Definitions, Class of Prohibitions Advertisement - Section 3, Classes of exempted advertisements, Powers of entry, search etc., Offenses and penalties, Scrutiny of misleading advertisements relating to drugs, Manner in which advertisements may be sent confidentially, Case Studies.
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Drug Magic Remedies Act controls objectionable ads
1. Dr. Ambekar Abdul Wahid
M. Pharm, Ph. D
Department of Pharmaceutics
Dr. Vithalrao Vikhe Patil Foundation’s
College of Pharmacy
Vadgaon Gupta (Vilad Ghat) PO MIDC
Ahmednagar (MS), India
E-mail: wahidambekar@gmail.com
Drug and Magic Remedies
(Objectionable Advertisement) Act
1954 and Rules 1955
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2. Drugs & Magic Remedies Act
(Objectionable Advertisement) Act 1954
Citation: Act No. 21 of 1954
Territorial Extend: India (expect) Jammu & Kashmir
Date of Commenced: 1 April 1955
Bill published on: 30 April 1954
This act controls the advertisement of drugs and remedies
that claim to have medical properties and makes doing so
as a cognizable offence.
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3. This act prohibits the advertisement of products that
claim to have medical or magical properties (eg.
Talisman, Mantra, Amulet)
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Talisman Mantra Amulet
4. Objectives
An Act
To control the advertisement of drugs in certain cases
To prohibit the advertisement for certain purposes of
remedies alleged to possess magic qualities…
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5. Definitions
Drug:
All medicines for internal or external use of human beings
or animals and all substances intended to be used for or in
the diagnosis, treatment, mitigation (reducing the
severity or painfulness) or prevention of any disease or
disorder in human beings or animals. Preparations applied
on human body for the purpose of repelling insects like
mosquitoes.
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6. ‘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;
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Definitions
7. Advertisement: 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;
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Definitions
8. 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 a person residing within the said
territories;
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Definitions
11. Class of Prohibitions Advertisement -
Section 3
1. Prohibition of Advertisement of Certain Drugs for
Treatment of Certain Diseases and Disorders:
For the procurement of miscarriage in women or
prevention of conception in women; or
The maintenance or improvement of the capacity of
human beings for sexual pleasure; or
The correction of menstrual disorder in women; or
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12. • 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
schedule, or in rules made under this Act.
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13. 2. 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:
Directly or indirectly gives a false impression regarding
the true nature or character of the drug; or
Makes a false claim for the drug; or
Is otherwise false or misleading in any material particular
are prohibited.
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14. 3. 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 purposes specified in section 3.
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15. 4. 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 2, 3 above.
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17. Classes of exempted advertisements
Any advertisement relating to a drug printed or
published by Government or any person with prior
permission of the Government
Any advertisement relating to a drug which is sent
confidentially in the prescribed manner to Registered
Medicinal Practitioner (RMP)
Advertisement s including any treatise or book
dealing with any of the matters relating to diseases
which are otherwise prohibited, provided published
from a bonafide scientific or social point of view
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18. Classes of exempted advertisements
(Continue…)
Any signboard or notice displayed by a Registered
Medicinal Practitioner (RMP) on his premises
indicating that treatment for any disease, disorder or
condition specified in Section 3.
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 Act.
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19. The advertisement should contain only the
information, required for the guidance of Registered
Medicinal Practitioner (RMP) regarding:
Therapeutic indications
Route of administration
Dosage and side effects of such drug or drugs.
The precaution to be taken in treatment with the drug
The distribution to such literature should be given to
Registered Medicinal Practitioner (RMP), dispensaries,
hospitals, medical and research institutions, chemists
and druggists or pharmacies.
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20. Exemption from application of Act:
The central government, for the public interest, may
permit any advertisement of any specified drug or class of
drugs by notification in the official gazette.
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22. Powers of entry, search etc.
1. Subject to the provisions of any rules made in this
behalf, any Gazette officer authorized by the state
Government may, within the local limits of the area
for which he is so authorized:
A. 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.
B. Seize any advertisement which he has reason to
believe contravenes any of provisions of this act.
