The Medical Council of India (MCI) has suggested some modifications to the regulations notified in December last that put a blanket ban on doctors for accepting gifts, travel facilities and hospitality from pharmaceutical companies in lieu of promoting their products.
While quantifying punishment for medical practitioners violating the provisions of the December 2009 Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, the MCI has suggested various degrees of punishments for doctors who accept gifts worth Rs.1,000 from any pharmaceutical or allied healthcare company instead of a total ban including one on research projects.
The punishments range from censure (for accepting gifts valued between Rs.1,000 and Rs.5,000) to removal from the Indian or State Medical Registry for more than one year (for accepting gifts worth more than Rs.1,00,000).
The recommendations, sent to the Union Health and Family Welfare Ministry for notification, also address other grey areas, including sponsorship of travel and lodging of medical practitioners participating in a conference, monetary grants and the question of clinical research funding.
According to the recommendations, a medical practitioner will not accept any travel facility within the country or outside, any kind of hospitality or cash or monetary gifts for self or family members for a vacation or even for attending conferences, seminars or continuing medical education programmes as a delegate. Punishment for violation of these clauses can range from censure to removal from Indian or State Medical Register for more than a year.
However, in the case of medical research projects funded by pharmaceutical and allied healthcare companies, the medical practitioner will have to take due permission from the competent authorities and ensure that such a research project has the clearance of national/State or institutional ethics committees and see to it that all prescribed legal requirements are fulfilled.
The source and amount of the funding has to be publicly disclosed at the beginning itself, proper facilities have to be provided to human volunteers if necessary for the project, and undue animal experimentations are not to be carried out. Importantly, the researcher will have the freedom to publish the results of the research in the greater interest of society and there shall be no compromise either with his or with the autonomy of the medical institution while conducting research.
Any kind of violation for the first time will invite censure but repeating the offence could invite the removal of the practitioner's name from the Medical Register. The period of removal would depend on the clause violated.
A medical practitioner is also not allowed to endorse any drug or product publicly and any study conducted on the efficacy or otherwise of these products will have to be presented to appropriate scientific bodies or published in an appropriate scientific journal.
“With these recommendations, we are looking at strict implementation of the regulations,” MCI president Ketan Desai said. There was some ambiguity on a few clauses in the regulations notified in December. “By clearly defining these we have resolved any confusion,” he said.