• directly or indirectly gives a false impression regarding the true character of the drug or
• makes a false claim for the drug or
• is otherwise false or misleading in any material particular.

The liability for such publicity will fall on the editor and publisher besides the advertiser.
In reply to a recent question in the Parliament (Lok Sabha Unstarred Question No 441 dated 24-07-97), the Minister of Information and Broadcasting, Shri S. Jaipal Reddy stated that Doordarshan permits advertisements only for such medicines which give relief to head-aches, body-aches, cough and cold etc. Some such medicines are Metacin, Crocin, Disprin, Aspro, Panjon, Anacin, Moov, Iodex, Vicks Vaporub, D-Cold and Glycodin.
From a strictly ethical point of view, even these advertisements are against the principles of rationality in promotion of medicines. This is mainly because these medicines offer only a false sense of cure and temporary relief, but no proper cure. But the price of the products being extracted from the consumers is very much on the high side.
In fact, India is one among the few countries who has the potential to be self-sufficient in drug production. But whether this capability has necessarily led to improved availability and accessibility of drugs for the prevailing diseases in the country is a pertinent question to be looked into. From available records it can be safety stated that somehow the drug needs of the patients and market conditions have not clearly matched. It may be argued that the large number of drugs in the market has helped better choice. But choice for whom? Has it really enhanced the health status of the people, No. Why is it so? There are many factors which are responsible for this state of affairs.
The export performance for drugs and pharmaceuticals in money terms gives a very impressive picture. The total value of export to 182 countries during 1995-96 was Rs 3366.17 crore. (Lok Sabha Starred Question No.400 21-3-1997). On the other side of the coin, the value of imports for bulk drugs and formulations was Rs 811.43 and Rs 173.02 respectively in 1994-95 and Rs 903.93 and Rs 191.09 respectively during 1995-96 (LS USQ. 2510 11-3-1997).

Rational Drug Therapy
Judicious and scientific use of drugs is one of the most elementary principles of disease management. Even if effective drugs are available at affordable costs, other issues like adequate and correct information, proper use, sufficient follow up etc. are matters which determine the end result of the administration of drugs. First of all, it is imperative that the concept of pharmacotherapy (treatment of illness by drugs) needs to be properly understood by the prescribers (doctors) and also by consumers in the interest of their own health.
Rational drug therapy is the corner stone of effective medical care as far as consumer interests are concerned. It means the use of the right drug for the right patient in the right amount for the right period.

