administration (www.dgda.gov.bd)

2. Market Share:


At present, local companies supply 90% medicines and multinational companies supply

10% medicines. This is the outcome of drug policy. One of the objectives of drug policy

was to reduce the ratio of imported drugs and ensure that people could get necessary

drugs good quality of, at minimum cost. But still, if we look at the drug market, we can

see that because of overpricing, general people cannot buy essential drugs. In this

sector Governments control has not yet been established fully.

3. Production and sale:

Every year in Bangladesh TK 1500 crore of traditional medicine ( unani_ ayurvedic, and

homeopathy) are produced and sold. On the other hand the production and sale of

allopathic medicines is around TK 7000 crore at a growth rate of 25%.

When the drug policy had been declared there were 167 local allopathic companies.

Among them 100 companies closed or switched their production to ayurvedic or unani

medicines. This is not at all a sign of improvement in industrial sector. '1`hese meddle

category companies faced the highest loss; because 60% of their medicines were

banned.

Now they are selling alternative traditional medicines. But there are a lot of confusion

about the quality of this medicine. They are making liquid medicines, which is banned in

drug policy. For making capsule, investment & technology is needed which local _

companies do not have and this is why they cannot compete in the market.

Multinational companies are making full use of this situation and increasing their profit.

4. Wholesale and Retail drug Stores:


At present in our country the numbers of wholesale stores is a 1208 and 30,000 retail

store. The above statistics is only of allopathic stores, but the numbers of traditional

stores are higher. After production wholesalers and retailers are making two or three

times more profit at the time of selling. As a result an abnormal situation is created in

drug market.

5. Licensed Drug Stores:

Drug administration issues drug licenses. In 1986 there were about 21000 licensed

pharmacies in this country. From them 16000 pharmacies’ licenses were cancelled in

only because there were no registered pharmacists from pharmacy council. Then in

1994 some licenses were reissued for two years. This situation is going on and on but no

change has occurred.

6. Drug stores without license & with fake license:

There are at least 70000 drug stores that are running either without license or with fake

licenses. That means govt. is depriving from ‘a lot of revenue every year. On the other

hand they are selling adulterant and expired medicines. This-situation is increasing day

by day.

Export of Medicine

It is very encouraging news that Bangladesh has became a drug exporting country

instead of importing one.


The statistics of last five years drug export are as follows:

2006 - 2663.39 million taka





It is indeed good news that at present drugs are exported to 83 countries including

Europe and America and other countries. The quantity of drugs & the number of

countries are increasing day by day by active support and efforts of present

government.

At present Bangladesh exports formulated medicines about 83 countries in the world.

Some of the countries name mention below:

Australia, Austria, France, Columbia, Vietnam, Greece, Sri Lanka, Malaysia, Finland,

Sweden, UK, Hongkong, Netherland, Norway, Thailand, Brazil, Venezuela, Mexico,

Philippines, Egypt, Pakistan, Ukraine, Curacao, Indonesia, Russia, South Africa, Jordan,

USA, Iran, Japan, Korea, Yeman, Bhutan, Guinea, Nepal, Sudan, Kenya, Myanmar,

Ghana, KSA, Kosovo, Papua New Guinea, Mauritius, Singapore, Afghanistan, Malta etc.

We are very optimistic that very soon; the pharmaceutical sector of Bangladesh would

be able to occupy a prestigious position in the international arena by the dynamic

leadership of the government of Bangladesh.


The impact of Trade Related Intellectual Property Rights (TRIPS)

TRIPS provides Bangladesh with great opportunities for increasing its pharmaceutical

exports. As a signatory of WTO /TRIPS, countries like China and India have already had

to implement “Patent Laws” in their countries and hence, these countries are no longer

allowed to export generic versions of patented drugs. For Bangladesh, the situation is

very different. As a LDC, Bangladesh has received exemption from abiding by the patent

laws until Jan. 1, 2016. Although, all the 49 LDCs have got this exemption, Bangladesh is

the only country that would really be able to capitalize on this opportunity by exporting

pharmaceuticals to other LDCs. Bangladesh pharmaceutical industry could tap into a

huge export market by value addition of raw materials. This is facilitated by marked

difference in the cost of production in the local market and the export prices)

Other opportunities for Bangladesh include “toll manufacturing” under which other

countries could get their products manufactured in Bangladesh. A number of

companies have already constructed facilities as per USFDA and UKMHRA standard and

are going for certification in the regulated markets. Joint ventures also may offer

opportunities, e.g. India and China have very good expertise in producing active

pharmaceutical ingredients (API) and formulation research and development (R&D) and

may like to manufacture generic API outside their countries as they cannot manufacture

any “patented” APIs in their countries after 2004. Bangladesh also has enormous

opportunities to go for joint ventures with these large global companies for

manufacturing pharmaceutical finished products.


