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Union of India - Section

Section 21 in The Drugs and Cosmetics Rules, 1945

21.

In this Part-
(a)[ "import license" means either a license in Form 10 to import drugs [* * *] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] [, excluding those specified in Schedule X, or a license in Form 10-A to import drugs specified in Schedule X;] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]
(b)"licensing authority" means the authority appointed by the Central Government to perform the duties of the licensing authority under these rules and includes any person to whom the powers of a licensing authority may be delegated under rule 22;
(c)"license for examination, test or analysis" means a license in Form 11 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of examination, test or analysis;
(d)[ "manufacturer", includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drugs manufacturing facilities duly approved by the National Regulatory Authority of that country, and who also has a free sale approval of the drugs approved by the said authority in the concerned country, and/or in other major countries. [Inserted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]
(e)"Registration Certificate" means a certificate issued under rule 27-A by the licensing authority in Form 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India.]