Apart from regulatory requirements, labelling of pharmaceutical products is required for identifying the content of drug, for providing administration instruction, storage requirement, expiry of the drug product etc. Labels should be able to provide essential and comprehensive information to patients and healthcare professionals. Labelling provisions of drugs in India is mandated by The Drugs and Cosmetics Act, 1940 and Rules, 1945 made thereunder.

Rule 96 and 97 of the Drug Rules, 1945 covers majority of the essential requirements, however, there are specific requirements for specific nature of products. Many a times common pharmaceutical professional find it difficult to decode the legal language provided in the Rule 96 and 97. In the present article, we have taken the onus onto ourselves to present the legal labelling requirements in a more palatable way for the easy understanding of all.

The labelling requirements for the drug products are as follows:

  1. The label of innermost container of any drug and on every other covering in which the container is packed shall bear at least following information

A. Name of the drug: The name of the drug shall be given as per following ways.

i. The proper name of the drug or fixed dose combinations (FDCs) drug (up to 2 drugs) shall be printed or written clearly and the proper name shall be at least two font size larger than the brand name or the trade name of the drug.

ii. The brand name or the trade name of FDCs of vitamin and other FDCs containing three or more drugs, shall be printed or written in a conspicuous manner below or after the proper name.

iii. The proper name of the drug shall be considered as following:

a. Exact name as given in Schedule F or Schedule F(l) for the drugs included in these schedules

b. For the drugs official in Indian Pharmacopeia or other pharmacopeias, the name or synonyms shall be as per the respective official pharmacopeia. The name shall be followed by I.P. in case the referred pharmacopeia is Indian Pharmacopeia, B.P. for British Pharmacopeia etc. Recognized abbreviations of Pharmacopeias shall be used.

c. For the drugs listed in official compendia as per Rule 124 of Drug Rules, 1945, the name or synonyms shall be as per the respective compendia. The name shall be followed by recognized abbreviations of the official compendia.

d. For drugs included in the National Formulary of India, the name or synonym specified in the NFI shall be used. The name shall be followed by the letters N.F.I.

e. For other drugs, the international non-proprietary name, if any, published by the World Health Organization shall be used.

f. In cases where an international non-proprietary name is not published or available, the name descriptive of the true nature or origin of the substance shall be used.

B. Correct statement of the net contents: The net contents 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.

 C. Content of active ingredients: The content of active ingredients shall be expressed in following ways:

      • For oral liquid preparations:
        • In terms of the content per single dose, the dose being indicated in 5 milliliters i.e. “Each 5 ml contains” Where the dose is below 5 milliliters the contents of active ingredients may be expressed in terms of one milliliter i.e. “Each ml contains”
        • Where the single dose is more than 5 milliliters, the content of active ingredients shall be expressed in terms of minimum single dose as approved by the licensing authority;
      • For liquid parenteral preparations
        • Ready for administration, in terms of 1 milliliter or percentage by volume or per dose in the case of a 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;
        • In terms of units or weight per milligram or gram, for drugs intended for parenteral administration and is formulated in solid form;
      • 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.
      • For other preparations, in terms of percentage by weight or volume or in terms of unitage per gram or milliliter as the case may

D. The name of the manufacturer and the address of the premises of the manufacturer where the drug has been manufactured (Name and address of importer and Import License number in case of imports). 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 i.e. “Mfg. by: XYZ Pharma, New Delhi”. Further, with respect to details of marketing firm, only the name of the marketer is sufficient due to low space.

E. Distinctive Batch number: A distinctive batch number is to be printed preceded by the words ‘Batch No.’ or ‘B No.’ or ‘Batch’ or ‘Lot No.’ or ‘Lot’. A batch number should be traceable to the particular batch from which the substance in the container is taken.

F. Manufacturing License number: Every drug manufactured in India shall bear on its label the license number of the manufacturer. The license number shall be preceded by the words ‘Manufacturing License Number’ or ‘Mfg. Lic. No.’ or ‘M.L.’.

The imported drugs shall bear the import license number preceded by the words “Import License”. Further the name and address of the importer shall also be mentioned.

G. Manufacturing and Expiry date: 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. The storage conditions shall also be as per Schedule P. 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. The shelf life may be extended by the licensing authority if stability data is produced by the manufacturer to justify such an extension.

H. The name of the marketer of the drug and its address, in case the drug is marketed by a marketer

2. Ensure that all the matter printed on the artwork shall be either printed or written in indelible ink and shall appear in a conspicuous or clear manner on all the packings i.e. Primary and Secondary.

3. Every drug intended for distribution to the medical profession as a free sample shall further bear on the label of the container the words ‘Physician’s sample—Not to be sold’, in addition to the other labelling provisions.

