A country of 108 million people with a tremendous market for drugs sold without prescription -the so called OTC drugs market -- is without any challenge. With this great number of formulations, a large number of products and formulation are entering into the marketing every year with regulatory approval. Those drugs are accepted in the health care systems through health professional and by self medication.
Apart from registered medical practitioners, un- registered medical practitioners, i.e. "quacks" play an active role in health care system. In this situation pharmaceutical promotion can influence not only the use of a product, but also act an active role in our benefit of use of medicines. We have to make it essential that the information available with in the promotional material needs to be authentic, balanced and not misleading. In India, like other countries, the promotional information of prescription drugs and drugs sold without prescription (OTC-Drugs) is regulated by national legislation. Code of Ethics for Advertisement of Drugs, is a guideline to regulate the promotion of prescription drugs as well as OTC drugs marketed in India. The object of this code is to ensure responsible advertising in promotion and the sale of medicines which may be purchased by public without prescription and for which therapeutic claim are made.
Considering the socio-economic condition in our country there is no way to avoid the situation of self-medication and is now important element in Indian health care systems. So promotion of medical products to the general public as well as healthcare professionals has to regulate with some code of ethics. Pharmaceutical promotion is a persuasive communication and the promotional materials are major source of drugs information to the health-professional. So this message should be factual, evidence based, unambiguous and balanced. Unfortunately in many countries, especially in developing countries, the promotion is not evidence based and also inaccurate. Inappropriate promotion leads health professionals and also the public to use of irrational use of drugs. For example, Aspirin is commonly promoted in developing countries as suitable for use of children and while antihistamines are promoted as appetite stimulants and certain other medicines as brain tonics.
Many countries in the world regulate the promotion of drugs through advertisement in different media. WHO advocated the regulation of promotion among all its member countries, which are consistent with national health policy. WHO has published Ethical Criteria for Medical drugs Promotion as a model of such guideline.
It is reality in present situation that a health professional obtains the information from commercial source of different pharmaceutical manufacturer through their sales professionals. Most of the time, pharmaceutical manufacturer claims that their newly introduced formulation is superior in respect of therapeutic efficacy to the existing formulation. Sales professionals produce their promotional documents and distribute the free samples along with eye catching visual-aids to target the increase of sales. Most of the time these documents aremisleading and confusing. The health professionals are initiated by such misleading documents and information to prescribe the product without justifying their claims. The relation between health professional and pharmaceutical manufacturer is very controversial subject to debate.
But there is no way to disagree in the present concept "doctor-industry" relation effect in the prescribing and professional behaviour. But this issue needs to frame a policy in respect of rational use of drugs as well as pharmaeconomic point of view.
In recent study it reveals that the pharmaceutical industry advertises the prescription drugs directly to consumer through different media as they use in case of OTC drugs. How well do consumers actually understand direct to consumer-advertisement? Does the advertisement lead to inform or educate the consumer? If we see the quality of direct to consumer advertisement that many TV- advertisements have been found to be in violation of Acts and Regulation and there are frequent infraction. Not only in a developing country like ours, but also in USA, it has been noted that 17 of 33 (52%) of TV advertisement violates US-FDA regulation. In 1998, the agency sent out 94 notices of violation between 1997 and mid 2001 (48 broadcast and 46 print media) the key reasons include are inadequate risk information, exaggerated benefit and unapproved use.
In our country, we can take an example of "Baby Oil" controversy of one multinational company and two big companies in Maharashtra. Finally, the drug authorities and the manufacturer settled the matter by deleting the word ``baby''. In fact, advertisements commonly contain misleading and inaccurate information in case of OTC drugs.
Drugs under Indian Systems of Medicines claim to cure the disease which are included in Schedule J, of drugs and Cosmetics Act 1940. Indication, given on label of such medicines violates the Act & guidelines which regulate the promotion of drugs. The educational value of promotional documents is very poor and doctors prescribe the drugs to their patient on the basis of relation with the manufacturer. There is no evidence of advertisement of drugs directly to the consumer have reduced the hospitalization of patient diseases and deaths.
In developing countries, due to the lack of literacy most of the people are biased and get misleaded by such type of advertisements. The public needs access to balanced, relevant, up to date, accurate and un-biased information about drugs and non-drug treatment.
Promotional activities are performed by sales personnel of pharmaceuticals manufacturer and advertisement of the product is initiated through electronic or print media. All promotional claims should be current, accurate, balanced and not misleading either directly by implication or omission. Promotional information should be in good taste and comparative and must conform to approved product information on the specific literature.
The code of conduct restricts many activities including those prescribed by legislation. Following steps can be brought to ethical code of advertisement and promotion of drugs:-
- Prescription medicine i.e., "Schedule-H drugs" cannot be promoted to the general public
- Manufacturer or traders cannot promote their product for indication that are not listed in the approved product information.
- Pharmaceutical representative or sales personal cannot promote the product over telephone unless the promotional material is marked urgent attention.
- Unsolicited reprint of journal articles must be consistent with the product information and the word "safe" cannot be used unless it is substantiated.
Code of conduct is an effective mechanism for controlling pharmaceutical promotion. In Australia a series of studies are conducted by clinical pharmacologists between 1985 to 1992 and the result shows the quality of information provided by the manufacturer was not always accurate.
In every year lots of new drug and new formulations are introduced in the market, most are "me too" products, not genuine innovations. 213 drugs are listed in national medicine list meant to treat 90% of illnesses at primary, secondary and tertiary level care. Considering the situation and negative impact in respect of irrational use, it needs medical profession to be alerted.
Central ethical committee has been formed to collect information unethical advertisement practice of pharmaceutical manufacturer. Currently regional committees are constituted at Chandigarh, Mumbai, New Delhi and Chennai and it may be extended to other state also to collect complaint and other information in respect of unethical promotion. Ethical committee acts as a co-coordinating centre to collect the complaint and related information with coordination to regional centre and forward to drugs control authority to pursue in the light of different laws and guidelines. The drugs control authority is empowered by this law to take necessary legal steps on this unethical promotion.
WHO's ethical criteria for medicinal drugs promotion stress the principle that the drug promotion should be in keeping with national health policies. National governments have to integrate the regulation of drugs promotion in broader health and drug policies or to consider special measure to control promotion of certain clause of drugs targeting certain groups.
Enforcement of legislation and code of conduct guiding promotional practice are vital in ensuring the promotional and advertising material in accurate, balanced and not misleading. It is essential that the health professional to become a more active participant in this process. Government must be prepared to play an active role, where code of ethics appears to be failing and providing resource for strengthening the regulatory machinery to increase the effectiveness of the systems. To get more efficient results, the government has to form co-ordination group with different organizations like organization of health professional, health personnel and associations participating in health care system, regula-tory bodies, academicians, consumer organization and organization of pharmaceutical manufacturers. U
- (Avijit Chakraborty is deputy director of Drugs Control, West Bengal)