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    drug policy of Bangladesh 1982

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    © All Rights Reserved
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    29 views17 pages

    Drug Policy of BANGALDESH 1982

    Uploaded by

    Tawhida Islam
    drug policy of Bangladesh 1982

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 17
    Report of the Expert Committee for Drugs ON THE NATIONAL DRUG POLICY OF BANGLADESH 1982 Government of the Peoples’ Republic of Bangladesh Directorate of Drug Administration Ministry of Health & Population Control March, 1986. Drug Admin. Publication No. 2 INtRODUCTION ‘The pet cepa consumption of modes étage in Bangladesh is about US § 1,00 par year and this iv onu of the lowest in the warld. Millions of our people have little access to the most sseential lifesaving drugs, and yet Bofors 1982, a large number of wasteful and undesirable medicinal produsts were manulacturad and marketed, mostly uncer commercial pressure, The mark at that timo was fieeded with various amortment ol tens, vitamin mistures, cough and cold remedies and many other Undesirable eombination Bteducts, while assantial Guys needed for primary and secondary levels of health core were in short supply. In view Of the scarce resources and the urgent need to-implemant health progtammas, it wae nacotsary to formulate anew diug policy as part of the national health policy. Soon after the promulgation of Martial Law in March 1982, tha Chi asked {0 inoduce 2 new natlonal dug policy designed to give priar casential drugs, and to remove from the market all harmful, useless and unde ble prod: Tha Govern. ment appainted an oight.membered Experi Committers for drafting the new national drug policy and te uate all the 4.340 drugs licensed at tnat time for sale In the fountry, beating In mind the country’s oiority health needs. Martial Law Admininliotor (eMLAy No the production of salected The Exnem Committos working day and night did a vey comnerdaSie jo, and submitted its Repott to mean V1 May 1832, Part ol this Repo ( exaluding the List of divgi to ba banned ) is publisned in this booklol. The fist of banned duys was published eather in Drug Administration Publication fo. 1, Agting on Hinsy recom mandutions of Ue Exec Commities. Lt, Gaverol H, M, Eshad. the Chiat Mastiat Law ‘Adminisiator, approved and enacted the Drugs ( Gontral } Ordinance, 1992 { Ord, He. VIII of 1982 ) on 12 dune 1982 as @ first sis in impleneating tha new national drug policy. Under this Ordinance, thu muistration of 1686 harmful, unnecessary ot otherwies undosirable drugs wos cancelled or auspendad, and these products were giadvalty withdrawn from the matket in phases, At the sama time, the “overnment adopted the draft national drug policy rocammandad by the Expon Committoa as the new Nationst Drug policy for Banglads Tho Expeit Committee identHied 16 guidelines for tha wealuation of madscinal products and for assazsing, ‘ehicit products should bo withdrawn or reformulated. These guidelines have been described and based On “sound therapeutice” by most experts in Bangladesh and abroad, Our Orug Adniiniswation follows these guidelines for continugus evaluation and monitoring of ol! mew and existing duge for the purpose of registration and licensiag. ‘The New policy has helped to incrense focal prodvetiun of diuge. Whereas me value a! louaily produced. dlugs was only Tk, 175 Crore in A961, thishes mached the level of Tk, 325 Crore in 1955, Thelocat induelry hos by now adljusted uself with the naw policy. The production copscities affected due to banning ja!some products have bean mara than compensated by the Increased volume of production af esxentint This was exactly tha underlying objective of withdrawing the fancy and useless products in the first Whereas tho share of 45 ezgeatial drugs for primary health care in local produztizn was only 30 percent in 1981, this hax now increased ta 65 percent in 1935. Many raw materials which were imported 4 earlier al an prices and to keep taom more stable, Unani, Ayurvedic and Homoeopathic drugs ware brought under th convo! of current drug legislations as @ consequence of