Proprietary Ayurvedic Medicine License: Filling Ingredient Information
Question: the govt forms ask for “therapeutic indications”, “pharmacological action” & “text reference” of the various ingredients used in ayurvedic drugs & body products. can you please guide me as to what these terms mean & from where can I extract the said information?
Disclaimer:
The rules and regulations pertaining to Drugs And Cosmetics Act and Rules keep getting updated. Hence, the author does not hold any accountability to the information provided below.
For any proprietary medicine license,
You require these three heading to be filled for each ingredient of the product. This is to prove that each ingredient contributes positively to the therapeutic purpose of the product.
1. Therapeutic indication – This is to substantiate your judgement to include this herb in the formula. For example, if you have applied for license for hair oil – and you are using amla in it, You have to get the reference of Amla having any of the benefits related to hair with terms like Keshya, Keshakara etc.
You can find these terms in text books like Bhavaprakasha, Sushruta Samhita, Charaka Samhita etc.
Or search for the herb in easyayurveda.com (this websiet) you may find the reference verse with explanation.
2. Pharmacological action – Is brief way in which the medicine acts – In case of Amla, it is – Being a Sheeeta veerya and Tridosha hara herb, with rasayana properties, Amla is a potent ingredient to promote hair growth.
3. Text reference: Text book reference with Shloka reference. It is the proof that the herb is explained in traditional Ayurvedic text book.
For example, from this page,
https://www.easyayurveda.com/
You can find that Amla reference is there is Sushruta Samhita Sutrasthana 46th chapter.
