Bare ActsThe DRUGS AND COSMETICS ACT AND RULES

Section 25

Licences for import of drugs manufactured by one manufacturer

Amendment status not verified — confirm the current text below against the official source.

Licences for import of drugs manufactured by one manufacturer.– (1) A single application may be made, and a single licence may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer: 1[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 licence shall be required in respect of the drugs manufactured by each such factory.] 2* * * * * 3[25A. Condition to be satisfied before a licence in Form 10 or Form 10-A is granted.___(1) A licence 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 licence applies; and (ii) the occupation, trade or business ordinarily carried out by the applicant: Provided that the licensing authority may refuse to grant a licence 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— 4[(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;] (ii) previous suspension or cancellation of the licence granted to him; he is not a fit person to whom licence shall be granted. (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.] ____________________________________________________________________________________

Section 25 – The DRUGS AND COSMETICS ACT AND RULES | DailyLaw.ai