Sunday 1 February 2015

IMA White Paper: What every doctor must know about THE DRUGS AND MAGIC REMEDIES (OBJECTIONABLE ADVERTISEMENTS) ACT, 1954

•             The act controls the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities

•             The act extends to the whole of India except the State of Jammu and Kashmir

•             “Advertisement” includes any notice, circular; label, wrapper, or other document, and any announcement made orally or by any means of producing or transmitting light, sound or smoke

•             “Drug” includes- A medicine for the internal or external use of human beings or animals; any substance intended to be used for or in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals; any article, other than food, intended to affect or influence in any way the structure or any organic function of the body of human beings or animals

•             “Magic remedy” includes a talisman mantra kavacha, and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation treatment or prevention of any disease in human beings or animals or for affecting or influencing in any way the structure or any organic function of the body of human beings or animals

•             “Registered medical practitioner” means any person: Who holds a qualification granted by an authority 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); or  who is entitled to be registered as a 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

•             “Taking any part in the publication of any advertisement includes- The printing of the advertisement; The publication of any advertisement outside the territories to which this Act extends by or at the instance of person residing within the said territories

•             Prohibition of advertisement of certain drugs for treatment of certain diseases and disorders. 

No person shall take 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 improvements 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) which may be specified in the rules made under this Act;

Provided that no such rule shall be made except-

 (i)        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, and
 (ii)       After consultation with the Drugs Technical Advisory Board constituted under the Drugs and Cosmetics Act, 1940 (23 of 1940), and, 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.

 4.        Prohibition of misleading advertisements relating to drugs

No person shall take any part in the publication of any advertisement relating to a drug if the advertisement contains any matter which directly or indirectly gives a false impression regarding the true character of the drug; or makes a false claim for the drug; or is otherwise false or misleading in any material particular.

 5.        Prohibition of advertisement of magic remedies for treatment of certain diseases and disorders as specified in Section 3.

 6.        Prohibit on of import into, and export from India of certain advertisement

No person shall import into, or export from, the territories to which this Act extends any document containing and advertisement of the nature referred to in Section 3, or Section 4, or Section 5, and any documents containing any such advertisement shall be deemed to be goods of which the import or export has been prohibited under Section 19 of the Sea Customs Act, 1878 (8 of 1978), and all the provisions of that Act shall have effect accordingly, except that Section 183, thereof shall have effect as if for the word “shall” therein the word “may” were substituted.

 7.        Penalty: Punishable in the case of a first conviction, with imprisonment which may extend to six months, or with fine, or with both and in the case of a subsequent conviction, with imprisonment which may extend to one year, or with fine, or with both.

 8.        Powers of entry, search: Any Sate Gazette Officer can enter and search at all reasonable times, with such assistants, if any, as he considers necessary, any place in which he has reason to believe that an offence under this Act has been or is being committed; seize any advertisement which he has reason to believe contravenes any of the provisions of this Act. The officer can examine any record, register, document or any other material object found in any place mentioned and seize them.
The provisions of the Code of Criminal Procedure, 1898 (5 of 1898), shall, so far as may be, apply to any search or seizure under this Act as they apply to any search or seizure made under the authority of a warrant issued under Section 98 of the said Code. After seizure anything under clause (b) or clause (c) of sub section (1) he shall, as soon as may be inform a Magistrate and take his orders as to the custody thereof

 9.        Offences by companies: If the person is a company ( corporate, firm, associations, AOPs) every person ( director, partner) who, at the time the offence was committed, was in charge of and was responsible to the company for the conduct of the business of the company as well as the company shall be deemed to be guilty of the contravention and shall be liable to be proceeded against and punished accordingly provided if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence.

9A.      Offences to be cognizable: An offence punishable under this Act shall be cognizable.

 10.      Jurisdiction to try offences: No court interior to that of a presidency magistrate or a magistrate of the first class shall try any offence punishable under this Act.

 10A.    Forfeiture: Where a person has been convicted by any court for contravening any provision of this Act or any rule made there under, the court may direct that any document (including all copies thereof), article or thing, in respect of which the contravention is made, including the contents thereof where such contents are seized under clause (b) of sub section (1) of section 8, shall be forfeited to the Government.