tha new drug policy, and this has mede thelr further davelopmant and modernization possible. The new drug policy hos already yielded good results, With the full implementation af ihe new National Drug policy: the supply position of assential drags in the country will improve further in the coming years, However, we have still 19 g¢ a tong way to fullil our national objective of ensuring avallability ‘of good quality esse: drugs for all who need them ai the various favels of tha health care systom at the most reasonable prices. td). Malor General M. Shamaul Haq Dated, Dhaka. Milnister for Health & Populatian cimstiol YO March 1986 Government of the neoaia's Republi¢ of Bangleda i pricts afe now belong imagtied at ednipetitivs prices, and this has heiged to wd.” —___ sia, ie DRUG SITUATION BEFORE THE DRUG POLICY OF 1982 In 1881, the people of Bangladesh spent an estimated amount af 150° crore taka on allopathic drugs of various kinds comprising about 3.600 brands, Nostiy one third of this money war spent on Unnvcessary. and usoless medicines such a3 vitamin mixtures. tonics. alkaliser, cough mixturas, di= (gestive enzymes, palliatives, gripa water, and hundreds of other similar products. Wheross, of tho Gaz diuga which the Government earlier lad salacted ta be asscniial, rat more than 90 were lor iy manufactured, It in @ féspaasibility of the Goveramomn to protect the connumant from being fosd.winked imo spending their scanty resources on useless, unnecoisery and at times harmful drugs. Tata wore 126 Uicentad pharmacoutias! mucutocturars In tho country but loca! production was dominated by @ght multinational companias who manufactured about 70% af the prod vets ‘Thora wore seredumesiced national eompanian who manufactured another 15% of the products, The remainicg Tex ware produced by 133 mall local companise who were cepable of praducing only simple Tiquid formuletions. n, Thay procured thelr row A foreign exchange, ‘All tha phamaceutical companies wete mainly engeged In formula materisis by Import, involving en annual expenditure of taka 60 crores Incomplete transfor at technology, retttctive Butingys practices, and purchase of raw materials by the muttinationsls at inflated priras from lige! Sources wore detrimental to our matlanal eenomy, ‘Though The mubinetionals hava il tho Technologied end know-how to produce tophinticated essential drugs and Danie phormaceutigal raw mateials, in Bangladesh these companies wore engaged mostly In formutation Of simple drugs including many useless products wuch ss vitomin mixtures, tonics, gripe water, ste, Jn spita of me 168 local pharmaceutical Industries, the county wes iN Impar Toka 25 Wo 20 race of Hinahed crugt every yeor, There Wasa seone 12 recce the muri of irnportabis iteme by Gaining thore which are rot ossontial or the substitutes of which ware [orally manufactured, Unoni, ayurvedic and homosonathic drugs wero exempted from contro! wider the tan crag lows, Consewantly, there wor & peolitwration of uselnicat, and harmful products of uncertain quality, Most highly misused products of this group wera the alone! cortsining tonics. ‘the Drugs Act 1940 which was the besic crug legislation, ts outdated ond grossly Inadequate. ‘the outdated legal plocedute Ficdered rather than helped prompt prosecution and penatiies, Much ‘ot the unetnical practices in mpnufacture and tau was poseible because af the wi jakness of the histing legislation. Furtet, the concept of drugs and medicines as en ential component of health sire waa missing. There was no provislon in the drugs Act for the contro! of prices of pharmece+ Utica! raw materials or finished products. Maximum retail prices of finished drugs wets fixed by the Ministry of Commerce under the ea ential Commodities Act ond Orders, There was no agoncy for onforcement of prices at etait level ; ny drugs tluctuated widely in the matkot according to demand and supoty. futther. thet aoe eee ontt) over the pricas of pharmaceutical caw and packaging material which contribute Test than 60% of the prices €& sade lavel, The same materiais were imported from differant sources bby different manutactuters at widely variable, pricos ranging up to four ties. aay In tha