A label of a product is one of its most notable features that leads to product identification. In the normal parlance, the process of labelling, thus, involves affixing or inscribing1 information onto a product as a way of imparting a distinct identity to it as well as to make available certain indispensible particulars about it to the public. Therefore, uniformity in the labelling requirements of different categories of products is a necessary corollary. The labelling requirements of Ayurvedic drugs in India are governed by the Drugs and Cosmetics (Act and Rules), 1940.
The Drugs and Cosmetics Act and Rules draw out a clear distinction between a 'drug' and an 'Ayurvedic, Siddha or Unani drug'. The provisions pertaining to labelling of a drug and an Ayurvedic, Siddha or Unani drug are governed by different chapter under the Drugs and Cosmetics Act and Rules. As per section 3 (2) (a) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as "Act"), an Ayurvedic, Siddha or Unani drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurveda, Siddha and Unani Tibb systems of medicine. The list as to the authoritative books of the Ayurvedic and Siddha Systems is provided under the Schedule I of the Act.
Law relating to the labelling and packing of Ayurvedic (including Siddha) or Unani drugs under Rules
The Rule 161 of the Drugs and Cosmetics Rules, 1945 provides a detailed account of the manner in which the labelling of an Ayurvedic, Siddha or Unani drug must be undertaken. The Rule states that there shall be considerably displayed on the label of the container or package of an Ayurvedic (including Siddha) or Unani drug the following details;
However, the Rule provides that if needed, standardized abbreviations prescribed for parts and form of ingredients in the official Ayurveda, Siddha and Unani Pharmacopoeias and Formularies, may be used on the label. Further, if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same is to be printed separately and must be enclosed with the packing with a reference to the same be made on the label.
Further, the container of a medicine for internal use made up ready for the treatment of human ailments if it is made up from a substance specified in Schedule E (1) should be labelled conspicuously with the words 'Caution: To be taken under medical supervision' both in English and Hindi language.
According to Rule 161 (3) 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 Ayurvedic (including Siddha) or Unani drug and on any other covering in which the container is packed namely-
A true list of all the ingredients with the botanical names of plant based ingredients along with plant part(s) and form of ingredients, in which, these are used in the manufacture of the drug together with their quantity must be conspicuously displayed on the label of the package of an Ayurvedic (including Siddha) or Unani drug. In addition to this, a reference to the method of preparation as prescribed in the authoritative books specified in the First Schedule of the Act also needs to be mentioned on such Ayurvedic, Siddha or Unani drugs that do not fall in the category of patent or proprietary Ayurveda, Siddha or Unani drugs. In case a drug made for internal use for the treatment of human ailments contains a substance specified in Schedule E(1) of the Act, such drug has to be compulsorily labelled with the words 'Caution: to be taken under medical supervision' both in English and Hindi languages in a conspicuous manner.
Along with these, the following must be printed or written in indelible ink in a conspicuous manner on the label of the innermost container of any Ayurvedic (including Siddha) or Unani drug including Patent or Proprietary ones and on any other covering in which the container is packed the name of the drug:
- statement of the net content in terms of weight, measure or number;
- name and address of the manufacturer;
- the manufacturing license number, batch number, date of manufacture and date of expiry of the Ayurvedic (including Siddha) or Unani drug;
- the words "Ayurvedic medicine"or "Siddha medicine" or "Unani medicine" should also be clearly specified;
- if the medicine is for external application, the same needs to be clearly disclosed by mentioning 'For external use only' on the label;
- in case of drugs intended for distribution to the medical profession as a free sample, the label should be overprinted with the words 'Physician's sample. Not to be sold'.
Pertinently, it is to be noted that any transparent cover or any wrapper-case or other covering used solely for the purpose of packing, transport or delivery is not required to be labelled as per this rule.
Rule 161A provides certain exemptions in labelling and packing provisions for Ayurvedic (including Siddha) and Unani drugs that are to be exported, in as much as such drugs can be adapted to meet the specific requirements of the law of the country importing them.
Consequences of non-compliance in the labelling
It is also apposite to note at this stage that an Ayurvedic, Siddha or Unani drug is considered to be misbranded under Section 33E of the Act if it is not labeled in the prescribed manner. Any Ayurvedic, Siddha or Unani drug is deemed to be a 'Misbranded drug':-
- if it is so coloured, coated, powdered or polished that damage is concealed, or if it is made to appear of better or greater therapeutic value than it really is; or
- if it is not labelled in the prescribed manner; or
- if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
The Act under Section 33EEC prohibits the manufacture, sale or distribute a misbranded Ayurvedic, Siddha or Unani drugs. Furthermore, whoever acts in contravention of this mandate is punishable with imprisonment for a term which may extend to one year and with fine which shall not be less than Rs. 20,000/- or three times the value of the drugs confiscated, whichever is more.2
Hence, by virtue of the abovementioned provisions of the Act and Rules, it becomes amply clear that errors in the labelling of the Ayurvedic, Siddha or Unani drugs manufactured or labelled may cause the Ayurvedic, Siddha or Unani drugs to be brought in the category of 'misbranded drug'. Therefore, it becomes pertinent to ensure that labelling on its manufactured products is in consonance with the requirements under the Act and Rules.
2. §33-I, Drugs and Cosmetics Act, 1940.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.