Section 74(c) in The Drugs and Cosmetics Rules, 1945
(c)the licensee shall either in his own laboratory or in any other laboratory approved by the licensing authority [under Part XV(A) of these rules] [Inserted by G.S.R. 1172, dated 23.8.1977 (w.e.f. 10.9.1977).] test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of five years from the date of manufacture;
