Extensive media coverage of the unethical, “you-scratch-my-back-I-scratch yours” nexus between most doctors and drug companies has spurred the Medical Council of India (MCI) to take action. In a notification issued last month, MCI has banned all relationships that can potentially harm the patients and bring medical practice to ridicule. The new rules cover both individual doctors and professional associations. Some examples:
Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied health care industry. Since there is no mention of any monetary ceiling, even small value items are not permitted.
Travel: Any travel facility inside or outside the country for self and/or family members even for attending conferences, seminars, workshops, CME programme etc is not permitted. In the past drug manufacturers and doctors used to argue that such facilities were meant to advance the scientific knowledge and hence not improper. MCI has rejected this self-serving logic.
Hospitality: Any hospitality like hotel accommodation for self and family members under any pretext stands prohibited.
Cash or monetary grants: Receiving funds by doctors under any pretext has been banned. Funding for medical research, study etc. can only be received through approved institutions by modalities laid down by law / rules / guidelines adopted by such approved institutions. Such funding is to be publicly disclosed.
Medical research: Doctors are allowed to carry out research projects funded by pharmaceutical and allied healthcare industries under certain specific conditions such as after prior permission from the competent authorities including the Drugs Controller General, India (DCGI), relevant Hospital Ethics Committee, provision of proper facilities to human volunteers, public disclosure of the source and amount of funding at the beginning of the research itself. Above all the medical practitioner must have the freedom to publish the results of the research by inserting such a clause in the agreement or any other document before accepting such assignment.
Most drug companies routinely prohibit the publication of clinical trial results by individual investigators/hospitals under one pretext or the other. In such a scenario, there is an in-built risk of concealing unfavourable results of drug and medical devices trials to the detriment of patients. Endorsement: of any commercial product by doctors was already banned in the year 2002. Two important additions have been made to his rule. Firstly, the professional associations of doctors are also barred from endorsements and secondly, any study conducted on the efficacy or otherwise of such products shall be presented to and/or through appropriate scientific bodies or published in appropriate scientific journals only. Thus doctors should not permit the use of results of such studies for any purpose by interested companies.
Violation of any of the MCI directives is considered “Misconduct” and therefore can invite penalties in the form of suspension or cancellation of registration to practice. While the new rules deserve appreciation and applause, the real test will be the level and extent of implementation. Stronger and sharper teeth can be added to MCI regulations by amending relevant sections of the Income Tax Rules. All facilities with monetary value received by medical professionals from healthcare industry should be deemed to be perquisites in the hands of recipients and hence taxable. Similarly all expenses incurred by drug, medical devices and other healthcare companies in violation of MCI rules should be disallowed by amending income tax rules. Dr. Chandra M. Gulhati, Editor, Monthly Index of Medical Specialities, New Delhi, India.
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