What is Drugs and Magic Remedies Act, 1954?

 Drugs and Magic Remedies (Objectionable Advertisements) Act 1954

The Drugs and Magic Remedies:

1. a medicine for the internal or external use of human beings or animals;

2. any substance intended to be used for or in the diagnostic, cure, mitigation , treatment or prevention of disease in human beings or animals;

3. 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;

4. any article intended for use as a component of any medicine, substance or article, referred to in sub-clauses (i), (ii) and (iii);

(i). 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). 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.

a. 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 l .No.

Name of the disease, disorder or condition

S l .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

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.

Legislative Intent of Drugs and Magic Remedies Objectionable Advertisement Act, 1954

Advertisement and media are playing a significant role in our daily lives. The drug industries to promote the growth in their industries are often prone to promoting misleading advertisements of drugs, which is not only legal to do but also costs the life of the human being who buys and consumes the drugs. To avoid such misfortunes the Central Government has brought forward an enactment in the year 1954 called Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 and Drugs and Magic Remedies (Objectionable Advertisement) Rules, 1955.

In the case of Hamdard Dawakhana and anr., v The Union of India and others (AIR 1960) the legislative intent of the act was challenged.

Facts of the case 

The petitioners challenged the constitutional validity of the Drug and Magic Remedies Objectionable Advertisement) Act, 1954 under Article 32 of the Indian Constitution 1949.

The allegations brought forward by the petitioners was that the actions taken against them violated their fundamental rights under: 

1.      Article 19(1)(a) of the Indian Constitution 1949 provides advertisement as a vehicle of means of which freedom of speech and expression is guaranteed.

2.      Article 19(1)(f) of the Indian Constitution 1949 which is now omitted.

3.      Article 19(1)(g) of the Indian Constitution 1949 states respondents are violating their fundamental right to practice any profession or carry on any occupation, trade and business.

4.      Article 14 of the Indian Constitution 1949 on the ground of discrimination.

5.      Article 21 of the Indian Constitution 1949.

The petitioners also opined that soon after the Drugs and Magic Remedies Objectionable Advertisement Act, 1954 had come into operation, they had faced a lot of difficulties in the matters of publicity of their products and various objections were also raised by the authorities relating to their advertisements. 

The drugs controller on December 4, 1958, gave notification to the petitioners telling them that they were in contravention of Section 3 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954 and asked them to take back the products that were sent to Bombay and other states along with that controller stopped the sale of forty of the products as mentioned in the petition. 

The petitioners contended that the drugs bore the Unani nomenclature which had been recognised throughout the world for several centuries past and also said that the manufacture of the drugs was against the fundamentals rights and ultra vires and so it should be declared null and void.

The counter-affidavit was submitted by the respondents and stated that the main purpose of the act is to prevent people from self-medicating about various serious diseases and found that some medicines tend to induce people to resort to self-medication by reasons of elated advertisements it was thought it was necessary to put a complete check on. 

The Chopra Committee was formed in 1930 mainly to investigate into the quality and strength of drugs imported, manufactured and sold in India and also recommended the steps for control of such imports, manufacturer and sale in the interest of the public and as such the Chopra Committee Reports the Drugs Act was passed in 1940. 

Judgment

As the object of the Acts were discussed in the Chopra Committee, the implementation of the Act was justified, but the fundamental rights as guaranteed by the Constitution had to be kept in mind. 

Reason of enactment of Drugs and Magic Remedies Objectionable Advertisement Act, 1954 

Below mentioned points are considered to be important reasons for the enactment of Drugs and Magic Remedies Objectionable Advertisement Act, 1954:

·        Before the enactment of this Act, there was no law to punish the unprincipled and unscrupulous people who were engaged in false advertisements and claimed miraculous health, particularly health. 

·        The people were engaged in false advertisements of various drugs and medical remedies were also advertised without any fear.

·        Their advertisements not only possessed a threat to society at large but also to the people who believed in such advertisements and acted accordingly.

·        The government enacted strict rules to prevent the self-medication by the consumers regarding various diseases and conditions.

