(1) If the level and test or analysis method of a drug is not mentioned in the collections or texts according to rules 4 and 5, whether such drug is public safe, effective, or not, or the method adopted for testing or analysis of such drug If it wants to agree that it is not right, the department can consult the drug advisory committee in this regard and based on the advice given by the committee, the department will determine the level of such drug and the related test or analysis method.
(2) If the level of a drug cannot be determined because it is not mentioned in the Nepal Official Drug Collection or related books or any drug collection or book as per Schedule-1, the person who manufactures the drug shall submit an application to the Department in the format as per Schedule-2 to determine the level of such a drug. /p>

(3) If an application is made according to sub-rule (2), the department may seek the advice of the drug advisory committee regarding the determination of the level of such medicine and the department shall determine the level of such medicine based on the advice given by the said committee.
(4) When determining the level of medicine according to sub-rule (3), if it is necessary to determine any scientific and technical methods for testing or analyzing that medicine, the department will also determine such methods in consultation with the Drug Advisory Committee.

(5) When determining the level of any medicine to be imported into Nepal, if the department requests the level or method of determining the level of such medicine from the person or organization importing such medicine, the person or organization shall submit the level or method of determining the level of such medicine to the department.