Section 6, Clinical Establishments (Registration and Regulation) Act, 2010 [S25-JJS]
As at 7 September 2026. In force from 8 October 2010.
6. Grant of licence.—(1) An application for a licence to undertake the manufacture of drugs shall be made to the Licensing Authority in Form 25, accompanied by a fee of five hundred rupees. (2) The Licensing Authority may, after making such inquiry as it thinks fit, grant the licence subject to such conditions as may be prescribed, or, for reasons to be recorded in writing, refuse to grant the licence. (3) A licence granted under this section shall be valid for a period of three years from the date of its grant and may be renewed in such manner as may be prescribed. (4) The Licensing Authority may, after giving the licensee an opportunity of being heard, suspend or cancel a licence for contravention of any condition thereof.
Defined terms in this text (3)
drug: Section 2, Clinical Establishments (Registration and Regulation) Act, 2010 [S25JE4] (In this Act, unless the context otherwise requires,—): "drug" includes all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals
drug: 19 more definitions.
Licensing Authority: Section 2, Clinical Establishments (Registration and Regulation) Act, 2010 [S25JE4] (In this Act, unless the context otherwise requires,—): "Licensing Authority" means the authority appointed under section 4 to grant licences under this Act
Licensing Authority: 21 more definitions.
manufacture: Section 2, Clinical Establishments (Registration and Regulation) Act, 2010 [S25JE4] (In this Act, unless the context otherwise requires,—): "manufacture" in relation to any drug, includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug with a view to its sale or distribution
manufacture: 36 more definitions.
Made under this section, or naming it (0)
none
Cited by (3)
Section 5, Clinical Establishments (Registration and Regulation) Act, 2010 [S25-JHZ], 8 October 2010, Band A. "section 6".
Section 66, Clinical Establishments (Registration and Regulation) Act, 2010 [S25-MEW], 8 October 2010, Band A. "section 6".
Rule 5, Clinical Establishments (Registration and Regulation) Act Rules, 2012 [S25-YBV], 13 January 2012, Band A. "section 6 of the Act".
Not held (0)
none
Duties published under this section (1)
D11-XMJ. Every manufacturer: Obtain a licence before undertaking the manufacture of drugs; apply in Form 25, fee five hundred rupees; Before the activity begins; licence valid three years; Form 25. Published by Directorate General of Health Services, Ministry of Health and Family Welfare (synthetic record).