Rule 6
Categorization Of The Drugs
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(1) If the categorization & tests or analytical method of any drug has not been mentioned in the pharmacopoeia or the encyclopedia pursuant to rule 4 & 5, then if it has to be intended to determine that whether such drug has been safe to the people, efficacious or qualitative or not ? or whether the methodology to be followed to test or analyze such drug has been appropriate or not ?, the department may take consultation of Drug Advisory Committee and
the department shall determine the methodology for categorization, related test or analysis of such drugs.
(2) If the categorization of any drugs, can not be made due to the reason of not mentioned in Nepal official pharmacopoeia or encyclopedia related to it or any other pharmacopoeia or encyclopedia pursuant to Schedule–1, the person producing the drug shall submit an application, in the department, to categorize such drug, in the format
prescribed in Schedule–2.
(3) If the application pursuant to sub rule (2) has been submitted, the department may take consultation of the drug Advisory Committee about the categorization of such drug and the department shall determine the category of such drug also on the basis of such consultation.
(4) While making categorization of drug pursuant to sub rule (3). If it has been found necessary that any scientific and technical methodology have to be determined for the test and analysis of the drug, the department shall also determine such methodology by taking the consultation of the drug Advisory Committee on it.
(5) In determination of the category of drugs that have been imported in Nepal, If the department asks for the category or methodology for categorization of such drug to the person or agency importing such drug, then the person or agency who imports such drug shall submit the category or methodology for categorization of such
drugs to the department.
(1) If the categorization & tests or analytical method of any drug has not been mentioned in the pharmacopoeia or the encyclopedia pursuant to rule 4 & 5, then if it has to be intended to determine that whether such drug has been safe to the people, efficacious or qualitative or not ? or whether the methodology to be followed to test or analyze such drug has been appropriate or not ?, the department may take consultation of Drug Advisory Committee and
the department shall determine the methodology for categorization, related test or analysis of such drugs.
(2) If the categorization of any drugs, can not be made due to the reason of not mentioned in Nepal official pharmacopoeia or encyclopedia related to it or any other pharmacopoeia or encyclopedia pursuant to Schedule–1, the person producing the drug shall submit an application, in the department, to categorize such drug, in the format
prescribed in Schedule–2.
(3) If the application pursuant to sub rule (2) has been submitted, the department may take consultation of the drug Advisory Committee about the categorization of such drug and the department shall determine the category of such drug also on the basis of such consultation.
(4) While making categorization of drug pursuant to sub rule (3). If it has been found necessary that any scientific and technical methodology have to be determined for the test and analysis of the drug, the department shall also determine such methodology by taking the consultation of the drug Advisory Committee on it.
(5) In determination of the category of drugs that have been imported in Nepal, If the department asks for the category or methodology for categorization of such drug to the person or agency importing such drug, then the person or agency who imports such drug shall submit the category or methodology for categorization of such
drugs to the department.