Section 122P(ix) in The Drugs and Cosmetics Rules, 1945
(ix)The licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the rules, these would come in force four months after publication in the [Official Gazette] [Published in the Gazette of India, Extraordinary, Part II, Section 3(i), dated 22.1.1993 (w.e.f. 22.5.1993).].