July 20, 2024

Import of Drugs under D & C Act

Import of Drugs under D & C Act

Forms and manner of application for import license

Import licences:

An import licence in Form l0 shall be required for ‘import of drugs’ excluding those specified in Schedule X, and an import licence in Form 10-A shall be required for the import of drugs specified in Schedule X. 

Form and manner of applications for import licence: 

(1) An application for an import license shall be made to the licensing authority in Form 8    specified in Schedule X. and in Form 8-A for drugs specified in specified X, either by the manufacturer himself having a valid wholesale license for sale or  distribution of  drugs under these rules, or by the manufacturer’s agent in India either having a  valid licence under the rules to manufacture for sale of a drug or having a valid wholesale licence  for sale or distribution of drugs under these rules and shall be accompanied by a license fee of  one thousand rupees for a single drug and an additional fee at the rate of one hundred rupees for  each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the  manufacturer:

PROVIDED that in the case of any subsequent application made by the same importer for import license for drugs manufactured by the same manufacturer, the fee to accompany each such application shall be one hundred rupees for each drug.   

(2) Any application for import license in Form 8 or Form 8A. As the case may be, shall be accompanied by a copy of the Registration Certificate issued in Form 41 under rule 27-A:    

PROVIDED that in case of emergencies the licensing authority may. With the approval of the Central Government, issue an import license in Form 10 or 10-A, as the case may be, without the issuance of Registration Certificate under rule 27-A. for reasons to be recorded in writing.   

(3) A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the license issued under this rule if the original is defaced, damaged or lost.


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