VIEW POINT
NATIONAL DRUG POLICY OF BANGLADESH: SOME PITFALLS IN IMPLEMENTATION Fazle Rabbi Chowdhury, H.A.M.Nazmul Ahasan and M.Mizanur Rahman*
A BSTRACT Drug development, manufacturing and marketing have become one of the most important sectors throughout the world for various reasons. Realizing its importance, the World Health Organization (WHO) has stressed the need of a formulated drug policy in every country of the world.1 Bangladesh responded very early to this. Experiences over the decades have shown that the said policy could not fulfill in toto the declared objectives. Our aim is to describe some of the lacunae for which total implementation of drug policy is still struggling. For this purpose, we meticulously analysed our Drugs Control Ordinance1982 (with an amendment brought in1994) and upcoming National Drug Policy. We mainly focussed on three factors pointed out by WHO, which are crucial of a drug policy, which include price limitation, quality and rational use. We found great variations in price which need to be controlled. Regarding quality, safety and efficacy, we have to be more cautious. Rational use of drugs is also an area to be focussed on. Every physician should prescribe proper drug with due indication and in rational way. This pitfall of implementation might happen in many countries of the world and it needs a global discussion so that the future policy makers can mitigate the demand of the nation. KEY WORDS:
Drugs. Drug policy. lmplementation. Bangladesh.
INTRODUCTION Medicinal drugs have a crucial role in disease treatment and prevention. As such medicines’ development, manufacture and marketing have become one of the most important area throughout the world for various reason. The tremendous increase in pharmaceutical sector results in development and marketing of agents of spurious or of only little value thus creating the so-called ‘therapeutic jungle’- from where drugs relevant to the health needs of the people need to be sorted out. This concept was developed and elaborated by World Health Organization (WHO) experts during mid seventies and came to be known as ‘Essential drug concept’.1 Besides, WHO pointed out the need of a formulated policy development incorporating the concept of “Essential drug” for every nation of the world. Bangladesh was one of the only 14 countries throughout the world to respond properly and to develop a National Drug Policy in 1982.2 This well formulated policy produces some tremendous effect on rapid development of the local pharmaceutical industries as well as makes an overall improvement in the drug sector of Bangladesh. Some examples are given below:(a) The number of pharmaceutical companies has increased from 177 in 1982 to 300 in 2004.3 (b) The essential medicine also become available with the increase in the volume of local production. The monetary
Department of Medicine, Khulna Medical College Hospital, Khulna, Bangladesh. *Department of Surgery, Khulna Medical College Hospital, Khulna. Bangladesh. Correspondence: Dr. Fazle Rabbi Chowdhury, Flat No – 4/D, ‘Ruby Tower’ 49, Dilu Road, New Eskaton, Dhaka, Bangladesh. E-mail:
[email protected] Received September 13, 2005; accepted: April 16, 2006.
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value of which grew from taka 1,730 million in 1981 to about taka 41,000 million in 2002.3 (c) In most of the cases drug prices stabilized, including (practically a drop in price in real term) by only 20% compared to an increase of 179% in the consumer price index.3 (d) Less dependency on imports and prioritization of useful drugs saved the country approximately U.S. $600 million.3 In spite of these improvement the said policy could not fulfill in toto the declared objective of providing essential drugs to all those who need them, about which the future policy makers should be cautious. In this paper some of those lacunae are discussed and we think this will help all the health personnel of the world who are in close touch with all aspects of health related policy-making and its implementation.