then dtug laws, thera was no prnivison for regulating technology wansfar and/or licensing Jgreenant with foreiga collaborstors, Similarly there wes neither provision for protesilan ef ‘gonsum against drag hazards a9¢ thara wat protection of national Interest in respect of patent rights of yurmageutical substaac us Recopalting the right of every citizen to enjoy the highs! possible level of haalin cee, « japan uigont need to mobilise and make economic and effective uss of all available retources for roving tha state of health of oUt poopie. fuga being mos exsantial tools for health care, chose tunnot ba vested just as any other commorcial product, (n ¥9B1, ot more than 20% of the poalation had ecomss €/2a to to mast eastnval drugs for their health naods end yar the movka fas flooded with huadreds of uisléss or non-asesatal medicinal products: ‘The problem of incraasing costs of exnendiiure on drugs A citdicines as become @ crucial jue bath for the public health and the private sectors, It was, therefore, nesded to teke urgent ups 1a dulld up an éconemies! and ficient drug aupply system to mest the nriority heath néeds ol the country ond to feduca unnocestary wastage on ussless or non-essential drugs and medicines Drug Adesinistration under the Ministry of Health is tha main aponcy for adminisustion and enforcement a arug legislation. It haa onty 32 otficars of which 20 sarva ax lnepecters, This number Is aro lp inadequate There are Two govemftant dup testing laboratotien, one in Dhake and the other vr Chittagong. The combined lord of thaie laboratories exceed 5000 samples par year, The stati Gad oqupment of these laboroties ata grostly inadeguste, In the country there gre about fy009 retail pharnacies and another 1209 whalesaless. The Gavomment utilizes only 10% of the tuyl available drugs; tne ramainihg 90% is utilized by the private sector. NATIONAL DRUG POLICY OF 1982 4. Neod for a National Drug Policy + The problem in tewect of fg supply are multisectoral and complex, Thet thero it 8 noad tor lige quantity af essentiel, effizzcious and economic drugs for both the public ond private sectors Cannot ba disputed, io fect. if the essential drugs ate not teadily available at reasonable cost, [a national objortva of health for all by the yaar 2000 cannot b» acnioved. In the context of seares resources and urguney ef implamencation of health programs, it Is All the more important mat a rational drug policy bo formulated as a part of national hoaltn policy. This policy should graure procurement, local produttl3.1, quality canrol, distributlon and utilization of drugs under uni- fea lagesintiva ond adminiautative control, Qnly on the basis of such a policy con effective measures uo taken to provide widest coverage with tha mast relevant essential d/ugs at the mini. (tum cost, 2, Objective: The objectves of the national drug policy are: 2.1 to provide administrative asd [igistative support for ensuring quality and availability of oss. ‘ntial drgs which afé of ralovanco to tha health naeds of the majority of the population, es of diya and madicings and 19 @ ive wices, 2.2 wo roluco the pr a pidcurament of raw materials ai the mast compar (a) 2.8 to oliminate us ral ani hormiul drugs from the market, 24 to promote local praduction of finished drugs as woll ag of basic pharmaceutical téw and packaging materials in the country, 2.5 to ensure co.ordinotion among various adminisirativa branches of the Government in respect of drug control and drug supply system, 26 develop dug monitoring and information system to pravant wasteful misuse of drug to ‘ensure their groper utilization, 2.7 10 pramota sciantific development and application of unant, ayurvedic and homosopathie madicinas and to ensure theif standardization and quality by bringing these under the purview of drug lesiglation, 28 to Improve the standard of hosplts! pharmacies and prlvate retail pharmacies by improving the facilities for aducstion and treiting of proferslonal pharmacists, 8, IDM -DtB0: 2,9 to encure GMP and each manufacturing company employing qualifi pharmacists, ACTION REQUIRED To achieve the odjective of national dug palicy end to provide guidelines for the formulation of programme