The legal aspects of marketing of medicine:

There are certain rules to follow in the production and marketing process drugs in

Bangladesh regulated by the Govt, for the benefit of the general mass. The government

of Bangladesh has compiled some rules so that the people can easily get the essential

and life saving medicines at a suitable price and that the qualities of the medicines are

best possible. There are also specified penalties in the law for production and marketing

of low quality and adulterated drugs. The rules are described as go after:

Bangladesh Penal Code - 1860

Act — 274: Adulteration in Herbal Material:

“If any person knowingly mixes adulterants in the herbal medicines which decrease

utility, hampers medicinal value; or even distracts and takes part in selling such herbal

material or produced medicines by saying that they are not adulterated, then it is a

crime. That person will be imprisoned for 6 months or will be fined maximum TK 1000 or

the both for any kind of descriptions."

Special Power act- 1974

Act — 25(Ga):

"If anyone sells or issues for treatment, any herbal material or produced medicines by

knowing that there is adulteration in such products, which can decrease the utility or

activity or even is harmful for health."


In this case the punishments are — death penalty or life time imprisonment or labor

imprisonment for 14 years and monetary punishment.”

Revised Drug (control) act- 1997:

Punishments for illegal advertisements and rights:

In this case maximum punishment-- Rigorous jail for 3 years and line of Tk 2,00,000 or

both .

Specialists of Government made these policies but under the pressure of rich helping

countries they cannot reject patents of harmful drugs and cannot punish them As a

result people become confused and take this low quality and date expired drugs.

Penalties of the offences and Drug Control Policy -1982.

Sections Offences Maximum penalties

Section—16 Production or distribution of 2 hundred thousand Taka or

banned, unregistered, false, laborious imprisonment for

adulterated medicines. 10 years.

Section-17 Producing or selling of 1 hundred thousand Taka or

medicines which are low in laborious imprisonment

quality. 5 years.

Section -18 Importing the drugs which are 50 thousand Taka or laborious

not approved by the Govt. imprisonment for 3 years


Moral aspect of drug marketing:

Morality means understanding the drawn line between good and evil; right and wrong

and performing the must be performed responsibilities and obligations. But morality in

marketing business refers prevalence of truthfulness, honesty, integrity and above all

doing fair business. Meeting social-needs, impartial competition, well—informed

advertisement, consumer independence etc play a vital role in determining the moral

aspects of drug marketing. The moral sides of drug manufacturing and marketing are as

follows:

• Drug manufacturers and marketers must bear this in mind that medicines are not

luxury products; rather they are essential, life saving artifacts. That’s why; medicines of

proper quality (unadulterated) must be available in the market according to the demand

(necessity) of the consumers.

• The manufacturers must work with honesty while producing drugs. They should use

appropriate amount of raw materials in the manufacturing process and also shouldn’t

produce the drugs that are banned by Govt.

• Airing; publishing in posters and announcing false advertising is strictly prohibited by

law. The manufacturers and marketers should not engage themselves in such act.

Moreover, the advertisements of drugs should be informative enough and no alluring

offer must be given.

• The Manufacturers must not supply date expired medicines in the market. Date of

manufacturing, date of expiry and also the usage should be mentioned in the packet of

the drugs.


• According to the drug policy, a registered pharmacist must be present in each and

every drug store. And, no drugs will be sold without prescription. The owner of

pharmacies should strictly abide by this law.

• Drug manufacturer companies should work for the welfare of the society.

• Possible side effects should be informed before the selling.

• Drug stores must be kept open as long as possible.

• The sales person must not advise any substitute drug.

• Drug sellers must not create artificial crisis and from that price hike.

• The doctor will prescribe only the medicine not the medicine store or brand

intentionally to the patient.

Patients' Rights:

The United Nations approved 10 right of the patients are adopted all over the world. If

anybody notices any sort of violation of such right of patients or any other consumer

right may complain to CAB (Consumers Association of Bangladesh) with proof through

correspondence or personally. The l0 patient rights are as under:

l. Receiving easily available and worthwhile health care;

2. Receiving impartial and guaranteed health care;

3. Receiving health information and health education;

4. Right to determine appropriate doctor or health officer;

5. Right to determine suitable health center;


6. Right to approve the treatment procedure after being informed properly;

7, Right to participate in one’s own health care proceedings;

8. Right to ensure the prevalence of honor, status and secrecy;

9. Right to complain when proper services are not acquired;

10. Right to be prevented from mistreatment.


Some events about the violation of Drug Policy from some

previous years are mentioned

Practical Scenario of Drug Market in Bangladesh

Fake Drugs Flood Bangladesh

News report in 2003

While Bangladesh's mammoth pharmaceutical industry exports drugs to as many as 52

countries worldwide, new investigations reveal an estimated US $150 million worth of

spurious drugs are posing a risk to public health at home. In its annual testing of 5000

drug samples this year, the Public Health and Drug Testing Laboratory (PHDTL) detected

300 drugs that are either counterfeit or of very poor quality. Significantly, these

include many popular antibiotics and lifesaving drugs.

