DRUGS AND MAGIC REMEDIES ACT, 1954 AND RULES 1955: PURPOSE, PROHIBITED & EXEMPTED ADVERTISEMENTS
The regulations outlined in this Act are supplementary and do not diminish the authority of any other existing laws.
PURPOSE
This act was enacted to:
(1) Regulate specific categories of advertisements pertaining to drugs, and
(2) Prohibit misleading advertisements regarding magic remedies that falsely claim miraculous properties,
(3) Address associated matters.
DEFINITIONS
1. Advertisement:
This encompasses:
(1) Any form of written or visual communication like notices, circulars, labels, or similar documents,
(2) Any oral announcements or signals such as light, sound, or smoke.
2. Magic Remedy:
This includes Talismans, Mantras, Kavachas, or any similar charm claiming extraordinary powers:
(a) For diagnosing, treating, or preventing diseases in humans or animals, or
(b) For affecting or altering the structure or organic function of the body or animal.
3. Drug:
This encompasses the following:
(1) Medicines for internal or external use for humans or animals,
(2) Substances intended for diagnosing, curing, mitigating, treating, or preventing diseases in humans or animals,
(3) Articles (excluding food) that affect or alter the structure or organic function of the human or animal body,
(4) Articles used as components of any medicine.
4. Registered Medical Practitioner:
Refers to any individual,
(i) Holding qualifications granted by authorities specified in, or notified under, Sec. 3 of the Indian Medical Degrees Act, 1916, or specified in the schedules to the Indian Medical Council Act, 1956, or
(ii) Eligible for registration as a medical practitioner under the relevant state laws pertaining to medical practitioner registration.
PROHIBITED ADVERTISEMENTS CATEGORIES
1. Advertisements of Drugs intended for the treatment of specific diseases and disorders, e.g.,
(a) For inducing miscarriage or preventing conception in women, or
(b) For correcting menstrual disorders in women, or
(c) For enhancing human sexual pleasure, or
(d) For diagnosing, curing, alleviating, treating, or preventing any diseases, disorders, or conditions as specified in the schedule or rules under this Act.
2. Advertisements of Magic Remedies claiming efficacy for any purposes specified in category 1 above for the treatment of specific diseases and disorders.
3. Misleading Advertisements related to drugs:
Advertisements concerning a drug or drugs that,
(a) Directly or indirectly present a false impression of the true nature of the drug or drugs, or
(b) Make false claims regarding such drug or drugs.
DISEASES, DISORDERS, AND CONDITIONS AS PER THE SCHEDULE
Appendicitis, Arteriosclerosis, Blindness, Blood poisoning, Bright's disease, Cancer, Cataract, Deafness, Diabetes, Diseases and disorders of the brain, optical system, and uterus, Disorders of menstrual flow, Nervous system, and prostatic gland, Dropsy, Epilepsy, Female diseases (in general), Fevers (in general), Fits, Form, and structure of the female bust, Gallstones, Kidney stones, and bladder stones, Gangrene, Glaucoma, Goitre, Heart diseases, High or low blood pressure, Hydrocele, Hysteria, Infantile paralysis, Insanity, Leprosy, Leucoderma, Lockjaw, Locomotor ataxia, Lupus, Nervous debility, Obesity, Paralysis, Plague, Pleurisy, Pneumonia, Rheumatism, Ruptures, Sexual impotence, Smallpox, Stature of a person, Sterility in women, Trachoma, Tuberculosis, Tumours, Typhoid fevers, Ulcers of the gastrointestinal tract, Venereal diseases including syphilis, Gonorrhoea, Soft chancre, Venereal granuloma, and Lymphogranuloma.
EXEMPTED ADVERTISEMENTS CATEGORIES
(Provision for Savings, under this Act):
The following advertisement types are not prohibited under this Act, meaning this Act does not apply to these types of advertisements.
1. Advertisements related to drugs printed or published by the Government or any other person with prior permission from the Government.
2. Advertisements regarding a drug sent confidentially in the prescribed manner to Registered Medical Practitioners.
3. Advertisements, including any book or treatise (a written or printed composition), addressing matters concerning diseases, disorders, or conditions that are otherwise prohibited, provided they are published from a genuine scientific or social perspective.
4. Displayed signboards or notices by Registered Medical Practitioners on their premises indicating that they provide treatment for diseases, disorders, or conditions specified in the schedule under this Act or in the rules made under this Act.
5. Advertisements related to drugs that comply with the following conditions:
(a) Leaflets or literature accompanying drug packaging, or advertisements of drugs in medicinal, pharmaceutical, scientific, and technical journals.
(b) Therapeutic index or price lists published by licensed manufacturers, importers, or distributors of drugs (under the Drugs and Cosmetics Act, 1940, and the rules thereunder), or medical literature distributed by Medical representatives.
With the condition that:
(i) The advertisement should only contain information necessary for registered medical practitioners regarding:
(a) Therapeutic indications;
(b) Route of administration;
(c) Dosage and side effects of such drug or drugs; and
(d) Precautions to be taken during treatment with the drug.
(ii) The distribution of such literature should be directed to registered medical practitioners, dispensaries, hospitals, medical and research institutions, chemists and druggists or pharmacies.
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