1[(1) The Central Government may 2 [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 analysing drugs 3 [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 3 [or cosmetic] is of standard quality;
(d) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;
4 [(dd) prescribe under clause (d) of 5 [section 17A] the colour or colours which a drug may bear or contain for purposes of colouring;]
6 [(dda) prescribe under clause (d) of section 17E the colour or colours which a cosmetic may bear or contain for the purposes of colouring];
(e) prescribe the forms of licences 7 [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 8 [or of cosmetics 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 9 [the qualifications of such authority] and the fees payable therefor 9 [and provide for the cancellation or suspension of such licences in any case where any provision of this Chapter or the rules made thereunder is contravened or any of the conditions subject to which they are issued is not complied with];
9 [(ee) prescribe the records, registers or other documents to be kept and maintained under section 18B;
(eea) prescribe 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 10[to prevent cure or mitigate] and such other effects which a drug may not purport or claim to have;
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1. Subs. by Act 11 of 1955, s. 15, for sub-section (1).
2. Subs. by Act 68 of 1982, s. 29, for "after consultation with the Board" (w.e.f. 1-2-1983).
3. Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964).
4. Ins. by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964).
5. Subs. by Act 68 of 1982, s. 29, for "section 17B" (w.e.f. 1-2-1983).
6. Ins. by Act 26 of 2008, s. 14 (w.e.f. 10-8-2009).
7. Subs. by Act 68 of 1982, s. 29, for "for the manufacture for sale" (w.e.f. 1-2-1983).
8. Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964).
9. Ins. by Act 68 of 1982, s. 29 (w.e.f. 1-2-1983).
10. Subs. by Act 11 of 1955, s. 15, for "to cure or mitigate"
(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 1 [or cosmetics], 2 [including the use of packing material which comes into direct contact with with the drugs] and prohibit the sale, stocking or exhibition for sale, or distribution of drugs 1 [or cosmetics], packed in contravention of such conditions;
(j) regulate the mode of labelling packed drugs 1 [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 thereunder;
(l) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the lable or wrapper of any patent or proprietary medicine containing such drug;
3 *
* * * *
4 [(n) prescribe the powers and duties of Inspectors 2 [and the
qualifications of the authority to which such Inspectors shall be
subordinate] and 5 [specify the drugs or classes of drugs of 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 therefor;
6 [(p) specify the offences against this Chapter or any rule made thereunder in relation to which an an order of confiscation may be made under section 31;
7 ***]
(q) 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 1 [or cosmetic or class of cosmetics] 8 [and];
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1. Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964).
2. Ins. by Act 68 of 1982, s. 29 (w.e.f. 1-2-1983).
3. Cl. (m) omitted by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964).
4. Subs. by Act 35 of 1960, s. 10, for cl. (n) (w.e.f. 16-3-1961).
5. Subs. by Act 21 of 1962, s. 22, for "the drugs or class of drugs" (w.e.f. 27-7-1964).
6. Subs. by Act 13 of 1964, s. 24, for cl. (p) (w.e.f. 15-9-1964).
7. The word "and" omitted by Act 26 of 2008, s. 14 (w.e.f. 10-8-2009).
8. Ins. by, s. 14 ibid. (w.e.f. 10-8-2009).
1 [(r) sum which may be specified by the Central Government under section 32B.]
2 * * * * *
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1. Ins. by Act 26 of 2008, s. 14 (w.e.f. 10-8-2009)
Section 31A Application of provisions to Government departments
Section 32 Cognizance of offence
Section 32A Power of Court to implead the manufacturer, etc.
Section 32B Compounding of certain offences
Section 33 Power of Central Government to make rules
Section 33A Chapter not to apply to Ayurvedic, Siddha or Unani drugs
Section 33B Application of Chapter IVA
Section 33C Ayurvedic and Unani Drugs Technical Advisory Board
Section 33D The Ayurvedic, Siddha and Unani Drugs Consultative Committee
Section 33EE Adulterated drugs
Section 33EEB Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs
Section 33EEC Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drugs
Section 33F Government Analysts
Section 33H Application of provisions of sections 22, 23, 24 and 25
Section 33J Penalty for subsequent offences
Section 33KA Disclosure of name of manufacturer, etc
Section 33KB Maintenance of records and furnishing of information
Section 33L Application of provisions to Government departments
Section 33M Cognizance of offences
Section 33N Power of Central Government to make rules