India makes clinical studies mandatory for Ayurveda, Siddha and Unani medicines

India is bringing in good clinical practice (GCP) guidelines mandating scientific evaluation of drug products based on the traditional medicinal systems like ayurveda, siddha and unani (ASU).

Through the implementation of GCP for ASU and TM medicines, the government aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the ASU medicine and other TM under investigation are properly documented.

The Department of Ayurveda, Unani, Siddha and Homoeopathy (Ayush), under the ministry of health, government of India has recently issued a draft gazette notification informing about the guidelines for good clinical trials on Ayurveda, Siddha, Unani (ASU) medicines and other traditional medicines (TM).

The new guidelines for good clinical practice are formulated based on GCP guidelines for clinical trials on pharma products.

The guidelines seek to establish two cardinal principles, namely, protection of the rights of human subjects and authenticity of ASU medicine/other TM clinical trial data generated.

“The complexities of ASU medicines and other TM research necessitate a more elaborate set of guidelines that address a physician’s ethical and scientific responsibilities such as obtaining informed consent or disclosing risk while involved in ASU medicines and other TM research,” the draft states.

The fundamental tenet of GCP is that in research on man, the interest of science and society should never take precedence over considerations related to the well being of the study subject.

The draft guideline mandates that these norms should be followed for developing medicinal products based on all ASU medicines and other TM research in India.

Clinical research guidelines should be practicsed at all stages of drug development, whether prior or subsequent to product registration in India for ASU medicines that include all products intended for internal and or external use.

The new guideline also cover the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani tibb systems of medicine as specified in the first schedule

Traditional medicine is defined as the sum of total of the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures in India, used for the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illnesses, which do not find a mention in First Schedule of Drugs and Cosmetics Act 1940.

Recently, Ayush mandated that manufacturers of ayurveda, siddha and unani systems of medicines 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).