Jolted into action, the health ministry's Drug Administration authorities have launched a

drive against illegal and fake drug vendors in the country. Preliminary findings reveal

Bangladesh boasts a whopping 80,000 unlicensed drugstores. Drug Administration chief

Abdul Gani expresses his helplessness in combating the menace,"There are so many

illegal operators that we cannot cope. Our 25 branches across the country are staffed

with just 40 drug superintendents and inspectors. We act when we get specific

complaints. But this set up is hopelessly inadequate."


Gani points out that smuggled drugs are the biggest threat, as this is a grey area which is

totally unmonitored. Remarks retired medical professor Nurul Islam, "In the absence of

quality controls, any dishonest importer can smuggle in fake drugs at a takeaway price

and sell them at a higher price." The rampant growth of contraband drugs is blamed on

the poor quality of health services and cutthroat competition between drug

manufacturers. The 100,000 strong industry produces drugs worth over US $500 million.

Worse, the acute shortage of doctors and clinics in rural areas forces patients to

purchase off-the-counter drugs sans a prescription. This helps fake drug vendors to

thrive, stresses pharmaceutical industry executive, Dr Reaz Ahmed

A large percentage of patients also travel to neighboring India for treatment, returning

with prescriptions of Indian drugs. To cater to them, dozens of unauthorized

pharmaceutical establishments have mushroomed on the Bangladesh border. These

units either smuggle in Indian drugs or manufacture fake ones that threaten the lives of

thousands of patients, observes chief of the Drug Testing Laboratory, Dr AK Zakaria.

Although doctors warn these drugs could be causing deaths, no survey has so far been

conducted to assess their negative impact on public health. Recently, the Drug Testing

Laboratory found that a popular drug used for strokes and brain hemorrhages ?

Cavinton ? was being marketed minus its main chemical ingredients. Remarks Zakaria,

"It is obvious that patients who used this counterfeit drug have either died or suffered

an ordeal."


Ironically as the general secretary of the Bangladesh Pharmaceutical Industries

Association, Nazmul Hasan remarks, "The presence of fake and illegal drugs in

Bangladesh is itself surprising because we manufacture over 96 per cent of our

requirements and even export drugs." Hasan adds that the value of fake and contraband

drugs flooding the market is estimated to be between US $100 million and $150 million.

According to him, these drugs are produced in hundreds of fly-by-night drug factories

functioning along the borders of Bangladesh, India, Pakistan, China and Thailand.

Paradoxically though, as the president of the Chemist and Druggist Association Sadequr

Rahman points out, the pharmaceutical industry is Bangladesh's second largest foreign

exchange earner, boasting exports to 52 countries.

The industry comprises over 800 drug-manufacturing companies, 230 of which

manufacture allopathic drugs, 255 producing traditional herbal drugs, 300 engaged in

the manufacture of modern herbal drugs and 80 homeopathic drug producing outlets.

Rahman alleges that apart from some three dozen leading allopathic drug

manufacturers, the rest are involved in the production of fake and low quality drugs.

Ahmed terms this cannibalistic marketing of competing companies. As he puts it, "Due

to its high returns, businessmen with no commitment to health services have started

investing in the pharmaceutical sector. Their companies thrive on faking popular brands

and manufacturing drugs sans authentic ingredients. The low prices help their drugs to

sell." Ahmed relates a recent personal experience where a child pneumonia patient

urgently needed a lifesaving injection called Ceftiane. He recounts, "The injection was


administered thrice but the child failed to respond. We then realized the brand might be

false. After changing it, we administered the same drug and it worked."

He points out that many companies manufacture fake post-operative antibiotics like

Cephradine and Hydrocortisone. Fungus-coated saline fluids and used syringes are also

commonly found. In addition, most drug manufacturers lack suitable storage facilities

and enclose tablets and capsules in such low quality foil that it is impossible for them to

retain their potency.

Fake drugs make inroads

Wed. June 25, 2003 in the newspaper The Daily Star

Counterfeit versions of a number of life-saving medicines are being made and sold in

Bangladesh, putting patients at serious risk.