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23. C. Examine any record, register, document or any other
material object found in any place mentioned in clause (a)
and seize the same if he has reason to believe that it may
furnish evidence of the commission of an offence
punishable under this act.
2. Provisions of the code of criminal procedure, 1898 shall
may apply to any search under this act.
3. Where any person seizes 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.
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Powers of entry, search etc.
(Continue…)
24. Offenses and penalties
1. Contravention of any of the provision of this Act
or rules there under :
Punishable with imprisonment up to six months or
with fine or with both; on first conviction.
Punishable with imprisonment up to one year or with
fine or with both; on subsequent conviction.
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25. 2. In case of contravention of the provisions of the Act by
a company, every person who, at the time of the
commission of the offences, was in-charge and
responsible for the conduct of company business shall
be deemed to be guilty and liable for the punishment.
However, such person is not liable for punishment if
he proves that the offences was committed without his
knowledge or that he has taken all the precautions to
prevent the commission of such offences.
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Offenses and penalties (Continue..)
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Any person authorized by the state Government in this behalf may, if
satisfied, that an advertisement relating to a drug contravenes the
provisions of act.
May order the manufacturer, packer, distributer or seller of the drug to
furnish with in specified time regarding the composition of the drug or
the ingredients as he feels necessary for holding the scrutiny of the
advertisement.
It shall be the duty of the manufacturer, packer, distributor or seller of
the advertised drug to comply with the order. Failure to comply with such
order is considered as an offense.
No publisher or advertising agency shall be held to be guilty of the
contravention of the provisions of the act merely by publishing the
advertisement, unless such publisher or advertising agency has failed to
comply with any direction made by the authority.
Scrutiny of misleading advertisements relating to drugs
27. Manner in which advertisements may
be sent confidentially
All documents containing advertisements relating to drugs
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 wholesaler or retail
chemist being given. Such document shall be 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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28. Obtaining previous sanction of the government
for publishing an advertisement
For obtaining previous sanction of the Government, to publish
any advertisements discussed under exempted advertisements in
this Act, the person has to apply to the concerning officer
appointed by Central Government or State Government.
The application should mention the registered name and the
trade name of the drug, the detailed composition and any special
reasons justifying the sanction of the government.
The authorized officer then should submit such application to
the respective Government for sanction.
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30. Case Studies
1. Action against a self-styled baba who advertises
offering "magic treatment" to patients.
The division bench of Acting Chief Justice AK Sikri and
Justice RS Endlaw sought response from the
governments by and asked petitioner AK Jain to make
city-based Nirmal Baba a party in the case.
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31. The petitioner alleged that Nirmal Baba (Nirmal Jit Singh
Nirula) had been advertising in different electronic and
print media claiming to offer "magical treatment" while
claiming himself to be a "representative of god".
The petitioner sought a ban on all the advertisements by
the Baba, saying that such publicity was contrary to the
provisions of the Drugs and Magic Remedies
(Objectionable Advertisements) Act, 1954.
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32. The common man is being misled by the self-styled Nirmal
Baba under the belief that the problems of a particular
person will be solved with his blessings...the baba is
spending lakhs of rupees on his advertisements and has
earned more than Rs. 200 crores within a few years in
Delhi.
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33. 2. MD of Kunnath Pharmaceuticals convicted for
violation of Magic Remedies Act:
In September 2009, the company had given
advertisement in a leading magazine violating the
provisions of the Act. The advertisement stated that
the product cured infertility by enhancing sexual
capability and fertility. The drug inspector argued in
the court that the advertisement was in contravention
of the provisions of Section 3 (b) of the Act and item
number 48 of the Schedule of the Act.
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34. About the violation case, drug inspector John said
‘Musli Power Xtra’ manufactured by Kunnath
Pharmaceuticals is a good Ayurvedic product, but the
case was taken for giving publicity violating DMROA
Act. The Drugs & Magic Remedies (objectionable
advertisement) Act clearly specifies the prohibition
of advertisement for certain drugs, especially in
the category of drugs described as aphrodisiac.