 11.      Officers to be deemed to the public servants: Every person authorized under section 81 shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code (45 of 1860).

 12.      Indemnity: No suit, prosecution or other legal proceeding shall lie against any person for anything which is in good faith done or intended to be done under this Act.

 13.      Other laws not affected: The provision of this Act is in addition to, and not in derogation of the provisions of any other law for the time being in force.

 14.      Savings. -Nothing in this Act shall apply to-

 (a)       Any sign board or notice displayed by a registered medical practitioner on his premises indicating that treatment for any disease, disorder or condition specified in section 3; the Schedule or the rules made under this Act, is undertaken in those premises; or

 (b)       Any treatise or book dealing with any of the matter specified in section 3 from a bonafide scientific or social standpoint; or

 (c)       Any advertisement relating to any drug sent confidentially in the manner prescribed under section 16 only to a registered medical practitioner; or

 (d)       Any advertisement relating to a drug printed or published by the Government; or

 (e)       Any advertisement relating to a drug printed or published by any person with the previous sanction of the Government granted prior to the commencement of the Drugs and magic Remedies (Objectionable Advertisement) Amendment Act, 1963 (42 of 1963).  Provided that the Government may, for reasons to be recorded in writing withdraw the sanction after giving the person an opportunity of showing cause against such withdrawal.

 15.      Power to exempt from application of Act are with the Central Government that to only in public interest and by notification in the Official Gazette.

 16.      Power to make rules: The Centre Government may, by notification in the Official Gazette, make rules to specify and disease, disorder or condition to which the provisions of section 3 shall apply and prescribe the manner in which advertisement of articles or things referred to in clause (c) of section 14 may be sent confidentially. Every rule must be passed by the parliament.    

 THE SCHEDULE:  [See Sections 3(d) and 14]: Name of the disease, disorder or condition
Appendicitis; Arteriosclerosis; Blindness; Blood poisoning; Bright's disease; Cancer; Cataract;      Deafness; Diabetes; Diseases and disorders of the brain; Diseases and disorders of the optical system;      Diseases and disorders of the uterus; Disorders or menstrual flow; Disorders of the nervous system;     Disorders of the prostatic gland; Dropsy; Epilepsy; Female diseases (in general); Fevers (in general);  Fits; Forms and structure of the female bust; Gall stones, kidney stones and bladder stones;  Gangrene; Galucoma; Goitre; Heart diseases; High or low blood pressure; Hydrocele; Hysteria; Infantile paralysis; Insanity; Leprosy; Lecuoderma; Lockjaw; Locomotor atoxia; Lupus; Nervous debility; Obesity;     Paralysis; Plague; Pleurisy; Pneumonia; Rheumatism; Ruptures; Sexual impotence; Small pox; Stature of persons; Sterility in women; Trachoma; Tuberculosis; Tumours; Typhoid fever and  Veneral diseases, including syphilis, gonorrhoea, soft chancre, veneral, granulima and lympho granuloma. (total 54 diseases)
Asthma , AIDS added in the rules ( total 56)

The Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955

Scrutiny of Misleading Advertisements Relating to Drugs

Any state government authorized person if satisfied, that an advertisement relating to a drug contravenes the provisions of section 4, by order, require the manufacturer, packer, distributor or seller of the drug to furnish, within such time as may be specified in the order or such further time as may be allowed in this behalf by the person so authorized information regarding the composition of the drug or the ingredients thereof or any other information in regard to that drug as he deems necessary for holding the scrutiny of the advertisement and where any such order is made, it shall be the duty of the manufacturer, packer, distributor or seller of the drug to which the advertisement relates to comply with the order. Any failure to comply with such order shall, for the purposes of section 7, be deemed to be a contravention of the provisions of section 4:

Manner in which Advertisements may be sent Confidentially


All documents containing advertisements relating to drugs referred to in clause (c) of sub-section (1) of section 14, shall be sent by post to a registered medical practitioner by name or to a wholesale or retail chemist, the address of such registered medical practitioner or wholesale or retail chemist being given. Such document shall bear at the top, printed in indelible ink in a conspicuous manner, the words. “For the use only of registered medical practitioners or a hospital or a laboratory”].

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