New ayurvedic and herbal medicines would require clinical data supporting thier safety and efficacy in humans to win marketing approval in India, according to the proposed draft guidelines by the government of India.
Manufacturers of ayurveda, siddha and unani systems of medicines will have to submit detailed clinical data regarding safety study/data, evidence or experience of efficacy from published literature, evidence or experience of efficacy in the form of “proof of effectiveness by published data or pilot clinical trials” for obtaining marketing permission from the authorities.
If a manufacturer wants to market an existing medicine for a new indication from the ayurvedic classical reference books, which are officially recognized, he would require published data and proof of efficacy as pre-requisites for licensing, as per new guidelines mooted by Department of Ayush (Ayurveda, Unani, Siddha and Homeopathy) under the health ministry which sets standards for the formulations belonging to these classical medicine streams.
Ayurvedic health supplements & ayurvedic cosmetics would need photocopy of references from official texts to get a license. If the indication is different from those mentioned in the official texts, safety and effectiveness study submissions are needed.
For water extracts of herbs mentioned in the official texts, no special data is required. However, if if it is to marketed for new indication, then proof of effectiveness is to be generated and submitted for issue of a license.
In the case of hydro-alcoholic extracts of herbs mentioned in the official texts safety data, published literature data and proof of effectiveness data are required as a pre-requisite for licensing , in addition to textual references mandates the draft notification by Department of Ayush amending the licensing conditions for ASU medicines and proprietary ASU medicines.
The amendment draft notification also introduces new rules 158(B) to categorize ayurvedic and herbal products.
At present, the herbal medicines from ayurveda, siddha and unani streams are included in a single category under the Drugs & Cosmetic Rules.
These herbal formulations will now be put under four new categories while retaining the current definition of ASU medicine which is referred as classical or grantha formulations.
All those medicines that use ingredients mentioned in the texts will be categorized as Proprietary Ayurvedic Medicine (PAM).
Supplement formulations from ayurveda or unani or siddha will officially use the term “Balya” – nutrition and strength giver; “Poshak” – health promoter: positive health promoter, formulations and ayurvedic ingredients that are recommended in official books for promotional and preventive health.
The cosmetic products belonging to ayurveda or unani or siddha medicines will be termed `’Soundarya Prasadak”. This deals with formulations having ingredients that are recommended in official books. These drugs are recommended to promote ‘Soundarya’ or beauty related to skin, hair & body care.
The department of Ayush has officially allowed a new category for ayurvedic extracts.
For ayurveda or unani or siddha extracts, the terms officially used in the notification are ‘Aushadh Ghana’ extracts obtained from plants mentioned in the official books including aqueous (water) or hydro-alcohol (water + ethanol).