No. MCI-211(1)/2009 (Ethics)/55667.-In exercise of the powers conferred by Section 33 of the Indian Medical Countil Act, 1956 (102 of 1956), the Medical Council of India with the previous sanction of the Central Government, hereby makes the following Regulations to amend the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002:-
1. (i) These Regulations may be called the “Indian Medical council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2009 Part I”.
(ii) They shall come into force from the date of their publication in the Official Gazette.
2. In the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002”, the following additions/medications/decisions/substitutions, shall be, as indicated therein:-
3. The following clause shall be added after clause 6.7:-
“6.8 Code of conduct for doctor and professional association of doctors in their relationship with pharmaceutical and allied health sector industry.
6.8.1 In dealing with pharmaceutical and allied health sector industry, a medical practitioner shall follow and adhere to the stipulations given below:-
(a) Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied healthcare industry and their sales people or representatives.
(b) Travel facilities: A medical practitioner shall not accept any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations, etc., from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conference, seminars, workshops, CME programme etc. as a delegate.
(c) Hospitality: A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext.
(d) Cash or monetary grants: A medical practitioner hall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity under any pretext. 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, in a transparent manner. It shall always be fully disclosed.
(e) Medical Research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is obliged to know that the fulfillment of the following items (1) to (vii) will be an imperative for undertaking any research assignment/project funded by industry-for being proper and ethical. Thus, in accepting such a position a medical practitioner shall:-
(i) Ensure that the particular research proposal(s) has the due permission from the competent concerned authorities;
(ii) Ensure that such a research project(s) has the clearance of national/state/institutional ethics committee/bodies;
(iii) Ensure that it fulfills all the legal requirements prescribed for medical research;
(iv) Ensure that the source and amount of funding is publicly disclosed at the beginning itself;
(v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research projects);
(vi) Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way;
(vii) Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document/agreement for any such assignment.
(f) Maintaining Professional Autonomy: In dealing with pharmaceutical and allied healthcare industry a medical practitioner shall always ensure that there shall never be any compromise either with his/her own professional autonomy and/or with the autonomy and freedom of the medical institution.
(g) Affiliation: A medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacities, as consultants, as researchers, as treating doctors or in any other professional capacity. In doing so, a medical practitioner shall always:
(i) Ensure that his professional integrity and freedom are maintained:
(ii) Ensure that patients interest are not compromised in any way;
(iii) Ensure that such affiliation are within the law;
(iv) Ensure that such affiliations/employments are fully transparent and disclosed.
(h) Endorsement: A medical practitioner shall not endorse any drug or product of the industry publically. 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 in a proper way”.
Lt.Col. (Retd.) Dr. A. R. N. SETALVAD, Secy.
Foot Note: The Principal Regulations namely, “Indian Medical Council (Professional Conduct, Etiquete and Ethics) Regulations, 2002” were published in Part III, Section (4) of the Gazette of India on the 6th April, 2002, and amende vide MCI notification, dated 22-2-2003 and 26-5-2004.