Schedule – 2 (Related sub rule (2) of Rule (6)

Format of the application for the categorization of the drug
The Administrator
Department of Drug Administration
Ministry of Health.
I/we have submitted this application, to categorize the drug pursuant to
the sub rule (2) of rule 6 of Category of Drugs Rules, 2043 mentioning the
following details and sticking a stamp of Rs. 1.00 (One Rupee).
(a) The chemical or biological name and quantity of the drug
(b) The purity of the drug :
(c) The identification of the drug :
(d) Test or analytical methodology of the drug and result
(e) The methodology for qualitative and quantitative evaluation of the drug
(f) The solvent substance contained in the drug
(g) The limit of solvent substance and the methodology to determine it:
(h) The utility of the drug and using methodology
(i) Dose of the drug
(j) If the production license has been taken for the production of the drug then the date and the office from which such production license has been taken
(k) The attested copy of production license has been attached or not :
The drug producing person or agency’s
Signature :
Name & Surname :
Address :
Date