Drug and Magic Remedies Act 1954.pptx
- 1. Drugs and Magic Remedies Act 1954 (Rules 1955) Objectionable Advertisements Act Ms. Chaitali C. Dongaonkar, M.Pharm (QA), PGDPL, Department of Pharmaceutics, PES Modern College of Pharmacy(For Ladies), Moshi, Pune.
- 2. Contents Introduction Objectives Definitions Prohibitions of certain Advertisements Classes of Exempted Advertisements Offences and Penalties Latest Amendment
- 3. Introduction Extends in India except the State of Jammu and Kashmir Applies = persons domiciled in the territories extends who are outside the said territories Forced = 1st April, 1955
- 4. Objectives To control the advertisement of drugs in certain cases To prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities To provide for matters connected therewith
- 5. Definitions 1. Advertisement 2.Drug 3.Magic Remedy 4.Registered medical practitioner 5.Taking any part in the publication of any advertisement
- 6. Advertisement Includes any - Notice, Circular, Label, Wrapper or other documents Any announcement - orally, by any means of producing Transmitting - light, Sound or Smoke
- 7. Drug Internal or external use of human beings/animals Any Substance: Diagnosis, Cure, mitigation, treatment or prevention of disease Any article: NOT food, affect or influence in any structure or function of body Any article: use as component of medicine, substance or article
- 8. Magic Remedy Talisman, mantra, kavacha, any other charm of any kind Posses miraculous power: for diagnosis, cure, mitigation, treatment, prevention of any disease Affect or influence in any structure or function of body
- 9. Registered Medical Practitioner Qualification = specified in, or notified under Section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916) Specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 1956) Registered = medical practitioner under any law for the time being in force in any State to which this Act extends relating to the registration of medical practitioner
- 10. Taking any part in the publication of any Advertisement 1. Printing of the advertisement 2. The publication of any advertisement outside the territories to which this Act extends by or at the instance of a person residing within the said territories
- 11. Misleading Advertisement False advertisement Deceptive illustrations Use of cinematic tricks & misleading images Discounts and gifts Unrealistic attributes
- 12. Examples: 1.GlaxoSmithKline: - Online banner ads for its migraine medication Treximet featuring a migraine sufferer holding her head in her hands. - The picture caption read, "I just want to take my head off." She was smiling happily in the next photo--after taking Treximet.
- 13. GSK didn't do enough to highlight the serious risks of taking Treximet Which appeared in quickly scrolling text at the bottom of the banner. These include heart attack, stroke and gastrointestinal bleeding.
- 15. Certain drugs for treatment of certain diseases and disorders 1. any part in the publication of any advertisement referring to any drug in terms which suggest or are calculated to lead to the use of that drug for (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 disorder in women; or (d) the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule, or any other disease, disorder or condition (by whatsoever name called)
- 16. Provided that no such rule shall be made except— 1. in respect of any disease, disorder or condition which requires timely treatment in consultation with a registered medical practitioner or for which there are normally no accepted remedies; 2. after consultation with the Drugs Technical Advisory Board constituted under the Drugs and Cosmetics Act, 1940 (23 of 1940), 3. if the Central Government considers necessary, with such other persons having special knowledge or practical experience in respect of Ayurvedic or Unani systems of medicines as that Government deems fit.
- 17. Misleading advertisements relating to drugs • If the advertisement contains any matters which — (a) directly or indirectly gives a false impression regarding the true character of the drug; or (b) false claim for the drug; or (c) false or misleading in any material particular.
- 18. Magic remedies for treatment of certain diseases and disorders No person carrying on or purporting to carry on the profession of administering magic remedies Publication of any advertisement referring to any magic remedy Directly or indirectly claims to be efficacious for any of the purposes specified in section 3.
