Lessons from Bangladesh National Drug Policy 1982 Continuingly Educate Physicians at Undergraduate and Postgraduate level to understand and remember the economics of cost-effective, affordable quality medicines for the people and the clever game of pharma industries President H. M ErshadconstitutedanExpert Committee in April, 1982 with Dr. Nurul Islam, Professor of MedicineandDirector of Institute of Postgraduate Medicine and Research (IPGMR) and 7 other members to evaluate all drugs locally manufactured and importedintoBangladesh The Expert Committee had developed 16 simple criteria of which 12 are medico-pharmacogical and 4 are politico-economic, important ones are: Only single ingredient products were recommended for easy quality assurance and evaluations of side- effects, adversereactionsandcontraindications. * Combinations not to be allowed except for few exceptional products such as ORS, B-complex, Iron- folic, cotrimexazoleetc. * No cough mixtures, throat lozenges, gripe water, Alkalies, Tonics, Enzyme Digestive Mixtures etc has little or no therapeutic value and creates wrong impressioninthemindsof thepeople Key features Big bottles of liquid Vitamines and minerals will not tobeallowed. However, only pediatric dropswill beallowedin15ml bottle. Chemicals and galenical preparations not included in the latest edition of British Pharmacopeia and British Pharmaceutical Codexwill beprohibited. Key features Multinational companies (MNCs) are allowed to manufacture all registered drugs except antacid and vitamins provided they have their own factories in Bangladesh However, MNCs will be allowed to produce injectable vitamins because of higher technology No foreign brands will be allowed to be manufactured in Bangladesh under third party license Key features Imports will not be allowed if similar products are manufactured locally Production of basic raw materials will be encouraged and be given protection The Indian Drugs Act of 1940 will be amended to incorporate to control of manufacture and sale of Ayurvedic, Unani andHomeopathicdrugs Recommended heavy penalty for possessing or selling stolen drugs from the government hospitals Key features Physicians should not own retail pharmacy. Registered pharmacist should own and manage retail chemist pharmacy shops Key features National Drug Control Committee for registration of drugs, PriceControl Committee for fixation of prices of formulation products andrawmaterials Review Committee for hearing appeals be reconstituted with qualified professional representatives of manufacturers (NOT OWNER), medical faculties and consumer protectionsocieties Key features Directorate of Drug Administration must be adequately strengthened with qualified human resources (Pharmacologists, independent financial analyst, health economists etc) to inspect periodically all manufacturing units and collection of samples for quality check up and detection of fake, spurious and substandard drugs. Key features Total number of registered products both locally 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 156 local manufacturers. Over 1700 drugs banned and withdrawn 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. Drug is a special commodity, whose usefulness, 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 drugs manufactured locally and imported, giving a good return on the investment of the pharmaceutical industries Price Fixation Strategy For Price fixation purpose, all available drugs locally produced and imported are placed in 5 categories A. Simple repackaging without any processing or formulations. 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. Price Fixation Strategy Category of Drug Cost of raw and packaging material Production, distribution, overhead and profit Trade or whole sale price Retailers commission on 15% 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 Price Fixation Strategy Cost of Raw Materials (RM) (both active ingredients 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 Price Fixation Strategy Drug Prices in Taka had fallen between 50% and 75% despite increase in Taka-Dollar conversion rate. Quality of manufactured drugs improved remarkably 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 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 pharmaceutical companies and improved quality control Changes followed during 1984-94 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 had exported Taka 4212 million ($ 52.6 million) worth of medicines to 84 countries. Situation in 2010s:Drug Price started rising Sales of herbal medicine had jumped to Taka 10000 million ($ 125 million) in 2010 against Taka 10 million in 1980 2 Allopathic doctors found to be prescribing herbal medicines whose quality and appropriateness raise big question. Drug prices started shooting up since early 2010 along with higher number of irrational and unethical prescriptions. Deaths in governments hospitals & private clinic were reported in daily newspapers 3,4.5 Situation in 2010s: drug prices started rising Unethical promotions by Pharma representatives leading to sudden influx of unethical and irrational prescriptions Azithromycin is frequently used for diarrhea by General Practitioners as promoted with unethical research among poor patients without their informed consent by ICDDR,B 6 Pharma reps bribing doctors directly 7 and they violate every norms to check doctors prescriptions in medical college hospitals 8 Unethical Promotions and Irrational Prescriptions Unethical promotions and irrational prescriptions (cont.) Doctors are writing more prescriptions for Nitazoxanide instead of Metronidazole for amoebiasis and diarrheas; 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 Government Drug 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 Aggressive and unethical promotion increases irrational prescriptions leading to multiplication of profit of the companies Counterfeit version of costly drugs are surfacing in progressive order. More spurious and substandard drugs freely moving into the market. Counterfeit Counterfeit is a sharing mechanism of sinful excessive profit. By 1994, some national pharmaceuticals achieved tremendous growth and invested their profit in other business for faster return. They became greedy and quietly bribed health ministry top personnel. A 6 member committee was constituted, majority members were well known for their opposition to NDP `82. A departmental order was passed on their recommendation in gross violation of the spirit of the NDP `82. Why such reversal? 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 drugs were excluded from the Listed Drugs. Why such reversal? 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? Profit for Indicative Price Drugs is enormous, while profit in listed drugs is reasonablebut not even 10 percent of the indicativepricegroup Why such reversal? All committees were reconstituted with greater number of drug industry owner representatives On the other hand, Medical Association is poorly 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? Easy excessive profits made pharma companies reckless 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? They cleverly change the mark-up systemof 117 listed drugs. Existing 5 categories were expanded to 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 preparations 100 125 225 3. Antiviral, Antiinfective, Antifungal 100 130 230 4. Oral Antibiotics 100 130 230 5. 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 Some Price Comparisons of Listed Drugs and IndicativePricedDrugs 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 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 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