The document outlines general labeling requirements for drugs, including:
1) The proper drug name should be printed more conspicuously than the trade name, if any.
2) The net contents must be stated in metric units by weight, measure, volume, or number of units.
3) Active ingredients must be stated by amount per dose or volume for liquids, by weight or percentage for solids, and by content per unit for tablets and capsules.
4) The manufacturer's name and address must be included.
2. General labelling requirements
1. Proper name of the drug should be printed in a more conspicuous manner than the trade
name, if any
2. A correct statement of the net contents in terms of weight, measure, volume, number of
units of activity, as the case may be, are expressed in metric system.
3. The content of active ingredients-
(a) For oral liquid preparations in, terms of the content per single dose i.e. 5ml or multiple
thereof. Where the dose is below 5ml the contents of active ingredients may be expressed
in terms of one ml or fraction thereof.
(b) For liquid preparations ready for administration, in terms of 1ml or percentage by
volume or per dose in the case of a single dose container. If the preparation is contained
in an ampoule the composition may be shown on the label or wrapper affixed to any
package in which such ampoule is issued for sale.
(c) For drugs in solid form intended for parental administration in terms of units or weight
per mg or gram.
(d) For tablets, capsules, pills etc. in terms of the contents in each unit.
(e) For other preparations, in terms of percentage by weight or volume or in terms of units
per gram or ml.
3. 4. The names and address of the manufacture. In case of the drug contained in an ampoule or
a similar small container it is enough if only the name of the manufacturer and his principal
place of business are shown.
5. Manufacturing licence Number or Mfg. Lic. No.
6. A distinctive batch number, the figure representing the batch number being preceded by the
words “Batch No”, or B. No, or Batch or Lot No or Lot.
7. The label of innermost container of the following categories of drugs and every other
covering in which the container is packed shall bear a conspicuous red vertical line on the left
side running throughout the body of the label (not less than 1mm in width) without disturbing
the other printed conditions on the label:
Narcotic analgesics, hypnotics, sedatives, tranquillizers, corticosteroids, hormones,
hypoglycemics, anti microbials, anti-epileptics, antidepressants, anticoagulants, anti-cancer
drugs and all other drugs under schedules G, H and X.
