The MCI Ethics Committee, Executive Committee and the GBM passed the following amendments in the Ethics Regulations and the same are due to be notified in the official gazette.

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MEDICAL COUNCIL OF INDIA

NOTIFICATION

New Delhi,the …May,2010

No.MCI-211 (1)/2010(Ethics)/–In exercise of the powers conferred by Section 33 of the Indian Medical Council Act, 1956 (102 of 1956), the Medical Council of India with the previous sanction of the Central Government, hereby takes the following Regulations to amend the “Indian Medical Council (Professional Conduct,Etiquette and Ethics) Regulations,2002:–

(i) These Regulations may be called the “Indian–Medical Council (Professional Conduct, Etiquette and Ethics)’ (Amendment) Regulations, 2010″.

(ii) They shall come into force from the date of their publication in the Official Gazette.
In the “Indian Medical Council (Professional Conduct, Etiquette and Et
hics) Regulations, 2002″, the following additions/modifications/deletions/substitutions shall be, as indicated therein: -
(i). The title of Section 6.8, as amended vide notification dated 10112/2009, shall be further amended by deleting the words “and professional association of doctors” as under:-

“6.8 Code of conduct for doctors in their relationship with pharmaceutical and allied health sector Industry.”
(ii). Section 6.8.1.(b),as amended vide notification dated 10112/2009, shall be substituted as under:–

b) Travel Facilities: A medical practitioner shall not accept any travel Facility inside the country or outside, including rail, road, air, ship, cruise tickets, paid vacation, etc. from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, CME Programme, etc. as a delegate.

(iii). Action to be taken by the Council for violation; of Section 6,8, as amended vide notification dated 10/12/2009: shall be prescribed by further amending the Section 6.8.1 as under:–

SECTION ACTION
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 health care industry and their sales people or representatives Gifts more than Rs. 1,000/– upto Rs. 5000/–:Censure

Gifts more than Rs.5000/– upto Rs. 10000/–: Removal from Indian Medical Register or State Medical Register for 3(three) months

Gifts more than Rs. 10000/- to Rs.50.000/-: Removal from Indian Medical Register or State Medical Register for six months.

Gifts more than Rs. 50,000/– to Rs 1,00,000/–: Removal from Indian Medical Register or State Medical Register for One Year.

Gifts more than Rs. 1,00,000/–: Removal for a period of more than one year from Indian Medical Register or State Medical Register.

b) Travel facilities: A medical practitioner shall not accept any travel facility inside the country or outside, including rail, road, air, ship, cruise tickets, paid vacations etc. from any pharmaceutical or allied healthcare industry or their Indian representatives for self and family members for vacation or for attending conferences, seminars, workshops, CME programme etc as a delegate. Expenses for travel facilities more than Rs. 1,000/–upto Rs. 5000/–: Censure

Expenses for travel facilities more than Rs. 5,000/– upto Rs. 10000/–: Removal from Indian Medical Register or State Medical Register for 3(three) months

Expenses for travel facilities more than Rs. 10000/– to Rs. 50,000/–: Removal from Indian Medical Register or State Medical Register for six months

Expenses for travel facilities more than Rs. 50,000/–: to Rs 1,00,000/–: Removal from Indian Medical Register or State Medical Register for One Year

Expenses for travel facilities more than Rs. 1,00,000/–: Removal for a period of more than one year from Indian Medical Register or State Medical Register

c) Hospitality: A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext Expenses for Hospitality more than Rs. 1,000/-upto RS.5000/–: Censure

Expenses for Hospitality more than Rs. 5,000/– upto RS.10000/–: Removal from Indian Medical Register or State Medical Register for 3(three) months

Expenses for Hospitality more than Rs. 10000/– to Rs. 50,000/–: Removal from Indian Medical Register or State Medical Register for six months

Expenses for Hospitality more than Rs. 50,000/– to Rs 1,00,000/–: Removal from Indian Medical Register or State Medical Register for One Year

Expenses for Hospitality more than Rs. 1,00,000/–: Removal for a period of more than one year from Indian Medical Register or State Medical Register

d) Cash or monetary grants: A medical practitioner shall not receive any cash or monetary grants from any pharmaceutical .and allied health care 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 I rules guidelines adopted by such approved .institutions, in a transparent manner. It shall always be fully disclosed. Cash or monetary grants more than Rs. 1,000/– upto Rs.5000/–: Censure

Cash or monetary grants more than Rs. 5,000/– upto Rs.10000/–: Removal from Indian Medical Register or State Medical Register for 3(three) months

Cash or monetary grants more than Rs. 10000/– to Rs. 50,000/–: Removal from Indian Medical Register or State Medical Register for six months

Cash or monetary grants more than Rs. 50,000/–: to Rs 1,00,000/–: Removal from Indian Medical Register or State Medical Register for One Year

Cash or monetary grants more than Rs. 1,00,000/–: Removal for a period of more than one year from Indian Medical Register or State Medical Register

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 (i) 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 committees/bodies.
(iii) Ensure that it fulfils 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 project(s).
(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.
First time censure, and thereafter removal of name from Indian Medical Register or State Medical Register for a period depending upon the violation of the clause.
f) Maintaining Professional Autonomy: In dealing with pharmaceutical and allied name from Indian Medical Register or State 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, First time censure, and thereafter removal of name from Indian Medical Register
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 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 affiliations are within the law.
(iv) Ensure that such affiliations/employments are fully transparent and. disclosed.
First time censure, and thereafter removal of name from Indian Medical Register or State Medical: Register for a period depending upon the violation of the clause.
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” First time censure; and thereafter removal of name from Indian Medical Register’ or State Medical Register.”

(Lt. Col (Retd.) Dr. A.R.N. Setalvad)
Secretary
Medical Council of India

Foot Note:       The Principal Regulations namely: “Indian Medical Council (Professional Conduct, Etiquette and Ethics) ‘Regulations, 2002″ were published in Part – III, Section (4) of the Gazette of India on the 6th April, 2002, and amended vide MCI notification dated 22/02/2003, 26/0512004& 10/12/2009