Labelling and Packing Requirements for Ayurvedic, Siddha and Unani Medicines

An Ayurvedic, Siddha and Unani madicine should follow rules and regulation for manufacturing and packaging. In this article, we will discuss, what type of matter should be printed at these medicines packaging?

There are two types of Ayurvedic, Siddha and Unani Medicines:
1. Classical Medicines
2. Patent or proprietary medicines

Labelling requirements are same for both types of medicines expect classical medicines are sold with same name as mentioned in authoritative books whereas patent or proprietary medicines are sold with a particular brand name.

Labelling Requirements for Indian Market:
Every ayurvedic, siddha and unani medicine should be either printed or written in indelible inked lable or container having recommended information on it. There should be conspicuously displayed on the container or package of medicines, a true list of all ingredients with their botanical names and form of ingredients used with quantity of each ingredient. In case of classical medicines reference to the method Authoritative book should also be mentioned.

If list of ingredients are large and can’t be written at label then list of ingredients should be printed separately and enclosed with packing and reference should be mentioned at label.

If a medicine meant to be internal use contains any ingredient that is specified in Schedule E(1), be labelled with word “Caution: To be taken under medical supervision” both in English and Hindi language.

Other Requirements:

Other than mentioned above a medicine’s label/container should have following particular either printed or written in indelible ink:

  • Name of the drug i.e. same name as mentioned in authoritative books for classical medicines and brand name for patent or proprietary medicines
  • Net Content i.e. accurate weight, volume or numbers etc
  • Name and Address of manufacturer
  • Manufacturing License Number in form of either Manufacturing License Number or Mfg. Lic. No. Or M.L.
  • Batch Number or Batch or Lot Number or Lot No. Or Lot
  • Date of Manufacturing and Date of Expiry
  • The Words ‘Ayurvedic Medicine’ or ‘Siddha Medicine’ or ‘Unani Medicine‘
  • ‘FOR EXTERNAL USE ONLY’ If medicine is meant for external application
  • The words “Physicians sample. Not to be sold” if it is distributed as free samples to medical professionals

Labelling Requirements for Export:
Labelling requirement for export purpose should be adopted to meet requirement of country in which drug is to be exported but following particulars should be mentioned along with requirement of importing country.

  • Name of the Ayurvedic, Siddha and Unani drug (Single or compound formulations;
  • The name, address of the manufacturer and the number of licence under which the drug has been manufactured;
  • Batch or lot number;
  • Date of manufacture, along with the date for ―Best for use before
  • Main ingredients, if required by the importing country;
  • For export
Where Ayurvedic, Siddha and Unani Single or compound drug not classified under the First Schedule or Schedule E-(I), is required by the consignee(importing agent) to be not labeled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the Licensing Authority.

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