All about Drugs and Magic Remedies Objectionable Advertisement Act, 1954 

The Drugs and Magic Remedies Objectionable Advertisement Act, 1954 was enacted by the Central government in 1954 to curtail the freedom of the advertisers of the drugs and prohibit the advertisement of drugs, which claimed to have certain magic remedies. Important sections of this act are the prohibition of advertisement of certain drugs for the treatment of certain diseases and disorders.

Prohibition of advertising of certain drugs for the treatment of certain diseases and disorders

Section 3 of the Drugs and Magic Remedies Objectionable Advertisement Act,1954 states that no person shall engage themselves in the publication of advertisement of drugs which will as a consequence of the publication of the advertisement, bring about the following consequences:

·        the use of drugs will either results in procurement of miscarriage of women or it will prevent the conception of the women; or

·        the use drug will either results in the maintenance or improvement of the capacity of human beings for sexual pleasure; or

·        drugs dealing with the menstrual disorder in women in; or

·        drugs dealing with diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition which have been specified in the schedule or any other disease or condition as specified under the Drugs and Magic Remedies Objectionable Advertisement Act, 1954.

Prohibition of misleading advertisements related to drugs 

Section 4 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954 provides that no person shall take a part in the publication of advertisement relating to a drug if that advertisement contains any one of the matter as mentioned below which may result either:

·        directly or indirectly gives a false impression regarding the true character of the drug; or

·        is engaged in making a false claim for the drug; or

·        Is engaged in misleading in any material particular.

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

Section 5 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954 provides that no person shall be allowed to work on administering magic remedies and shall not engage themselves in the publication of the advertisement of magic remedies for the treatment of certain diseases and disorders as mentioned under Section 3 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954.

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

Section 6 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954 states no person shall be allowed to import or export from, any documents which are prohibited under Section 3, 4 and 5 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954.

Penalty for contravention

Section 7 of the Drugs and Magic Remedies Objectionable Advertisement Act,1954 states if any person contravenes the Act or any rules made under this Act are:

·        For the first conviction, the person shall be liable for either imprisonment which may extend to six months or with fine or both if the situation arises.

·        For the second time involving the same offence, the person shall be liable for either imprisonment which may extend to one year or with fine or both if the situation arises.

Jurisdiction to try offences

Section 10 of the Drugs and Magic Remedies Objectionable Advertisement Act,1954 states that no court inferior to that of a Presidency Magistrate of the first class shall be allowed to try an offence which is punishable under this act.

Case laws related to misleading of advertisement

Bhanwar Kanwar vs R.K.Gupta & Anr 

·        In this case, an advertisement was published in the newspaper “JanSatta” by the respondent which offers a total cure of fits with Ayurvedic Medicine by Dr R.K Gupta. 

·        The appellant who read the newspaper brought her son to the clinic. The appellant was made to pay INR 2150 as consultancy charges and the cost of medicines. 

·        The medicines given by respondents were claimed to be the combination of a hundred herbs. 

·        As the appellant son took the medicines regularly his health conditions started to get worse day by day. 

·        The patient used to get fits only when he was suffering from high fever but now even without fever he used to get fits.

·        After continuing the treatment for five years an enquiry was made regarding the prescription of tablets.

·        On the enquiry, it was found that the small white tablets which were prescribed by the doctor were selling which is not meant for children and it was also found that respondents were passing off the allopathic medicines as ayurvedic medicine for which he was not competent to prescribe. 

Judgment

The doctor was held liable for medical negligence, criminal negligence, misleading advertisement and breach of duty and was liable to pay INR 5 lakhs as compensation to the appellant.

Ajay Gautam v Amritsar Eye Clinic & Ors.

·        In this case, the doctors were engaged in unfair trade practice by publishing a misleading advertisement in the newspaper.

·        After reading the advertisement in the newspaper the complainant got an impression that the defective vision could be corrected to the normal vision by the use of an excimer laser machine acquired by the doctor.

·        The correction of the complainant’s vision did not achieve completely as it was mentioned in the newspaper and therefore the doctor and hospital were guilty.

Judgment

The doctor and hospital were guilty for indulging in unfair trade practices and for violating the code of ethics regulating by publishing the misleading statement and were liable to pay INR 1 lakh to the complainant.

