Advertising in Pharmaceutical Industry in India

Group 5:

Arneet K Sahni Nandita Pant Akanksha Sharma Nidhi Megha A Singh Priya Ranjan Vishesha Chaturvedi

Background of India Pharma Industry

Companies in Indian pharmaceutical industry can broadly be classified into two categories Indian origin companies (domestic companies) and foreign companies (MNCs).

Some of the major players include GlaxoSmithKline, Cipla , Dr. Reddys Laboratories, Ranbaxy, Pfizer etc.

The Indian pharmaceutical market is expected to touch US $ 74 billion in sales by 2020 from US $ 11 billion in 2012.

The pharmaceutical market has grown at 15.7% during 2011, with major growth drivers being in the area of anti-diabetics, derma and vitamins.

Drug markets are basically characterized in to Over the Counter Drugs (OTC) and Prescription based drugs

Market stats

Promotion" refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.

Drug promotion also includes the activities of medical representatives, drug advertisements to physicians, provision of gifts and samples, drug package inserts, direct-to-consumer advertisements, periodicals, telemarketing, holding of conferences, symposiums and scientific meetings, sponsoring of medical education and conduct of promotional trials

The blurring boundaries of what constitutes fair practices are of intense debate in issues involving drugs promotion.

Advertising, as distinct from promotion is generally used as a direct measure to popularize a particular drug or a remedy. It is governed by the Drugs and Magic Remedies Act

http://www.cci.gov.in/images/media/completed/PharmInd230611.pdf

Advertising claims
Claims involve projecting the prescription drug as the best available product, including claims that the product has highest prescription. Some products are being promoted based on effectiveness trials conducted by the same companies marketing them. Other products are promoted based on reward schemes and offers

Clinical trials are often rigged (enroll only young subjects in trials, even if the drugs being tested are meant to be used mainly in older people)

The most pertinent issue in these cases is the information asymmetry that a consumer encounters.

Few instances of unethical practice exposed

Clevudine (Phamasset Inc), three professors of medicine from AIIMS, KBN Medical College, Gulbarga and RG Kar MedicalCollege, Kolkata located at different places and thousands of miles apart from each other sent a word for word identical letters of recommendation.

Sertindole (Lundbeck), an anti-psychotic drug, three experts locatedat three different places (head of the department of psychiatry of Stanley Medical College, Chennai, doctor from Psychiatric Nursing Home, Ahmedabad and HoD psychiatry of LTM Medical College,Mumbai) wrote letters of recommendation in nearly word-by-word,identical language.

Three opinions from Prof of orthopedics, AIIMS; consultant at Dayanand Medical College, Ludhiana and professor of orthopedicsfrom St Johns Medical College, Bangalore, on rivaroxaban( Bayer), a drug for prevention of clotting, "are ditto copies of each other.

Caught red-handed writing scientific recommendations of their own products and submitting them to the Drug Controller General of India (DCGI)

Issues
OTC drugs: Label comprehension with regard to disease symptoms, directions for use, warnings, etc is extremely important BUT MISSING

OTC products also do not indicate specified doses for children

In case of prescription of a drug- where the doctor is decision maker for the ultimate user - the patient, the industry has a powerful influence on prescribing habits

Popular news reports and mapping of recent incidence of collusion between the profit-oriented pharmaceutical companies, pharmacists and doctors

Practices of luring doctors through gifts, rewards, schemes, including delivering large amount of free samples are in violation of general ethical guidelines laid down by the WHO

Steps to be taken
A written, well-defined code of ethics and training the professionals to adopt patient welfare as their primary responsibility while making decisions Direct to Consumer marketing should be strictly regulated clear articulated guidelines to deal with specific issues such as gifts, sponsorships. Advertising material to be subjected to review by relevant public agencies . unbiased & reliable- should be made available in public domain or on a website for public to see who has given what opinion

Medical opinion-

Regulatory agencies should be politically & financially insulated from commercial companies.

Independent drug safety boards should be established.

Legal penalties or even license cancellation in case of violation.

In May 2011, the Department of Pharmaceuticals (DoP) came out with a draft Uniform Code of Pharmaceutical Marketing Practices (UCMP) to address the issue of Unethical marketing practices in India.

Lessons learnt

The MCI has already framed law for doctors prohibiting them from accepting any freebies from pharmacy companies but the practice continues..
The US government is proposing to bring in a law that would require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment. Indian Pharmaceutical industry spent over 25% of their annual turnover on sales promotion alone as compared to a paltry 7% on research and development in 2008-09. India has the dubious distinction of its pharmaceutical market being flooded with about 90,000 formulation packs and brands. Of the top 10 products which accounted for 10% of the medicines sold in the Indian market, two belong to the category of irrational vitamin combinations and cough syrup while the other is a liver drug of unproven efficacy. Standard Treatment Guidelines will list the preferred drug and non-drug treatments for common health problems. Each drug treatment the name, dosage form, strength, average dose (pediatric and adult), number of doses per day and number of days of treatment. Tamil Nadu is already following it.