(1) The Central Government may, ¹[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 :

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²[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.]

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(2) Without prejudice to the generality of the foregoing power, such rules may

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(a) specify the drugs or classes of drugs ³[or cosmetics or classes of cosmetics] for the import of which a licence is required, ⁴[and prescribed 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] ;

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(b) prescribe the methods of test or analysis to be employed in determining whether a drug ³[or cosmetic] is of standard quality ;

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(c) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;

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⁵[(cc) prescribe under clause (d) of ⁶[section 9A] the colour or colours which a drug may bear or contain for purposes of colouring;]

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(d) specify the diseases or ailments which an imported drug may not purport or claim ⁷[to prevent, cure or mitigate] and such other effects which such drug may not purport or claim to have;

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(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;

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(f) prescribe the places at which drugs ³[or cosmetics] may be imported, and prohibited their import at any other place;

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(g) require the date of manufacture and the date of expiry of potency to be clearly and truely 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;

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(h) regulate the submission by importers, and the securing, of samples of drugs ⁸[or cosmetics] for examination, test or analysis by the Central Drugs Laboratory, and prescribed the fees, if any, payable for such examination, test or analysis;

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(i) prescribe the evidence to be supplied, whether by accompanying documents or otherwise, of the quality of drugs ⁶⁶[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 ⁸[or cosmetics] detained pending admission;

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(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 ⁸[or cosmetics] imported for the purpose only of transport through, and export from, ⁹[India];

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(k) prescribe the conditions to be observed in the packing in bottles, packages or other containers, of imported drugs ⁸[or cosmetics] ¹⁰[including the use of packing material which comes into direct contact with the drugs];

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(l) regulate the mode of labelling drugs ⁸[or cosmetics] imported for sale in packages, and prescribe the matters which shall or shall not be included in such labels;

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(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;

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(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 ;

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(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 ⁸[or cosmetics or class of cosmetics].

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¹[33N. Power of Central Government to make rules.--(1) The Central Government may, ³[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:

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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.

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(2) Without prejudice to the generality of the foregoing power, such rules may--

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(a) provide for the establishment of laboratories for testing and analysing ²[Ayurvedic, Siddha or Unani] drugs;

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(b) prescribe the qualifications and duties of Government Analysts and the qualifications of Inspectors;

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(c) prescribe the methods of test or analysis to be employed in determining whether any ⁴[Ayurvedic, Siddha or Unani] drug is labelled with the true list of the ingredients which it is purported to contain:

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(d) specify any substance as a poisonous substance;

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(e) prescribe the forms of licences for the manufacture for sale of ⁴[Ayurvedic, Siddha or Unani] drugs ⁵[and for sale of processed Ayurvedic, Siddha or Unani drugs,] the form of application for such licences, the conditions subject to which such licences may be issued, the authority empowered to issue the same and the fees payable therefor; ⁵[and provide for the cancellation or suspension of such licences in any case where any provision of this Chapter or rules made thereunder is contravened or any of the conditions subject to which they are issued is not complied with];

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⁶[(f) prescribe the conditions to be observed in the packing of Ayurvedic, Siddha and Unani drugs including the use of packing material which comes into direct contact with the drugs, regulate the mode of labelling packed drugs and prescribe the matters which shall or shall not be included in such labels;]

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(g) prescribe the conditions subject to which small quantities of ⁴[Ayurvedic, Siddha or Unani] drugs may be manufactured for the purpose of examination, test or analysis; and

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⁷[(gg) prescribe under clause (d) of section 33EE the colour or colours which an Ayurvedic, Siddha or Unani drug may bear or contain for purposes of colouring;

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(gga) prescribe the standards for Ayurvedic, Siddha or Unani drugs under section 33EB;]

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⁸[(ggb) prescribe the records, registers or the documents to be kept and maintained under section 33KB; and]

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(h) any other matter which is to be or may be prescribed under this Chapter.]

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(1) The Central Government shall, as soon as may be, establish a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to carry out the functions entrusted to it by this Act or any rules made under this Chapter :

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Provided that, if the Central Government so prescribes, the functions of th e Central Drugs Laboratory in respect of any drug or class of drugs ¹[or cosmetic or class of cosmetics] shall be carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in respect of such drug or class of drugs ¹[or such cosmetic or class of cosmetics] shall be exercised by the Director of that Institute or of that other Laboratory, as the case may be.

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(2) The Central Government may, after consultation with the Board, make rules prescribing

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(a) the functions of the Central Drugs Laboratory;

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(d) the procedure for the submission to the said Laboratory ³[under Chapter IV or Chapter IVA] of samples of drugs ¹[or cosmetics] for analysis or test, the forms of the Laboratorys reports thereon and the fees payable in respect of such reports;

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(e) such other matters as may be necessary or expedient to enable the said Laboratory to carry out its functions;

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(f) the matters necessary to be prescribed for the purposes of the proviso to sub-section (1).

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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 :

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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.]

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(2) Without prejudice to the generality of the foregoing power, such rules may--

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(a) provide for the establishment of laboratories for testing and analysing drugs ³[or cosmetics];

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(b) prescribe the qualifications and duties of Government Analysts and the qualifications of Inspectors;

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(c) prescribe the methods of test or analysis to be employed in determining whether a drug ³[or cosmetic] is of standard quality;

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(d) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;

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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;]

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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];

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(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];

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⁹[(ee) prescribe the records, registers or other documents to be kept and maintained under section 18B;

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(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;

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(eeb) prescribe the manner in which copies are to be certified under sub-section (2A) of section 22;]

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(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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(g) prescribe the conditions subject to which small quantities of drugs may be manufactured for the purpose of examination, test or analysis;

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(h) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the lable 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;

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(i) prescribe the conditions to be observed in the packing in bottles, packages and other containers of drugs ¹¹[or cosmetics], ¹²[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 ¹¹[or cosmetics], packed in contravention of such conditions;

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(j) regulate the mode of labelling packed drugs ¹¹[or cosmetics], and prescribe the matters which shall or shall not be included in such labels;

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(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;

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(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;

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¹⁴[(n) prescribe the powers and duties of Inspectors ¹²[and the qualifications of the authority to which such Inspectors shall be subordinate] and ¹⁵[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;]

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(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;

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¹⁶[(p) specify the offences against this Chapter or any rule made thereunder in relation to which an order of confiscation may be made under section 31; ¹⁷***]

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(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 ¹¹[or cosmetic or class of cosmetics] ¹⁸[and];

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¹⁹[(r) sum which may be specified by the Central Government under section 32B.]

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