November 2017, Boston, Massachusetts

Legends and Conversations

This picture was from the American Association for the Study of Liver Diseases' (AASLD) annual meeting, The Liver Meeting in November 2017, where I was invited to present my award winning work on Ayurveda related liver diseases.

The person in the audience with whom I am having a short but impressive conversation is Professor Herbert L. Bonkovsky, a senior Professor of Medicine, at The University of Connecticut Health Center at North Carolina, USA. Professor Bonkovsky is internationally famous for many clinical studies,important among those was his identification of liver damage due of green tea extracts in the year 2005-2006 [ http://annals.org/…/hepatotoxicity-associated-supplements-c…]

He asked me how, much of the Ayurveda medicines, came to the public for use in Kerala. I told him through prescriptions, over the counter from shopkeepers and fake doctors. There was an Ayurveda outlet at every nook and corner of the city and more coming up every month. Who regulates them? Who checks them? Who watches the patients' when they are on these 'medicines'? How do we know these are safe? How do we know what the effects are in the short, intermediate and long term? What do these do to the human body and to the specific organ systems?

No one knows that well.

He just said, 'We have to take these off the market before it harms someone else'.

In Indian regulations, the major class of Ayurveda, Siddha, or Unani (ASU) drugs included are:

1. Classical ASU drugs as mentioned in the authoritative books of ASU system drugs, which are manufactured and named in accordance with the formulations described in the classical Ayurveda texts. For this category, issue of license to manufacture is based on citation in authoritative books and published literature, unless the drug is meant for a new indication when proof of effectiveness is required - basically, if the drug is straight from the Ayurveda textbooks, it does not require testing.

2. Patent or proprietary Ayurveda medicine makes use of ingredients referred in the classical Ayurveda texts, but with modifications by the company, to manufacture products different from the classical medicine (for example Orthoherb, Kamilari, Kamilari Plus, BGR-34 etc...) For this category issue of a license to manufacture requires proof of effectiveness, based on the pilot study as per relevant protocol for ASU drugs - any drug modified from the classical teaching needs testing before commercialization.

and...3. Phytopharmaceutical drug, a new classification introduced recently. It is defined as purified and standardized medicine with defined minimum four chemicals (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation, or prevention of any disease or disorder - MOST of the private company Ayurveda and herbal drugs come under this.

In India, classical Ayurveda, Siddha and Unani drugs are under the regulation of Department of AYUSH. In contrast, 2015 regulatory requirements states that Ayurveda drugs that fall into the 3rd category as above are under the purview of the Central Drugs Standards Control Organization (CDSCO). This means, every proprietary Ayurveda and herbal drug needs to pass regulatory submission requirements for scientific data on quality, safety, and efficacy to evaluate and permit marketing on similar lines to synthetic, chemical moieties (modern medicines)

In Schedule Y, the newly added Appendix I B for Drug Regulation specifically states that data on new Ayurveda drugs falling into the 3rd category be submitted along with the application to conduct clinical trial BEFORE import or manufacture.

In 2010, Department of Ayurveda, Unani, Siddha, and Homeopathy (AYUSH) introduced Rule 158(B) which made the requirement of proof of effectiveness for licensing of a patent or proprietary Ayurveda and herbal medicine.

A famous example of a drug that bypassed ALL THESE regulations and came to the public directly, making the owner an overnight millionaire was the famous Immuno-Q (Ayurveda for curing HIV-AIDS) made by Fair Pharma owned by Majeed.

There are thousands of such drugs let loose into the public currently. Who's responsibility is the public's health? If there are no proper Government regulation, it is up to the public to take care of themselves.

BEFORE you look at buying or using ANY Ayurveda and Herbal, Siddha or Unani medicine, look very closely for safety, effectiveness and long term effects of these drugs. For modern medicines, these are always available as package inserts with the medicine box.

Take care of yourselves. Because no one else is bothered about you