THE
OBJECTIVES OF A NATIONAL DRUG POLICY World Health Organization (WHO) points out three objectives as crucial of a national drug policy.1 These are: 1. Access: equitable availability and affordability of “essential medicine“ including traditional medicines.1 2. Quality: the quality, safety and efficacy of all medicines.1 3. Rational use: implies promotion of therapeutically sound and cost-effective use of medicine by health professionals and consumers.1 This paper discusses these objectives from Bangladesh perspective. (A) P RICE LIMITATION : In our 1982 drug policy, 150 drugs were selected as “essentials”. 2 According to existing drug policy, maximum retail price (M.R.P) of every essential drug will be fixed by the Directorate, Drug Administration, an Administrative Authority under the JCPSP 2006, Vol. 16 (5): 368-370
National drug policy of Bangladesh
Ministry of Health and Family Welfare, Government of People’s Republic of Bangladesh.2 At present in Bangladesh there are one hundred and seventeen (117) essential medicines, the prices of which are fixed by the drug administration.2 In case of others, company price is endorsed by the administration. However, the real situation does not reflect the principle of price fixation. One or two example is enough to prove this. “Ciprofloxacin” is a life saving antibiotic and vastly used for many diseases. Even at present, cost of Ciprofloxacin extends from Tks 5 to 14, a price variation of 180%.4 It is very difficult to explain this variation in price. Whether the cheaper one is made at low cost sacrificing the quality and its reverse is also true. Policy makers throughout the world should be cautious and need to address the problem and formulate effective line of action to control all these illogical price variation. The drug administration should check this abnormality regarding price and quality. The government should take immediate action about it and every body in the country should know its fate. This sort of things might happen in any county of the world. (B) Q UALITY, SAFETY AND EFFICACY: Still there is no adequate drug testing facility in Bangladesh. Presently, drug administration has a laboratory but it is quite inadequate for the total demand. We know that as a developing country, we have many limitations. The government should try to take immediate initiative to establish at least 6 well equipped drug testing laboratories in the divisional cities as well as to enact a legislation that every company have to cross this testing hurdle before marketing a drug, and have to pay for it. Another important thing is, in relation to the formation of Technical Committee that addresses technical aspects (quality, safety and usefulness) of a drug approval for marketing registration. Most of the members of this committee are not specifically related to this sector. On the other hand, every practitioner should be cautious in prescribing a new drug. The example of cox-2 inhibitor is enough to prove it. Since 1999 celecoxib, rofecoxib, valdecoxib etc. are being widely used all over the world including Bangladesh in a wide range of various arthritis and pain syndromes.5 But within 4 years (in September, 2004) rofecoxib was withdrawn from the market.6 Before withdrawal, the combined yearly sales of cox-2 inhibitor exceeded $5 billion.6 Three randomized, placebocontrolled trials provided new evidence about the cardiovascular risks of rofecoxib, celecoxib and valdecoxib.7 From this example, the integrity of the American Drug Safety System has been questioned. How did such problem arise and how can they be prevented in the future?8 Steven Galson, acting director of the center for Drug Evaluation and Research, United States, said: “ our current drug approval system has demonstrated that we don’t always understand the full magnitude of drug risks prior to approval of drug products”.8 According to a September 2001 report by USA Today, 55% of all FDA advisory panelists had financial interests in the drugs they reviewed. A transcript of the most recent arthritis advisory panel meeting in June 2004 showed that seven of the 14 panelists, including the panel’s chairperson received waivers for financial conflict of interest.9 If this is the picture of United States Federal Drug Administration (FDA) about
