Section 122 in The Drugs and Cosmetics Rules, 1945
122. Substances specified in Schedule C(1)
.-The following provisions shall apply in the case of a substance specified in Schedule C(1):-(a)The container shall comply with the requirements, if any, specified in Schedule F or Schedule F(I) [or as specified] [Inserted by G.S.R. 663(E), dated 3.7.1992 (w.e.f. 3.7.1992).], as the case may be.[* * *] [Clause (b) omitted by G.S.R. 19, dated 15.12.1977 (w.e.f. 7.1.1978).](c)The substance shall conform to the standards of strength, quality and purity specified in Schedule F or Schedule F(1), [or as specified] [Inserted by G.S.R. 663(E), dated 3.7.1992 (w.e.f. 3.7.1992).], as the case may be, and the tests for determining the strength, quality and purity of the substance shall be those specified in Schedule F or Schedule F(I) [or as specified] [Inserted by G.S.R. 663(E), dated 3.7.1992 (w.e.f. 3.7.1992).], as the case may be.(d)The test for determining the strength, quality and purity of a substance specified in Schedule F or Schedule F(I) [or as specified] [Inserted by G.S.R. 663(E), dated 3.7.1992 (w.e.f. 3.7.1992).], as the case may be, shall be applied to samples taken from the final product after each manufacturing process has been completed.(e)The substance should be stored in a cool place and away from light.[Part X-A] [Inserted by G.S.R. 944(E), dated 21.9.1988 (w.e.f. 21.9.1988).] Import Or Manufacture Of New Drug For Clinical Trials Or Marketing
