Scientific Promotion of Pharmaceuticals Products in India

 

Scientific Promotion of Pharmaceuticals  Products in India

 Principles for promotion

 promote medicines in a country after marketing authorizations have been granted in that country.

medicines are promoted only for the approved indication(s), consistent with approved prescribing information.

2. Promotional information

Consistent with FDA-approved prescribing information (where it includes benefit claims for the medicine).

Promotional materials may not necessarily be limited to using only the verbatim of the approved product information (‘the label’).

Promotional information respects the context and intent of information in the approved label, and statements from the label may not be reproduced out of context.

Clear, legible, up-to-date, accurate, fair, objective, and balanced.

• Capable of substantiation (verifiable).
• Based on relevant evidence and sufficiently complete to enable the recipient to form their own opinion of the medicine

Promotional Information should not be:

• Misleading – by distortion, exaggeration, misrepresentation, undue emphasis, omission, or in any other way.
• Knowingly offensive or disparaging.
• Disguised in any way.
• Where published studies are referred to, clear references should be included in the material.
• Comparisons between different medicines that provide information relative to a comparator (including a placebo) should be based on relevant and comparable aspects of the medicines.
• Claims for superior potency of a medicine (i.e., the medicine has a lower effective dose) should be avoided unless they can be linked to a practical advantage such as a reduction in adverse reactions or cost of effective dosage.
• Medicines must not be stated as being ‘better’ or ‘superior’ without reference to the comparator.
• Medicines must not be stated as being the best, greatest, strongest (or other superlative words that indicate the highest quality or degree) unless it can be substantiated as a statement of fact.
• The use of in-vitro laboratory or animal data to support claims of a health benefit is permitted only where the type of data is made clear and there is an established link between that data and the health benefit (e.g., a publicly available consensus by the scientific community and/or regulatory authorities).
• It must not be stated that medicine has no side effects, toxic hazards, or risks of addiction or dependency. The word ‘safe’ must never be used to describe effects on patients, and the words ‘safely’ or ‘safer’ must never be used to describe our medicines without qualification.

3. Artwork: Artwork, including graphs, illustrations, photographs, and tables which are taken from publications and included in promotional material:

• Clearly indicate the precise source(s) of the artwork.
• Are faithfully reproduced; except where adaptation or modification is required to comply with local laws, regulations, or applicable industry codes, in which case it is clearly stated that the artwork has been adapted and/or modified.
• Are authorized for use by relevant copyright law

4. Endorsements, quotations, testimonials, and the like attributed to individuals or organizations such as government agencies, professional bodies, or independent agencies are:

• Verifiable (by citing published references or obtaining approval of the promotional material from the individual or organization).
• Consistent with the approved prescribing information and approved by the same criteria as any promotional claim.

• Follow requirements set by the organization (for example written approval in advance of the final promotional material by Legal, Regulatory, and Medical).

5. Promotional meetings:

The purpose of the promotional meetings is to proactively provide scientific or medical information about our authorized medicines and/or the associated diseases.

• Promotional meetings only occur when you can ensure that the meeting adheres to the requirements of CME and other relevant requirements of the UCPMP including that the data presented and materials provided do not promote off-label use of your medicines.
• For any promotional meeting, it is the scientific content of the program that attracts a delegate to attend.
• Promotional meetings should only be permitted in disease areas where you have an approved medicine.

6. Promotional Aids:

Promotional aids (sometimes called brand reminder items) can be given to HCPs/OHS provided they are of minimal value (to be defined under the local laws and industry codes), relevant to the professional activities of the recipient, and provided on an infrequent basis. Promotional aids may carry product branding and company branding.

7. Principles for scientific engagement:

Scientific engagement is the non-promotional interaction and exchange of information between your company and external communities to advance scientific and medical understanding.

• This includes the appropriate development and use of your medicines, understanding the management of disease, and improving patient care.
• The activities and materials associated with scientific engagement are non-promotional in nature and intent, and proportional to the scientific need.
• There is a clear distinction between scientific engagement and promotional activities.

8. Scientific engagement activities: Seeking external advice, insights, and information.

• Scientific communication of our research.
• Supporting independent medical education.
• Scientific interactions with payers, governments, and public health organizations. includes papers in peer-reviewed journals and presentations in the core program of medical congresses.
• Whether a proposed activity or material meets the principles for scientific engagement requires medical judgment with consideration of intent, perception, proportionality, and timing.
• The intention is clear, transparent, and non-promotional.
• The activity would not be perceived as being promotional.
• The timing and scale are proportionate to the scientific need.
• There is a legitimate need for the activity at the time it occurs.