The fakes are usually of no therapeutic value.

Counterfeiters are cashing in on a demand as patients struggle to pay the high cost of

genuine drugs, and get away with their fraud because of poor government supervision

of the pharmaceutical industry.

Last November the government's drug-testing laboratory at Mahakhali identified

fraudulent copies of a drug named Cavinton, used for strokes and brain haemorrhages.

The fake Cavinton was found to lack one of the main chemical ingredients of the real


drug. Cavinton costs around Tk 300 for 50 tablets compared with Tk 130-Tk 150 for the

fakes.

Most fakes are made by dishonest pharmacists, according to industry sources. But some

small pharmaceutical companies appear also to be involved.

"Some are involved in this practice, it is true. We have heard of people doing it in Zinzira

(a suburb of Dhaka). They are harming the people and not paying taxes to the

government," S M Shafiuzzaman, President of Bangladesh Pharmaceuticals Association,

told The Daily Star.

In 2001 the government cancelled licences of 44 small companies for producing

counterfeit drugs. It is not however known how many were prosecuted. Twelve others

were restricted to producing particular items. But the clampdown has not stopped the

practice.

The drug administration occasionally raids Babubazaar, the country's biggest drug

market, and seizes illegal products. Sources in Babubaazar said that at least 15 kinds of

counterfeit drug brands are available, including counterfeit versions of Perictin,

Cavinton, Pathaydin, Kenakta Vayal and Eldakton. Unscrupulous traders also put

patients at risk by selling drugs that have crossed their expiry dates. They change or

cover up the original expiry date on the packet.

Industry sources say that drugs worth Tk 700 crore a year are smuggled into the country

or produced illegally, out of a total national drug market of Tk 3,000 crore.


The government has only two testing laboratories and 37 drug supervisors for the entire

country, which accounts for the poor supervision in the sector.

Officials say they are doing their best. "We are active within our limited manpower to

free the market from counterfeit medicines. Whenever we get information we

immediately take action", said Dr. Abdul Gani, Director of Drug Administration.

The leaders of the Druggists and Chemists Association disagree. They say the

government is not doing enough to control illegal manufacture and trade, and that

many officials have been bribed to allow fake drugs onto the market.

"Our people are poor, and most cannot afford the medicine they need. Dishonest

producers and traders are cheating them. The government is not taking adequate

action," said Md. Sadekur Rahman, President of the Association.

Rid's syrup unauthorised, toxic element found

Thursday, July 30, 2009

Says probe report on paracetamol tragedy

The government-formed probe committee has found presence of poisonous Diethylene

Glycol in the paracetamol syrup of one pharmaceutical company after examining 300

samples of paracetamol and vitamin syrup of 10 companies.

The seven-member body submitted its report to Health Minister AFM Ruhal Haque

yesterday.


The committee headed by Joint Secretary (hospital) Abdul Jalil was formed on July 21

following the deaths of about 25 children due to renal failure in the last one and a half

months. It was supposed to submit its report within five working days.

Ruhal at a press briefing at the ministry said Rid Pharmaceutical obtained licence to

produce paracetamol suspension but it manufactured paracetamol syrup in violation of

the rules.

"Furthermore, instead of Propylene Glycol, they used poisonous Diethylene Glycol

which is used in tannery and battery industries," he said.

The health minister said legal actions would be taken against the company.

Meanwhile, the company's factory has been sealed off and its products have been

withdrawn from the market.

However, no poisonous compound was found in its vitamin syrup, the committee

members said.

They said all deaths from renal failure were not caused due to the presence of

Diethylene in paracetamol.

"It will require further research to find out the reasons behind the deaths of the rest,"

said chairman of pediatric nephrology department and committee member Prof

Moazzam Hossain.

Renal failure might occur due to various reasons including the presence of Diethylene in

paracetamol, he added.


Ruhal told reporters that enquiry would be conducted to find out whether any

unscrupulous inspector or drug superintendent helped the company.

The minister said the government will set up an international-standard drug testing

laboratory to ensure drug safety. Besides, the Drug Administration would be reformed

and strengthened.

About 34 children with renal failure were admitted to the Dhaka Shishu Hospital and the

BSMMU. Of them, 25 died leading to formation of the probe body.

Marketing of adulterated medicine to be prevented

Thursday, June 11, 2009 in the newspaper The Daily star

Says PM

A delegation of Bangladesh Association of Pharmaceutical Industries meets Prime

Minister Sheikh Hasina at her office in Dhaka yesterday.


http://www.thedailystar.net/newDesign/photo_gallery.php?pid=92024

Prime Minister Sheikh Hasina asked for updating the country's existing laws governing

the pharmaceutical industry to fully utilise the export prospects, as the industrialists

hope for the highest foreign currency earning through this sector in future.