4. The preparations containing alcohol content equal to or more than 3 per cent v/v, the quantity of alcohol shall be stated in terms of the average percentage by volume of absolute alcohol in the finished products.

5. For mechanical contraceptives: The particulars to be printed or written on the label of a mechanical contraceptive shall be as specified in Schedule R of the Act.

6. For contraceptives other than mechanical contraceptives: In addition to all the provisions mentioned in the present article, following particulars shall be mentioned clearly:

  • The date of manufacture;
  • The date up to which the contraceptive is expected to retain its properties;
  • The storage conditions

For oral contraceptives, only the date of manufacture is sufficient to display on the label of the container.

7. The provisions of labelling as mentioned in Rule 96 of Drug Rules, 1945 are not applicable on the transparent cover or of any wrapper, case or other covering used solely for the purpose of packing, transport or delivery.

8. The date of expiry shall be in terms of month and year. The date of expiry shall be preceded by the words ‘Expiry date’

9. The container of an embrocation, liniment, lotion, [ointment, antiseptic cream,], liquid antiseptic or other liquid medicine for external application shall be labelled with the words in capital “FOR EXTERNAL USE ONLY”.

10. The container of a medicine for veterinary use shall be labelled with the words “Not for human use; for animal treatment only”, and shall bear a symbol depicting the head of a domestic animal

11. Caution or warning as per Rule 97 of Drug Rules, 1945: The label of inner most container of the drugs and every other covering in which the container is packed shall bear a caution or warning, as applicable, depending on whether the drug is covered under Schedule G or Schedule H or Schedule H1 or Schedule X, as specified in rule 97 of Drug Rules, 1945. The caution or warning as applicable shall be written in legible black coloured font size in a completely red rectangular box without disturbing other conditions printed on the label.

The drugs which are not covered under Schedule G or Schedule H or Schedule H1 or Schedule X as per Drug Act, but are categorized as Narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemic, antimicrobials, antiepileptics, antidepressants, anticoagulants and anti-cancer drugs shall bear the caution or warning, as the case may be, applicable for those drugs covered under Schedule H. The said caution or warning shall be on the inner most container of drugs and every other covering in which the container is packed.

The above clauses are not applicable to following:

  • Preparations intended for animal treatment;
  • Preparations intended for external use;
  • Ophthalmic preparations and ear drops;
  • Sterile preparations such as sutures, surgical dressings etc
  • Preparations intended for parenteral use.

Box warnings/ cautions and other details as per drug schedules are as follows:

  • Schedule G Drugs: It shall also bear the following box caution –

Schedule G Caution

    

  • Schedule H Drugs: The label shall bear the symbol Rx clearly displayed on the left top corner of the label. It shall also bear the following box caution –

Schedule H Caution

 

  • Narcotic Schedule H drugs: Schedule H drugs which come in the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985, shall bear the symbol NRx written in ‘RED’ colour and shall be displayed on the left top corner of the label. It shall also bear the following box warning –

Schedule H Warning

  • Schedule X drugs: Schedule X drugs, shall bear the symbol XRx written in ‘RED’ colour and shall be displayed on the left top corner of the label. It shall also bear the following box warning –

Schedule X warning

  • Schedule H1 drugs: Schedule H1 drugs, shall bear the symbol Rx written in ‘RED’ color and shall be displayed on the left top corner of the label. It shall also bear the following box caution –

 

Schedule H1 Caution

  • Narcotic Schedule H1 drugs: Schedule H1 drugs which come in the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985, shall bear the symbol NRx written in ‘RED’ color and shall be displayed on the left top corner of the label. It shall also bear the following box caution –

 

Schedule H1 Warning

  1. The container of a medicine for treatment of food producing animals shall be labelled with the withdrawal period of the drug for the species on which it is intended to be used. In case the withdrawal period is not validated, the withdrawal period shall not be less than seven days for eggs or milk, twenty-eight days for meat from poultry and mammals including fat and offal, five-hundred-degree days for fish meat.
  2. In case of New Drugs, the contents and claims on artwork submitted to the CDSCO during CT 21 application shall also be considered. Any warning or instructions issued by CDSCO shall also be considered during artwork design.
  3. After inclusion of all the clauses of Drugs and Cosmetics Act, 1940, few of the clauses relevant to Legal Metrology Act, like pricing etc. shall also be considered.

The current article has focused only on the general requirements of labelling of drug products in India. However, as mentioned above special products like biologicals etc. have some additional requirements for labelling. Labelling requirements of such special products will be discussed in our future articles. Stay tuned for more!

References:

  1. Drugs and Cosmetics Act, 1940 and Rules, 1945 made thereunder