Regulatory guidelines for promotion of Prescription drugs in India . ©Mark IV Medical communication

Regulatory guidelines for

promotion of

Prescription drugs in India .

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

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 ©Mark IV Medical communication

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

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 . ©Mark IV Medical communication

Promotion of prescription drugs to consumers ( DTC advertising ).

Promotion of self medication products ( OTC medications ).

Provision of non promotional information .

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 Preamble ©Mark IV Medical communication

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

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 . Printed promotional Material ( including advertisements) ©Mark IV Medical communication

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 .

This should include the following : Approved Indications Dose Method of use Succinct statement of contraindications, precautions and side effects Abbreviated prescribing information ©Mark IV Medical communication

This should include the following :

Approved Indications

Dose

Method of use

Succinct statement of contraindications, precautions and side effects

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 Misleading claims ©Mark IV Medical communication

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

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. Substantiation of claims ©Mark IV Medical communication

It is a short advertisement consisting of Name Simple statement of indications to designate therapeutic category Such reminders may avoid API . Reminder advertisements ©Mark IV Medical communication

It is a short advertisement consisting of

Name

Simple statement of indications to designate therapeutic category

Such reminders may avoid API .

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 CME ©Mark IV Medical communication

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

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 Medical samples ©Mark IV Medical communication

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

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. ©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.

Including audiovisuals The same requirements that apply to printed materials also apply to electronic promotional materials and websites. Electronic Media ©Mark IV Medical communication

Including audiovisuals

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

• 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. Websites ©Mark IV Medical communication

• 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.

Limited to , Travel Meals Accommodation Registration fees Sponsorship ©Mark IV Medical communication

Limited to ,

Travel

Meals

Accommodation

Registration fees

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. Hospitality ©Mark IV Medical communication

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.

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

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.

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. Compensation ©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.

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 . International Medical conferences ©Mark IV Medical communication

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 .

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 Compiled by ©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

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