• The Right Drug
  Specificity is what RDT is all about. In other words, from among the large number of medicines available, the choice must be specific to the most appropriate one. This is the first condition. The rightness will be determined by the efficacy, affordability, side-effects, long-term effects etc. If a cheap alternative, equally potent, is available, a rational prescriber will definitely recommend that to the patient. This may sound out-moded and unfashionable. The trend is to go for highly powerful third generation drugs and formulations which may cost a fortune to the consumers! It is supposed that a responsible doctor will never be swayed by this unreasonable trend.
• The Right Patient
  The second condition that the drug for the right patient signals relativity. A particular medicine may be very appropriate for a specific patient due to several reasons, but may not be advisable for another patient. Even if the disease is the same, the impact of drugs may vary from one person to another, depending upon the nature and extend of the disease and the general health conditions of the patient. The success of the treatment also will depend on several other clinical, social and economic conditions of the patient. The doctor must have a good grip of these factors to decide on the right medicine for the right patient.
  This is easier said than done. We have seen in umpteen situations where practitioners prescribing medicines without really understanding the exact nature of the disease in the patient; a shot in the dark. This callous approach is the antithesis of the RDT and many a time it may cost dearly for the patient. In other words it can be classified as ‘medical negligence’, which are actionable before the law. An essential point to remember here is that some people are allergic to certain or several medicines. There are few prescribed pre-testing methods before giving them medicines. These need to be adhered to in the interest of the patients. Administering right drugs to the wrong patient, and giving wrong drugs to the right patient are not unknown in medical annals. Cases of infusing wrong blood into a patient which has deadly consequences or causing diseases like Hepatitis B or even HIV through improper attention to innocent patients are the worst forms of not giving the right care and medicines to the right patient.
• The Right Amount
  The condition of the right amount and the right period are closely interrelated. The impact of medicine depends on the quantity of drugs consumed by the patient through properly regulated dosages. This means that the doctors should have a correct idea of the quantity of the drug required to remove the disease condition and the frequency of administration to maintain the required drug level, within the tolerance limits of the patient, but powerful enough to kill the pathogenic agents.
  The right drug administered in larger amounts beyond the tolerance level can cause unwanted complications and reactions.
  Quick and high doses of drugs can even lead to cardiac or respiratory arrests and probable death of patients. On the contrary, the right drug administered in insufficient quantities infrequently can also have undesired results like slow/no cure or worsening of the conditions or development of newer problems.
  Medicines come in packs of varying quantities ranging from .50 milligrams to 1 gram. The prescriber should necessarily be accurate about the dosage considering the gravity of the disease, and be patient-specific such as adult and child dosages.
• The Right Doses
  The right period necessarily means the length and frequency of the medicines to be taken by the patient. In certain diseases the medication may have to be continued uninterrupted for very long periods. Certain disease causing pathogens are long acting and they need prolonged treatment with drugs to completely eliminate them like the case of TB. In these cases the dosages may be altered during periodic evaluations by the doctor. Proper instructions by the physician and faithful observance of the same by the patient are key factors in this respect. Medicines will have to be continued even when the patient feels relieved of discomfort or external symptoms of the disease for which he/she started treatment in the first place. Antibiotics are a case in point. The symptoms of infection may disappear in a short time, but this does not mean the disease has been cured. A complete course of medicine is necessary to eliminate all the strains of infection and to avoid the possibility of relapse. Incomplete treatment also results in development of resistance of the bacteria to the drug. This has serious repercussions. When the same disease recur, this particular medicine becomes useless and more potent drugs will be required to handle the situation. The threat from the deadly P. falciparum (cerebral) malaria and TB, which are assuming ominous proportions, is largely because of resistance from incomplete treatment and from default in treatment. Even in money terms it works out to be costlier to handle such situations, apart from the serious health damages they cause.
• The General Scenario
  Traditionally people believed that the doctor always knew the best and their advices were above suspicion. Whatever the doctor suggest or carry out are accepted without doubting doctors’ bona-fides. This confidence of the people was largely well-founded on facts. But the medical profession moved from the earlier idealistic state to a more commercial and a competitive state. And brought with it, deliberately or otherwise, some of the inherent shortcomings of the latter. The result was the creeping in of innumerable irrationalities in their practices which included the indiscriminate use of unnecessary drugs, unnecessary surgical interventions and unwanted pathological tests/investigations and whimsical charges. All these are resorted, not in the interests of consumers, but for other reasons like personal gain, profit and social recognition. Ignorance of doctors also have a role here. All these unwelcome practices have caused considerable damages to the cause of medical care and people’s health.

The Status of RDT
This state of affairs was the prime reason for the society to drive for a rational drug therapy. The concept is still in the nascent stage. The struggle is on but the movement is slow. There are a great deal of odds health activists and consumers are faced with in this struggle. The powerful drug industry, with their money power and shrewd marketing strategies, had an upper hand over the unorganised consumer community. But the movement has a global backing, reflections of which are even seen in India, especially since the last two decades. This needs to get greater attention so as to ensure consumer safety and health.
A major problem in this area is the attitude of the medical professionals. There is no wholehearted or universal acceptance and practice of the concept of rational drug therapy. Drug lobbies do their bit to keep these medicos under their influences so that their products get prescribed without raising questions on their rationality. It is a sad commentary on the profession that a large number of practitioners are slaves of these propaganda specialists.
The campaign for Rational Drug Therapy has been more successful in countries where the information flow is better, educational levels are greater and the overall social consciousness and development have been faster. In India the success is very limited, confined only to certain sections of the society or individuals. It has a host of reasons behind. Apart from the general level of ignorance among the people and practitioners of medicine, social beliefs and indifferences, there are some other specific reasons as well.

