2023-04-19T09:59:05
Power of Central Government to make rules.—(1) The Central
Government may, 30[after consultation with or on the recommendation of the
Board] and after previous publication by notification in the Official Gazette,
make rules for the purpose of giving effect to the provisions of this Chapter:
Provided that consultation with the Board may be dispensed with if the
Central Government is of opinion that circumstances have arisen which render
it necessary to make rules without such consultation, but in such a case the
Board shall be consulted within six months of the making of the rules and the
Central Government shall take into consideration any suggestions which the
Board may make in relation to the amendment of the said rules.]
(2) Without prejudice to the generality of the foregoing power, such rules
may—
(a) specify the drugs or classes of drugs 31
[or cosmetics or classes of
cosmetics] for the import of which a licence is required, 32[and prescribe the
form and conditions of such licences, the authority empowered to issue the
same, the fees payable therefor and provide for the cancellation, or suspension
of such licence in any case where any provision of this Chapter or the rules
made thereunder is contravened or any of the conditions subject to which the
licence is issued is not complied with];
(b) prescribe the methods of test or analysis to be employed in determining
whether a drug 2
[or cosmetic] is of standard quality;
(c) prescribe, in respect of biological and organometallic compounds, the units
or methods of standardisation;
4
[(cc) prescribe under clause (d) of 33[section 9A] the colour or colours which a
drug may bear or contain for purposes of colouring;]
(d) specify the diseases or ailments which an imported drug may not purport
or claim 34[to prevent, cure or mitigate] and such other effects which such drug
may not purport or claim to have;
(e) prescribe the conditions subject to which small quantities of drugs, the
import of which is otherwise prohibited under this Chapter, may be imported for
the purpose of examination, test or analysis or for personal use;
Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 13 of 64
(f) prescribe the places at which drugs 2
[or cosmetics] may be imported, and
prohibit their import at any other place;
(g) require the date of manufacture and the date of expiry of potency to be
clearly and truly stated on the label or container of any specified imported drug
or class of such drug, and prohibit the import of the said drug or class of drug
after the expiry of a specified period from the date of manufacture;
(h) regulate the submission by importers, and the securing, of samples of
drugs 2
[or cosmetics] for examination, test or analysis by the Central Drugs
Laboratory, and prescribe the fees, if any, payable for such examination, test or
analysis;
(i) prescribe the evidence to be supplied, whether by accompanying documents
or otherwise, of the quality of drugs 35 [or cosmetics] sought to be imported, the
procedure of officers of Customs in dealing with such evidence, and the manner
of storage at places of import of drugs x
[or cosmetics] detained pending
admission;
(j) provide for the exemption, conditionally or otherwise, from all or any of the
provisions of this Chapter and the rules made thereunder of drugs *[or
cosmetics] imported for the purpose only of transport through, and export from,
36[India];
(k) prescribe the conditions to be observed in the packing in bottles, packages or
other containers, of imported drugs
37[or cosmetics] 3
[including the use of
packing material which comes into direct contact with the drugs];
(1) regulate the mode of labelling drugs J
[or cosmetics] imported for sale in
packages, and prescribe the matters which shall or shall not be included in such
labels;
(m) prescribe the maximum proportion of any poisonous substance which may
be added to or contained in any imported drug, prohibit the import of any drug
in which that proportion is exceeded, and specify substances which shall be
deemed to be poisonous for the purposes of this Chapter and the rules made
thereunder;
Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 14 of 64
(n) require that the accepted scientific name of any specified drug shall be
displayed in the prescribed manner on the label or wrapper of any imported,
patent or proprietary medicine containing such drug;
(o) provide for the exemption, conditionally or otherwise, from all or any of the
provisions of this Chapter or the rules made thereunder of any specified drug or
class of drugs L
[or cosmetics or class of cosmetics.
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