Can India stop drug companies giving gifts to doctors?

Regulating relationships between doctors and pharma

Such marketing has attracted attention in recent years, denting the reputation of drug companies and doctors and exposing India’s weak regulation, spurring the government and the doctors’ regulator to try to regulate the doctor-pharma nexus better.3

In January the Medical Council of India (MCI), urged all doctors registered under the MCI Act to prescribe generic medicines “as far as possible” and to ensure rational prescribing of drugs. The circular, reminding doctors of regulations issued in 2002, was issued to principals of medical colleges, directors of hospitals, and presidents of all state medical councils.4

“The circular is a bid to educate the medical community, including doctors, and make them aware about the increased availability of generic drugs. We need to instil confidence about the use of generic [generic in the Indian context means off-patent medicines sold under chemical names] drugs,” the MCI’s chairman, K K Talwar, told the BMJ.

Drug quality rather than cost

But not all doctors, including the Indian Medical Association, are in support.5 They say that prescribing must focus on drug quality rather than cost, and they point out that some formulations contain more than one active ingredient and do not exist in generic form.

“The highest quality drugs with best possible pharmacological properties should be used. Doctors should prescribe generic drugs if their quality is of a high standard,” said Anoop Misra, chairman of the Delhi based private hospital Fortis Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology.

The Indian drug market, with more than 30 000 formulations, is worth more than 720 billion rupees (£8.6bn; €10bn; $13bn) a year.6 India does not allow direct advertising of drugs to patients, but pharma companies engage in practices such as giving free gifts or sponsoring exotic trips.1 In return they hope that doctors will prescribe that particular company’s brand of drug rather than one made by a competitor.

“The Indian pharma market is predominantly made up of off-patent medicines, in which there is fierce competition as the same drug may be made by a dozen or more companies. The commercial needs of countless, fiercely competing companies have led them to depend on the 3Cs: convince if possible, confuse if necessary, and corrupt if nothing else works,” C M Gulati, editor of the Monthly Index of Medical Specialities, told the BMJ.

Drug promotion

At least some of the costs of drug promotion must ultimately be borne by patients, concluded the 45th parliamentary committee report on health.1 This represents a huge burden, particularly in a country where 78% of spending on health is by patients out of their pockets, and 70% of expenses are for drugs, according to the high level expert group on universal health coverage.7

During 2008-09, the drug industry in India spent more than a quarter of its annual turnover on sales promotion, compared with 7% on research and development.7 Promotion includes the cost of employed sales representatives.

Many doctors agree that there needs to be a system to deal with violators of the code and clear punishments but won’t speak out against the practice. Previous moves by the government, the MCI, and industry associations have had little effect.

Codes of conduct

In 2011, the Department of Pharmaceuticals (DoP), part of the Union Ministry of Chemicals, introduced a draft, voluntary code of conduct for the drug industry, which banned all gifts to doctors and clamped down on foreign junkets by banning continuing medical education events sponsored by industry.8

The code, similar to the MCI guidelines announced in 2009, aimed to bring transparency to sales promotion and prohibited doctors from accepting gifts from drug manufacturers.9 The code also laid down rules about advertising and promotional material, claims and comparisons of medicinal products, activities and conduct of medical representatives, samples, hospitality, sponsorship, and meetings with healthcare providers.

Though this draft was issued two years ago, the DoP is yet to adopt a uniform code agreed by the entire industry, despite calls from the parliamentary committee on health to bring in a mandatory code of conduct.

The DoP has a conflict of interest because its mandate is to promote the drug industry, explained Gulati, adding, “The code has not put an end to unethical promotions as it’s a voluntary code and would only work if made mandatory.”

Industry experts think that the income tax circular issued in August last year might have more impact.10 It said that drug companies must pay tax on what they spend on freebies, and doctors who receive must also pay tax on the value of the gift.

The pharma industry has also drawn up guidelines. Industry associations, including the Organisation of Pharmaceutical Producers of India (OPPI), which represents the multinational companies that account for a fifth of the industry in India, and the Indian Pharmaceutical Alliance, which represents the domestic industry’s interests, finalised guidelines on gift giving recently.11

Ranjit Shahani, vice-chairman and managing director of Novartis India, and president of the OPPI, told the BMJ, “Our code is very specific and stringent. We’ve been following a strict code since 1996, and have only modified it over the years. Recently, the code was modified to include transparency in clinical drug trials, and banned all trials conducted for ‘disguised promotion’ of medicines.”

He claimed that there are few violators among multinational drug companies. However, these voluntary guidelines have not stemmed the practice entirely, and doctors and industry experts have called for stricter regulation.

Governmental regulation

“The promotion by pharma companies of their business and brand requires strict governmental regulation, which also needs to be enforced. Such regulation is required more for companies from India than multinational companies,” said Misra. India lacks the strict regulatory apparatus and means to enforce regulation, he added.

Both doctors and pharma companies need ethical regulation, he said. “The watchdog body should blacklist pharma companies or doctors if they are found wanting. Penalties should be defined and incremental. The penalties should be such that there is fear of violation of guidelines. The watchdog body should be independent of the MCI.”

Companies could also be required to publish all payments made to doctors above a certain value in their accounts, as is practice in other countries. US law, for example, requires drug companies to disclose payments made to doctors for research, consulting, speaking, travel, and entertainment, over a certain value.

“We need to differentiate here certain marketing practices which may be genuine, like imparting scientific or technical education on a particular medicine, undertaken by sales representatives of companies,” Shahani added.