Schedule – 5 (Related to sub rule 2 of rule 12)
The matters to be mentioned in a label
1. Name of the drug and quantity.
2. Category and sub category of the drug.
3. Out of Allopathic, Ayurvedic, Yunani and Homeopathic system the drug belongs to which system.
4. The name of the major (active) ingredient, quantity and the name of the encyclopedia with which the drug belongs to.
5. The name of the drug production company, address and country.
6. The serial number of recommendation letter provided for the establishment of drug industry.
7. The serial number of production license provided for the production of the drug.
8. The Batch No. of the drug.
9. The date of production of the drug.
10. The date of expiry for the drug that expires.
11. The price of the drug.
12. The storing method (technique) and management of the drug.
13. If the drug belongs to the sub category 1 & 2 of category “a” the words “Caution Poison” and “May not be sold without the prescription of a register medical practicener ” and if the drug belongs to the category “b” then the words “Caution” and “May not be sold without the prescription of a register medical practicener”.
14. The quantity of the drug that may be used in relation to the age.
15. The method of use of the drug.
16. If for the drug that have been used for external use only then the words “only for external use.”
17. If the drug that have been used only for the animal except than the human being then the words “Not for human use”.
18. If the drug that have been used in operation or injection or similar other technique of sending the drug inside the body has not been sterilized during the production then the words “Not sterilized, shall not be used without sterilization”.