- 19. Import into, and export from, India of certain advertisements Import into, or export from, the territories to which this Act extends any documents containing an advertisement of the nature referred to in section 3 or in section 4 or section 5 Any document containing any such advertisements shall be deemed to be goods of which the import or export has been prohibited under section 19 of the Sea Customs Act, 1878
- 20. Exempted Advertisements Any sign boards or notices = displayed by Registered Medical Practitioner (RMP) indicating that treatment is undertaken for the disease or disorder Advertisements relating to which are otherwise prohibited
- 21. Exempted Advertisements Any books or treaties: diseases or ailments which are otherwise advertised, provided published from bonafide scientific or social standing Any drug related advertisements sent confidentially, in the prescribed manner, to RMP’s. However, such advertisements should bear the following words on top, in a conspicuous manner For the use only of RMP or a Hospital or a Laboratory
- 22. Exempted Advertisements Any advertisement relating to a drug printed or published by the Government or The prior permission of the Government Advertisements, labels or set of instructions which are permitted under the Drugs and Cosmetics Act or Rules made there under The Central Government: may permit the advertisement, in the interest of the public
- 23. Advertisements Exempted Conditionally 1. Class of Advertisement: A. Leaflets or literature accompanying packing of drugs B.Advertisements of drugs in medical, pharmaceutical, scientific and technical journals
- 24. Conditions (i) The advertisement = it is required for the guidance of a registered medical practitioner relating to: (a) Therapeutic indications of the drug (b) Administration and dosage of the drug (c) Side effects of the drug (d) The precautions to be observed in the treatment with the drug (ii) The responsibility - any claim made in the advertisement is not false, exaggerated or misleading shall lie on the advertiser
- 25. Advertisements Exempted Conditionally 2. Class of Advertisement: 1. Price lists or therapeutic indexes published by manufacturers, importers or distributors of drugs duly licensed under the Drugs and Cosmetics Act 1940 and the Rules there under. 2. Medical literature distributed by medical or distributors of drugs, duly licensed under the Drugs and Cosmetics Act, 1940 and the Rules there under
- 26. Conditions (i) Conditions (i) and (ii) above. (ii) The distribution of such literature to the registered medical practitioners, hospitals, dispensaries, medical and research institutions, chemists and druggists or pharmacies - licensed = provisions of the Drugs and Cosmetic Rules
- 27. Procedure for Sending Advertisements Confidentially All the documents containing advertisements relating to drugs to be sent confidentially shall be sent by post to an RMP by name, or to a wholesaler or retail chemist the address of such RMP or wholesaler or retail chemist at the given address. Such documents shall bear at the top, printed in indelible ink in a conspicuous manner the words "For the use of registered medical practitioner or a hospital or a laboratory".
- 28. Offences and Penalties Contravenes any of the provision imprisonment = upto six months or with fine or both on a first conviction imprisonment upto one year or fine or both on any subsequent conviction.
- 29. Offences and Penalties Company : every person at the time the offence was committed in charge : responsible for the conduct of its business Company : deemed to be guilty and punished
- 30. Offences and Penalties unless it is proved that the offence was committed without his knowledge or that he had exercised due diligence to prevent the commission of that offence. the offence by a company was committed with the consent or connivance or is attributable to any neglect on the part of any director, manager, secretary etc. such person deemed to be guilty of that offence and punished accordingly.
- 31. Offences and Penalties the court may direct the forfeiture of any document, article or thing, in respect of which the contravention is made including then contents thereof. An offence punishable under this Act shall be cognizable and cannot be tried by any court inferior to that of a presidency magistrate or a magistrate of the first class. No suit, prosecution or another legal proceeding shall lie against any person for anything done in good faith or intended to be done under this Act.
- 32. List of Diseases or Disorders Schedule J: Diseases which cannot be claimed to be cured (Drugs and Cosmetics Rules, 1945). Prohibition of advertisement of certain drugs for treatment of certain diseases and disorders like AIDS, Appendicitis, Arteriosclerosis, Asthma… so on.. (54 Diseases)
- 33. ASCI (Advertising Standards Council of India)