Section 158 in The Drugs and Cosmetics Rules, 1945
158. Conditions of license.
- A license in Form 25-D shall be subject to the conditions stated therein and to the following further conditions, namely:-(a)The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or by any other person on his behalf, of the raw materials and finished products.(b)The licensee shall allow an Inspector appointed under the Act to enter any premises where the manufacture of a substance in respect of which the license is issued is carried on, to inspect the premises, to take samples of the raw materials as well as the finished products, and to inspect the records maintained under these rules.(c)[ The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.] [Inserted by G.S.R. 331(E), dated 8.5.1984 (w.e.f. 8.5.1984).]
