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33. Power of Central
Government to make rules. � [(Note:
Subs. by Act 11 of 1955, sec.15, for sub-section (1)) (1) The Central Government
may [(Note: Subs. by Act 68 of 1982, sec.29, 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) Provide for the
establishment of laboratories for testing and analyzing drugs [(Note: Ins. by
Act 21 of 1962, sec.22 (w.e.f. 27-7-1964)) or cosmetics] ;
(b) Prescribe the
qualifications and duties of Government Analysts and the qualifications of
Inspectors ;
(c) Prescribe the methods of
test or analysis to be employed in determining whether a drug [(Note: Ins. by
Act 21 of 1962, sec.22 (w.e.f. 27-7-1964)) or cosmetic] is of standard quality
;
(d) Prescribe, in respect of
biological and organ metallic compounds, the units or methods of standardization
;
[(dd) (Note: Ins. by Act 13 of
1964, sec.24 (w.e.f. 15-9-1964)) Prescribe under clause (d) of [(Note: Subs. by
Act 68 of 1982, sec.29, for "section 17B" (w.e.f. 1-2-1983)) section 17A] the
colour or colours which a drug may bear or contain for purposes of colouring ;]
(e) Prescribe the forms of
licences [(Note: Subs. by Act 68 of 1982, sec.29, for "for the manufacture for
sale" (w.e.f. 1-2-1983)) for the manufacture for sale or for distribution], for
the sale and for the distribution of drugs or any specified drug or class of
drugs [(Note: Ins. by Act 21 of1962, sec.22 (w.e.f. 27-7-1964)) or of cosmetic
or any specified cosmetic or class of cosmetics], the form of application for
such licences, the conditions subject to which such licences may be issued, the
authority empowered to issue the same [(Note: Ins. by Act 68 of 1982, sec.29
(w.e.f. 1-2-1983)) the qualifications of such authority] and the fees payable
therefore [(Note: Ins. by Act 68 of 1982, sec.29 (w.e.f. 1-2-1983)) and provide
for the cancellation or suspension of such licences 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 they are issued is not complied with] ;
[(ee) [(Note: Ins. by Act 68
of 1982, sec.29 (w.e.f. 1-2-1983)) Prescribe the records, registers or other
documents to be kept and maintained under section 18B ;
(eea) Prescribed the fees for
the inspection )for the purposes of grant or renewal of licences) of premises,
wherein any drug or cosmetic is being or is proposed to be manufactured ;
(eeb) Prescribe the manner in
which copies are to be certified under sub-section (2A) of section 22;]
(f) Specify the diseases or
ailments, which a drug may not purport or claim [(Note: Subs. by Act 11 of 1955,
sec.15, for "to cure or mitigate") to prevent, cure or mitigate] and such other
effects which a drug may not purport or claim to have ;
(g) Prescribe the conditions
subject to which small quantities of drugs may be manufactured for the purpose
of examination, test or analysis ;
(h) 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 drug or class of drugs, and prohibit the
sale, stocking or exhibition for sale, or distribution of the said drug or class
of drugs after the expiry of a specified period from the date of manufacture or
after the expiry of the date of potency ;
(i) Prescribe the conditions
to be observed in the packing in bottles, packages, and other containers of
drugs [(Note: Ins. by Act 21 of 1962, sec.22 (w.e.f. 27-7-1964)) or cosmetics],
[(Note: Ins. by Act 68 of 1982, sec.29 (w.e.f. 1-2-1983)) including the use of
packing material which comes into direct contact with the drugs] and prohibit
the sale, stocking or exhibition for sale, or distribution of drugs [(Note: Ins.
by Act 21 of 1962, sec.22 (w.e.f. 27-7-1964)) or cosmetics] packed in
contravention of such conditions ;
(j) Regulate the mode of
labeling packed drugs [(Note: Ins. by Act 21 of 1962, sec.22 (w.e.f. 27-7-1964))
or cosmetics], and prescribe the matters, which shall or shall not be included
in such labels ;
(k) Prescribe the maximum
proportion of any poisonous substance which may be added to or contained in any
drug, prohibit the manufacture, sale or stocking or exhibition for sale, or
distribution 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 ;
(l) Require that the
accepted scientific name of any specified drug shall be displayed in the
prescribed manner on the label or wrapper of any patent or proprietary medicine
containing such drug ;
(m)(Note: Clause (m) omitted
by Act 13 of 1964, sec.24 (w.e.f. 15-9-1964))
[(n) [(Note: Subs. by Act 35
of 1960, sec.10, for clause (n) (w.e.f. 16-3-1961)) Prescribe the powers and
duties of Inspectors [(Note: Ins. by Act 68 of 1982, sec.29 (w.e.f. 1-2-1983))
and the qualifications of the authority to which such Inspectors shall be
subordinate] and [(Note: Subs. by Act 21 of 1962, sec.22, for "the drugs or
class of drugs" (w.e.f. 27-7-1964)) specify the drugs or classes of drugs or
cosmetics or classes of cosmetics] in relation to which and the conditions,
limitations or restrictions subject to which, such powers and duties may be
exercised or performed ;]
(o) Prescribe the forms of
report to be given by Government Analysts, and the manner of application for
test or analysis under section 26 and the fees payable therefore ;
(p) [(Note: Subs. by Act 13
of 1964, sec.24 for clause (p) (w.e.f. 15-9-1964)) specify the offences against
this Chapter or any rule made there under in relation to which an order of
confiscation may be made under section 31 ; and ]
(q) 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, sec.22 (w.e.f. 27-7-1964)) or cosmetic or class
of cosmetics].
COMMENTS
It was obligatory on the part of
the rule making authority to satisfy the Court that it was necessary in the
facts and circumstances of the case to enhance the fees payable for the
renewal of licence in the manner as has been sought to be done; M/s Jaiswal
Medical Hall v. Union of India, AIR 1988 Pat 266.
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