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Kerala Ayurveda wins rare US patent for herbal formulation uniquely processed in ancient Indian tradition

By Anand Parthasarathy
December 19 2022: Kerala Ayurveda Ltd (KAL), one of the oldest full-spectrum ayurveda companies in India and the world, with a continuous eighty-year tradition, has won its first patent from the US Patent Office, for an herbal composition that addresses disorders related to metabolic syndrome
The announcement was made last month on the side-lines of the 9th World Ayurveda Congress in Goa.
US patents are difficult to obtain since proving novelty and efficacy with already known herbal ingredients is a major challenge, KAL was able to accomplish this through its proprietary processing method, which has also been granted a patent. Despite the fact that it is a herbal formulation, the product has undergone rigorous pre-clinical and clinical trials, as well as pharmaceutical procedures such as double-bind placebo-controlled trials, to establish its efficacy and safety
(In such trials, some participants get the treatment, the others get a harmless placebo, an inactive substance like sugar or starch. No one—not even the research team—knows who gets the treatment, and who receives the placebo.  Since participants, family members, and staff all are “blind” to the treatment while the study is underway, the study is called a “double-blind, placebo-controlled” clinical trial.)
To support its patent application, KAL underwent pre-clinical testing at   the Fremont, California-based drug discovery company, Renovel Discoveries Inc., followed by double-bind clinical studies at Banaras Hindu University. Like most of its products launched in the US, the formulation also met the ‘California Prop 65’ standard, deemed to be among the most stringent in the world for drugs and even exceeding some standards set by the (US) Food and Drug Administration.
From ancient wisdom to modern practices
Among a small minority of practitioners of traditional and pristine form ayurvedic medicine of the Kerala School, KAL has made a successful transition to the ranks of modern pharmaceutical and wellness companies, with a strong presence in markets like US and the European Union.
The company runs Kerala Ayurveda Academy, in Milpitas, in the heart of the US Silicon Valley in California, the largest vocational ayurvedic institute in the US; it has a network of 3000-plus professionals of ayurveda and a slate of 200 products specially made for the American market.  The Academy recently opened a branch in Norway, after KAL launched its business there last year.
Manages metabolic disorders
The patent (no 11,491,202)   awarded last month to nine researchers of KAL, based in Kerala, Bangalore and the US and states that it “generally relates to an herbal composition effective in management of disorders related to metabolic syndrome…. The invention further relates to the use of the  herbal composition in preparation of food supplements, pharmaceuticals and nutraceuticals for the management of disorders related to metabolic syndrome.”
The patent specifies: “The herbal composition comprises of herbs selected from Curcuma longa, Emblica officinalis, Vernonia anthelmintica, Tinospora cordifolia, Trigonella foenum-graecum, Ixora coccinea and Syzygium cumini.”
These are better known in India as (respectively):  Haridra, Amalaki, Aranyajeeraka, Guduchi, Methi, Paranthi and Jamun.
Pharmacist and Senior Scientist, Jayashree Madhavan, one of the  co-inventors credited in the patent, explains that as in all new formulations launched by KAL, the basic studies are made by ayurvedic vaidyans and sanskrit scholars based in Kerala  who   consult ancient root texts of ayurveda like Ashtanga Hrudayam and Sahasrayogam. Once they have brainstormed to decide on a new formula, KAL’s R&D laboratory, takes over and applies intense and pharmaceutical rigour to realise the product in a manner that meets  stringent national and international production standards, before releasing samples for clinical trials.
“In all this we keep the original Kerala tradition of ayurveda intact”, KAL Chairman Ramesh Vangal, told ‘Swarajya’ in a privileged briefing, “The Kerala School of Ayurveda -- probably because the region never suffered an invasion – remains its purest, most pristine form in India and we do not deviate from it.”
“Our main goal with this latest invention was to establish safety, purity and efficacy as well as providing a standardised process for such herbal compositions, resulting in batch-to-batch consistency”
More in pipeline
Products based on the newly patented formulation – which could include capsules, tablets, granules or liquids -- should be in the Indian and international markets in 3 to 6 months, Vangal added, revealing that the companies have another 6-7 formulations under development for patenting, in a 10-product series they have codenamed K-10.  These would address complaints like obesity, arthritis, gout, irritable bowel syndrome and osteoporosis.
Ayurveda Acharya Vaidyan Kollasseril Govindan Kunju Panicker, a doyen in the field of Ayurveda, founded Kerala Ayurveda in 1945 at Aluva near  Kochi. His son Dr K Anil Kumar, continues in the family tradition and today serves as Executive Director of KAL. The company still houses its main plant and herbal garden, nearby at Athani, just off the Kochi International Airport.
Kerala Ayurveda’s sharp transition into a technologically and digitally driven international enterprise, while still firmly rooted in ancient ayurvedic traditions, is generally acknowledged to have happened after 2005 when the company became part of the Katra Group, cofounded by IIT-Madras and London Business School alumnus Ramesh Vangal , in 2001.
However  KAL retains its separate – and proud – identity within  the Katra group, exemplified by its mantra: ‘Traditional roots with a modern voice’. Its mission is to ‘take Ayurveda global’ and by leveraging the India arbitrage ‘From India’, and ‘For India’.

This article has appeared in Swarajya