Clinical pharm

Marketing of pharmnaceuticals, whether of the ethical or proprietory variety, can go a long way in meeting the health-care needs of the people, especially of the vast majority living in far-flung villages.

The piropagation of household medicines and widening the distribution network for these medicines, the autthor argules, becomes specially importanit in the context of the limited resouirces available for extend- ing medical care facilities. THE pharmaceutical industry inherited by independent India in 1947 was, by and large, a processing and formulating enterprise based on imported fine chemicals and btlk drugs, and the valtue of its annuLal production then was n)o more than ls 10 crores.

The early post-independeence years proved to l)e a turning point in the history of the :ndustry, for it was during this period that several in4ternational com- paniies set up facilities in India for manufacturing a wide ranige of soplhisti- cated druigs.

Thanks to its phenomenal grsowth during the sixties, the plharma- ceutical industry has now becomne a basic industry producing almost all the essential drugs anad meeting the coun- try’s requiiremnents of formulations in fuill and of btulk d lruigs to a consider- able extent; so muich so that the United Nations Developmiient Organisation has placed India in Group 5 representing the miiost advaniced stage.

This means that the pharmaceutical inidustry in our country has now attained a level of operation coqnpared to international standards in production, technology and the quality of its products. There can be no better proof of this than the fact that, as many as 100 essential druigs ar-e manufactured today from basic stages as againist only two in 1948. Notwithstanjdinig the gains made in the health-care field, it shotuld be appreciated that thb country has a long way to go to achieve even minimum stalndards of health especially when oneconsiders the vast  rural areas where modern health facilities do. not exist, and wlhere 80 Per cenit of the total popt ilation live.

HIoxv formiiidable this challeng(-eX is call be realised fr omii the followilng: (1) In spite of thlec substantial pro- gress mladle in drug tlherapy, the average life expectation in India is still lower and the death rate higher than those in developed couniitries. (2) Abotut lhalf of all recorded deaths are among children under five chiefly fronm infectious diseases anid malnutrition. (3)

Importantly, the majority of the rutral population does niot have any wortlhwhile health facilities availaible; rather, large number of villages in our country do not even get water which is safe to drink. Therefore, in the- years to comiie the iniduLstry has to address itself to, the task of catering to the dFrLgs require- nments of the rutral Inidia anid contribute to the improvement of health care of villagers.

‘To appreciate the importance of the pharmaceutical industry, it is necessary to understand the natitrec and usage of its prodtucts. Too often one loses sight of the fact that a drug is not a conI- modity like soap, hair oil, blade, etc, which a consumer generally wanits to I)uy of his own accord.

Indeed, a drug is not so much a product as it is a tool in the healing process very mnuch like the doctor, the midwife, the hos- pital, the dispensary, etc. Unlike other products of day-to-day use, drugs are never wanted – they are needled be- cause they become essential in the treatment of diseases. Therefore, Un- like other expendittures, that on medi- cines should be looked upon as a cost of keeping onie hale and hearty. The real measure of the value of drugs and the inedutstry which produices them. is the therapeuitic jolb which they per- forIm.

Tlius, the prime responsibility of the lpharimiaccutical indtustry is to search foi, develop and prodtuce better anld newer drugs anlcl to uiae them available, thereby assistinig the miledical an(i para-medical p)ersomlml in their task of tackling the health problems of the people. lHURALT. iIAliT1 AND IROi 01()F PSI)AIIMACEUVICAI. , INDUSTIItY A lot has been talkked1 about and written oni this subject in general, and the inadeqttacies of healtlh facilities in particular to the economiiically weaker section of the rurial population.

On the government’s side a lot of money and effort has been spent to imiiprove health facilities in the country, more particsularly in rutral areas, as can be seen from Table 1. The cturrent government thinking highlights the need for rural health- care measures. This becomes evident when one takes a look at the national priorities wvhich aim at the welfare of the rural coimmunity in preference to the urban. In the area of health-care, there will be a significant increase of medical facilities in rural areas.

