National Medicines Policy

8/10/2019 National Medicines Policy

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A Long History of National Medicines Policy:

where are we now?

Lessons fromBangladesh National Drug Policy 1982

Continuingly Educate Physicians at

Undergraduate and Postgraduate level to

understand and remember the economicsof cost-effective, affordable quality

medicines for the people and the clever

game of pharma industries


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President H. M Ershad constituted an ExpertCommittee in April, 1982 with Dr. Nurul

Islam, Professor of Medicine and Director of

Institute of Postgraduate Medicine andResearch (IPGMR) and 7 other members to

evaluate all drugs locally manufactured and

imported into Bangladesh


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The Expert Committee had

developed 16 simple criteria of which

12 are medico-pharmacogical and 4are politico-economic, important

ones are:


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Only single ingredient products were recommendedfor easy quality assurance and evaluations of side-effects, adverse reactions and contraindications.

* Combinations not to be allowed except for fewexceptional products such as ORS, B-complex, Iron-folic, cotrimexazole etc.

* No cough mixtures, throat lozenges, gripe water,Alkalies, Tonics, Enzyme Digestive Mixtures etc haslittle or no therapeutic value and creates wrongimpression in the minds of the people

Key features


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Big bottles of liquid Vitamines and mineralswill not to be allowed. However, only pediatricdrops will be allowed in 15 ml bottle.

Chemicals and galenical preparations notincluded in the latest edition of BritishPharmacopeia and British PharmaceuticalCodex will be prohibited.

Key features


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Multinational companies (MNCs) are allowed tomanufacture all registered drugs except antacidand vitamins provided they have their ownfactories in Bangladesh

However, MNCs will be allowed to produceinjectable vitamins because of higher technology

No foreign brands will be allowed to bemanufactured in Bangladesh under third partylicense

Key features


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Imports will not be allowed if similar products aremanufactured locally

Production of basic raw materials will be encouragedand be given protection

The Indian Drugs Act of 1940 will be amended toincorporate to control of manufacture and sale of

Ayurvedic, Unani and Homeopathic drugs

Recommended heavy penalty for possessing or sellingstolen drugs from the government hospitals

Key features


8/33

Physicians should not own retailpharmacy. Registered pharmacistshould own and manage retailchemist pharmacy shops

Key features


9/33

National Drug Control Committee forregistration of drugs, Price Control Committee

for fixation of prices of formulation products

and raw materials

Review Committee for hearing appeals be

reconstituted with qualified professional

representatives of manufacturers (NOTOWNER), medical faculties and consumer

protection societies

Key features


10/33

Directorate of Drug Administration mustbe adequately strengthened withqualified human resources

(Pharmacologists, independent financialanalyst, health economists etc) to inspectperiodically all manufacturing units and

collection of samples for quality checkup and detection of fake, spurious andsubstandard drugs.

Key features


11/33

Total number of registered products bothlocally produced and imported from 122

foreign companies of 22 countries were 4340

of which 1742 were found to be harmful,

inappropriately formulated or

therapeutically ineffective. Out of 1742

harmful and / or ineffective drugs, 176 were

imported and 949 were manufactured by 156local manufacturers.

Over 1700 drugs banned and withdrawn


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Capitalist countries had exported

more ineffective, useless or harmful

drugs than that of socialist countries.West German and Swiss Companies

ranked very high in mischiefs.


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Drug is a special commodity, whoseusefulness, safety and quality cannot be

judged by the consumer even though they pay

for it

To protect the consumer, government will

check and fix the price of all drugsmanufactured locally and imported, giving a

good return on the investment of the

pharmaceutical industries

Price Fixation Strategy


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For Price fixation purpose, all availabledrugs locally produced and imported are

placed in 5 categories

A. Simple repackaging without any processing orformulations.

B. All oral medicines and topical preparations other

than antibiotics.

