The Drug Rules are exhaustive and they spell out the medicines which can be
given only on prescription and those that do not require prescription. The rules
also specify when a particular drug will be treated as of standard quality. They
provide for detailed instructions concerning manufacture, storage and sale.
There are also detailed guidelines concerning the conduct of clinical trials.
Quality control in drugs is sought to be ensured through licensing and
supervision procedures.
Section 17. Misbranded Drug- for the purposes of this Chapter, a drug shall be
deemed
misbranded-
(a) If it is so coloured, coated, powdered or polished that damage is concealed
or if it is made to appear of better or greater therapeutic value than it really
is; or
(b) If it is not labeled in the prescribed manner; or
(c) If its label or container or anything accompanying the drug bears any
statement, design or device which makes any false claim for the drug or which is
false or misleading in any particular.
Section 17A. Adulterated Drugs- a drug shall be deemed to
be adulterated-
(a) If it consists in whole or in part, of any filthy, putrid or decomposed
substances; or
(b) If it has been prepared, packed or stored not under sanitary conditions
whereby it may have been contaminated with filth or whereby it may have been
rendered injurious to health;or
(c) If its container is composed, in whole or in part, of any poisonous or
deleterious substances which may render the contents injurious to health; or
(d) If it bears or contains, for purposes of colouring only, a colour other than
one which is
prescribed; or
(e) If it contains any harmful or toxic substance which may render it injurious
to health; or
(f) If any substance has been mixed there with so as to reduce its quality or
strength.
Section 17B. Spurious Drugs- a drug shall be deemed to be
spurious-
(a) If it is manufactured under a name which belongs to another drug; or
(b) If it is an imitation of, or is a substitute for, another drug or resembles
another drug in a manner likely to deceive or bears upon it or upon its label or
container the name of another drug unless it is plainly and conspicuously marked
so as to reveal its true character and its lack of identity with such other
drug; or
(c) If the label or container bears the name of an individual or company
purporting to be the manufacture of the drug, which individual or company is
fictitious or does not exist; or
(d) If it has been substituted wholly or in part by another drug or substance;
or
(e) If it purports to be the product of manufacture of whom it is truly a
product
Section 18. Prohibition of manufacture and sale of certain drugs and cosmetics-
From such date as may be fixed by the State Government by notification in the
official Gazette in this behalf, no person shall by himself or by any other
person on this behalf-
(a) Manufacture for sale or for distribution, or sell, or stock or exhibit or
offer for sale, or distribute) Any drug which is not of a standard quality, or
is misbranded, adulterated or spurious;
ii) Any cosmetic which is not of a standard quality or is misbranded or
spurious;
iii) Any patent or proprietary medicine, unless there is displayed in the
prescribed manner on the label or container thereof the true formula or list of
active ingredients contained in it together with the quantities, thereof;
iv) Any drug which by means of any statement, design or device accompanying it
or by any other means, purports or claims to prevent, cure or mitigate any such
disease or ailment, or to have any such other effect as may be prescribed;
v) Any cosmetic containing any ingredient, which may render it unsafe or harmful
for
use under the directions, indicated or recommended vi) Any drug or cosmetic in
contravention of any provision of this Chapter or any rule made there under;
(b) Sell or stock or exhibit or offer for sale, distribute any drug or cosmetic
which has been imported or manufactured in contravention of any of the
provisions of this Act or any rule made there under;
(c) Manufacture for sale or for distribution, or sell, or stock or exhibit or
offer for sale, or distribute any drug or cosmetic, except under, and in
accordance with the condition with the conditions of, a licence issued for such
purpose under this Chapter Provided that nothing in this section shall apply to
the manufacture, subject to prescribed conditions, of small quantities of any
drug for the purpose of examination, test or analysis:
Provided further that the Central Government may, after consultation with the
Board, by notification in the Official Gazette, permit, subject to any
conditions specified in the notification, the manufacture for sale or for
distribution, sale stocking or exhibiting or offering for sale or distribution
of any drug or class of drugs not being of standard quality.
Section 3: Prohibition of advertisement of certain drugs for treatment of
certain
diseases and disorder- 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) procurement of miscarriage in women or prevention of conception in women; or
(b) maintenance or improvement of the capacity of human beings for sexual
pleasure; or
(c) correction of menstrual disorder in women; or
(d) diagnosis, cure, mitigation, treatment or prevention of any disease,
disorder or condition specified in the Schedule, or any other 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 rule 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 Drugs Technical Advisory Board constituted
under the Drugs and Cosmetics Act, 1940 and, if the Central Government considers
necessary, with such other persons having special knowledge or practical
experience in respect of Ayurvedic or Healthcare Case Unani systems of medicines
as that Government deems fit
Section 4: Prohibition of misleading advertisement 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) makes a false claim for the drug; or
(c) is otherwise false or misleading in any material
particular.
Sale and Stocking of Drugs:
The Supreme Court has concluded:
1) Licences under Rules 61 & 62 proviso will extend to grant of licences for
wayside depots or ‘emergency stores’ or ‘vehicles’, but every storage for sale
must have a licence.
2) Licences permitting sale by a vehicle cannot automatically cover cases of
‘emergency storage’ or storage in transit. The words of Section 18(c) and Rule
62 are mandatory being plain and admitting no exceptions.
3) Applying the mischief rule of interpretation, storage even though for a short
spell or on an ad hoc basis and without intent to sell at that place but as a
part of the sale business comes within the scope of ‘storage for sale’ in
Section 18(c) & Rule 62.
Patents Act:
The amendments to the Patents Act coupled with India’s obligation
under
TRIPS, and the increasing efforts by pharmaceutical companies to profit from the
changes in the law. The new Patents Act is characterized by two main trends.
On the one hand, it generally follows quite closely the requirements of the
TRIPS Agreement. The amendments made generally favour the drug/process developer
over the society. The duration of patents in the health sector has been, for
instance, dramatically increased from seven to 20 years.
On the other hand, the new Patents Act uses some of the exceptions and
qualifications included in TRIPS to foster public health goals. It uses, for
instance, health-related exceptions in Sec.3 of the Act which determines which
inventions are not patentable.
One of the most controversial sections is regarding licensing.
While TRIPS generally imposes a stricter compulsory licensing regime than that
provided under the Patents Act, 1970, the amendments make use of some of the
possibilities opened by the Doha Declaration. It specifically mentions that
patents granted should not ‘impede protection of public health’ and should not
prohibit the Central Government from taking measures to protect public health.
Further, it recalls that patents should be granted to make the benefits of the
patented invention available at reasonably affordable prices to the public.
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