How- ever, the task is so stuipendous and the gaps are so wide that unless there is an awareness amuong tlie institutions, social organisations and the pharrna- ceutical indtustry alike that they share a great responsil)ility in imiiproving the health care mleastures of the. couLntry’s neglectedl weaker section, and lend a helpinr haztnd to the governments’ effort, little cani be achieved by way of progress in this dlirection. The problem of health-care ultimiiately boils down to. three major tasks:

(1) Bringing doctors’ services within easy reach of rural population throulgh rural hospitals, primary health centres, dispensaries, etc, and disseminating the much- needed information on pharma- ceutical products and their therapeutic uses to the medical personnel engaged in this task. (2)

Educatinig the rur al masses al)out safe anid reliable remedies for comnmion, iminor ailIneints like colds, coughs, hbeadache, etc, thlus promiioting the concept of self-medication which is so widely adopted in Western coulntries (lespite the excellent medical facilities available tlhere. (. 3) A;aking n odern drutgs availaleAc to the vast rural areas iunreach- e(l as yet.

The task b)eforc the pharmaceutical industry, there- fore, is not on-ly to produce the required volutme of drugs but to ensure that the pro(lducts are of the right quiality, priced right and are withinl easy reach of the economically weaker, rur al po- pulation. M-95 This content downloaded from 103. 254. 86. 40 on Tue, 2 Dec 2014 02:27:15 AM All use subject to JSTOR Terms and Conditions ?

Review ot Management August 1978 ECCfOMIC AND POLITICAL WEEKLY TABLE 1: FIFTH PLAN TARGETS AND OUTLAY ON PUBLIC HEALTH Targets Outlay (Rs Crores) Primary health centres 5351 Minimum needs programme 291. 47 Medicine, educational and Primary sub-centres 43076 research 94. 56 Rural hospitals 1293 Training programme 17. 20 Control of communicable Medical colleges 99* diseases 168. 61 (13000) Hospitals and dispensaries 155.

62 Indigenous system of Doctors 176000 medicine 27. 73 Nurses 123000 Other programmes 40. 80 Hospital beds 321600 Total 796. 00 *13,000 seats in 99 medical colleges. PHARMACEUTCAL PROMOTON Promotion in one form or another is employed by every business irrespective of the commdity it produces.

However, to the pharmaceutical industry which is required by drug rules and medical ethics to communicate sophisticated in- formation on drug usage, and that too to a critical and highly qualified audi- ence, namely, the medical profession, the promotion of its products is essenti- ally the business of disseminating pro- duct knowledge relevant to the doctors’ needs. As a matter of fact, pharma- ceutical promotion is a vital source of technical information and makes an important contribution towards educat- ing the profession in the right usage of the drugs.

It is relevant to note at this juncture that there are three fundamental ele- ments in product costs in any modern industry’ or business, and pharmaceuti- cal ipdustry is no exception. These are high technology manufacturing costs, selling/promotion costs and research! development costs. In drug industry particularly, the products are rather numerous and diverse, indicated for a host of disease-conditions, and each pioduct has its own promotional re- quirements to suit the needs of various specialities in medical practice which further adds to the costs.

This becomes all the more important when the iin- dustry has to serve ‘doctors in rural areas who are not highly qualified and yet are called upon to treat a wide variety of diseases prevalent in the rural community. As said before, the unique aspect of pharmiaceutical promotion is the com- munication of complete prescribing information on the drugs to highly qualified medical men.

In view of the advances in drug therapy witnessed during the post-independence period, it is only natural that the members of the medical profession wish to stay abreast of the new discoveries and developments taking place in the me- dical world from time to time. For such a target audience, communication about the vital information on drugs is more than mere promotion it is a service. The job of communicating inform- ation and promoting the pharmaceuti- cal products to the profession is done through: (i)

Medical representatives (ii) Advertising the products in medical journals (iii) Direct mailings on products to doctors (iv) Clinical papers presented at medical conferences, especially for a new product Of these, the medical representative plays by far the most important role in that it is he who details a product thoroughly to, a practising doctor. He discusses the composition, mode of action of each ingredient, indications, d6sage, side-effects, precautions, con-tra-indications, pack and price of the product. it is he to whom a doctor raises serveral queries concerning.