C. All oral forms of antibiotics

D. Hormone and steroid preparations

E. All sterile preparations.



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Category of

Drug

Cost of raw

andpackaging

material

Production,

distribution,overhead and

profit

Trade or whole

sale price

Retailers

commission on15% on MRP

MRP without excise

duty/VAT

A 100 27.50 127.50 22.50 150.00

B 100 91.25 191.25 33.75 225.00

C 100 95.50 195.50 34.50 230.00

D 100 138.00 238.00 42.00 280.00

E 100 189.00 289.00 51.00 340.00

Source: Bangladesh Drug Administration, 1992



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Cost of Raw Materials (RM) (both activeingredients and excipients) and Packaging Materials

(PM) are based on landed cost, conversion of US

Dollar to Taka, transport cost from port to factory,Advance Income Tax (AIT) and custom duties and

other taxes. Value Added Taxes (VAT) is added after

the fixation of Maximum Retail Price (MRP).Cost of RM and PM usually be reviewed once a

year. Suggested strategy entitled them double figure

profit over their investment



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Drug Prices in Taka had fallen between 50%

and 75% despite increase in Taka-Dollar

conversion rate.

Quality of manufactured drugs improvedremarkably due to vigilance of Drug

Authority.

Drug market had enhanced from Taka 1000

million to over Taka 25000 million. 10

powerful national companies emerged.

Changes followed during 1984-94


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National companies had taken over 60% business

while they had less than 20% business in 1981.

Country started producing about 90% of

Bangladesh needs.

BAPI (Bangladesh Association of Pharmaceutical

Industries) who condemned NDP 1982 had

congratulated Bangladesh Government in 1986 for

helping the unexpected growth of pharmaceuticalcompanies and improved quality control

Changes followed during 1984-94


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Success in domestic market and little export

Pharmaceutical sector recorded sales of Taka

87880 Million ($ 1098 million) and meets

almost 97% of local demand and grew

23.6% in term of sales in 2011 according

to IMS report 1

36 local companies and 3 MNCs hadexported Taka 4212 million ($ 52.6 million)

worth of medicines to 84 countries.

Situation in 2010s:Drug Price started rising


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Sales of herbal medicine had jumped to Taka10000 million ($ 125 million) in 2010 against Taka

10 million in 1980 2

Allopathic doctors found to be prescribing herbalmedicines whose quality and appropriateness raise

big question.

Drug prices started shooting up since early 2010

along with higher number of irrational andunethical prescriptions. Deaths in governments

hospitals & private clinic were reported in daily

newspapers 3,4.5

Situation in 2010s: drug prices started rising


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Unethical promotions by Pharma representativesleading to sudden influx of unethical and irrational

prescriptions

Azithromycin is frequently used for diarrhea by General

Practitioners as promoted with unethical research amongpoor patients without their informed consent by ICDDR,B 6

Pharma reps bribing doctors directly 7 and they

violate every norms to check doctors prescriptionsin medical college hospitals 8

Unethical Promotions and Irrational Prescriptions


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Unethical promotions and irrational prescriptions (cont.)

Doctors are writing more prescriptions for Nitazoxanide

instead of Metronidazole for amoebiasis anddiarrheas; Azithromycin for diarrhea, typhoid and PID

Other misused drugs are caffeine with paracetamol,

Diclofenacs, Statins, Irrational vitamin preparations with all

sorts of mineral which cannot be detected in GovernmentDrug Laboratory; Benzodiazepines, sex hormones, steroids,

Terbinafine, Butenafine, Crotamiton etc

Promoting Directly to Consumers through daily newspaper

with separate advertising sheet on Dukoral (a Swedish

company, Crucell product) for prevention of diarrhea and

cholera tactfully using name of WHO and ICDDR,B


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Aggressive and unethical promotion increasesirrational prescriptions leading to

multiplication of profit of the companies

Counterfeit version of costly drugs aresurfacing in progressive order.

More spurious and substandard drugs freely

moving into the market.

Counterfeit

Counterfeit is a sharing mechanism

of sinful excessive profit.


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By 1994, some national pharmaceuticals

achieved tremendous growth and invested their

profit in other business for faster return.

They became greedy and quietly bribed healthministry top personnel. A 6 member committee

was constituted, majority members were well

known for their opposition to NDP `82. Adepartmental order was passed on their

recommendation in gross violation of the spirit

of the NDP `82.

Why such reversal?


