Executive Summary:
This document outlines amendments to the Indian Medical Council Professional Conduct, Etiquette and Ethics Regulations, 2002. These amendments, referred to as the "Indian Medical Council Professional Conduct, Etiquette and Ethics Amendment Regulations, 2015," address the code of conduct for doctors in their relationships with pharmaceutical and allied health sectors. The regulations come into force from the date of their publication in the Official Gazette (February 1, 2016).
Key Points / Main Content:
Gifts and Travel Facilities:
-Medical practitioners are prohibited from accepting travel facilities (rail, road, air, ship, cruise tickets, paid vacations, etc.) from pharmaceutical or allied healthcare industries for themselves or their family members.
-Medical practitioners shall not receive any gift more than Rs. 1,000 from any pharmaceutical or allied healthcare industry.
Penalties for Violations Related to Gifts, Travel and Hospitality:
* Gifts or Hospitality expenses more than Rs. 1,000 up to Rs. 5,000: Censure.
* Gifts or Hospitality expenses more than Rs. 5,000 up to Rs. 10,000: Removal from the Indian Medical Register or State Medical Register for 3 months.
* Gifts or Hospitality expenses more than Rs. 10,000 to Rs. 50,000: Removal from the Indian Medical Register or State Medical Register for 6 months.
* Gifts or Hospitality expenses more than Rs. 50,000 to Rs. 1,00,000: Removal from the Indian Medical Register or State Medical Register for 1 year.
* Gifts or Hospitality expenses more than Rs. 1,00,000: Removal for a period of more than 1 year from the Indian Medical Register or State Medical Register.
Cash or Monetary Grants:
* Medical practitioners are prohibited from receiving cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purposes.
* Funding for medical research can only be received through approved institutions, with full transparency and disclosure.
Penalties for Violations Related to Cash or Monetary Grants:
* Cash or monetary grants more than Rs. 1,000 up to Rs. 5,000: Censure.
* Cash or monetary grants more than Rs. 5,000 up to Rs. 10,000: Removal from the Indian Medical Register or State Medical Register for 3 months.
* Cash or monetary grants more than Rs. 10,000 to Rs. 50,000: Removal from the Indian Medical Register or State Medical Register for 6 months.
* Cash or monetary grants more than Rs. 50,000 to Rs. 1,00,000: Removal from the Indian Medical Register or State Medical Register for 1 year.
* Cash or monetary grants more than Rs. 1,00,000: Removal for a period of more than 1 year from the Indian Medical Register or State Medical Register.
Medical Research:
-Medical practitioners may participate in research projects funded by pharmaceutical and allied healthcare industries, ensuring due permission, ethical clearances, legal compliance, and transparency.
-Disclosure of funding sources and amounts is required at the beginning of the research.
-Proper care and facilities must be provided to human volunteers.
-Undue animal experimentation should be avoided.
-Researchers retain the freedom to publish research results.
Maintaining Professional Autonomy:
-Medical practitioners must ensure no compromise with their professional autonomy or the autonomy of the medical institution.
Affiliation with Industry:
-Medical practitioners can work for pharmaceutical and allied healthcare industries in various professional capacities, maintaining integrity, ensuring patient interests are not compromised, and adhering to legal and transparency requirements.
Endorsement:
-Medical practitioners shall not publicly endorse any drug or product of the industry. Studies on product efficacy should be presented through scientific bodies or published in scientific journals.
Impact Analysis:
Medical Practitioners:
Impact: Stricter regulations on accepting gifts, travel facilities, and monetary grants from pharmaceutical and allied health sectors. Need to ensure transparency and ethical conduct in research and affiliations with industry. Potential penalties for non-compliance, including censure or removal from the Medical Register.
Action Required: Adhere to the revised guidelines on gifts, travel, hospitality, and funding. Ensure transparency in research activities and industry affiliations. Maintain professional autonomy and avoid endorsements.
Pharmaceutical and Allied Health Sector Industry:
Impact: Restrictions on providing gifts, travel facilities, and monetary grants to medical practitioners. Need to ensure research funding is transparent and ethical.
Action Required: Revise marketing and promotional practices to comply with the new regulations. Ensure research funding agreements meet ethical and transparency standards.
Medical Council of India:
Impact: Increased responsibility for monitoring and enforcing the revised code of conduct.
Action Required: Develop mechanisms for monitoring compliance and investigating violations. Ensure consistent application of penalties for non-compliance.
Key Entities Referenced
Indian Medical Council Act, 1956: A law enacted in 1956, empowering the Medical Council of India to make regulations.
Medical Council of India: The governing body responsible for regulating medical education and practice in India.
Indian Medical Council Professional Conduct, Etiquette and Ethics Regulations, 2002: The original set of regulations governing the professional conduct, etiquette, and ethics of medical practitioners in India, which this notification seeks to amend.
Indian Medical Council Professional Conduct, Etiquette and Ethics Amendment Regulations, 2015: The new regulations introduced to amend the 2002 regulations.
New Delhi: The location where the notification was issued; New Delhi, NCT of Delhi
Section 33: Section 33 of the Indian Medical Council Act, 1956 that confers powers to Medical Council of India
Indian Medical Register: A national registry of qualified medical practitioners in India.