Zhe use of the product in the types of patients he sees in his dar. y-to-day prac- tice, and thus collects complete inform- ation on the product and its relative advantages over similar other products in the market. Indeed, Derrick Dunlop, former Chairnan of the Britisl Ministry of Health’s Committee on the Safety of Drugs, gave eloquent testimony to the value of the detailman or medical re- presentative, whose work is the single most important and expensive com- ponent of the pharmaceutical promo- tion in the following words:

Valuable products should not be kept secret nor should manufacturers just have to hope that -doctors will stumble upon them as -they read medical joutnals -which they often fail to do. I have found that visits by well-briefed detailmen are the most effective means by which phy- sicians and pharmacists can learn of new medicines and pharmaceutical developments. In my experience, most representatives are men of integrity and understanding, who, because of the specialised and topical information they bring, can -given half a chance -perform a most useful service for the busy practi- tioner.

Having detailed the product and satisfied the doctor on his queries, the medical representative leaves behind detailing literature and reprints of papers on clinical trials on the product for the doctor to read through. Also, he hands over samples of his product for the doctor to try on his patients.

The job of a medical representative is a difficult one. He has not only to con- vince a doctor on the efficacy and safety of his product but has to fight his way in the lhighly competitive mar- ket of pharmaceuticals. More often than not, a single visit doesn’t suffice for the purpose and be has to make repeat calls reminding the doctor of his product and get him, at some stage, to prescribe it.

In rural areas, however, because of the transport problems and prohibitive promotional costs a medii- cal representative is not able to make frequent calls. With the growing need of health- care facilities in the rural areas in future, it is obvious that educating th3 profession through the medical repres- entative alone will become difficult in terms of accessibility and cost. It is, therefore, suggested that on thv indus- try’s side this problem could be tack- led through direct mail to follow-up the visits of the medical representative, thereby reducing the frequency of calls.

It is understood, of course, that these mailings should be preferably in regional languages and comprehensible enough to the rural doctors. To help the industry in this onerous task, the government should establish centres in rural areas,, where seminars should be arranged from time to time with ihe active participation of the industry for disseminating in- formation to rural doctors on the pro- ducts and other developments of medi- ca! importance.

Further, doctors should be provided with, interest-free loans to enable them to stock essential medi- cines. -HousEHoLD MEmicIEs IN RURAL HEALT-CAim Health care is a need as basic to human beings as food, clothing and shelter. However, the task is too big and growing to be fulfilled by medical profession alone; and it becomes im- perative that all concerned -the indi- M-96 This content downloaded from 103. 254. 86.

40 on Tue, 2 Dec 2014 02:27:15 AM All use subject to JSTOR Terms and Conditions ECONOMIC AND POLITICAL WEEKLY Review of Management August 1978 TABLE: 2 RURAL DIsTRIBUTioN OF SOME HousEoLD MEDIc1NES No of Villages Carrying Brand* Rural* Rural Per Cent Population Per Cent Product Group/ Company Offtake Outlets No of Total (000s) of Total Brand (000s) Carrying Villages Rural the Brand Population Rubs and Balms Vicks Vaporub RHL 6,800 178,000 140,000 25 22,430 40 Rubex Alembic 700 14,000 13,300 2 2,193 5 Analgesics Anacin Geoffrey MANNERS 10,050 431,000 216,000 38 25,439 58.

Aspro Nicholas 4,950 258,000 130,000 23 16,667 38 Avedan Sarabhai 5i0 72,000 36,000 7 5,263 12 Cough Lozenges Vicks Cough Drops RHL 4,850 167,000 120,000 21 15,351 35 strepsils Boots 1,150 23,000 19,000 3 2,631 6 vocacil Parle 225 9,000 7,000 1. 3 1,140 2. 6 Cough Syrups Formula-44 RHL 700 14,000 13,000 2. 3 2,018 4. 6 Glycodin Alembic 4,000 26,000 23,000 4. 1 3,596 8. 2 * Projected Figures Source: ORG Rural Audit, January-March 1978 vidual, the family and the society as a whole -have to actively participate in the home treatment through household medicines for minor ailments, if this basic need is to, be fulfilled.

This be- comes all the more important for our rural community for whom the available medical facilities today are far too inadequate. Household medi- cines, therefore, play an important role in satisfying the day-to-day health-care needs of our rural population against common, minor illnesses. The goal of household medication is to serve as the first-line health guardian for every person. Only in that way will it be possible to produce, the res- ponsible and well-informed consumers who can treat themselves correctly for day-to-day minor illnesses.

