Amendment status not verified — confirm the current text below against the official source.
Subs. by G.S.R. 491 (E), dt. 25-7-1991. Drugs and Cosmetics Rules, 1945 118 (2) In the case of powders, liquid orals, ointments etc., one “Batch Number” shall be assigned to all the containers filled from one homogenous bulk. (3) In the case of tablets, capsules, lozenges, troches, etc., one “Batch Number” shall be assigned to the products manufactured from one homogenous mix ready for compression or filling. (4) In the case of parenteral preparations sterilized by steam under pressure, one “Batch Number” shall be assigned to all containers filled from one homogenous bulk solution and sterilized in one sterilizer load. (5) In the case of containers of parenteral preparations filled from one homogenous bulk solution and sterilized in more than one sterilizer load, the “Batch Number” assigned to the containers in the different sterilizer loads shall be the same “Batch Number” as is assigned to the homogenous bulk solution, provided the samples taken from all the sterilizer loads pass the sterility test, and are kept separate from one another until the report of the sterility test is available. Explanation.— For the purpose of chemical and other tests, representative samples from all containers filled from the homogenous bulk solution should be taken. (6) In the case of parenteral and other sterile products filled aseptically, a “Batch Number” shall be assigned to all containers filled from one homogenous mix during one filling operation, the filling operation being completed in a period of not more than a day and during which no schedule change in the filling assembly is made. When containers are filled from one homogenous mix, in a number of filling operations, the “Batch Number” assigned to the containers filled in individual filling operations shall be the same “Batch Number” as is assigned to the homogenous mix, provided the samples taken from all the different filling operations pass the sterility tests, and are kept separate from one another until the report of the sterility test is available. Explanation.-For the purpose of chemical and other tests, representative samples from all containers filled from the homogenous mix should be taken. (7) In the case of medicinal gases produced by a continuous process of operation a week’s production from one tank load shall be considered as a Batch. (vi) Every drug manufactured in India shall bear on its label the number of the licence under which the drug is manufactured, the figure representing the manufacturing licence number being preceded by the words “Manufcaturing Licence Number” or “Mfg. Lic. No.” or “M.L.”. (vii) Drugs specified in Schedule P and their preparations including combinations with other drugs shall bear on their labels the date of manufacture, and the date of expiry of potency, and the period between the date of manufacture Drugs and Cosmetics Rules, 1945 119 and the date of expiry shall not exceed that laid down in the said Schedule 1[under the conditions of storage specified therein. 2[Drugs and their preparations not included in Schedule P], shall bear on their labels the date of their manufacture and also the date of their expiry which shall not exceed sixty months from the date of manufacture:] Provided that this period may be extended by the Licensing Authority specified in clause (b) of Rule 21 in respect of any specified drug if satisfactory evidence is produced by the manufacturer to justify such an extension. (viii) Drugs specified in Schedule C(1) and their preparations including combinations with other drugs shall bear on the labels (a) the date of manufacture, (b) date of expiry of potency fixed by the manufacturer, and (c) where such drugs are imported, also the number of licence under which the drug is imported, preceded by the words “Import Licence”: 3[4[Provided that drugs in bulk form included in Schedule C(I) which are not ready for use and not included in Schedule P need not bear on the label the date of expiry of potency fixed by the manufacturer:] Provided further that] no reference shall be made to any other 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 or advertisement enclosed therewith]. (ix) Every drug intended for distribution to the medical profession as a free sample shall, while complying with the labelling provisions under clauses (i) to (viii), further bear on the label of the container the words ‘Physician’s Sample—Not to be sold’ which shall be overprinted. 5[(x) If any preparation contains not less than 3 per cent by volume of alcohol the quantity of alcohol shall be stated in terms of the average percentage by volume of absolute alcohol in the finished products.] 6[(xi) In addition to the other particulars which are required to be printed or written under these Rules, the label of innermost container of the following categories of drugs and every other covering in which the container is packed shall bear a conspicuous red vertical line on the left side running throughout the body of the label which should not be less than 1mm in width and without disturbing the other conditions printed on the label under these rules, namely: — ____________________________________________________________________