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1. A list of 117 drug (referred as Listed Drugs

should remain under existing price control

regulation, 26 of 117 Listed Drug were

contraceptives intravenous solution and

vaccines.

2. Fast selling drugs such as cimetidine,

Ranitidine, Diclofenac, Cephalosporins,

vitamins with minerals and newer drugswere excluded from the Listed Drugs.

Why such reversal?


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3. Every manufacturer should ensure 60 % of drugs it

produces are Listed Drugs.

4. To ensure sufficient production of Listed Drugs

duties on unlisted drug may be raised to 15%

Clause 3 & 4 never been enforced

5. Prices of drug not in Listed Drugs will be fixed by

pharmaceutical manufacturing companies

themselves. This is called Indicative Price on

which Drug Authority will add 15% VAT.

Why such reversal?


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Profit for Indicative Price Drugs is

enormous, while profit in listed drugs is

reasonable but not even 10 percent of the

indicative price group

Why such reversal?


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All committees were reconstituted withgreater number of drug industry owner

representatives

On the other hand, Medical Association ispoorly represented by only one junior

teacher

Drug Administration are allowing more and

more combination drugs, all of which are in

INDICATIVE PRICE Category

Why such reversal?


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Easy excessive profits made pharma companiesreckless and making misleading statements

implicating of Dollar Taka conversion rate as a

reason for increase price. As a counter

misinformation, continuously propagating that

pharma exports will soon overtake garment

export. Present pharma export is not even 1

percent of total national export.

Why such reversal?


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They cleverly change the mark-up system of 117

listed drugs. Existing 5 categories were expandedto 9 categories to harness further profit out of

Listed Drugs group

Why such reversal?

Sl.Product RM+PM Markup

MRP

without VAT

1. Repacking 100 50 150

2.Oral preparation except

Antibiotics and FP preparations100 125 225

3. Antiviral, Antiinfective, Antifungal 100 130 230

4. Oral Antibiotics 100 130 2305. Sustain Release Tablet/ Capsule 100 180 280

6. FP Pills 100 180 280

7. Dispersible Tablets 100 200 300

8. Steroid and Hormones 100 240 340

9. Aseptic Preparations 100 240 340


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Some Price Comparisons of Listed Drugs and

Indicative Priced Drugs

Why such reversal?

Listed Drugs Unit price Indicative Price Drugs Unit price

Tablet Metronidazole

400 mg

Tk 1.20 Nitazoxanide

500 mg

Tk 10.00

Erythromycin

500 mg

Tk 8.00 Tab. Azithromycin

500 mg

Inj. Azithromycin

500 mg

Tk 30.00

Tk 250.00

Ung Whitfield

25 gm

Tk 10.00 Terbinafine Tube

5g

Tk 50.00

Benzyl Benzoate Lotion

100 ml

Tk 18.00 Crotamiton

60 ml

Tk 66.00

Tab. Paracetamol

500mg

Tk 0.60 Tab. Paracetamol

500 mg with 65 mg Caffeine

Tk 1.80

Tab. Paracetamol

665 mg extended release

Tk 2.50


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Teaching of clinical pharmacology

and pharmaco-economics is of

utmost importance to protect

peoples health from the greed of

the pharma industries.

APCNMP, Sydney 28 May 2012


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1 Pharma sales rise 20 pc; outlook is bright, The daily Star, Dhaka, 21 May 2012.2 Herbal medicine market to cross Taka 2500 crore by 2010, The Daily Star, 20 may

2012.3 Child died within 2 minuits of injection: Alleged irrational treatment, Daily Azadi,

Chittagong 8 October 2008.4 Injection given wrongly in Kushtia Government Hospital, Daily Prothom Alo,

Dhaka 6 February 2009.5 Death from Azithromycin injection, Daily Somokal, Dhaka 23 April 2010.6 Diarrhea prevention and oral Azithromycin. Daily Prothom Alo, 7 April 2010.7 Doctors are taking money from drug companies, Daily Bangladesh Protidin, Dhaka

24 May 2012.8 Representatives are reckless in hospitals, Daily Bangladesh Protidine, Dhaka 24

May 2012.

References

Documents

National Medicines Policy