Drugs and Magic Remedies Objectionable Advertisement Rules,1955

The Central Government enacted the Drugs and Magic Remedies (Objectionable Advertisements) Rule, 1955. Below are a few important rules:

Scrutiny of misleading advertisements related to drugs

Rule 3 of the Drugs and Magic Remedies Objectionable Advertisements Rule, 1955 states that any person, authorised by the state government in this behalf, it is satisfied with an advertisement relating to drugs, contravening the Section 4 of the Drugs and Magic Remedies Objectionable Advertisement Act 1954, then that person may give directions to the manufacturer, packer, distributor and seller to hand over a composition of the drug for holding the scrutiny of the advertisement and checking upon if it complies with the directions issued by the authorised person. Any person contravening the said order shall be liable under Section 7 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954.

How advertisement may be sent confidentially

Rule 5 of the Drugs and Magic Remedies Objectionable Advertisements Rule, 1955 states documents which contain the advertisements relating to the drugs as mentioned in clause(c) of sub-section (1) of Section 14 shall send a copy of the advertisement to the registered medical practitioner or the retail chemist or the wholesale chemist through the registered post.

Prohibition of advertisement of drugs for the treatment of disease 

Rule 6 of the Drugs and Magic Remedies Objectionable Advertisements Rule, 1955 states that no person shall be allowed to take part in the publication of the advertisement relating to the drugs which could be used for diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, or condition specified in the schedule which is annexed to the rules.

Conclusion

Keeping the consumer’s interest in mind, India should adopt the legal policies which are prevalent in other countries. In Canada, the Canadian Pharmaceutical Advertising Advisory Board has been established. The important role of this board is that before the advertisement of the drug is displayed for the promotion, the doctors or health providers have to get approval from the board to advertise their drugs. The board consists of representatives of medical journals, physicians, consumer groups, pharmaceuticals and advertising boards. India should adopt a legal policy to prevent misleading advertisements relating to drugs.

 

Health Ministry proposes changes to Drugs and Magic Remedies Act

Claims such as miraculous cure for AIDS or change of an unborn baby’s sex by ingesting a medicine will attract imprisonment of up to five years and a fine of up to ₹50 lakh, according to a new draft law mooted by the Centre.

The Ministry of Health and Family Welfare has proposed to amend the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, in order to keep pace with changing time and technology, it said in a circular released on Monday.

The new draft is named The Drugs and Magic Remedies (Objectionable Advertisements) (Amendment) Bill, 2020, and enlists 78 diseases and conditions, in which false claims of cure, including any audio visual publicity, representation, endorsement or pronouncement made by means of light, sound, smoke, gas, print, electronic media, internet or website , including any notice, circular, label, wrapper, invoice, banner, poster or any such other document, will be considered.

Other conditions/diseases include heart ailments, blindness, respiratory conditions, cancer, change in hair colour, deafness, diabetes, epileptic fits, fairness of skin, hydrocele, mental retardation, insanity, improvement of memory, improvement of size and shape of sexual organ and duration of sexual performance, paralysis, piles, stammering, leprosy, sterility in women and tuberculosis.

According to the draft, the first conviction will attract imprisonment which may extend to two years and a fine of ₹10 lakh; subsequently, it may go up to five years and a fine of up to ₹ 50 lakh.

‘Implementation, the key’

Mahesh Zagade, former Food and Drug Administration Commissioner of Maharashtra, said that the government can amend the law and make fines stringent, but implementation will remain the key. “The question is, over the past 66 years, how many convictions occurred under the existing law which calls for six months imprisonment that can be extended up to a year? There has been hardly any. ,” Zagade told Businessline.

Health ministry releases Draft DMR Amendment Bill, 2020

 

The Union health ministry has released the draft Drugs and Magic Remedies (Objectionable Advertisements) (DMR) (Amendment) Bill, 2020 for effective compliance.

The ministry’s initiative in this regard comes close on the heels of concerns raised at several quarters on implementation and effectiveness of the DMR Act, 1954.

The proposed draft bill clearly defines Advertisement, Penalty and the disorders covered under the ambit of the Act which shall be called the Drugs and Magic Remedies (Objectionable Advertisements) (Amendment) Act, 2020.

