law: Drugs and Cosmetics Act, 1940
  12. Power of Central Government to make rules
  (1) The Central Government may, 58[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:
   59  [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 60[or
  
  cosmetics or classes of cosmetics] for the import of which a license is
  
  required, 61[and prescribe the form and conditions of such licenses,
  
  the authority empowered to issue the same, the fees payable therefor and
  
  provide f or the cancellation, or suspension of such license 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 license is issued is not complied
  
  with];
  (b) prescribe the methods of test or analysis
  
  to be employed in determining whether a drug 60[or cosmetic] is of
  
  standard quality;
  (c) prescribe, in respect of biological and
  
  organometallic compounds, the units or methods of standardization;
   62  [(cc) prescribe under clause (d) of 63[section
  
  9A] the colour or colors which a drug may bear or contain for purposes of
  
  coloring;]
  (d) specify the diseases or ailments which an
  
  imported drug may not purport or claim 64[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 60[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 60[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 60[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 60[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 60[or cosmetics] imported for the purpose
  
  only of transport through, .and export from, 28[India];
  (k) prescribe the conditions to be observed in
  
  the packing in bottles, packages or other containers, of imported drugs 60[or
  
  cosmetics] 65[including the use of packing material which comes into
  
  direct contact with the drugs].
  (l) regulate the mode of labeling drugs 60[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;
  (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 60[or
  
  cosmetic or class of cosmetics].