the following actions wre 14 bé taken: 3. Selection and provision of essential drugs; The major strategy is te overcame constraint of limited resources for the optimum utilization. This also colle for the olimination of ail unnassazaty, urelase drags and deuga of doubtful efficacy from the marke. A limited list of 189 sssential drugs considerad adequate for most therapeutic purpoaes shall be selected, Out of th:s about 45 asnantlal drugs will be selected jor the primary level of health care on the basis of priority health nead, cost, safety, and lity of (reatment of commen diseases and symptoms by up 10 Thano level health workers, Besides. for the protection of tha watt majority people in the rural areas from hazards of uadue pre- ys and in an stiempt to giv them relief by basic heath workers, it ia exzential to limit the essential drugs to 12 whieh era considered safe and adequate for common medical problems. The list | the-esanntial drugs ora appended herewith ( Appendix! j, Besides, thors may be a list cl another about 100 supplanentary drugs needed for tortiary level health cors by spacialists tAppendx.ll), The various brands of drugs in tha market shall be evalua id cantinuaisly on tha basis of ther ysofulaess, ossentiality end as por guidelines and evitotia deve. lnped for this purmose (Appondix-ti) and cost-effectiveness in the light of up to date available infor. mation. In future, only products which are considered essentis| and relevant ta health needa of the Jeountry und are consistent with thie policy shall be licomed or sigisverod, The eolected aatentiol jugs shall ba given preferential westment terms of licensing, import authorization, dutles and jother financial ben: ‘The selected 45 estential drugs for primary health cara shall be allawad to b> manufactured or tid only under their generic names. As oan a3 possible and nat tater than 1983, a Notional Formulary will be prepared and published, which shell include all the formulations thar will ba allow- Jed for manufacture, import or sole in this country, Products such ay liquid vitemin mixtures, mulll> ple combinations of potent drugs, combination of antibiotics whh other active drugs, alkali mixtures, c4y rips waters, cough mixtures, tonics, balms, digestwa anzyms preparations, habitorming arugs, vans pubs and other similar useless and nonessential products will be identitiad and their ficensing/regis- jtian shall be canceled so that such products ore complately allmiasted trom Bangladesh. RUG ACT }2 The pruge Ast 1940 shall be revised of replaced by a now drug legitlation incorporating provi. slant for— i. a system of registration of all medicinal greducts including ayurvedic, unaai and homeopathic medisin . enforcement of good manufacturing practices ; ii, full control of labelling and advertisomant : jv, control of prices of finished drugs and pharmaceutical, raw ma Preieription control of toxic, poisonaus and habit forming drugs; vi, summary tial for offences in special drug couns ; vil, hoovy penalties. including, confiscation of equipment and properties for manufacture and oF selling of spurious end sub-standard drugs; departmental adjudiciation for fine of up to teke 10,000/—; heavy penalty for possessing oF sailing of drugs stolen from government stores, hospitals and dispersaries ; x, regultion of technology tianster and licensing agreement with fersign collaborators : x1, restriction of ownership of retail pharmacies to professional pharmacists only: if, conval af manufacture and sale of unani, ayurvedic and homecpathic drugs wii, the patent lews in respect cf pharmaceutical substances shall be revised : Product patent in respent of phammacsutical substences shall not be allowed, Process patent may ailowed far a ted period of time if only the basic substance ls manulactured within tha country. tariff structure in respect of pharmaceutical raw materials for sclacted essential drugs, quality control vipment and chemicals shall be revised. A drug technical advisory board consisting of representatives ji pharmacoutical profession, industry, phomecy deptt, of the university. representations from the protas “d organisations and expers from tha pratassion shall be constiwied