This ap- plies particularly to our economically backward rural community which is today deprived of even primary health facilities, unlike its urban counterparts. Towards achieving this goal, house- hold medicines meet certain fundamen- tal requirements: (1) They fulfil a basic human need, health-care. (2) They serve as a health-care alternative to a sick person at a lower cost compared to that of professional services and pre- scription drugs. (3) They bring down considerably the rising governmental expendi- ture towards rural health-care in particular.

(4) They reduce the pressure on the limited medical and para-medi- cal resources available today in our country. Household medicines are commonly associated with the age-old herbal remedies and nostrums used through tradition, and which are often mixed up with the modern household medi- cines.

While this belief is fast disap- pearing in the developed countries in view of the availability of modern household medicines, the distinction between these two categories is much less clear in developing countries. In India too herbal remedies have been used by the people for centuries and have their own place in the health-care system.

During the last few decades, hovever, there have been revolutionary changes in the health-care system ot both the developed and the developing countries embracing the subject of household medication. These are: (1) Ingredients of pharmacopoeal standards have taken the place of herbs.

(2) Crude rnanufacturing processes have been replaced by modern scientific methods of manufac- ture. (3) Instead of trial and error ap- proach, household medicines now undergo all relevant expert procedures* as to analysis, phar- macology, toxicity studies and clinical tests to ensure the safety and efficacy before they are released for marketing.

(4) In place of haphazard develop- ment there is greater emphasis on organised research and new dis- coveries in area of household medication. These changes have given birth to modern household medicines which, therefore, posssess the required scientific validity and have facilitated its integ- ration with Allopathic system of medi- cines. Household medicines are thus a set of allopathic medicines which satisfy the following essential characteristics: (a)

They have been developed for relief of symptoms and condi- tions usually minor and self- limiting in nature which can be readily recognised by consumers without medical supervision.

This is relevant in the context of the health care needs of our rural population. (b) Their proper use must be with- in the comprehension of . the average consumers – they should give label directions that can be understood and followed with- out professional guidance. Again, we keep here in mind semi- literate villagers. (c) Finally, and most importantly, the effectiveness and safety of these products must reach high level of attainable consistency when used without medical supervision. In the benefit-to- risk judgment that underlies the regulatory status of these pro- ducts, safety must carry the greater weight.

This makes the household medicines the first line of treatment in the hands of villagers who do not need to seek professional advice. There are many studies that show that as much as three-fourths of all health-care is self-care which usually involves the use of household medi- cines. The first line of defence against illness or injury occupies a strategic position in the environment of grow- M-97 This content downloaded from 103. 254. 86. 40 on Tue, 2 Dec 2014 02:27:15 AM All use subject to JSTOR Terms and Conditions Revie-w of Management August 1978 ECONOMIC AND POLITICAL WEEKLY ing cost of the health care system.

No wonder, therefore, that this universally well-accepted practice has been receiv- ing greater and greater acceptance both among the consumers as well as profes- sional bodies, including WHO, through- out the world. In our country too mil- lions of people today rely upon house- hold medicines with greater confidence han ever before in urban as well as rural aras.

Efficacy derives from two effects: (a) the pharnacology of the product, and (b) the person’s expectation of its effects. If we are looking at a product design- ed for its specific therapeutic effects -like insulin for diabetes or penicillin for pneumonia – we must achieve efficacy by pharmacological means. In such medicines expectation effect is minimal.

However, in products designed exclusively for symptomatic effects such as household medicines, the bal- ance is more or less reverse of that are you a small investor in company shares ? then you canl get your DIVI DEN D without any TAX DEDUCTION I If you are not a company and your total income, including the dividend, is likely to be less than the minimum liable to income-tax (i. e. Rs. 10,000 at present in the case of individuals, Hindu undivided families, firms, association of persons, body of individuals and artificial juridical persons), you can get the full amount of the dividend declared by the company without deduction of any tax at source.