As per a notice, “Ministry of health and family welfare, Government of India proposes to amend the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 in order to keep pace with changing time and technology. In this regard, a draft bill has been prepared and released to solicit suggestions, comments, objections from the public or stakeholders with regard to the said draft Bill.”

“The suggestions, comments or objections may be forwarded within 45 days from the date of issue of this notice by email at drugsdiv-mohfw@gov.in or by post to Under Secretary (drugs Regulation), Ministry of health and family welfare, Room No. 414 A, D Wing, Nirman Bhawan, New Delhi - 110011,” the notice stated.

In the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (hereinafter referred to as the principal Act), in section 2, for clause (a), the following clause shall be substituted, namely (a) "advertisement" means any audio or visual publicity, representation, endorsement or pronouncement made by means of light, sound, smoke, gas, print, electronic media, internet or website and includes any notice, circular, label, wrapper, invoice, banner, poster or such other documents provided that label or wrapper is an advertisement only if it contains any information or claim other than provided in the rules."

In the principal Act, in section 3, in the clause (d), (a) in sub-clause (ii) at the end, the word "or" shall be inserted; (b) after sub-clause (ii) so amended the following sub-clause shall be inserted namely (iii) after consultation with Ayurvedic, Siddha and Unani Drugs Technical Advisory Board (DTAB) constituted under section 33C of the Drugs and Cosmetics (D&C) Act, 1940 in respect of Ayurvedic, Siddha and Unani system of medicines."

In the principal Act, for section 7, the following section shall be substituted, namely "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 first conviction, with imprisonment which may extend to two years and fine upto ten lakh rupees, in the case of a subsequent conviction, with imprisonment which may extend to five years and fine upto fifty lakh rupees."

In the principal Act, in the section 8 (2), for the words and figures "the Code of Criminal Procedure, 1898 (5 of 1898)", the following shall be substituted, namely "the Code of Criminal Procedure, 1973 (2 of 1974)".

In the principal Act, in the section 9A, for the words and figures "the Code of Criminal Procedure, 1898 (5 of 1898)", the following shall be substituted, namely “the Code of Criminal Procedure, 1973 (2 of 1974)".

In the principal Act, for the schedule, the following schedule shall be substituted, namely “The Schedule [See section 3(d) and 14]”.

Name of the disease, disorder or condition covered under the draft bill are AIDS, angina pectoris, appendicitis, arteriosclerosis,  blindness, blood poisoning, bronchial asthma, cancer benign tumor, cataract, change in colour of hair and growth of new hair, change of foetal sex by drugs, congenital malformations, deafness, diabetes, diseases and disorders of the uterus, epileptic fits and psychiatric disorders, encephalitis, fairness of the skin, form and structure of the breast, gangrene, genetic disorders, glaucoma, goitre, hernia, high or low blood pressure, hydrocele, insanity, increase in brain capacity and improvement of memory, improvement in height of children or adults, improvement in size and shape of the sexual organ and in duration of sexual performance, improvement in the strength of the natural teeth, improvement in vision, jaundice or hepatitis or liver disorders, leukaemia, leucoderma, maintenance or improvement of the capacity of the human being for sexual pleasure, mental retardation, sub normalities and growth.

It also includes ailments like myocardial infarction, obesity, paralysis, parkinsonism, piles and fistulae, power to rejuvenate, premature ageing, premature greying of hair, rheumatic heart diseases, heart disease, sexual impotence, premature ejaculation and spermatorrhoea, spondylitis, stammering, stones in gall-bladder, kidney, bladder, varicose vein, bright's disease, diseases and disorders of brain, disorders of menstrual flow, disorders of the prostatic gland, dropsy, female diseases (in general), hysteria, infantile paralysis, leprosy, lockjaw, locomotor ataxia, lupus, plague, pleurisy, pneumonia, rheumatism, ruptures, smallpox, sterility in women, trachoma, tuberculosis, typhoid fever, ulcers of the gastro-intestinal tract, venereal diseases, including syphilis, gonorrhoea, soft chancre, venereal granuloma and lympho granuloma, pyorrhea and sensitive teeth.

 

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