Section 108 in The Drugs and Cosmetics Rules, 1945
108. Container.
- [(1) No substance specified in Schedule C shall be sold or offered for sale unless it has been sealed in a previously sterilised container made of glass or any other suitable material approved for the purpose by the licensing authority appointed under rule 21, in such manner as may, in the opinion of the licensing authority, suffice to preclude the access of bacteria:Provided that it shall not be necessary to use a previously sterilised container if the filled and sealed container is to be sterilised after the sealing and such sterilising procedure would render the products sterile. However, the licensing authority may, for any special reasons, direct the licensee to pre-sterilise such containers.] [Substituted by G.S.R. 245, dated 3.2.1976 (w.e.f. 21.2.1976).](2)When any such substance is issued in liquid form in containers which are sealed in such a manner that portions of the contents can be withdrawn for use on different occasions, the liquid shall contain a sufficient proportion of some antiseptic to prevent the growth of any organism which may be accidentally introduced in the process of removing a portion of the contents of the container:[Provided that nothing in this sub-rule shall apply to a penicillin suspension in oil and wax.] [Inserted by S.O. 115, dated 4.1.1961 (w.e.f. 14.1.1961).](3)The container shall comply with such further requirements, if any, as are specified in Schedule F or Schedule F(I) as the case may be, in that behalf.(4)The licensing authority may in the case of any particular preparation of any such substance dispense with any of the requirements of this rule or of Schedule F or Schedule F(I), as the case may be, and may make such additional requirements, as having regard to the nature of the preparation, they may deem necessary.
