SCHEDULE G
[See rule 30 (11)]
ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION
1. Promotion of drugs.- (1) For the purposes of this Schedule, "promotion" means all informational and persuasive activities by manufacturer and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.
(2) All claims concerning a drug for the purposes of promotion shall be reliable, accurate, truthful; informative, balanced, up to date, capable of substantiation and in good taste. Such claims shall not contain misleading, unverifiable statements, omissions likely to induce medically unjustifiable use of a drug or to give rise to under risks. The word "safe" shall not be used with respect to promotion unless properly qualified. Comparison of products shall be factual, fair and capable of substantiation. Promotional material shall not be designed so as to disguise its real nature.
(3) Scientific data in the public domain shall be made available, on request, to prescribers and any other person entitled to receive it as appropriate to their requirements. Promotion in the form of financial or material benefits shall not be offered to or sought by health care practitioners to influence them in the prescription of drugs.
2. Advertisements in any form made to physicians and health-related professionals.-(1) The wording and illustrations in advertisements to physicians and related health professionals shall be fully consistent with the approved scientific data sheet for the drug concerned or other source of information with similar content. The text shall be fully legible.
(2). While introducing the drug to the physician for the first time in shall contain full product information, on the basis of the approved scientific data sheet or similar document and shall contain, among others, the following information:-
(a) The generic name(s) of the active ingredient(s);
(b) the content of active ingredient(s) per dosage form or regimen;
(c) the generic name(s) of other ingredient(s) known to cause problem(s)
(d) the approved therapeutic uses;
(e) dosage form or regimen;
(f) side-effects and major adverse drug reactions;
(g) precautions, contra-indications and warnings;
(h) major interactions;
(i) the name and address of manufacturer or distributor; [--]
(j) reference to appropriate scientific literature ; and
(k) Price of the drug, ; and
(3) Reminder advertisements shall include, amongst others, at least the international non-proprietary name or generic name, the name of each active ingredient and the price of drug and the name and address for the manufacturer or distributor for the purpose of receiving further information.
3. Advertisements in any form to the general public.- (1) Advertisements to the general public, where permissible, shall help people to make rational decisions on the use of drugs determined to be legally available without a prescription. While advertisements shall take account of people’s legitimate desire for information regarding their health they shall not take undue advantage of people’s concern about their own health. Advertisement shall not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. Although health education aimed at children is highly desirable, drug advertisements shall not be directed at children. Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug.
(2) When lay language is used the information shall be consistent with the approved scientific data or other legally determined scientific basis for approval. Language which brings about fear or distress shall not be used.
(3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:-
(a) The generic name(s) of the active ingredient(s);
(b) major indication(s) for use; (S.R.O. 1362(I)/96-28.11.96).
(c) major precautions, contra-indications and warnings, if any; and
(d) name of manufacturer or distributor.
4. Information on price to the consumer shall be accurately and honestly portrayed.
4. Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. They shall be adequately trained so as to posses sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. Employers shall be responsible for the basic and continuing training of their representatives. The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. criteria.
(2) Medical representatives shall make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data or other source of information with similar contents.
(3) Employers shall be responsible for the statements and activities of their medical, representatives. Medical representative shall not offer inducements to prescribers and dispensers. Prescribers and dispenses shall not solicit such inducements. In order to avoid over-promotion, the main part of the volume of sales they generate.
5. Free samples of prescription drugs for promotional purposes.- Free samples of drugs may be provided in modest quantities to prescribers, preferably on request.
6. Free samples of non-prescription drugs to the general public for promotional purposes.- There shall be no free sampling of non-prescription drug to the general public for promotional purposes.
7. Symposia and other scientific meetings.- The intimation regarding scientific symposia, seminars, conferences and such meetings where sponsored by a pharmaceutical manufacturer or distributor shall be clearly communicated in advance. The invitation letter should accurately reflect the presentations and discussions to be held. Entertainment or other hospitality, offered to members of the medical and allied professions shall be secondary to the main purpose of the meeting and shall be kept to a modest level.
8. Post-marketing scientific studies, surveilance and disseminaion of information.- (1) The Registration Board shall be made aware of any post-marketing clinical trials for drugs that are conducted and the results thereafter as soon as possible.
(2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion.
(3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority.
9. Packaging and labelling.- Appropriate information being important to ensure the rational use of drugs, all packaging and labelling material shall provide information consistent with that approved by the Registration Board and if no such approval is available it shall be, consistent with that approved by the drug regulatory authority of the country from which the drug is imported or other reliable sources of information with similar content. Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule.
10. Information for patients contained in package inserts, leaflets and booklets.- (1) Adequate information on the use of drugs shall be made available to the patients where it is necessary for rational use of a drug. In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. If package inserts or leaflets are used for promotional purposes, they shall comply with the ethical criteria enunciated in this Schedule. The wording of the pcakge inserts or leaflets, if prepared specially for patients, shall be in lay language subject to the condition that the medical and scientific content is properly reflected.
(2) In addition to approved package inserts and leaflets wherever available the preparation and distribution of booklets and other information material for patients and consumer shall also comply with the ethical criteria enunciated in this schedule.
[No. F. 8-1/90--AU (Vol-11.)]
DR. F.R.Y. FAZLI,
Deputy Director General (Pharmacy)/Drugs Controller.
(S.R.O. 1362(I)/96 28.11.1997)
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