9. Use and selection of vendors:

External vendors do not develop scientific engagement plans or content (e.g., selection and interpretation of scientific data).

• Vendors can be used for operational support (e.g., formatting, layout, design, artwork, copy editing, researching references, printing, logistics, and overall project management) when the required capabilities or capacity are not available within the company.
• Vendors engaged to provide operational support for the development of content (e.g., copy editing, researching references) are trained and understand that the Company is responsible for reviewing and approving content.

10. Seeking external advice, insights, and information:

Seek advice (on pre-determined questions), insights, and information related to scientific research, diseases, medicine development, disease management, market access, commercialization, or other medicine-related matters through (a) Advisory boards and 1:1 type consultancy (advice seeking from individuals on a consultancy basis). (b) Pre-planned informal discussions with individuals or groups. (c) Spontaneous discussions at scientific/medical congresses.

11. Do’s & Don’ts Promotion of Drugs & Scientific Promotion of Drugs

Do’s	Don’ts’s
The drug must be consistent with the terms of the MA	Don’t promote medicines without marketing authorizations granted by DCGI
Information about Drugs must be verifiable, UpToDate, and accurate	Must not be misleading directly or indirectly
Must be fair, accurate, and balanced
Must be capable of substantiation, if required must be given without any delay by medical and pharmacists including the pharma industry.	The word ‘safe’ must never be used without qualification
Claims for usefulness must be based on UpToDate evaluation of all evidence	Don’t state that medicine has no side effects, toxic hazards, or risks of addiction or dependency.
	Don’t use the word “New” for drugs that are generally available and promoted for therapy for more than 12 months in India.
Comparisons must be fair, factual, and capable of substantiation	Must not be misleading, omission and undue emphasis
	Brand names must not be used in comparisons without consent/NOC
	Clinical and scientific opinion of HCP must not be disparaged
All promotional materials of MA holders must be by UCPMP, D&C Act, DMRA, and Copyright Act.	Mailings and journal advertisements must not be designed to disguise in nature
Promotional materials to HCP must have ·       Name of Drug ·       List of API ·       Address of MA holder ·       Recommended dosage/method of administration ·       AE, Warnings, Precautions, and Contraindications ·       Date of information generated or updated	Promotional material must not resemble editorial matter for Paid journal publications
Promotional material must confirm in text and illustration the canon of good taste	Must not offend the recipient
	Don’t use the name and photo of HCP
Technical and other information must have the date of printing and the last reviewed date	Don’t imitate devices, copy slogans or general layouts used by other companies to avoid misleading
Audio-visual materials must be supported by printing material.	Postcards, exposed mailings, wrappers, and envelopes must not contain material that may be advertising material and unsuitable for public view

12. Applicable laws and Regulations:

On Marketing & Promotion of pharmaceutical & Health care products in India:

1. Uniform Code for Pharmaceutical Marketing Practices (“UCPMP”) applies to pharmaceutical companies, medical representatives, and agents of pharmaceutical companies such as distributors, wholesalers, retailers, and pharmaceutical manufacturer’s associations.

• Key Provisions
• No gifts, pecuniary advantages, or benefits in kind may be supplied, offered, or promised by a pharma company or its agents to persons qualified to prescribe or supply drugs.
• Companies or their associations/representatives shall not extend any travel facility inside or outside the country, or any hospitality like hotel accommodation to healthcare practitioners and their family members under any pretext.
• It also prescribes additional conditions that are to be observed while providing samples.
• Companies or their associations/representatives shall not pay any cash or monetary grants to any healthcare professional under any pretext.
• Further, as per the UCPMP Code, to appoint Medical Practitioners/HCPs as affiliates there should be a written contract, the legitimate need for the services must be documented, and criteria for selecting affiliates must be directly related to the identified need. However, the number of affiliates retained must not be greater than the number necessary to achieve the identified need, and the compensation must be reasonable.

1. ADVERTISEMENT OF DRUGS:

 The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 (“DMRA”), and the Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955 (“DMR Rules”) prohibit the advertisement of certain drugs for the treatment of specific diseases and disorders. The schedule of the DMRA provides a list of diseases for which any advertisement is prohibited.

• WHAT IS PROHIBITED UNDER SECTIONS 3, 4 & 5 OF DMRA?

(a) the procurement of miscarriage in women or prevention of conception in women; or

(b) the maintenance or improvement of the capacity of human beings for sexual pleasure; or

(c) the correction of menstrual disorders in women; or

(d) the diagnosis, cure, mitigation, treatment, or prevention of any disease, disorder, or condition specified in the schedule.

