Drugs Registration Rules, 2038 (1981)  

 

Rule 4B: Registration prior to importation of drug: (1) For purposes of Sub-section (2) of Section 8A of the Act, a person who intends to import a drug shall make an application to the Department, setting out the following details of the drug which he intends to import, in the format as referred to in Schedule-4C, for the drug import registration certificate:  

 

a) A certified copy of the certificate issued by an authentic body certifying that the manufacturer has followed good manufacturing practices,  

b) Product specification of the manufactured drug, 

c) Method of analysis of the manufactured drug and test report  conducted by a laboratory specified by the Department, 

d) Pharmacopoeia standard, 

e) A sample of the manufactured drug, 

f) Other matters specified by the Department.  

 

(2) Notwithstanding anything contained in Sub-rule (1), in making an

application to import any Ayurvedic, homeopathic and other traditional drug, the  following details shall be attached with it: 

a) Details mentioned in the book or literature, 

b) Product specification of the manufactured drug, 

c) Recommendation of the concerned body in the case of a  patented drug, 

d) A sample of the manufactured drug, and  

e) Other matters specified by the Department. 

 

(3) If, on making necessary inquiry into the application received pursuant to Sub-rule (1), the Department deems proper to import the drug mentioned in the application, it shall register such drug in the format as referred to in Schedule-4D and issue the certificate in the format as referred to in Schedule-4E by collecting the drug registration fees as prescribed in Schedule-14 for each drug.  

 

(4) Notwithstanding anything contained in Sub-rules (1) and (2), the Department may, on recommendation of the drug advisory committee, issue the import recommendation letter for importing the following drug in the following circumstance:  

a) In the case of a life saving drug, on the basis of the concerned doctor,  

b) Where a drug is imported as a grant to a governmental or nongovernmental body or organization, 

c) Where a governmental body imports a drug as per the international bidding system.