The drugs and magic remedies

By:
N. Sai sree
I/II M PHARMACY
(Regulatory affairs)
3-Oct-18 1CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
Under the guidance of:
Dr. N. Lakshmi Prasanthi

CONTENT
Examples and instances of Misleading Advertisements
Objectives of ACT.
Extent and Commencement
Definitions.
Classes of Prohibited Advertisements.
Classes of Exempted Advertisements.
Exemption from Application of ACT.
Offences and Penalties.
Scrutiny of misleading advertisements relating to drugs.
Manner in which advertisements may be sent confidentially.
Obtaining previous sanction of the Government for publishing an advertisement.

EXAMPLES ANDINSTANCES OF MISLEADING
ADVERTISEMENTS
Promise to cure horrible diseases like cancer and AIDS.
A medical practitioner advertising his clinic and claiming that he
offered a definite cure for epilepsy; Indian Medical Association
(IMA) in this case declared him a fraud based on the findings of the
committee that he was giving his patients lethal drugs in high doses.
India is the land of spiritualist of babas and sadhus. There has not
been a law specifically to prosecute those making false spiritual
claims and deceive people.

3-Oct-18 CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES 4
Consumer Education and Research society, Ahmedabad, brought to notice of
regulatory authority in Gujarat, sale and promotion of certain health gadgets by
Conybio Health Care, in violation of Drugs and Magic Remedies (Objectionable
Advertisements) Act. Company was found promoting and distributing sun shade to
cure from migraine and sun stroke, socks for acidity, pillow covers for spondylitis,
palm guards for Parkinson's disease, eye-shade for sinusitis, T-shirts for high or, low
blood pressure, bed sheets for paralysis strokes.
When the regulator asked the company to produce scientific
evidence to support the effect of infrared rays, which it claimed to
be present in the products, the company said it had never
undertaken such studies by any recognized Indian Misleading
Advertisements and Consumers Institute. Subsequently, the
regulator prohibited the sale and promotion of the products.

CASE STUDIES:
I. 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.

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. "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,"

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.
 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.
 He said the company, through advertisement, was claiming
that the product could treat infertility in both men and
women. The product is formulated from Safed Musli
(chlorophytum borivilianum) known as Indian herbal
aphrodisiac.

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.

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) Chaturbhuj Pharmaceutical Company (B-
Gap contraceptive tablet): The
advertisement’s claim, “Herbal Garbhnirodhak
Tablet”, was not substantiated with supporting
data and with any evidence of product details
such as approval from regulatory authorities and
is misleading. Claim, “Sirf ek goli six maah ke
liye” (one tablet anti pregnancy contraceptive
drug effective for six months) was not
substantiated with proof of product efficacy and
is misleading by gross exaggeration.

6) 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.
7) 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.

OBJECTIVE
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…

Extent And Commencement.
 It extends to the whole of India except the States of Jammu and Kashmir,
and applies also to persons domiciled in the territories to which this Act
extends who are outside the said territories.
 It shall come into force on such date as the Central Government may, by
notification in the Official Gazette.
 1st April 1955 vide Notification No. S.R.O. 511 dated 26th February,
1995, Gazette of India, 1955, Part 11, Section 3, Page 449.

DEFNITIONS
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.

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.
Magic remedy
includes:

DRUG
(i) A medicine for the internal or external use of human beings or
animals.
(ii) Any substance intended to be used for or in the diagnosis, cure,
mitigation, treatment or prevention of disease in human beings or
animals.
(iii) 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.
(iv) Any article intended for use as a component of any medicine.

‘REGISTEREDMEDICAL PRACTITIONER’
Any person:
(i) who holds a qualification granted by an
authority specified in, or notified under,
section 3 of the Indian Medical Degrees Act,
1916 or specified in the Schedules to the
Indian Medical Council Act, 1956.
(ii) 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.

CLASSESOF PROHIBITEDADVERTISEMENTS
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
 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.

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.

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.
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.

CLASSES OF EXEMPTED ADVERTISEMENTS
 Any advertisement relating to a drug printed or published by GOVT. or any person with prior per
mission of the Government
 Any advertisement relating to a drug which is sent confidentially in the prescribed manner to
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
 Any signboard or notice displayed by a 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

The advertisement should contain only the
information, required for the guidance of RMP
regarding:
•Therapeutic indications
•Route of administration
•Dosage and side effects of such drug or
drugs and,
•The precaution to be taken in treatment with
the drug.
The distribution to such literature should be
given to RMP, dispensaries, hospitals, medical
and research institutions, chemists, druggists.
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.
3-Oct-18
22CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES

OFFENSES AND PENALITIES:
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.

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.

Scrutiny of misleading advertisements relating to drugs
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.
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.
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.
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.

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.
Prohibition of advertisement of drugs for treatment of disease:
 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 rule.

OBTAININGPREVIOUSSANCTIONOF THEGOVERNAMENTFOR PUBLISHINGAN
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.

CONCLUSION:
It is very apparent by the nature of the Act that there is no opportunity to share
information related to a drug with a consumer/patient directly by
manufacturers/importers in order to prohibit self-medication. In order to
protect consumer interest, the government should establish an independent
broadcast regulator who will draw up a strict code of practice particularly for
telemarketing services so that only those products and gadgets that do not go
against Drugs and Magic Remedies Act and have proven significance are
allowed to be endorsed in media.

REFERENCES:
 http://www.commonlii.org/in/legis/num_act/damraa1954459
 https://en.wikipedia.org/wiki/Drugs_and_Magic_Remedies_(Objectionable_
Advertisements)_Act,_1954
 http://www.rfhha.org/images/pdf/Hospital_Laws/Drugs_magic_remedies_%
28%20advertisement%29_act.pdf
 Kuchekar B. S., Khadatare A. M., Itkar S. C.; Textbook of Forensic
Pharmacy; Ninth edition; Published By Nirali Prakashan; Pg. No. - 7.1
to 7.6
 The Gazette of India. The Drugs and Magic Remedies (Objectionable
advertisements) Act 1954. No. 21 of 1954
 Jain NK. A textbook of forensic pharmacy. 6th ed. New Delhi: Vallabh
Prakashan,2003.

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