India’s extensive traditional knowledge has taken a paradigm shift towards ‘reverse pharmacology’ with botanicals being used extensively for innovative, efficacious and safe product development, said Dr DB Anantha Narayana, chief scientific officer, Ayurvidye Trust, and Chairman, Scientific Panel, nutraceuticals, FSSAI.
Since these leads have documented long history of safe and effective usage, developing opportunities to use them, standardize, make dosage decisions, formulation development and a confirmatory efficacy studies can be expected give several new products, he added.
Botanicals and their concentrates offer leads to provide health benefits with Nutraceuticals. India has demonstrated number of such botanical based safe and effective products. This has led to bring out a product in a span of 4-5 years including human interventional clinical trials through confirmatory studies of phase III with far lower expenses than a new drug development.
Many national laboratories in India are taking this approach and a number of health supplement products are under different stages of development. Such supplements or nutraceuticals are regulated by the Foods Safety Standards Authority of India (FSSAI) and do not go through drug approval process.
In order to deal with the future challenges in healthcare, we see the need to look at supplements, nutraceuticals and food route as an area of future approach and development, said Dr Narayana at the Global Disease Challenges of Traditional Medicine in the 21st Century-The Best Opportunities for Taiwan and India where Prof. Jue-Liang Hsu Ph.D/Vice Dean, College of Agriculture, National Pingtung University of Science and Technology moderated the event.
Innovations in product offerings which can be stand-alone products replacing current drugs, or add-ons to the current medications are two big baskets. The segment of pain and pain management, together with treatment for bones, joints, muscles, headache, migraine offer a big area. More than 25% of arthritic patients and cardiac patients cannot consume current anti-inflammatory NSAIDS drugs. It is here Boswellia serrata, Hirabool, Ginger, Guggul, offer safe and effective actives. A number of externally applied products that offer immediate relief can make combos to oral products. The basket of actives is too large to list here, he said.
Disturbed lifestyle and unhealthy eating habits have affected liver health and as many as 50 different botanicals and nutraceuticals can be found for innovation. Forced stay indoors, lower consumption of fluids have impacted kidney health and increased incidence of urinary stone and infection.
Punarnava, Gokhru, Varuna, Palash are few herbs, and D-Mannose are sure shot actives to develop for this area. Guduchi, Ashwagandha, Amla, Tulsi, Kalmegh amongst more than 20 herbs, and Zinc, Vitamin C, Vitamin B12, Vitamin D are some of the top immunomodulatory herbs to look at. Ashwagandha, Kalonji, Bhringaraj, Valerian, Jatamansi, Sarpagandha, passion flowers and Ginseng. Niche products can be developed for women’s health, autoimmune disorders like thyroid and gastro intestinal disorders have more than 25 leads with published data The list can be expanded with expert advice.
With enhanced interest on botanicals global regulation also recognise history of usage. Unlike two decades ago, pharmacopeia standards for quality are available in IP, USP, BP, Japanese Pharmacopoeia, European Pharmacopoeia, WHO monographs on botanicals and botanical extracts. Researchers from academia, pharmacy, pharmacology institutions have undertaken in-vivo as well as human studies that undertake the safety and efficacy of these botanicals.