Any Misleading Advertisement relating to

(a) directly or indirectly gives a false impression regarding the true character of the drug, or

(b) make a false claim for the drug; or

(c) are otherwise false or misleading in any material particular.

the advertisement of magic remedies for the treatment of certain diseases, claiming directly or indirectly to be efficacious for any of the purposes specified in Section 3.

1. WHAT IS PERMITTED?

(a) Any signboard or notice displayed by a registered medical practitioner on his premises indicating the treatment for any disease, disorder, or condition specified in Section 3.

(b) Any treatise or book dealing with any of the matters specified in Section 3 from a bonafide scientific or social standpoint.

(c) Any advertisement relating to any drug sent confidentially to a registered medical practitioner.

(d) Any advertisement relating to a drug printed or published by the government.

(e) Any advertisement relating to a drug printed or published by any person with the previous sanction of the government.

Advertisement is allowed concerning certain types or classes of drugs by various notifications by the Ministry of Health and Family Welfare.

The central government notified that the provisions of clause (a) of Section 3 in so far as they relate to the prevention of conception in women and those of Section 6 shall not apply to or about any advertisement in respect of contraceptives, provided that the advertisement shall relate only to such contraceptives approved by the government.

 Classes of advertisement are permitted subject to certain conditions.

• Leaflets or literature accompanying packings of drugs.
• Advertisement of drugs in medical, pharmaceutical, scientific, and technical journals
• Price Lists or Therapeutic indexes published by manufacturers, importers, or distributors of drugs duly licensed.
• Medical Literature distributed by medical detailers appointed by manufacturers, importers, or distributors of drugs, duly licensed.
• Advertisement of chemical contraceptives for oral use only if the advertisement relates to chemical contraceptives for oral use having the following composition per tablet.
• DL-Norgestrel 0.30 mg. Ethinyl Estradiol 0.30 mg. or
• Levonorgestrel 0.15 mg. Ethinyl Estradiol 0.03 mg. or
• Centchroman 30 mg.

1. Under Drugs & Cosmetics Act,1940, Drugs & Cosmetics Rules 1945

• The Central Government amended Rules 74 and 78 of the Drugs & Cosmetic Rules and notified that no advertisement can be made in respect of Schedule H, H1, and X except with the previous sanction of the Central Government.
• The Central Government amended the Rule and Rule 170 is inserted in Part XIX to prohibit the advertisement of Ayurveda, Siddha, and Unani drugs unless a unique identification number is obtained from the licensing authority.

1. Judicial Precedents: The Supreme Court in the Hamdard Davakhana case[1] held that the main object and purpose of the DMRA is to prevent people from self-medicating about various diseases. Self-medication to treat serious diseases mentioned in the DMRA and the DMR Rules has a deleterious effect on the health of the community and is likely to affect the well-being of the people. Having thus found that some medicines tend to induce people to resort to self-medication because of elated advertisement, it was thought necessary in the interest of public health that the puffing of advertisements is put to a complete check and that the manufacturers are compelled to route their products through recognized sources to be properly tested and considered by expert agencies.

• The SC further held that the Act read as a whole, does not merely prohibit advertisements relating to drugs and medicines connected with diseases expressly mentioned in Section 3 of the Act but also covers all advertisements which are objectionable and unethical and are used to promote self-medication or self-treatment.
• In the matter of Cipla Ltd Vs State[2] decided in 2018 by the Madras High Court, Cipla was prosecuted for the advertisement of EK Pill, an emergency contraceptive. The drug contained Levonorgestrel 1.5 mg whereas the notification dated 30.04.1992 of MHFW permitted the advertisements of the drugs viz., Levonorgestrel 0.15 mg. The petitioner was granted approval from DCGI which was later withdrawn. However, the approval of DCGI was in force on the date of the offense, so the petitioners were given relief.
• In the matter of Mahesh Ramnath Sonawane Vs, The Union of India[3], a PIL filed by a petitioner sought action against the advertisement of Tablet D’ Cold total, Syrup D’ Cold and Cough, Gelusil MPS antacid, Glycodin Cough Syrup, Benadryl Cough Formula on various TV channels. It was held that Section 2(b) of the Drugs & Cosmetics Act, 1940 which defines ‘drug’, is an inclusive definition that has got a very wide sweep. It, therefore, does not restrict itself to any particular type of medicine or drugs. Thus, advertisements cannot be used to promote self-medication or self-treatment of any drug.

[1] Hamdard Davakhana and Others V/s. The Union of India and Others AIR 1960 SC 554: Cri. LJ 735: 1975 Drug Cases P 233

[2] CRL.O.P.No.19364 of 2015

[3] 2014 SCC On-line Bom 4008