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.
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