Container

Section 108 of the Drugs and Cosmetics Act and Rules deals with container. 3(1) No substance specified in Schedule C shall be sold or offered for sale unless it has been sealed in a previously sterilized 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 o

3(1) No substance specified in Schedule C shall be sold or offered for sale unless it has been sealed in a previously sterilized 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 sterilized container if the filled and sealed container is to be sterilized after the sealing and such sterilizing procedure would render the product sterile. However, the Licensing Authority may, for any special reasons, direct the licensee to pre-sterile such containers.

(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substance is issued in liquid form in containers which are sealed in such a manner that portions of the contents can be withdrawn for use on different occasions, the liquid shall contain a sufficient proportion of some antiseptic to prevent the growth of any organism which may be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. 1. Ins. by G.S.R. 108 (E), dt. 22-2-1994 w.e.f. 22-6-1994. 2. Amended by F. 1-5/47-D, dt. 25-11-1949. 3. Amended by F. 1-6/62-D, dt. 2-7-1969. 4. Subs. by G.S.R.647 (E), dt. 28-10-1998. 5. Amended by G.S.R. 245, dt. 21-2-1976.

(3) The container shall comply with such further requirements, if any, as are specified in Schedule F or Schedule F (1) as the case may be, in that behalf. 1(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 Schedule For Schedule F (1) as the case may be, and may make such additional requirements, as having regard to the nature of the preparation, they may deem necessary. 2109. Labelling .- (1) The following particulars and such further particulars, if any, as are specified in Schedule F or Schedule F (1), as the case may be, shall be printed or written in indelible ink on the label of every phial, ampoule or other container of a substance specified in Schedule C and on every other covering in which such phial, ampoule or container is packed- (a) where a drug is imported, the number of licence under which it is imported, preceded by the words 'Import Licence':

Provided that no reference shall be made to any other import licence number granted by any authority outside India on any label or container or in any covering in which the container is packed or in any other matter of advertisement enclosed therein;

(b) where a test for potency in units is required by these rules, a statement of the potency in units defined in terms of relation to the standard preparation specified in Schedule For F (1), as the case may be : 1. Man Kan Meme Provided that this clause shall not apply in the case of vaccine lymph;

(c) where a test for potency or maximum toxicity is required the date upto which the substance if kept under suitable conditions may be expected to retain a potency not less than stated on the label of the container or not to acquire a toxicity greater than that permitted by the test, as the case may be. The date of expiry shall be in terms of month and year and it shall mean that the drug is recommended for use till the last day of the month. The date of expiry shall be preceded by the words 'Expiry date' :

Provided that nothing in these rules shall be deemed to require the labelling of any transparent cover or any wrapper, case or other covering used solely for the purpose of packing, transport or delivery.

(2) The particulars prescribed in clause (a) of the preceding sub-rule shall be printed or written in indelible ink either on the label borne by a container of vaccine lymph or on a label or wrapper affixed to any package in which the container is issued for sale. The said particulars shall be indelibly marked on the sealed container of surgical ligature or suture or printed or written in indelible ink on a label enclosed therein. 1. Amended by F.1-6/62-D, dt. 2-7-1969. 2. Amended by G.S.R.19, dt. 7-1-1978.

(3) The following particulars, and such further particulars, if any, as are specified in Schedule F or Schedule F (1), as the case may be, shall be printed or written in indelible ink either on the label borne by the container of any substance specified in Schedule C or on a label or wrapper affixed to any package in which any such container is issued for sale, namely :- (a) the date on which the manufacture of the particular batch from which the substance in the container is taken was completed as defined in Schedule F or Schedule F(1), or if there is no definition in Schedule For Schedule F(1) as hereafter defined in this rule and in the case of vaccine prepared from concentrates, the date of completion of the final products and the bottling for issue;

(b) where an antiseptic substance has been added, the nature and the percentage proportion introduced;

(c) the precaution necessary for preserving the properties of the contents up to the date indicated in clause (c) of sub-rule (1).

(4) For the purpose of clause (a) of sub-rule (3), the date on which the manufacture of a batch is completed shall be- (a) in cases where a test for potency or toxicity is required by these rules or not being so required, is accepted by the Licensing Authority as sufficient for the purpose of fixing the date of completion of manufacture, the date on which the substance was removed from cold storage after having been kept at a temperature not exceeding 5° C continuously for a period not exceeding two years from the time when the last test was completed, (b) in cases where no such test is required or accepted- (i) if the substance is a serum obtained from a living animal, the earliest date on which any material contributing to the batch was removed from the animal;

(ii) if the substance was obtained by the growth of organisms or artificial media, the earliest date on which growth was terminated in any of the material contributing to the batch:

Provided that if a batch of the substance (including all material contributing to this batch) has for a period of not more than three years been kept in cold storage at a temperature not exceeding 5℃ continuously from the earliest practicable date after that on which growth was terminated in the material as the case may be, the date of removal from cold storage shall be treated as the date on which the manufacture of the batch is completed;

(c) in all other cases, the date on which the substance is filled in the container. 1[109-A. Labelling of Medical Devices .- The labelling of Medical Devices shall conform to the Indian Standards Specifications laid down from time to time by the Bureau of Indian Standards in addition to any other requirement prescribed under the said rules.]

Section 108, The Drugs and Cosmetics Act and Rules (Act 23 of 1940).