Section 122F in The Drugs and Cosmetics Rules, 1945
122F. Form of application for license for operation of Blood Bank/processing of whole human blood for components/manufacture of blood products for sale or distribution.
(1)Application for the grant and/or renewal of license for the operation of a Blood Bank/processing of human blood for components/manufacture of blood products shall be made to the licensing authority appointed under Part VII in [Form 27-C or Form 27-E, as the case may be,] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).] and shall be accompanied by [license fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection thereof or for the purpose of renewal of license] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).]:Provided that if the applicant applies for renewal of license after its expiry but within six months of such expiry the fee payable for the renewal of the license [shall be rupees six thousand and inspection fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees one thousand per month or a part thereof in addition to the inspection fee] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).]:Provided further that a licensee holding a license in [Form 28-C or Form 28-E, as the case may be,] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).] for operation of blood bank/processing of whole human blood for components/manufacture of blood products, shall apply for grant of license under sub-rule (1) before the expiry of the said license on [Form 27-C or Form 27-E, as the case may be,] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).] and he shall continue to operate the same till the orders on his application are communicated to him.[* * *] [Explanation omitted by G.S.R. 733(E), dated 21.12.2005 (w.e.f. 21.12.2005). Earlier it was substituted by G.S.R. 89(E), dated 14.2.1996 (w.e.f. 14.2.1996).](2)A fee of [rupees one thousand] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).] shall be paid for a duplicate copy of a license issued under this rule, if the original is defaced, damaged or lost.(3)Application by a licensee to manufacture additional drugs listed in the application shall be accompanied by a fee of [rupees three hundred] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).] for each drug listed in the application.(4)On receipt of the application for the grant or renewal of such license, the licensing authority shall,-(i)verify the statements made in the application form;(ii)cause the manufacturing and testing establishment to be inspected in accordance with the provision of rule 122-I; and(iii)in case the application is for renewal of license, call for informations of past performance of the licensee.(5)If the licensing authority is satisfied that the applicant is in a position to fulfill the requirements laid down in the rules, he shall prepare a report to that effect and forward it [along with the application and the license (in triplicate) to be granted or renewed, duly completed] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).] to the Central License Approving Authority:Provided that if the licensing authority is of the opinion that the applicant is not in a position to fulfill the requirements laid down in these rules, he may, by order, for reasons to be recorded in writing, refuse to grant or renew the license, as the case may be.(6)If, on receipt of the application and the report of the licensing authority referred to in sub-rule [(5)] [Corrected vide Corrigendum G.S.R. 447(E), dated 10.6.1993 to G.S.R. 28(E), dated 22.1.1993.] and after taking such measures including inspection of the premises by the Inspector, appointed by the Central Government under section 21 of the Act, and/or along with the Expert in the field concerned if deemed necessary, the Central License Approving Authority, is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules, he may grant or renew the license, as the case may be:Provided that if the Central License Approving Authority is of the opinion that the applicant is not in a position to fulfill the requirements laid down in these rules he may, notwithstanding the report of the licensing authority, by order, for reasons to be recorded in writing, reject the application for grant or renewal of license, as the case may be, and shall supply the applicant with a copy of the inspection report.
