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Sales License for Ayurvedic, Siddha and Unani Medicines

We Files RTI request to ministry of AYUSH regarding sales license for ayurvedic, siddha and unani medicines. Download RTI Pdf file by clicking here Here what reply we get: - Query we sent: Dear Sir, I want to clarify that is there any type of drug license required to sale, purchase, retail and distribution of ASU (Ayurvedic, Siddha and Unani) Medicines ? Thanks Reply we received from Department: Dear Sir, I am to refer to your Request for information under RTI Act, 2005, received vide letter dated 20.10.2021 and to say that the information sought by you is not available with the Ministry of AYUSH. Rule, 154 & Rule, 157 of Drugs & Cosmetics Rules, 1945 provides the guidelines for license to manufacture for sale of Ayurvedic (including Siddha) and Unani drugs and Rule 158(B) provides Guidelines for issue of license with respect to Ayurveda, Siddha or Unani drugs under section 3(a) & 3(h) (ii) of Drugs & Cosmetics Act 1940 and enforcement of these legal provisions of the D

What are the Herbal Medicines, Herbs, Herbal Materials amd Herbal Preparations?

Herbal medicines:

Herbal Medicines include herbs, herbal materials, herbal preparations and finished herbal products that have medicinal value. 

Check out list of Herbal medicines here

Herbs:

Herbs include crude plant material such as leaves, flowers, fruit, seeds, stems, wood, bark, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered.

Herbal materials:

Herbal materials are either whole plants or parts of medicinal plants in the crude state. They include herbs, fresh juices, gums, fixed oils, essential oils, resins and dry powders of herbs. In some countries, these materials may be processed by various local procedures, such as steaming, roasting, or stir baking with honey, alcoholic beverages or other materials. 

Herbal preparations:

Herbal preparations are the basis for finished herbal products and may include comminuted or powdered herbal materials, or extracts, tinctures and fatty oils, expressed juices and processed exudates of herbal materials. They are produced with the aid of extraction, distillation, expression, fractionation, purification, concentration, fermentation or other physical or biological processes. They also include preparations made by steeping or heating herbal materials in alcoholic beverages and/or honey, or in other materials. 

Finished herbal products or herbal medicinal products:

Medicinal products containing as bioactive substances exclusively are herbal drugs or herbal drug preparations. They may consist of herbal preparations made from one or more herbs. If more than one herb is used, the term mixed herbal product can also be used. They may contain excipients in addition to the active ingredients. In some countries herbal medicines may contain, by tradition, natural organic or inorganic active ingredients, which are not of plant origin (e.g. animal materials and mineral materials). Generally, however, finished products or mixed products to which chemically defined active substances have been added, including synthetic compounds and/or isolated constituents from herbal materials, are not considered to be herbal. 

Check list of top herbal products companies in India

Medicinal plant:

A plant, either growing wild or cultivated used for its medicinal purposes.


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