State Medical Register: A state-level registry of qualified medical practitioners.
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MEDICAL COUNCIL OF INDIA
NOTIFICATION
New Delhi, the 28th January, 2016
No. MCI-211(1)/2010(Ethics)/163013.—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 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, 2015.”¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 5
(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/modification/deletions/substitutions, shall be, as indicated therein:-
3. (i) The title of Section 6.8, as amended vide notification dated 10/12/2009, 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 10/12/2009, 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 Gifts more than Rs. 1,000/- up to Rs. 5,000/- :
from any pharmaceutical or allied healthcare industry Censure
and their sales people or representatives.
Gifts more than Rs. 5,000/- up to Rs. 10,000/-:
Removal from Indian Medical Register or State
Medical Register for 3 (three) months.
Gifts more than Rs. 10,000/- to Rs. 50,000/- :
Removal from Indian Medical Register or State
Medical Register for 6(six) months.
Gifts more than Rs. 50,000/- to Rs. 1,00,000/- :
Removal from Indian Medical Register or State
Medical Register for 1 (one) year.
Gifts more than Rs. 1,00,000/-: Removal for a
period of more than 1 (one) year from Indian
Medical Register or State Medical Register.
b) Travel facilities: A medical practitioner shall not Expenses for travel facilities more than
accept any travel facility inside the country or outside, Rs. 1,000/- up to Rs. 5,000/-: Censure
including rail, road, air, ship, cruise tickets, paid
vacations etc. from any pharmaceutical or allied Expenses for travel facilities more than Rs.
healthcare industry or their representatives for self and 5,000/- up to Rs. 10,000/-: Removal from Indian
family members for vacation or for attending Medical Register or State Medical Register for
conferences, seminars, workshops, CME programme 3 (three) months.
etc. as a delegate.
Expenses for travel facilities more than
Rs. 10,000/- to Rs. 50,000/-: Removal from Indian
Medical Register or State medical Register for 6
(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 1 (one) year.
Expenses for travel facilities more than
Rs. 1,00,000/-: Removal for a period of more than6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III —SEC. 4
1 (one) year from Indian Medical Register or State
Medical Register.
c) Hospitality: A medical practitioner shall not accept Expenses for Hospitality more than Rs. 1,000/-
individually any hospitality like hotel accommodation up to Rs. 5,000/-: Censure
for self and family members under any pretext.
Expenses for Hospitality more than Rs. 5,000/-
up to Rs. 10,000/-: Removal from Indian Medical
Register or State Medical Register for 3 (three)
months.
Expenses for Hospitality more than Rs. 10,000/-
to Rs. 50,000/-: Removal from Indian Medical
Register or State Medical Register for 6 (six)
months.
Expenses for Hospitality more than more than
Rs. 50,000/- to Rs. 1,00,000/: Removal from
Indian Medical Register or State Medical Register
for 1 (one) year.
Expenses for Hospitality more than
Rs. 1,00,000/-: Removal for a period of more than
1 (one) year from Indian Medical Register or State
Medical Register.
d) Cash or monetary grants:- A medical practitioner Cash or monetary grants more than Rs. 1,000/-
shall not receive any cash or monetary grants from any up to Rs. 5,000/-: Censure
pharmaceutical and allied healthcare industry for
individual purpose in individual capacity under any Cash or monetary grants more than Rs. 5,000/-
pretext. Funding for medical research, study etc. can up to Rs. 10,000/-: Removal from Indian Medical
only be received through approved institutions by Register or State Medical Register for 3 (three)
modalities laid down by law/rules/guidelines adopted months.
by such approved institutions, in a transparent manner.
It shall always be fully disclosed. Cash or monetary grants more than Rs. 10,000/-
to Rs. 50,000/-: Removal from Indian Medical
Register or State Medical Register for 6 (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 1 (one) year.
Cash or monetary grants more than Rs.
1,00,000/-: Removal for a period of more than 1
(one) year from Indian Medical Register or State
Medical Register.
e) Medical Research: A medical practitioner may carry First time censure, and thereafter removal of name
out, participate in, work in research projects funded by from Indian Medical Register or State Medical
pharmaceutical and allied healthcare industries. Register for a period depending upon the violation
A medical practitioner is obliged to know that the of the clause.
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.¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7
(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 documents/agreement for
any such assignment.
f) Maintaining Professional Autonomy :- In First time censure, and thereafter removal of name
dealing with pharmaceutical and allied healthcare from Indian Medical Register or State Medical
industry a medical practitioner shall always ensure Register.
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 First time censure, and thereafter removal of name
pharmaceutical and allied healthcare industries in from Indian Medical Register or State Medical
advisory capacities, as consultants, as researchers, Register for a period depending upon the violaton
as treating doctors or in any other professional of the clause.
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.
h) Endorsement:- A medical practitioner shall not First time censure, and thereafter removal of name
endorse any drug or product of the industry from Indian Medical Register or State Medical
publically. Any study conducted on the efficacy Register.
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.
Dr. REENA NAYYAR, Secy. I/c.
[ADVT.-III/4/Exty./100/347]
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, 26/05/2004 & 10/12/2009.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.