At the same time, she said the government would take necessary action to prevent the

marketing of fake and adulterated medicines in the local market.

The Prime Minister made the remarks when the Board of Directors of Bangladesh

Association of Pharmaceutical Industries (BAPI) led by its President Salman F Rahman

and Secretary General Abdul Muktadir called on her at her office yesterday.

The BAPI donated Tk 50 lakh by cheque and medicines worth Tk 1 crore to the Prime

Minister's Relief Fund for the succour of the victims of cyclonic storm Aila that recently

hit the country's coastal districts.

The Prime Minister said it is a matter of pride that world-class medicines produced in

Bangladesh are exported to 72 countries of the world.

“But, at the same time, you have to keep it in mind that local market is the priority

sector as it has to be ensured that common people get all necessary medicines with

standard quality and at cheap rate,” she told the country's medicine-business magnets.

Reports have it that there are lots of substandard medicines at local markets. Also,

prices of many brands of medicines are not affordable for the poorer sections of people.

Finance Minister AMA Muhith, Health Minister Dr AFM Ruhul Haque, Adviser to the

Prime Minister Dr Syed Mudasser Ali, Foreign Minister Dr Dipu Moni, Secretary of the


Prime Minister's office Mollah Waheeduzzaman, Prime Minister's Press Secretary Abul

Kalam Azad and Health Secretary Sheikh Altaf Ali were present on the occasion.

Nazmul Hassan MP, BAPI's adviser, through a power-point presentation informed the

Prime Minister about the prospects and problems of the industry.

“If the government can remove some legal barriers to exporting medicines within the

next three years, we are going to be the largest forex earner,” he said.

Hassan put forward several demands that include modernising the Drug Administration,

setting up Independent Drug Testing Laboratory, Clinical Testing Bioequivalence Centre,

Active Pharmaceutical Ingredients (API) Industrial Park, allowing the industries to spend

sufficient amount of money in operating office abroad in line with the rules of foreign

markets, changing Bangladesh Bank's limit to spending necessary finance over

registration cost and sending product samples abroad.

As for example, Hassan said according to Bangladesh Bank's rule, a pharmaceutical

industry in Bangladesh annually can spend maximum US$ 30,000 for operating office

abroad whereas only in Russia or Singapore a company needs approximately US$ 25,000

per month for setting up office and giving salaries of the employees.

Besides, a pharmaceutical industry has to send US$ 22,000 as the fee for only product

registration in some countries and the fee has to be renewed every five years. On the

other hand, only as bioequivalence-test charge, a company needs to send US$ 50,000-

100,000.


Fake medicine factory busted

Monday, October 18, 2010 in the news paper The daily star

A team of Rapid Action Battalion yesterday busted a fake homeopathy medicine factory

and arrested five people in this connection from Old Dhaka's Babu Bazar area.

They also seized around 1,200 litres of rectified spirit from the spot.

The arrestees are factory manager Mohammad Jasim Uddin, workers Nazrul Islam,

Alamgir Hossain, Mizanur Rahman and Mohammad Mainuddin.

Owner of the factory Hero Kamal, however, managed to escape arrest.

A team of Rab-10, accompanied by Superintendent of Drug Administration Akib Hossain,

raided the factory on the first floor of S Ahmed Market in Mitford.

The team seized around 1500 bottles, each containing 100ml of rectified spirit, said Maj

Harun-ur-Rashid, deputy director of the Rab unit.

They also seized 18 drums of this highly concentrated ethanol, each containing 60 litres.

The team found the workers putting labels of different homeopathy medicines of

foreign and local brands on the bottles. Huge numbers of labels were also recovered

from the site, added Maj Harun.

The arrestees admitted they used to supply the spirit to various homeopathy stores in

different districts. They failed to produce any registration document before the team for

running the factory and marketing homeopathy medicine.


The Rab official said they had information about drug addicts collecting such spirit from

homeopathy medicine stores.

Hero Kamal rented the store as a godown, said a local trader, adding the owner and

workers used to work inside it on weekends keeping doors closed.

