Regulatory guidelines for

promotion of

Prescription drugs in India.

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The Organization of
Pharmaceutical Producers of India
(OPPI) has developed
a code of practice for its members,
based on the IFPMA.

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• Sets out standards for ethical
promotion of pharmaceutical
products to healthcare
professionals.

• Implementation of the code is a matter

of self regulation and self discipline

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 Does NOT seek to regulate -

• Promotion of prescription drugs to consumers

(DTC advertising).

• Promotion of self medication products (OTC

medications).

• Provision of non promotional information.

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 Industry relationships with healthcare
professionals must support, and be consistent
with, the professional responsibilities that
healthcare professionals have towards their
patients.

Pharmaceutical companies must maintain high

ethical standards when conducting promotional
activities and comply with applicable legal and
professional requirements
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 All printed promotional materials other than
reminder advertisements must be legible and
include :
• the name of the product (normally the brand
name),
• the active ingredients,
• the name and address of the pharmaceutical
company or its marketing agent,
• date of production of the advertisement,
• the abbreviated prescribing information.
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This should include the following:

• Approved Indications

• Dose

• Method of use

• Succinct statement of contraindications,

precautions and side effects

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• Promotional material should not mislead by
distortion, exaggeration, undue emphasis or
omission, or in any other way

• Absolute or all-embracing claims should be used

with caution and only with adequate
qualification and substantiation.

• Descriptions such as ‘safe’ and ‘no side effects’

should generally be avoided and should always
be adequately qualified

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 Promotion should be capable of
substantiation either by reference to the
approved labeling or by scientific evidence.
Such evidence should be made available, on
request, to healthcare professionals.

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 It is a short advertisement consisting of

• Name
• Simple statement of indications to
designate therapeutic category

Such reminders may avoid API.

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 • Promotion should not be
disguised. Clinical assessments,
post-marketing surveillance and
experience programmes, and post-
authorization studies must not be
disguised promotion.

• Material relating to pharmaceutical

products and their uses, whether or
not promotional in nature, that is
sponsored by a company should
clearly indicate by whom it has
been sponsored

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• In accordance with local laws and regulations,
free samples of a pharmaceutical product may
be supplied to healthcare professionals in order
to enhance patient care.

• Samples should not be resold or otherwise

misused.

• Companies should have adequate systems of

control and accountability for samples provided
to healthcare professionals, including how to
look after such samples while they are in the
possession of medical representatives
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 Cash
Payments in cash or cash equivalents (such as gift
certificate) must not be offered to healthcare
professionals.

Personal gifts
Gifts for the personal benefit of healthcare
professionals (including, but not limited to, music CDs,
DVDs, sporting or entertainment tickets, electronic
items) must not be provided or offered.

Cultural courtesy gifts

An inexpensive gift not related to the practice of
medicine may be given on an infrequent basis to
healthcare professionals in acknowledgement of
significant national, cultural or religious holidays.
©Mark IV Medical communication
 • Promotional aids
Promotional aids or reminder items may be
provided or offered to healthcare
professionals and appropriate
administrative staff, provided that the gift
is of minimal value and relevant to the
practice of the healthcare professional.

• Medical Utility items

Items of medical utility may be offered or
provided free of charge, provided that such
items are of modest value and beneficial to
the provision of medical services and for
patient care.

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 Including audiovisuals
The same requirements that apply to
printed materials also apply to electronic
promotional materials and websites.

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• The identity of the pharmaceutical company and
of the intended audience should be readily
apparent.

• The content should be appropriate for the

intended audience.

• The presentation (content, links, etc.) should be

appropriate and apparent to the intended
audience.

• India-specific information should comply with

local laws and the Drugs and Magic remedies Act.
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 Limited to,

• Travel

• Meals

• Accommodation

• Registration fees
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 • Companies should avoid using
renowned or extravagant venues.

• Hospitality should be limited to

moderate and reasonable refreshments
and/or meals incidental to the main
purpose of the event and should be
provided only to participants in the
event and not their guests.

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 • As a general rule, the hospitality
provided should not exceed what
healthcare professional recipients
would normally be prepared to pay for
themselves.

• No stand-alone entertainment or
other leisure or social activities should
be provided or paid for by member
companies. At events, entertainment
of modest nature, which is
secondary to refreshments
and/or meals, is allowed.

©Mark IV Medical communication

 Payments of reasonable fees and reimbursement
may be provided to healthcare professionals
who are providing genuine services as speakers
or presenters on the basis of a written
contract with the company at the event.

Other Healthcare professionals cannot be

compensated for time spent in attending an
event, e.g. a company-sponsored meeting or
scientific congress.

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 Promotional material (excluding
promotional aids) for a pharmaceutical
product not registered in the country of
the event should be accompanied by

• a suitable statement indicating the

countries in which the product is
registered,

• an explanatory statement indicating

that registration conditions differ
internationally.
©Mark IV Medical communication
•Medical Animation Library

•2D/3D Medical & Scientific Illustrations

•2D/3D Medical & Scientific Animations

•Flash based Interactive Applications

•Websites & Health Portals for Pharmaceutical &

Healthcare Industry

Written by-
Dr. Neelesh Bhandari
MD (Path), PGP Human Rights
Advisor (Medical Communications)
Mark IV Medical Communications.
http://tinyurl.com/drneelesh
©Mark IV Medical communication
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