HOW ? Apply to your 1. T. 0. in Form No. 14 for issuing a certificate authorising the company whose shares are held by you to pay to you such dividends without deduction of tax. OR If the dividend to be received from any company is less than Rs. 250 SEND to every such company a declaration (in duplicate) in the prescribed Form No. 14B. ~~~~~~~~~~~~~~~~~~~~I AVO IC)n CLAX oMIN C 1 Issued by: = DIRECTOR OF INSPECTION (Research, Statistics & Publication), INCOME-TAX DEPARTMENT, New Delhi-110001. davp 78/158 M-98 This content downloaded from 103.

254. 86. 40 on Tue, 2 Dec 2014 02:27:15 AM All use subject to JSTOR Terms and Conditions ECONOMIC AND POLITICAL WEEKLY Review of Management August 1978 required for specific therapy. There must be some pharmacological activitv but the element of expectation contri- butes more to the overall product effi- cacy. There is sufficient evidence to show that the subject’s expectation effect in the case of household medi- cines greatly depends upon the reputa- tion of the manufacturer.

The greater the reputation, the better is the subject’s expectation of its effects and greater is the overall efficacy of the medicine and consequently, the greater is the accept- ance. In other Iwords, a company’s reputation plays an important role in the consumer acceptance of household medicines.

Thus, modern household medicines are: (1) not so simple that they can be made by just anyone, but require expert technical know-how and sophisticated manufacturing pro- cesses and equipment as required for ethical drugs; (2) not of lower quality standard but follow the same exacting standanrs of quality and efficacy as in the case of ethical drugs; (3) No longer based on traditional non-scientific formulations but form an integral part of the al- lopathic system of medicine in terms of formulation and scintific validity; and (4)

No longer manufactured with traditional ingredients such as herbs, etc, but are of worldwide accepted pharmacopoeal stand- ards. Prior to obtaining the authorisation to bring them on the market, household medicines are submitted to the same relevant expert procedures as to ana- lysis, pharmacology, toxicology and clinical tests as prescription medicines. NEED FOR EDUCATIONAL PROGRAMMES Health education aims at arousing interest in people in improving their own welfare and developing a sense of responsilility for their own health.

Fundamentally, health education is a learning process which focuses on the attitudes of people towards health and their health practices. It concerns itself with understanding human behaviour -the psychology and ways of com- municating health information. Its aim is to impart knowledge and provide experience that will result in people having favourable attitudes about the importance of health and in motivating them to do whatever is necessary to attain and maintain an optimum health status for themselves, their families and others in their community.

It is, therefore, essential that people, especially in rural areas, most of whom are illiterate, need to be educated on several aspects of their own health-care: (1) The occurrence and incidence of common, minor illnesses such as cold, cough, stomach upset, etc. (2) A simple way to detect these common ailments which affect them in day-to-day life. (3)

Equally important are methods easy to understand and easy to practise by lay persons to treat these common ailments. It is of the utmost importance, at the same time, that the people should be educated, in their own home grounds and in their own verna- cular languages. The industry concerned with house- hold medication has the responsibility of supplying safe and effective medi-cines with properly labelled directions and cautions in a language that can easily be understood and practised by a layman without the help of the doctor.

The government’s role in health education is no less important. As a matter of fact in addition to providing specialised medical care it will be desirable to collaborate with doctors, phanrnacists, and industry in this stupendous task. Educating the people and producing quality household medicines are only half the job done. Unless these house- hold medicines are! made available to consumers, especially in the remote rural areas, the job cannot be said to be complete.

This will necessitate the development of proper distribution net- work using both conventional and un- conventional channels. Whatever little has been done in the course of the last few years, both in terms of making household medicines available to the rural community and also educating it in the usage of these medicines, has been achieved by only a few companies which possess the requisite expertise and experience acquired either on their own account or through their parent companies.

Some relevant statistics have been given in Table 2. In addition to the product groups mentioned in the Table, there are several others: antacids, digestives, laxatives, antidiarrhoeals, products for piles, products for worms, eye/ear drops, products for burns, dematological products, anti-acne pro- ducts, tonics, cold tablets, and products for muscular pain etc.

Most of these have yet to reach not only the rural areas but also the semi-urban areas but also the semi-urban areas where the day-to-day requirement of these commonly used products is as impor- tant as that in the major towns. From what has been discussed above, it is obvious that the only solution is to accelerate the propagation of house- hold medicines and widen the distribu- tion network so as to make such rrmedicines available even to the remot- est rural areas.