Underground 'drug factory' busted

Friday, November 5, 2010

Manufacturer held in drive; Rab tells of over 150 such units in Dhaka, outskirts; some

doctors said to be linked with unholy trade

A mobile court raids a fake

"medicine manufacturer" at the capital's South Manipur yesterday. Arrested Tazul

Islam,inset.Photo: STARShaheen Mollah with Wasim Bin Habib

The package made of glossy paper is very colourful. It reads 'SIRIO Nutrition OS Gold…15

Softgels…Dietary Supplement'.


http://www.thedailystar.net/newDesign/photo_gallery.php?pid=161340

It says the packet contains capsules of multi-vitamin and minerals for children and

pregnant women. In smaller print it says the medicine is made by Sirio Pharma Co. Ltd of

China and imported and distributed by SA Trading, Dhaka, Bangladesh.

The box says very clearly that each capsule contains 10 vitamins and six minerals among

other necessary ingredients. The label of the package also makes a good argument on

why one should take the capsules in order to have good health.

There is even a warning that all drugs should be kept out of the reach of children.

It is all very convincing to customers.

But little do they know that the capsules are made in a filthy 110-square-foot room at

South Monipur of Mirpur. And they are made by two young men barely in their 20's

with no educational qualification or sense of hygiene. The customers do not know that

they use their bare hands to make the capsules with a portable machine set up next to

the door of a toilet.

A mobile court busted the factory yesterday.

Workers Milon Bhuiyan, 20, and Sohel Roy, 21, secretly make the capsules in the room

for just Tk 3,500 a month. They work for a company named SA Trading, which has no

approval from any government organ. The owner of the company has been captured.

The so-called company has been making the capsules along with other 'dietary

supplements' and 'sex stimulation' capsules for more than two years and selling them to

wholesalers and pharmacies across Bangladesh.


The mobile court, backed by Rapid Action Battalion, and in association with the

Directorate General of Drug Administration and BSTI unearthed the 'medicine'

manufacturer yesterday.

In an eight-hour-long drive, they recovered 20 lakh capsules from a nearby warehouse

and packaging room. Keeping some for evidence, the court destroyed the rest.

They arrested Tazul Islam, 'chief executive officer' of SA Trading, and his wife Nadira

Islam, 'marketing and finance director' of the company, from their home.

The court fined them Tk 3 lakh and sentenced Tazul to one year's imprisonment.

The drive came a day after the High Court directed testing samples of all medicines

available in the market.

Tazul is not the only person making the capsules, more than 100 people are making and

marketing the capsules across the country, claimed Tazul.

Rab sources said they are now aware of about 150 such factories in Dhaka city alone,

which make drugs this way and sell them in the market. They said they will be on to

them.

Magistrate Anwar Pasha of the court said this sort of drugs is available in most

pharmacies in Bangladesh.

On information that people are being cheated with these 'medicines', the intelligence

wing of Rab carried out an investigation and found a number of such unauthorised

manufactures in and outside the capital, he said.


He said they conducted a drive in Amin Bazar Wednesday and found a number of such

factories.

They have not examined the ingredients and capsules yet, he added.

Anwar blamed a nexus of manufactures, a section of doctors and medical representative

for this menace.

"Some unscrupulous doctors especially those working at the outdoor sections of public

hospitals and their private chambers are prescribing these medicines as they are getting

a handsome amount of money from medical representatives for prescribing them," a

Rab official requesting anonymity said.

Rab officials said they have many prescriptions from doctors giving patients these

'drugs'.

They also said SA Trading illegally buys the empty capsule gelatine from the lone factory

in Bangladesh at a higher price.

Talking to The Daily Star Tazul claimed he imports the ingredients from China and sells

the ingredients to some wholesalers across the country apart from manufacturing them

in his so-called factory.

He said he has been making vitamin, protein, calcium and sex stimulation capsules since

March 2008 inside his two-room flat, which is also his office and home. The couple

actually live in the very room the capsules are made.


He said it costs him Tk 20-25 to make 30 capsules and he sells them for Tk 50-120 to

wholesalers. However, the maximum retail price printed on the label is between Tk 370-

500.

"These medicines are of good quality and I did not receive any complaint from

anybody," he claimed.

"We can produce 300 capsules within four to five minutes with the machine," said

worker Milon, adding, "Each of us produces 10,000 to 12,000 capsules a day."

Milon and Sohel told The Daily Star that they had been making the capsules for the last

two months. They said Tazul showed them how to make the capsules one day and the

two have been making them since.

Shafiqul Islam, medicine superintendent of DGDA, said Tazul failed to produce any

documents during the drive.

"Tazul has no approval to manufacture or sell the medicines or even to import the

ingredients," he said.

BSTI officials said the manufacturers do not have any approval from them and the so-

called company do not use its address on the packages.

Rezaul Hayat, a medical representative, who was inside the house during the drive, said

representatives working for SA Trading earn Tk 20,000-25,000 a month.


