FDA Maharashtra
 
Wednesday, 08-Feb-2012
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 The Drugs and Magic Remedies

The definition of drug under the Act is comprehensive and even the machine which is an article and covered by the definition. The definition of ‘drug’ in Section 2 is very comprehensive and exhaustive. Unlike definition of drug under Drugs and Cosmetics Act, 1940, it brings within its ambit, medicines of all systems including Ayurvedic drugs.

‘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 oroganic function of the body of human beings or animals;


‘Taking any part in the publication of any advertisement’ includes -

(i) the printing of the advertisement;

(ii) 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;

The definition prescribed by Section 2(d) is wide enough to take in the printing of the advertisement and the sending of it in any part of India”. Thus the newspapers, periodicals publishing the advertisements or printing the advertisements will be considered to be taking part in publication of the advertisements and in case where the advertisements are in violation of the provisions of the Act, they are also liable for penal action under the Act.

PROHIBITIONS:

Section 3, 4, 5 and 6 of the Act are prohibitory sections.

In view of provisions of Section 3 and 4, the Act seeks to prohibit advertisement not only of drugs for treatment of diseases and disorder
but also advertisement of drugs, which are false or misleading. By virtue of Section 5, the persons carrying on or purporting to carry on profession of administering magic remedies are prohibited from taking part in the publication of any advertisement referring to any magic remedy which directly or indirectly claims to be efficacious for any of the purposes specified in Section 3. Section 6 of the Act prohibits Import and Export of objectionable advertisements. Provisions of Section 3 to 6 are reproduced below for ready reference:-
Prohibition of advertisement of certain drugs for treatment of certain diseases and disorders –
Subject to the provisions of this Act, 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 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) which may be specified in the rules made under this Act.

Provided that no such rules 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 Drug Technical Advisory Board constituted under the Drugs and Cosmetics Act, 1940 (23 of 1940) and, if the Central Government considers necessary, with such order persons having special knowledge or practical experience in respect of Ayurvedic or Unani systems of medicines as that Government deems fit.


Prohibition of misleading advertisements relating to drugs –

Subject to the provisions of this Act, no person shall take any part in the publication of any advertisement relating to a drug if the advertisement contains any matter which –

(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) is otherwise false or misleading in any material particular.


Prohibition of advertisement of magic remedies for treatment of certain diseases and disorders –

No person carrying on or purporting to carry on the profession of administering magic remedies shall take any part in the publication of any advertisement referring to any magic remedy which directly or indirectly claims to be efficacious for any of the purpose specified in Section 3.


Prohibition of import into, and export from India of certain advertisements -

No person shall import into, or export from, the territories to which this Act extends any document containing an 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 1878) 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.

Penalty –

Whoever contravenes any of the provisions of this Act [or the rules made thereunder] shall, on conviction, be punishable –
(a) in the case of a first conviction, with imprisonment which may extend to six months or with fine, or with both;
(b) in the case of a subsequent conviction, with imprisonment which may extend to one year, or with fine, or with both.


Savings – Nothing in this Act shall apply to :

(a) any signboard 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 matters 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);


Drugs and Magic Remedies (Objectionable Advertisements) Act 1954

THE SCHEDULE
(See Section 3 (d) and 14)

S. No. Name of the disease, disorder or condition
1. Appendicitis
28. Hydrocele
2. Arteriosclerosis
29. Hysteria
3. Blindness
30. Infantile paralysis
4. Blood poisoning
31. Insanity
5. Bright’s disease
32. Leprosy
6. Cancer
33. Leucoderma
7. Cataract
34. Lockjaw
8. Deafness
35. Locomotor ataxia
9. Diabetes
36. Lupus
10. Diseases and disorders of the brain
37. Nervous debility
11. Diseases and disorders of the optical system
38. Obesity
12. Diseases and disorders of the uterus
39. Paralysis
13. Disorders of menstrual flow
40. Plague
14. Disorders of the nervous system
41. Pleurisy
15. Disorders of the prostatic gland
42. Pneumonia
16. Dropsy
43. Rheumatism
17. Epilepsy
44. Ruptures
18. Female disease (in general)
45. Sexual impotence
19. Fevers (in general)
46. Smallpox
20. Fits
47. Stature of persons
21. Form and structure of the female bust
48. Sterility in women
22. Gallstones, kidney stones and bladder stones
49. Trachoma
23. Gangrene
50. Tuberculosis
24. Glaucoma
51. Tumours
25. Goitre
52. Typhoid fever
26. Heart diseases
53. Ulcers of the gastro-intestinal tract
27. High or low blood pressure
54. Venereal diseases, including syphilis, gonorrhoea, soft chancre venereal granuloma and lympho granuloma

It is under consideration of Govt. of India to review the list of diseases mentioned in Schedule.

Important provisions of Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955 is reproduced below:

[Prohibition of advertisement of drugs for treatment of disease, etc – No person shall also take 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 the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule annexed to these rules.]


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