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safety and efficacy specially while prescribing new drugs, then what may be the situation in developing countries e.g. Bangladesh? Every policy maker should think about that and build effective mechanism to mitigate the problem. Conversely every practitioner should be cautious in prescribing newer drugs regarding their safety and efficacy. (C) USEFULNESS AND RATIONAL USE: The physicians are the ultimate judges in this regard. According to our 1982 drug policy, there is a clear indication that no company can market a drug of similar benefits as of the existing one with minor chemical difference. 2 but many companies are not abide by the act. So the whole society is exposed to unnecessary drug with potential risk. For an example, in case of cardiovascular disease, use of angiotensin converting enzyme inhibitor is very popular. At present, in Bangladesh, there are captopril, cilazapril, enalapril, fosinopril, lisinopril, perindopril, and ramipril in use.4 Of course, the efficacy of captopril and the related progeny is more or less same, but the price varies from 3 taka (approx. 2 Pak. rupees) per tablet to 18 taka (approx.12 Pak. rupees) per tablet is another example of the same class of agents.4,10 This corresponds to a variation of 500%! So every physician should use cost-effective drug. But many physicians are using others instead of captopril, possibly because of personal illegal interest and unethical, aggressive promotional activity of the pharmaceutical companies. Recently, different companies in our market launched a mixture of vitamins and mineral. But is there any justification of marketing this sort of drug in a country like Bangladesh? Ask yourself? What are the deficiency diseases we commonly found in Bangladesh in our common practice? Most are due to Vitamin A or Bcomplex, iron, calcium, iodine, or zinc deficiency. B-Complex or multivitamin preparation and/or specific mineral replacement is enough to treat these cases. There are very seldom diagnoses of selenium or vanadium deficiency or molybdenum deficiency, if ever. How many amount of tin are required for a healthy life? So, there is no point in prescribing these type of agents to our poor people. Because a single tablet costs about 6-7 taka (approx. 4-5 Pak. rupees), whereas common multivitamin takes only 1-1.5 taka (less than 1 Pak. rupees)/tablet. This type of vitamin-mineral mixture is still absent in the market of Britain, Australia, New Zealand and other European countries. British pharmacopoeia clearly indicates that there is no justification for prescribing multiple ingredient vitamin preparation.11 Even according to our 1982 drug policy, this is completely unlawful because a mixture of vitamin and mineral has no proven scientific basis. Another important issue in the last 4-5 years is the launching of many new agents by pharmaceutical companies in the world market including anti-hypertensive, hair tonic, antiimpotency, cholesterol lowering agents, anti-depressant, sleep regulating, anti-psychotic and anti-obesity agents etc.12 But there are very few new agents for the medical problems most common in developing countries like infectious diseases (examples being malaria, kala-azar, tuberculosis) or the poisoning antidotes like anti-snake-venom, dimercaprol (for heavy metal poisoning), naloxane (for narcotic poisoning) etc. So there should be a clear guidelines regarding this in every drug policy.
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CONCLUSION
5.
Ahasan HAM. Caution with Cox-2 inhibitors (editorial). BMJ Khulna 2004; 37.2: 27-60.
Last of all, the aim of every physician should be to prescribe proper medicine with due indication and in a rational way. It is only possible when there is an effective drug and health policy. So policy makers of every countries of the world, particularly developing countries like Bangladesh, Pakistan, India, Sri-Lanka etc. should pay attention to all these problems and come forward to make an effective drug policy that reflects greater interest of the community.
6.
Drazen JM. Cox-2 inhibitors: a lesson in unexpected problems (editorial). N Engl J Med 2005; 352: 1131-2.
7.
Psaty BM, Furberg CD. Cox-2 inhibitors - lessons in drug safety (editorial). N Engl J Med 2005; 352: 1133-5.
8.
Tanne JH. FDA will increase postmarketing surveillance of drugs, BMJ 2004; 329: 1203.
9.
Lenzer J. FDA bars own expert from evaluating risks of painkillers. BMJ 2004; 329: 1203.
REFERENCES
10. Edwin KJ. Renin and angiotensin. In: Hardman JG, et al. (edi.) Goodman & Gilman’s the pharmacological basis of therapeutics. 10th ed. Mc Graw-hill 2001: 809-42.
1.
W.H.O. Policy perspective on medicines - How to develop and implement a national drug policy 2003;Geneva: 1-6. Available from:URL : http://www.who.int/medicines.
2.
Ministry of Health and Family Welfare: Drug (control) ordinance, 1982, enacted by Government of People’s Republic of Bangladesh: 1-10.
3.
Ministry of Health and Family Welfare: National Drug Policy, 2004 (a preliminary paper), compiled by the Directorate of Drug Administration, Government of People’s Republic of Bangladesh: 2-13.
4.
Islam AFMS, Khan AA, Jahangir MS. Drug Bangladesh. Drug Information Center 2003.
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11. British National Formulary (BNF). 41st ed.; 2001: 428-33. Available from: URL: http//www.
[email protected]. 12. Sterckx S. The lack of access to essential drugs: the nature and magnitude of the problem. Drug and Health 2003; 5: 1-8. Available from: URL: http// www.drugandhealth-bd.org
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