• Absence of Unbaised Information
  Traders and manufacturers have a duty to provide unbiased information on the products to help the consumers make informed choices. This is a very reasonable and ethical demand in the interest of consumer protection. But in order to promote their products the producers and sellers tend to put out unsubstantiated claims, distorted facts and even half truths. Ordinary consumers have no way to ascertain the veracity of these informations.
  Under the Monopolies and Restrictive Trade Practices Act (MRTP Act) 1963 & 1991 making a false statement regarding the quality, composition or efficacy of the drugs or cosmetics will be treated as unfair trade practices and are actionable. It also deals with false or misleading statements concerning the need for or the usefulness of any goods or not giving essential information. This was proved in the Boots Company Limited case in 1987 (Enquiry No 401) where the company failed in their TV advertisement to give a warning that Coldarin should not be used by children below 12, except under medical advice. The Commission held this as an unfair trade practice.
  To compound the problem, drug production and formulations is almost entirely in the private sector in India. Lured by profit motives, these companies which are either collaborators of large multinational corporations or powerful indigenous business houses, thrive on public ignorance. Their business is often pushed forward by enlisting the support of health professionals and politicians. Effective intervention is crucial to regulate the quality of information given by manufacturers and to curtail their influence on the health professionals.
  The Right to Information is one of the six Consumer Rights recognised under the Consumer Protection Act of 1986. This means that the consumer can enforce this right in a court of law with regard to drugs as well as medical services.
  Rational use of drugs is possible only when there is complete and up-to-date information available to the doctor and patients. Only when the doctor has access to unbiased knowledge and information about drugs, he can instruct the patient and prescribe accurately. This information on drugs must include the price, nature, indications, contra-indications (i.e. where to use and where not use them) availability and benefits vs. hazards.
  It also implies that the patient should have some basic information on the drugs he/she is taking. This information should mainly come from the treating doctor. But more details can also be obtained from the information sheet given in the medicine packet or even from the wrapper of the medicine, pharmacist etc. The only hitch here is that medicines may be delivered to the patient without any wrapper, or the instructions may be in English (which the patient may not understand) and in many cases the writings may be too small to be properly read. Because of the basic faith in the doctor, even educated patients gloss over the other informations available.
  Mass media like newspapers and TV also carry warnings and information on certain drugs or batches of drugs. From time to time, The Drug Controller also releases names of drugs banned, restricted or withdrawn from the market to caution the unsuspecting doctors and consumers.
  Despite all these, it is a fact that proper information on drugs and rational drug therapy is insufficient. Lot more efforts need to go into this.
• Insufficient Treatment Facilities
  A large infrastructure of treatment centres from primary health centre, to sub-centres, community health centres, block and district hospitals to medical colleges and research centres have been established in the country. But the Government health services structure is catering only to about 10-15 per cent of the population. Private health services cater to around 75-80 per cent and the rest by the Indigenous Systems of Medicine. The quality of care provided in over-crowded government hospitals and in some of the privately run hospitals are far below acceptable levels. When large number of people have absolutely no access to drugs or any kind of health services, what to talk of Rational Drug Therapy. People have no choice but to accept whatever little is provided, rational or irrational, without questioning. The disadvantaged millions always have the worst of both - diseases and treatment.
• Poverty and Lack of Purchasing Power
  This is the worst enemy of the consumer empowerment process. Consumers’ options and rational decisions are determined by their economic status. They may be forced to compromise on quality because of their lack of purchasing power. RDT can succeed only in a reasonably balanced economic conditions.
• Lack of Rational Health and Drug Policy
  These are very important topics which call for very detailed analyses. It is beyond the purview of this write-up and will be attempted in a later article. Suffice it to say that a rational policy is the foundation for rational practices. India has a National Health Policy of 1983 and a revised Drug Policy of 1995. These important policies have great influence on the health standards of the people. A consumer perspective of these documents are vital for creating the right ambience for effective campaigns. In short, it is assumed that these policies have not been of a great value in promoting the concept of RDT in the country.
• Lack of Consumer Awareness
  A strong and organised consumer movement may act as a pressure group upon the government and the traders towards evolving consumer-friendly approach. But at present, this is not very visible. There are few consumer organisations active in areas of consumer products and services but very few in the area of health, especially drugs. There is a need to have more organisations to scientifically take up drug work, both from the point of view of public education as well as drug research and analysis.
  Agencies like the Voluntary Health Association of India (VHAI), New Delhi and Consumer Education and Research Centre (CERC), Ahmedabad have done pioneering work in this direction. The need is for more and more of such initiatives throughout the length and breadth of the nation.

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