to review from time to time far implemantatlon of drup policy, DRUG ADMINISTRATION 2 The Directoate of Drug Administration will be expanded and adequately stalfed with experts in med. ical and pharmaceutical sciences. In view af the gross inadequacy of drug inspectors. sli Thana Heatth Adminigteacors shall ba givan special course of training and be empowered to act as drug in spectors for the purpose, so thst they can take meaningful Sanctions against wholesalers. retailers and peddicrs of drugs at thane level and below. All the govomment drug control laboratories Should be brought under the contol of Drug Admirististion. A properly staffed and equipped Natl- erat Crug Contra! Ieborstory with appellate facilites will be set up aa early a1 possible, not tater than 198g. Besides its function in respeet of drug control and administtavon, the National Drug centro! ud aby Laborsiory will devote Itself to develop appropriate standards end specitications for unani and eyut. vedic diugs. It will alo help develop national formulatigns for unani and syurveaic drug The foes for licansing, registration and testing of drugs which are ridiculously low at present shall bo enhanced, Licensing oF registration fees for neve products which sre not included in me national list of essential drugs anall be very high (not less than taka SO00/- ). The renéwiola fees of lieonsing. topatration and testing shall be utilised for exPansion and dovelopment of drug admini stration and drug testing laboratories. No manulacturé: will be allowed 10 produce dugs without agoquate quality convol facilities, However, the small nutional drug manufacturers. moy pe allowed to esteblisn quality control laburatories on a collective basis, Local Production ‘The existing capacities of local pharmaceutical industries, especially those owned by Bangladeshi nationals, shall be avhaneed through liberal licensing for palancing and modemization and by ine reosing entitlement fer the import of raw materiais. Goverment facilities for the economic end ¢lficient production of essential drugs for primary health cere, invavenous fluid and vaccines sha be expanded. Multinational companies will not bo allowed te manufacture simple products ike common analgesics, vitamin, antacids, etc. Such products will be exclusively manufactured by local fits Local production of buric pharmacecuticals in bulk shall be promoted to attain salt. tolionce, To encourage such production, spacial benefits and protections will be pravided to private Investors, Tha public Industrial sector shall also take appropriate measuras for the lace production OF essential basic pharmaceuticals in bulk. including vital antibiotics, Control of Pricas Government shal! castro! the prices Of finished droge s¢ well os those of pharmaceutical raw ‘and packing materials ond intermediates. Level pricés will ba fixed for the 45 assentisl drugs for primary health care end thair corresponding raw matenals. It will be ensured that all raw and packoging materials of aceepteble quality are procured from intematianal sources at comp- ettive prices only, The retail pricés of finished drugs will ba fixed an tsa basis of casting and reatonable profitability, Undue overhead axpenditurs shall be preventad. A maximum of 100% mark up for fast moving Items and 150% fot slaw maving items cver cost of raw materials shall be sllowed. In the caso of injectable and sterile preparations, the mark-up mey go up to 200%. No mock-up will bs allowad on tha cast of packaging materials, but actual cost on them will be odded. ‘Tha agency responsible for diug contol end edministration shall be raspontible for the contral of pricing fend thait anforcemen Distribution and Utilization Retsil sale of drugs ard modicinas shall be allowod only unde tho supervision of qualified phammocists, ‘As $009 a5 poasipla, arrangement must be made to authorise the establishment of private retail pharma. clea within the promises of avery Government hospital uo to the Thana Health Complex, where under tho ownership (on leas} and management of qualifiad pharmacists. end under the supervision of haspital authoritles, essential drugs willbe made available for anle at fixed prices sgainst proscriptigns of ualifieg physiciens. 