24. [ Form and manner of application for import license. [Substituted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]
(1)An application for an import license shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8-A for drugs specified in Schedule 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 license under the rules to manufacture for sale of a drug or having a valid wholesale license 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 8-A, as the case may be, shall be accompanied by a copy of 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: [Inserted by G.S.R. 445(E), dated 30.4.1992 (w.e.f. 30.4.1992).][Provided further that Registration certificate shall not be required to be accompanied with an application for an import license under the rules for the import of in-vitro diagnostic kits and reagents, except for the diagnostic kits notified from time to time under sub-clause (iv) of clause (b) of section 3.] [Inserted by G.S.R. 35(E), dated 20.1.2005 (w.e.f. 20.1.2005).](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.] [Substituted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).][24-A. Form and manner of application for Registration Certificate. [Inserted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).](1)An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid wholesale license for sale or distribution of drugs under these rules, or by his authorized agent in India, either having a valid license under the rules to manufacture for sale of a drug or having a valid wholesale license for sale or distribution of drugs under these rules, and shall be accompanied by the fee specified in sub-rule (3) and the information's and undertakings specified in Schedules D-I and D-II duly signed by or on behalf of the manufacturer.(2)The authorisation by a manufacturer to his agent in India shall be documented by a power of attorney executed and authenticated either in India before a First Class Magistrate, or in the country of origin before such an equivalent authority, the certificate of which is attested by the Indian Embassy of the said country, and the original of the same shall be furnished along with the application for Registration Certificate.(3)(i)A fee of one thousand and five hundred US dollars or its equivalent in Indian rupees shall be paid along with the application in Form 40 as registration fee for his premises meant for manufacturing of drugs intended for import into and use in India.(ii)A fee of one thousand US dollars or its equivalent in Indian rupees shall be paid along with the application in Form 40 for the registration of a single drug meant for import into and use in India and an additional fee at the rate of one thousand US dollars or its equivalent in Indian rupees for each additional drug:Provided that in the case of any subsequent application for registration of additional drugs by the same manufacturer, the fee to accompany shall be one thousand US dollars or its equivalent in Indian rupees for each drug.(4)The fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110 001 or any other branch or branches of Bank of Baroda, or any other bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines":Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the Electronic Code of the bank in the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines", and the original receipt of the said transfer shall be treated as an equivalent to the bank challan, subject to the approval by the Bank of Baroda that they have received the payment.(5)The applicant shall be liable for the payment of a fee of five thousand US dollars [or its equivalent in Indian rupees] for expenditure as may be required for inspection or visit of the manufacturing premises or drugs, by the licensing authority or by any other persons to whom powers have been delegated in this behalf by the licensing authority under rule 22.(6)The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the Central Government in India or abroad, as may be required for examination, tests and analysis of drug.(7)A fee of three hundred US dollars [or its equivalent in Indian rupees] [Inserted by G.S.R. 35(E), dated 20.1.2005 (w.e.f. 20.1.2005).] shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.(8)No Registration Certificate shall be required under these rules in respect of an inactive bulk substance to be used for a drug formulation, with or without pharmacopoeial conformity.]
