Pharmabiz
 

DTC advertising of prescription drugs

Sunil S ChiplunkarWednesday, February 11, 2009, 08:00 Hrs  [IST]

The global pharmaceutical market grew to US$ 712 bn in 2007 at a compounded annual growth rate (CAGR) of 10% between 1999 and 2007. Moreover, it is expected to more than double in value to $1.3 trillion by 2020, as per a study by PWC. India, today stands as the world's 4th largest pharma market in volume and 13th largest in value terms. The retail Indian pharma market as per ORG IMS Sept 2008 is valued at Rs 33,605 crore with a growth of 12.8%. The world over pharma marketing is in a churn. Revenues are under pressure, product pipelines are not exciting, costs and risks of new drug discovery are growing to astronomical levels, and globalization is a sweeping force. In addition, regulatory standards in developed countries are becoming higher hurdle to market new drugs. Marketing The raison d'ĂȘtre of success in business is effective marketing approaches. Marketing is an organizational function to create, communicate, and deliver value to customers and manage customer relationships for mutual benefits. It processes deliver value to customers and generate customer delight, while strengthening profits to the organization. The core of marketing is increasing consumption of marketed products, and influencing lifestyle of target customers through responsible, attractive, and effective marketing communication activity. Pharma marketing communication activities should also support rational use of drugs. Regulating pharma marketing A drug is a special molecule that can affect human health through processes that only an expert can characterize. Hence, regulating drug marketing is a globally accepted principle. Ethical pharma manufacturers not only abide with external regulatory directives but also follow self-imposed regulations. In India, the main Acts influencing and regulating pharma advertising, marketing are The D&C Act, 1940 and Drugs & Magic Remedies (objectionable) advertisements Act, 1954. The D&C Act, 1940 has various Schedules. Hard core pharma drugs come under Schedule H or prescription drugs. Schedule X includes narcotic drugs. Schedule J provides a list of diseases for which drugs cannot claim to prevent or cure. Schedule V is for patent or proprietary preparations containing vitamins. Schedule K includes certain drugs that can be advertised to the public. Some formulations in this Schedule should be labeled 'not for medicinal use'. Household remedies like aspirin and paracetamol come under Schedule K - there was an attempt to allow legal market penetration of some Schedule K drugs to non chemist retail outlets. Mashelkar report on OTC drugs recommended that OTC drugs (that do not come under Schedule H or G - Schedule G contains drugs like insulin) should be included in Schedule K. Drugs & Magic Remedies (objectionable) advertisements Act, 1954, controls advertisements of drugs. It also prohibits the advertisement of certain purposes of remedies. This Act defines an advertisement to include print items, and any announcements oral or produced by light, sound or smoke. It also defines a drug and a magic remedy (talisman, mantra, kavacha etc) too. The Act provides a schedule of various diseases or disorders or conditions for which drugs cannot be advertised. Success in pharma marketing depends on the prescriptions generated by doctors. As a result, promotion to doctors is intense. Promotional visual aids are used. Promotional literatures are provided. Sponsorships to medical meets and CME programmes are routinely given. Gifts - both personalized and general items - are offered to doctors as thanks giving, and even as incentives to provide more prescriptions in favour of a brand. The gifts provided may be for clinical use or for the personal use of the physician. The problem of ethics related to providing gifts, and other services to physicians confronts pharma marketers at the international and national level. In India, to promote drugs in an ethical manner, OPPI launched its revised code of pharma marketing practices recently. For eg, (a) the code restrains pharma companies from influencing doctor's prescription by offering doctors and their families travel packages, gifts, shopping and entertainment expenses for promotion of their respective medicines. (b) While maintaining highest standards of quality of sponsorships and gifts, they have to be modest in value. This code was developed based on IFPMA code of pharma marketing practices. IFPMA (International Federation of Pharmaceutical Manufacturers and Associations), an NGO, represents national industry associations and research based pharma, biotech and vaccine companies from both developed and developing countries, OPPI is an active member of IFPMA, Geneva. Direct-to-consumer advertising of prescription drugs is a marketing phenomenon of two countries: USA and New Zealand. Prescription drugs are advertised so that the patient discusses this option with the doctor and sees if it is suitable for him or her. DTC advertising of prescription drugs empowers the patients' with knowledge to discuss with the doctor. It creates the 'informed patient'. It is of course not bereft of controversies. There are accusations that DTC is not a good idea for prescription drugs as it often creates over zealous advertising and misrepresentation of product benefits by pharma marketers. In India, DTC advertising of prescription allopathic drugs (Schedule H) is not allowed. Ayush (Ayurvedic, Unani, Siddha and Homeopathy) formulations are allowed public advertising to consumers as long as they do not infringe the Drugs & Magic Remedies Act, 1954. Today Calcium Sandoz range from Novartis and Iodex from GSK are Ayurvedic formulations. Schedule I gives a list of books to which Ayurvedic and Siddha formulations should conform to. On the whole, DTC advertising of prescription drugs helps patients gain information, knowledge, and will contribute to market expansion too. Pharma marketing is on the upswing in India. While recession plaques developed markets of the world, the large patient pool, increasing purchasing capacity and the growing Indian pharma market is seeing a lot of participation by interested pharma marketers. DTC advertising of prescription drugs ought to be permitted in the present day modern times given the explosion of media and availability of advertised content of prescription drugs on the internet. Advertising is an important reason for social development and improvement of living standards. DTC advertising of prescription drugs will also empower patients to consult with doctors as informed participants. Doctors hitherto hiding behind a wall of ignorance of the patient will now have to be careful and provide convincing advice to the informed patient. DTC advertising will put a check on unethical medical prescribing by doctors who bank on the ignorance of patients. DTC prescription drugs advertising will create a new generation of informed patients. Hence, DTC advertising of prescription and non-prescription drugs will create a healthier India. (The author is with Juggat Pharma (Pharma Division of Jagdale Industries Ltd), Bangalore)

 
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