This becomes especially important when one takes into con- sideration the limited resources avail- able to our country to extend medical care facilities. WHO defines health as “a state of complete social, mental and physical well-being and not merely an absence of disease”.

When looked against this background, one can appreciate the number of minor ailments and their frequency which a common man suffers fiom in his everyday life, thus forming the broadest spectrum in the health- care system. Obviously, no amount of professional service in terms of number of dloctors, dispensaries, hospitals, health centres, medical units and the rest of it would be able to cater to this huge requirement unless we sup- port and encourage the home treat- ment for minor ailments with household niedication.

Household medication is a very i’m- portant lower-cost alternative for con- sumers of the health care services. If the people are not encouraged to use household medication they can only turn to medical care which isi far more expensive and scarce. The result is they may leave minor illnesses uintreated and may have to suffer from symptoms which could even get exacerbated in absence of treatment.

In conclusion, in an agriculture- based economy and in a rural domi- nated country like ours, the marketing of pharmaceuticals whether of the ethical or proprietory variety, can go a long way in meeting the health-care needs of the teeming population resid- ing in far-flung villages not reached as yet. The absence of pukka roads, transport facilities, etc, are the handi- caps one has to encounter in develop- ing an effective rural penetration pro- gramme in terms of communication and distribution of the pharmaceutical pro- ducts.

However, in view of the current government thinking which lays great emphasis on the rural health-care deve- lopment, it will only be in the interest of the industry to make a beginning, however difficult and expensive that may appear at the first sight, in this direction. This content downloaded from 103. 254. 86. 40 on Tue, 2 Dec 2014 02:27:15 AM All use subject to JSTOR Terms and Conditions ECONOMIC AND POLITICAL WEEKLY Review of Management August 1978 required for specific therapy.

There must be some pharmacological activitv but the element of expectation contri- butes more to the overall product effi- cacy. There is sufficient evidence to show that the subject’s expectation effect in the case of household medi- cines greatly depends upon the reputa- tion of the manufacturer. The greater the reputation, the better is the subject’s expectation of its effects and greater is the overall efficacy of the medicine and consequently, the greater is the accept- ance.

In other Iwords, a company’s reputation plays an important role in the consumer acceptance of household medicines. Thus, modern household medicines are: (1) not so simple that they can be made by just anyone, but require expert technical know-how and sophisticated manufacturing pro- cesses and equipment as required for ethical drugs;

(2) not of lower quality standard but follow the same exacting standanrs of quality and efficacy as in the case of ethical drugs; (3) No longer based on traditional non-scientific formulations but form an integral part of the al- lopathic system of medicine in terms of formulation and scintific validity; and (4) No longer manufactured with traditional ingredients such as herbs, etc, but are of worldwide accepted pharmacopoeal stand- ards.

Prior to obtaining the authorisation to bring them on the market, household medicines are submitted to the same relevant expert procedures as to ana- lysis, pharmacology, toxicology and clinical tests as prescription medicines. NEED FOR EDUCATIONAL PROGRAMMES Health education aims at arousing interest in people in improving their own welfare and developing a sense of responsilility for their own health. Fundamentally, health education is a learning process which focuses on the attitudes of people towards health and their health practices.

It concerns itself with understanding human behaviour -the psychology and ways of com- municating health information. Its aim is to impart knowledge and provide experience that will result in people having favourable attitudes about the importance of health and in motivating them to do whatever is necessary to attain and maintain an optimum health status for themselves, their families and others in their community. It is, therefore, essential that people, especially in rural areas, most of whom are illiterate, need to be educated on several aspects of their own health-care: (1)

The occurrence and incidence of common, minor illnesses such as cold, cough, stomach upset, etc. (2) A simple way to detect these common ailments which affect them in day-to-day life. (3) Equally important are methods easy to understand and easy to practise by lay persons to treat these common ailments. It is of the utmost importance, at the same time, that the people should be educated, in their own home grounds and in their own verna- cular languages.

The industry concerned with house- hold medication has the responsibility of supplying safe and effective medi- cines with properly labelled directions and cautions in a language that can easily be understood and practised by a layman without the help of the doctor. The government’s role in health education is no less important.

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