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35. 3. Revital Issue:
In July 15 2013 Revital is described as a daily health supplement which
is a combination of eleven Vitamins, nine Minerals and Ginseng priced at
Rs 240 (30 capsules)
Revital was sold as a prescription drug for 15 years, but since 2003 it is
being sold as "over-the-counter-drug”.
Ginseng, which is one of the ingredients of Revital, has allegedly caused
several deaths in Germany, USA and UK due to its serious side effects.
It is understood that WHO had cautioned the regulatory authorities to
curb the non-medicinal use of Ginseng.
However, it continues being promoted openly in India through misleading
advertising, as an ingredient of an OTC product like Revital.
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36. 4. In January 2018 Reckitt Benckiser (India) Pvt. Ltd (Strepsils):
The advertisement’s claim, “Bacteria and Virus ko maare” was
inadequately substantiated and is misleading by ambiguity and
implication.
5. Patanjali Ayurved Limited (Patanjali Dant Kanti):
The advertisement's claims, "Effective Against Pyorrhoea, Swelling &
Bleeding of Gums, Yellowing Of Teeth, Sensitivity & bad Breath" and
"Protects your teeth for a longer time and provides a natural shield
against germs", were not substantiated and are misleading.
6. Cipla Health Ltd (Chocó-bite):
The advertisement’s claim, “Upto 100% immunity nutrients” is
misleading by ambiguity, implication and omission to mention that it
could be helpful only as a supplement to normal diet.
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38. Few examples of Advertisings Banned by
Advertising Standards Council of India (ASCI)
Reason:
The most common reason for banning was exaggeration of product efficacy
and exploiting consumers lack of knowledge.
This was followed by violations of the Drugs and Magic Remedies Act (DMR
Act) and the Drugs and Cosmetics (D&C) Rules and advertisements which
contravened various ASCI guidelines.
The other reasons comprised of providing facts which led to grave or
widespread disappointment in the minds of consumers, claims that were not
substantiated with any verifiable comparative data, claims which were
misleading by ambiguity or by implication.
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39. Examples of Ads Banned by Advertisings Banned
by Advertising Standards Council of India (ASCI)
1. RJR Herbal Hospital:
The advertisement’s claim, “Psoriasis can be cured
completely, after this treatment psoriasis was cured for
lifetime”
Was not substantiated with clinical evidence. The claim
is misleading by exaggeration.
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40. 2. Zydus Hospital
The advertisement’s claim, “No. 1 in Neurological
Emergencies” and “Gujarat’s largest & advanced neuro
science centre”
Were not substantiated with any verifiable comparative
data of the advertiser’s hospital and other similar
hospitals to prove that they are in leadership position
(No.1) and larger than the rest or through a third party
validation. The claims are misleading by exaggeration.
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41. 3. Britannia Industries Ltd (Britannia Whole Wheat
Bread)
The advertisement’s claim of the product being
“New” and contain “100% Whole Wheat Bread” on
front of pack.
The advertisement’s claim of the product being “New”
was not adequately substantiated and is misleading by
ambiguity and implication.
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42. 4. Borosil Limited Glass Works (Borosil)
The advertisement’s claim, (in Hindi) in the commercial,
“Borosil ka glass lunch box, yeh khaane mein
chemicals nahin chodtha”
The claim is misleading by ambiguity and gross
exaggeration and exploits consumer’s lack of knowledge.
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43. 5. Fortis Healthcare Ltd
The advertisement’s claim, “The most trusted
destination for Cancer treatment”
Was not substantiated with any market survey data or
any verifiable comparative data of the advertiser’s
hospital and other similar hospitals for cancer treatment,
or through a third party validation.
The claim, “Successful cancer treatment with 10000+
successful cases”
Was not substantiated with supporting evidence of the
cancer patients treated by the advertiser’s hospital, or
through a third party validation.
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