Section 85EA in The Drugs and Cosmetics Rules, 1945
85EA. [ Inspection before grant or renewal of license. [Inserted by G.S.R. 493(E), dated 9.6.1995 (w.e.f. 9.6.1995) as corrected by G.S.R. 184(E), dated 12.4.1996.]
- Before a license under this Part is granted or renewed in Form 25-C or Form 26-C, the licensing authority shall cause the establishment, in which the manufacture is proposed, to be conducted or being conducted to be inspected by one or more Inspectors appointed under the Act. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the substances to be manufactured and inquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the requirements of plant and equipment as laid down in Schedule M I read with the requirements of maintenance of records as laid down in Schedule U.