Fake drug factory busted, owner jailed

Friday, April 22, 2011from yhe news paper The daily star

Mobile court destroys 17 lakh substandard capsules, tablets

A mobile court of Rab yesterday busted a fake drug factory at Pallabi Eastern Housing in

the capital and destroyed more than 17 lakh sub-standard tablets and capsules.

The market price of the drugs was about Tk 1 crore, Rapid Action Battalion (Rab) said.

Rab Executive Magistrate Anwar Pasha, who led the drive, awarded two years' jail term

to Munirul Alam, owner of the factory F M Medi-royal Overseas (Bangladesh), and fined

him Tk 2 lakh in default of which he will have to serve three more months in prison.

Magistrate Pasha told The Daily Star that a detective team of Rab had come to know

that the factory was producing sub-standard drugs in collusion with some doctors.

During the raid, Rab found three employees of the factory manufacturing sub-standard

drugs at the ground floor of a six-storey building in an unhygienic condition.

During primary interrogation, the factory owner told Rab that he earlier served as an

employee of a medicine company. He left the job two years ago and started importing

raw materials from China to produce medicines.

He, however, could not show any valid documents in support of manufacturing

medicines, Rab said.


Munirul also confessed that he maintained a syndicate with doctors of different

hospitals to get the sub-standard medicines prescribed to the patients.

Trade in fake medicines

Wednesday, September 28, 2011 in the news paper The daily star

The health sector is regarded as a fundamental subject in national and international

documents. The government of Bangladesh has also signed many international

documents on this subject. In reality, we see that the number of private hospitals is

increasing much faster than that of public hospitals. This has resulted in roaring business

for the private hospitals because of inadequate number of government hospitals, and is

due to gradual transfer of health service from the public to the private sector. This trend

is seen in developing countries like India, Kenya, Cambodia, Vietnam and Pakistan.

Simultaneously, allocation of resources to the health sector is also decreasing

proportionately.

In Bangladesh, health service in the private sector got legal coverage through

proclamation of an ordinance in 1982. In 1984, another ordinance amending the 1982

ordinance was issued. Health service in private sector increased further during the 5th

Five Year Plan in 1996-2001. It received further incentives for growth in 200-06.

It has been alleged in a meeting of a Parliamentary Committee that common people do

not get medicine from government hospitals though large quantities of time expired

medicine are seen in the toilets of those hospitals. Due to such state of affairs people

are forced to buy medicines from outside.


Out of 168 pharmaceutical companies in the country only 62 follow the guidelines of the

World Health Organization (WHO). Only twelve of them are manufacturing medicines as

per standard laid down by WHO, and in majority of the laboratories there is dearth of

proper equipment and skilled personnel, mismanagement, lack of monitoring and illegal

entry of banned medicines.

Factories making fake and adulterated medicines have come up in many places,

including rural areas. In the largest wholesale market of medicines in the Mitford area in

Dhaka, the trading of these medicines is going on with impunity due to indifference or

lack of monitoring by the authorities concerned.

There are more than 250 companies that make allopathic medicines. There are also 800

companies which are producing unani, ayurvedic, herbal and homeopathic medicines.

Bangladesh exports 85 items of medicines to 72 countries. However, experts say that

only 50 to 60 pharmaceutical companies produce medicines of good standard and 50%

to 60% of the companies are producing medicines of low quality.

In July 2009, intake of fake paracetamol tablets resulted in the death of 28 children. The

writ petition moved by Human Rights and Peace for Bangladesh before the High Court

resulted in stoppage of production and marketing of eight medicines.

The drug administration has taken action against pharmaceutical companies. Apart from

this, an enquiry conducted by the permanent parliamentary committee on the ministry

of health found that the standards of more than one hundred companies do not meet

WHO guidelines and some of the products are far below standard.


Smuggling of banned medicines is rampant. The tendency of doctors to prescribe more

medicines than needed has been revealed in a research paper of Bangladesh Health

Watch in 2009.

There are about two lac twenty five thousand medicine shops in the country, out of

which 82,000 hold valid license. The majority of these pharmacies are run by

inexperienced and unskilled personnel.

As per government estimate, the number of generic medicines in the country is 1,200.

There are only two government drug testing laboratories which can test only three to

four thousand medicines yearly. We need at least ten more testing laboratories to

satisfy our demand.

Though the government is proceeding gradually to privatise the major part of the health

sector, it must provide good standard of medicines to the nation. It is surprising that

though a national medicine policy was formulated in 2005 it has remained

"controversial" during the last six years. It is time that recommendations of the

parliamentary committee on ministry of health are implemented as far as possible and

as quickly as possible.


