Labelling and printing requirements for Ayurvedic, Siddha and Unani Medicines:
A label (label, foil, box etc) should display following particulars in case of Ayurvedic, Sidha and unani medicines:
1. In respect of classical medicines, the 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 preparation together with quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and Adikarana, as are prescribed in the authoritative books specified in the First Schedule to the Act.
In respect of Patent or Proprietary Ayurveda, Siddha or Unani drugs, the true list of all ingredients with the botanical names of plant based ingredients along with part(s) and form of ingredients, in which, these are used in the formulation, with their quantity
Provided that if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with packing and reference be made to this effect on the label.
2. The container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule E (1), be labelled conspicuously with the words:
Caution: To be taken under medical supervision‘ both in English and Hindi language.
3. The name of the drug.
4. A correct statement of the net content in terms of weight, measure or number as the case may be. The weight and volume shall be expressed in metric system.
5. The name and address of the manufacturer.
6. 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.‘.
7. A distinctive batch number, the figure representing the batch number being preceded by the words Batch No. or Batch or Lot Number‖ or Lot No.or Lot or any distinguishing prefix.
8. The date of manufacture. For this purpose the date of manufacture shall be the date of completion of the final products, or the date of bottling or packing for issue.
9. The words Ayurvedic medicine or Siddha medicine or Unani medicine as the case may be.
10. The words ―FOR EXTERNAL USE ONLY‖ if the medicine is for external application.
11. The date of expiry of Ayurveda, Siddha and Unani medicines
12. Name of marketed by company if applicable
1. In respect of classical medicines, the 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 preparation together with quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and Adikarana, as are prescribed in the authoritative books specified in the First Schedule to the Act.
In respect of Patent or Proprietary Ayurveda, Siddha or Unani drugs, the true list of all ingredients with the botanical names of plant based ingredients along with part(s) and form of ingredients, in which, these are used in the formulation, with their quantity
Provided that if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with packing and reference be made to this effect on the label.
2. The container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule E (1), be labelled conspicuously with the words:
Caution: To be taken under medical supervision‘ both in English and Hindi language.
3. The name of the drug.
4. A correct statement of the net content in terms of weight, measure or number as the case may be. The weight and volume shall be expressed in metric system.
5. The name and address of the manufacturer.
6. 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.‘.
7. A distinctive batch number, the figure representing the batch number being preceded by the words Batch No. or Batch or Lot Number‖ or Lot No.or Lot or any distinguishing prefix.
8. The date of manufacture. For this purpose the date of manufacture shall be the date of completion of the final products, or the date of bottling or packing for issue.
9. The words Ayurvedic medicine or Siddha medicine or Unani medicine as the case may be.
10. The words ―FOR EXTERNAL USE ONLY‖ if the medicine is for external application.
11. The date of expiry of Ayurveda, Siddha and Unani medicines
12. Name of marketed by company if applicable
Hope above information is helpful to you....
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com
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