Gifts to doctors influence their prescribing patterns. Research has shown, quite unequivocally, that even a small gift, like a pen, can have an influence. The evidence on this is catalogued in detail on the website www.nofreelunch.org (1). The move of the Medical Council of India (MCI) to amend the code of ethics for doctors and incorporate a specific ban on gifts (2) must, therefore, be welcomed. It must be noted that the rule in India is far more stringent than that in other countries such as the United States. The new rule in India bans all gifts above Rs 1,000 in value. The recommended minimum punishment for accepting a gift up to a value of Rs 5,000 is censure, and above this value, suspension from the medical register for various periods is prescribed. Susan L Coyle, writing for the Ethics and Human Rights Committee of The American College of Physicians – American Society of Internal Medicine, considers as acceptable low cost gifts for office use like pens and calendars, low cost gifts of educational or patient care nature (like textbooks) and modest refreshment (3).

The laudable aim of such bans is to prevent the drug and medical device industry from influencing doctors to use inappropriate or expensive (or both) drugs and devices because of the benefits the doctor can receive for such use. As many commentators have pointed out, in medicine, the doctor decides and the patient pays; hence there is a special need to ensure that decisions are made solely in the interest of the patient.

Drug information in India

Good prescribing habits imply the availability of good information about drugs and medical devices. This means that the doctor must be aware, not only of the appropriate usage of drugs but also of the quality of the different suppliers and the prices. Unfortunately, in India such information is not easy to come by. In the United Kingdom, for example the Joint Formulary Committee publishes the British National Formulary (4) which lists all medicines available in Britain, the indications for their use and their side effects and prices. Similar publications exist in most of Europe. The European Union has established the European pharmacopoeia and is moving towards harmonisation.

In India, on the contrary, no official and reliable channel of information exists. Except for checking in the Monthly Index of Medical Specialties or the Current Index of Medical Specialties, there is no way for a doctor to know the relative prices of various brands of the same or similar drugs. Looking at hundreds of formulations from hundreds of companies is no easy task. The initiative of setting up drug information centres in several states has not taken off in a big way. One study (5) showed that in a period of three years from August 1997 to July 2000, only 132 of all queries (13.2%) made to these centres were from doctors.

Quality concerns

In a situation of poor regulation, the proportion of spurious to authentic drug formulations in India is estimated to range between 10% and 20%, the figure provided by the legitimate pharmaceutical industry in India and quoted by the World Health Organisation task force on spurious drugs (6). The Mashelkar Committee Report 2003 (7) put the percentage of spurious drugs in India at between 0.5% and 35%. The medical devices market is no different with a large number of small players many of whom are not compliant with good manufacturing practices. In 2005, 10 categories of medical devices were declared to be drugs and their manufacture needs approval from the Central License Approval Authority under the Central Drugs Standardisation and Control Organisation (8) . In private conversations, manufacturers of these products allege that the licensing authority demands bribes of about Rs 15 lakh to certify the manufacturing unit as quality compliant. It therefore remains uncertain if the company makes quality goods. In critical areas like stents for the heart, and orthopaedic implants, it is unclear if these products have been put through the rigorous testing required. The Central Drugs Standardisation and Control Organisation is understaffed and poorly run and it is difficult to repose confidence in this institution. Almost all the problems listed in the Mashelkar Committee Report 2003 still exist. They are: poor enforcement of laws, understaffing, failure to establish a National Drug Authority, inadequate testing facilities, lack of drug inspectors, non-existence of a data bank, and non-availability of accurate information.

It is alleged that bribes are a way of life here. Certification by the CDSCO is therefore no guarantee of quality, and doctors must seek other means to be assured of the quality of the drugs that they prescribe. One of the common tactics that doctors use is to prescribe only the products of multinational companies or large local companies in the belief that these companies need to protect their brand image and therefore will maintain quality. But the products of these companies are rarely the cheapest in the market.

Credibility gap in the Medical Council of India

There is also the problem of the huge credibility gap in the MCI. In recent years this statutory body of the government of India has been in the news for its poor regulation of medical education, its failure to play a leadership role in the governance of medical education and practice and several unsavoury allegations against its members. The situation has reached such a sorry pass that the government has expressed an intention to abolish it and replace it with another body. The way the Council is constituted lays it open to the shenanigans of people of little integrity. It is difficult to escape the conclusion that the present amendment to the ethical code is a feeble attempt to lay claim to ethical behaviour. The attempt is feeble because there is no way that this institution, which has never taken any action in spite of specific complaints and proof (9), is likely to take action now. And who is going to complain that the doctor has been given a gift? The drug or device company? The doctor?

If the Medical Council of India is really serious about setting right the numerous infractions of its ethical code, it needs to do much more than add another rule to a code which is seldom enforced. The present president, Ketan Desai, is seen to be so compromised that he should either resign or be removed. The method of composition of the council and the various state councils must be radically changed in order to allow people of integrity, instead of medical politicians, to come in. Today, membership of the council is sought after as an office of illegal profit and patronage. It needs to become what it is meant to be – a leader in developing, maintaining and enforcing the finest practices in medicine in the interests of the people of the country. Till that happens, all such cosmetic changes in rules will remain mere tokenism and achieve nothing.