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Union of India - Section

Section 25 in The Drugs and Cosmetics Rules, 1945

25. Licenses for import of drugs manufactured by one manufacturer.

(1)A single application may be made, and a single license may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer:[Provided that the drugs or classes of drugs are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit:Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs a separate license shall be required in respect of the drugs manufactured by each such factory.] [Added by Notification No. F. 1-19/48-D, dated 27.10.1949.][* * *] [Sub-Rule (2) omitted by S.R.O. 2136, dated 15.6.1957.][25-A. Conditions to be satisfied before a license in Form 10 or Form 10-A is granted. [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]
(1)A license in Form 10 or in Form 10-A shall be granted by the licensing authority having regard to-
(i)the premises, where the imported substances will be stocked are equipped with proper storage accommodation for preserving the properties of the drugs to which the license applies; and
(ii)the occupation, trade or business ordinarily carried out by the applicant:
Provided that the licensing authority may refuse to grant a license in Form 10-A in respect of any applicant where he is satisfied,-
(a)that the applicant has not complied with the provisions of the Act or these rules, or
(b)that by reasons of-
(i)[ his conviction under the Act or these rules or the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) or the rules made thereunder;] [Substituted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]
(ii)[ previous suspension or cancellation of the license granted to him, he is not a fit person to whom license shall be granted. [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]
(2)Any person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for making a representation in the matter, make such orders in relation thereto as it thinks fit.][25-B. Registration Certificate for import of drugs manufactured by one manufacturer. [Inserted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]
(1)A single application may be made, and a single Registration Certificate in Form 41 may be issued in respect of the import of more than one drug or class of drugs, manufactured by the same manufacturer:Provided that the drug or classes of drugs, are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit:Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs, separate Registration Certificates shall be required in respect of the drugs manufactured by each such factory.]