Asia Pacific | India’s code of medical ethics regulations

June 3, 2014

Medical Council of India

One recent update which needs to be noticed by the industry is the Third Amendment (the Amendment) made to the Code of Medical Ethics Regulations by Medical Council of India (MCI) in December 2009. It explicitly prohibits medical practitioners from receiving any gifts, travel facilities, hospitality, cash or monetary grants from pharmaceutical and allied health sector companies, nor signing endorsement on any drug or product of the industry publically. With respect to the medical research and advisory service, the amendment also set strict restrictions.

Many pharmaceutical companies may not be very familiar with the MCI. However, the MCI is a very powerful body among medical staff in India. It is the governing organisation that controls all medical education, registration, licensing and ethics of all medical personnel in India. A medical person is not permitted to practice medicine without a valid license from the MCI. Therefore, any violations of the MCI Code may result in a doctor losing his medical license. And, according to an interview with one Indian doctor, the MCI Code is implemented strictly in India.

 

Influences on the industry

Unlike the well-known Foreign Corrupt Practices Act (FCPA) and other anti-bribery laws, the MCI Code does not directly put pharmaceutical companies under the power, but regulates the conduct of doctors to achieve anti-corruption purpose.

Although the code does not ask the pharmaceutical companies to stop paying favours to doctors, it does ask the doctors to stop accepting these items. Considering that the healthcare industry and doctors have been always related to each other in terms of reputation and benefits, any improper acts from pharmaceutical companies may risk getting a doctor in trouble, and, further down the line, getting them in trouble too.

In reality, many pharmaceutical companies know they are not to give cash or lavish gifts to doctors under relevant anti-corruption laws. However, for the purpose of building good business relations with doctors, companies may not provide a doctor with a leisure travel directly, but invite them for medical seminars and conferences as a sponsor. By that way, companies may oblige a physician without bending the rules.

The latest amendment to the MCI Code, however, broadens the forbidden areas. Look at the “travel facilities”, for example, under the new stipulation – doctors shall not receive any travel facility inside or outside the country from any pharmaceutical companies, including conferences, seminars, workshops, Continuing Medical Education programmes, etc.

In addition, under the new code, medical research and working for affiliations are restricted as well. Some pharmaceutical companies expressed concerns that if there is any negligence in the process, retaining doctors to join a proper clinical trial or provide professional advice might be considered unethical under the code, and cause unnecessary trouble for the doctors and companies.

 

Response to the changing environment in India

Building trust with doctors is incredibly crucial for pharmaceutical and allied healthcare companies doing business in India. Compared to other emerging markets, the uniqueness of the Indian healthcare system rests with its relatively well-established private healthcare system. The operation of many hospitals, including day-to-day purchasing, pharmacy, labs, medical equipment, etc., is run privately. This means that all decisions with regard to patient care are made by individual or groups of doctors, making doctors very important as a client to pharmaceutical companies.

Understanding the MCI Code is only part of the compliance programme for pharmaceutical companies. To build a long, healthy and trusting relationship with doctors, companies must have a complete internal plan and effective strategy.

From a more practical perspective, companies need be aware that anti-corruption compliance is not an additional value to risk management, but an indispensable part of the whole corporate business. A small investment in a compliance programme – such as seeking professional advice, giving employees specific training and the adoption of anti-corruption systems – will help companies in the Indian market practice business better and avoid the much more expensive cost of a violation.

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