Make Medicare affordable

Monday, October 24, 2011 from the news paper The daily star

PM spurs World Health Summit on developing global, regional partnership

Prime Minister Sheikh Hasina has urged the world community to develop global and

regional partnership in health technology to ensure greater access to medicine at

affordable prices.

“Making health services accessible and affordable is a global challenge… our needs and

challenges require matching mobilisation of resources beyond public sources,” she said

in a keynote address at the opening session of the four-day World Health Summit

(WHS), 2011 that began here yesterday at the Charité - Universitätsmedizin Berlin,

Campus Mitte.

Mentioning that the summit's theme 'Today's Science-Tomorrow's Agenda', as timely,

Hasina said there is immense scope to develop collaboration among pharmaceutical

companies to enhance quality and scale up production and distribution of drugs.

She stressed the need for extending the flexibilities accorded to the LDCs within the

existing Intellectual Property Regime on pharmaceuticals beyond 2015.

The premier called for enhancing regulatory capacity to combat medical products of

inferior quality, safety and efficacy.

About the importance of preventive medicines, she said that as the world concentrate

on cutting-age technology and high-end health products, simple and cost-effective


interventions like immunisation must not be forgotten as they can help reduce

morbidity and disease burden.

Problem Statement

Bangladesh does not have a modern and sophisticated DTL with the facility of Bio-

equivalency testing available necessary for the manufacturing and export of

pharmaceuticals responding to high international standards. At the same time the

present DTL capacity is insufficient to fulfill all duties on the local drug market as well.

The locally available drugs have often been labeled as being of dubious quality and

therefore having serious health implications. However, in contradiction, there is a

fledgling private pharmaceutical that is exporting quality drugs. The TRIPS agreement

could have potential benefits for the country in terms of quality of drugs and revenue

thus fuelling growth.

The Directorate of Drug Administration has a limited capacity to check the quality

standards of drugs manufactured in the country. It was established as a Drug

Regulatory Authority under the Ministry of Health and Family Welfare, in 1976. There

are two Drug Testing Laboratories (DTL) in Bangladesh, one in Dhaka and the other in

Chittagong. These two DTLs are always engaged in testing numerous drugs being

introduced by about 200 pharmaceutical companies operating in the domestic sector.

The DTLs are not modern and sophisticated enough to carry out different types of tests

as required for export which are becoming more stringent by day. The Bangladesh


standard for good manufacturing practices (GMP) doesn’t stand up to the WHO level of

GMP inspection. As a result, only 30 companies have thus far received a GMP license

which allows them to export drugs to other countries.

Conclusion

People of the country have long been suspecting the spurious manufacture of medicines

in various parts of the country, and its sale through agents in the various medical stores

in league with the shop keepers. The percentage of spurious medicines including herbal

and Ayurveda medicines will be very large even though we do not have any study on it.

Administration of such medicines causes complications, severe illness, and precipitate

deaths.

The well co-ordinated drive has borne partial success. This should continue in every

ward of the city and in other distinct and divisional head quarters of the country. Since

local people are aware as to the locations of such spurious factories, their help is a must.

It would be a job well done if we are successful to crush this trade in poison. Stringent

punishment, if possible non-bailable, should be inflicted to curb this dangerous

business.

Bangladesh has a vibrant pharmaceutical sector. In 2004, the total size of the pharma

market of Bangladesh was estimated to be about $450M with an annual growth rate of

about 10%. The pharmaceutical industry in Bangladesh is paying the second largest

revenue to the Government’s exchequer (after the garment industry). Because of the


Drug control policy the market size has improved to be about $900M with an annual

growth rate of about 25%.

Local market. The finished formulation-manufacturing base of Bangladesh is very strong

as most of the pharmaceutical companies have their own manufacturing facilities.

Around 95 percent of the total demand of Bangladesh is being met by local

manufacturing. The industry lacks the capacity only for some specialized

pharmaceuticals, such as vaccines, drugs using recombinant DNA, anti-cancer drugs and

anti-retro virals.

Overseas Market. Since the late 80’s, Bangladesh started exporting finished

formulations to some of the neighboring less-regulated overseas markets like Myanmar,

Sri Lanka and Nepal. In the early 90’s few major companies took initiative to explore

some of the more-regulated markets like Russia, Ukraine, Georgia and Singapore.

Success in registering and marketing these products in these countries was a major

breakthrough for Bangladesh pharmaceutical industries. Today, Bangladesh

pharmaceutical industry has successfully started exporting its quality products to about

83 countries across four continents because of the successful implementation of Drug

Control Policy


Documents

Drug Control Policy of Bangladesh