3. The label states the name of preparation, percentage content of
drug of a liquid preparation, the amount of active ingredients of
a dry product, the liquid to be added to prepare a injection or
suspension from a dry preparation, the route of administration
and a statement of storage condition and expiry date. Also label
must indicate the name of manufacturer and distributor .
DEFINATION
The term labeling designates all labels and other written,
printed or graphic matter up on or in any package or wrapper
in which it is enclosed.
4. ï¶ The safe use of all medicine depends on users reading the
labelling and packaging carefully and accurately.
ï¶ All labels must be clear and concise and must bear all
necessary information regarding the safe use of a product .
IMPORTANCE OF
LABELLING
5. Various materials are used for labelling such as :
âąPaper
âąFoil
âąFabric
It is also possible to print directly on a bottle or other
containers.
TYPES OF LABELLING
6. All labels must be type written or computer generated. The
details, which must appear on the label of a dispensed
medicine are:
ï¶The name of the preparation .
ï¶The quantity
ï¶Instruction for the patient .
ï¶The date of dispensing .
ï¶Keep out of reach of children .
STANDARD
REQUIREMENT FOR
LABELLING
7. ï¶ Storage
ï¶ Temperature
ï¶ Light
ï¶ Instructions to the patient how to use
ï¶ Expiry date
ï¶ If there is any leakage it should not be used
ï¶ After using the product if any irritation is produced the
patient must be refer back to the physician
Additional labelling requirement
8. All labels of a drug should conform as per
the specification under the drugs and
cosmetics rules 1945.
That no person sell or distribute any drug
unless it is label in accordance with the rules
( Rule 95 of D & C act)
LAWS RELATED TO
LABELLING