Manner of Labelling .—
(1) Subject to the other provisions of these Rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed, namely :—
(i) The name of the drug−
The proper name of the drug shall be printed or written in a more conspicuous manner than the trade name, if any, which shall be shown immediately after or under the proper name and shall be-
(a) For drugs included in the Schedule F or Schedule F (1), the name given therein;
(b) For drugs included in the Indian Pharmacopoeia or the official pharmacopoeias and official compendia of drug standards prescribed in Rule 124, the name or synonym specified in the respective official pharmacopoeias and official compendia of drug standards followed by the letters I.P., or, as the case may be, by the recognized abbreviations of the respective official pharmacopoeias and official compendia of drug standards;
(c) For drugs included in the National Formulary of India, the name or synonym specified therein followed by the letters N.F.I.
(d) for other drugs, the international non-proprietary name, if any, published by the World Health Organisation or where an international non-proprietary name is not published, the name descriptive of the true nature or origin of the substance.
(ii) A correct statement of the net content in terms of weight, measure, volume, number of units of contents, number of units of activity, as the case may be, and the weight, measure and volume shall be expressed in Metric system.
(iii) The content of active ingredients−
This shall be expressed−
(a) for oral liquid preparations in terms of the content per single dose, being indicated in 5 millilitres 1:
Provided that where the dose is below 5 millilitres the contents of active ingredients may be expressed in terms of 1 millilitre; 2 or fraction thereof: 3
Provided further that where the single dose is more than 5 millilitres, the content of active ingredients shall be expressed in terms of minimum single dose as approved by the licensing authority
(b) For liquid parenteral preparations ready for administration in terms of 1 millilitre or percentage by volume or per dose in the case of single dose container :
Provided that if the preparation is contained in an ampoule it will be enough if the composition is shown on the label or wrapper affixed to any package in which such ampoule is issued for sale.
(c) For drugs in solid form intended for parenteral administration, in terms of units or weight per milligram or gram;
(d) For tablets, capsules, pills and the like, in terms of the content in each tablet, capsule, pill or other unit, as the case may be;
(e) For other preparations, in terms of percentage by weight or volume or in terms of unitage per gram or millilitre, as the case may be:
Provided that clause (iii) shall not apply to the pharmacopoeial preparations where the composition of such preparation is specified in the respective pharmacopoeia and to a preparation included in the National Formulary of India.
(iv) The name of the manufacturer and the address of the premises of the manufacturer where the drug has been manufactured:
Provided that if the drug is contained in an ampoule or a similar small container, it shall be enough if only the name of the manufacturer and his principal place of manufacture is shown.
(v) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded by the words Batch No.‘ or B. No.‘ or Batch‘ or Lot No.‘ or Lot‘.
(1) In the case of drugs manufactured by a continuous process, like manufacture of magnesium sulphate, pharmaceutical chemicals etc., the production resulting in one homogenous mix of the finished products shall be considered as one ―Batch.
(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 ―Manufacturing 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 and the date of expiry shall not exceed that laid down in the said Schedule under the conditions of storage specified therein.
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:
Narcotic analgestics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemics, antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer drugs and all other drugs falling under Schedules G‘, H‘, and X‘ whether covered or not in the above list:
Provided that the provisions of this clause shall not apply to: −
(a) Preparations intended for animal treatment;
(b) Preparations intended for external use;
(c) Ophthalmic preparations and ear drops; and
(d) Sterile preparations such as sutures, surgical dressings and preparations intended for parenteral use.
(xii) Drugs and their preparations including combinations with other drugs imported into the country shall also bear on the label, the license number under which the drug is imported, preceded by the words ―Import License‖ and the name and address of the importer.
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 (I) and their preparations including combinations in other drugs shall bear on their labels (a) the date of manufacture, and (b) date of expiry of potency fixed by the manufacturer:
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:
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.
(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.
(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: —
(i) The particulars to be printed or written on the label of a mechanical contraceptive shall be as specified in Schedule R.
(ii) The following particulars, in addition to those specified under sub-rule (1) shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container and on every other covering in which the container of a contraceptive, other than a mechanical contraceptive, is packed,
namely : −
(a) The date of manufacture;
(b) The date upto which the contraceptive is expected to retain its properties;
(c) The storage conditions necessary for preserving the properties of the contraceptive upto the date indicated in sub-clause (b) :
Provided that for oral contraceptives it shall be sufficient to display on the label of the container the date of manufacture only.
(i) The particulars prescribed in sub-rule (1) 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.
(ii) Nothing in these rules shall be deemed to require the labelling of any transparent cover or of any wrapper, case or other covering used solely for the purpose of packing, transport or delivery.
Where by any provision of these rules any particulars are required to be displayed on a label on the container, such particulars may, instead of being displayed on a label, be etched, painted or otherwise indelibly marked on the container:
Provided that, except where otherwise provided in these rules, the name of the drug or any distinctive letters intended to refer to the drug shall not be etched, painted or otherwise indelibly marked on any glass container other than ampoules.
Explanation.— For the purpose of this rule, the date of expiry shall be in terms of month and year and it shall mean that the drug is recommended till the last day of the month. The date of expiry shall be preceded by the words Expiry date‘.
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube