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12. Power of Central Government
to make rules. � (1) The Central Government may, [(Note: Subs. by Act 68 of
1982, sec.9, for "after consultation with the Board" (w.e.f. 1-2-1983))
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 [(Note: Ins. by Act 21 of 1962, sec.10 (w.e.f. 27-7-1964))
or cosmetics or classes of cosmetics] for the import of which a licence is
required, [(Note: Subs. by Act 68 of 1982, sec.9, for certain words (w.e.f.
1-2-1983)) and prescribe the form and conditions of such licences, the
authority empowered to issue the same, the fees payable therefore and provide
for the cancellation, or suspension of such licence in any case where any
provision of this Chapter or the rules made there under is contravened or any of
the conditions subject to which the licence is issued is not complied with;
(b) Prescribe the methods of
test of test or analysis to be employed in determining whether a drug [(Note:
Ins. by Act 21 of 1962, sec.10 (w.e.f. 27-7-1964)) or cosmetic] is of standard
quality ;
(c) Prescribe, in respect of
biological and organ metallic compounds, the units or methods of standardization
;
(cc) Prescribe under clause (d)
of [(Note: Subs. by Act 68 of 1982, sec.9 for "section 9B" (w.e.f. 1-2-1983))
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 [(Note: Subs. by Act
11 of 1955, sec.7, for "to cure or mitigate" 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 ;
(f) Prescribe the places at
which drugs [(Note: Ins. by Act 21 of 1962, sec.10 (w.e.f. 27-7-1964))
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 [(Note: Ins. by Act 21 of
1962, sec.10 (w.e.f. 27-7-1964)) 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 [(Note: Ins. by Act 21 of 1962, sec.10 (w.e.f. 27-7-1964)) 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 [(Note:
Ins. by Act 21 of 1962, sec.10 (w.e.f. 27-7-1964)) 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 there under of drugs [(Note: Ins. by Act 21 of 1962,
sec.10 (w.e.f. 27-7-1964)) or cosmetics] imported for the purpose only of
transport through, and export from, [(Note: Subs. by Act 3 of 1951, sec.3 and
Sch., for "the States.") India];
(k) Prescribe the conditions
to be observed in the packing in bottles, packages or other containers, of
imported drugs [(Note: Ins. by Act 21 of 1962, sec.10 (w.e.f. 27-7-1964)) or
cosmetics] [(Note: Ins. by Act 68 of 1982, sec.9 (w.e.f. 1-2-1983))
including the use of packing material which comes into direct contact with the
drugs];
(l) Regulate the mode of
labeling drugs [(Note: Ins. by Act 21 of 1962, sec.10 (w.e.f. 27-7-1964)) 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 there under ;
(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 there under of any specified drug or class of drugs
[(Note: Ins. by Act 21 of 1962 (w.e.f. 27-7-1964)) or cosmetics or
class of cosmetics].
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