82 Tragiional Unant, Ayurvedic and Homeapathis systems ot madicine havé a long iraditidn if many sountres including Bangladesn, These sysiems atanow axempted from the drug laws. Consequentiy. | unethical and not uncommonly harmful ploducts proliferate and alcahal containing tonics gre much | abused, | Appropriate action taquites ta ba taken fof necessary training of thelr personnel, sersening of the products and wherever possible, idantification of thair active ingredionte, and standardisation, A National Pharmacopoeia of Traditional Medicine should be prepered. CONCLUSION Drug Policy is insoporabie from Health Policy. Both sim at offering oplimum Health Caro for maximum number of people if nat the entire population. | Limited trained manpower snd resources complicated by population explosion pose serious challange for implementation ef an elfeetive health care programme, Tho national drug policy theretore requires to be drewn in the light of prev: circumstances in the Gountry. The one outlined here based on these principles. it is hoped that the implementation of this pol modification ab and when necessary will serva the aim of the Government ia offering Health Care FOR ALL, ANNEXURE—L LIST OF 150 ESSENTIAL DAUGS 1, List of 12 Essential Drugs for use by (25, Procaine Ponicillin Inj. the village laval Health Workers, 28, Tetrocyctinefoxytetracycling capfin|.| 4. Aspirin Tab, gintment | 2, Chloroquine phosphate tab/symp. 27. Phanobarbitana tab;inf_ 3, Aluminium hydnoxide gol tab. fouspen 28, Diazepam tabjin}. sion, 29, Chelrpromozing tab-/led ' fo Plpecatinm: biel 30. 1, V. Seling of ysrious strenghts | &, Glucose olucteolyia powder OF. (0. 9% 0. 25%, 0. 1855 ' 6. Phenoxy matty! penicillin (penicillin Vy th 4% doxtiose./0, 95 salina without } Tabsdty suspension. daztiose, I 7. Amsicillin capfsypytini.) 31. Dextrose in water (6%, 25%, 505) 8. Ergamatrine/Methylorgometrine mateate 32. Radittilled water {pyrogen free) amps | toblet pad inp. 33, Cholera fluid | 8, Foreus Sulphate Tab/Syrup. 10. Ephedrine tab.felixit, 11, Vitamin. A 200,000 units caps 100,000 : units inj, a 12, Chloramphenicol eyejear ointjdrap Propranolot tab i 18, Lidacaine 155 19, Isonlaxid with thiacetazona tab. | 20. Streptomycin wulphate Inj | 21, Matronidazole tab/olixirfinj. | | I ist of Additonal 33 Essemist Orage for 2. Ce-Tiimenamls tah /eusn, i primary health cave upto the Thana Health 40. Homatrapine drop. Complex level. 41, OT/DPT/PLOIO/TT Vaccines | 13, Patacetamal tab jélixit 42. Diptheria anti-toxin | 14, Pothiding Rydrochlaride In]. 43: Tab. vit B Comptex/multi vit. drapa 45. Sulphadoxin with pyrimethamine 15m, 18, Lovamisole tabjalixir 44, Ung. salieylic Acid and Beazoic Acid | 17, Chlomphenicaming tab sulphacetamidé @ya drop 10%. 20% drop/6% aint. Fiuorascein 10%, 20%, Iv. injection. Neomycin-baciteacin «poly mixineB combined a5 well ss teparate. Phen formin: Beclometnosone inhalant Plasma factors Human-gamma globuliasimmunoglobin ‘specific for certain ‘nesses. Ami-D.immunoglabin Inwavanous —aliman Invalipid; Aminosal Atonolal Sedium Valproato non masters, Gocaing Lignocaine 2% with adrenaline 1,200.000 Benzocaina tab. BIPP Paste (Biseu Pursitiny lodetorm & ANNE XURE—I1 Naomycin¢ bugitacia dintmant S-msthexyasoralon Triamsignalene tablet/cream Tot Clofazimine Injection Methylpredaisolona Acatate Mealrshalan trate 6. Morcaptopurine. Cytocine srabinaside Bleomvein ‘Methyl CONU Verapamil Nifedipine Disopyramide Dipyridamols Isasorbide dinitrate precainamide Oxprenolet Trimothaphan Saratasin Prazosin Sodium Nitroprusside Guanethigine tablets Chlorpraparmide Ciomiphena Gitrate ACTH Injection Injection Vatop(assin 20 unit Oxymotholone 60, cy 62 66, 67, es, Desmoprassia Nassl drop/injection Codeine Phosphate toblets Cholestyramine Sslazopyrine Lactulose Flutenazing Injection Naptonen Injection Ftupenthexol Lithium Carbonate Tab, Imipramine it 69. D.Penicilta nina tab.feap, 70. Sodium Aurathiomalate TI. Colchici-a taba 72. Sulphinpyrazono 73. Beclates 74, Cinerozina 75. Niciosamida 78. Miconazole aintmeatyinj 77-190 to ba detormined by Expert Committes tram time to time ANNGXURE

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