Limitations in scaling-up Ayurveda

Photograph by Katherine Hanlon

Yoga started in India, was exported to the West, became wildly popular there, and is now seeing a resurgence in interest in India.  Ayurveda, on the other hand, has not become anywhere near as widely accepted in the West as yoga has.  Passion, patriotism and antipathy to big pharma make an objective discussion on alternative remedies like Ayurveda somewhat difficult. What is tougher still is focussing the discussion on “genuine” Ayurveda and ignoring the myriad products that simply claim to be Ayurvedic.

Though I have used genuine Ayurveda and found it effective, there are serious constraints on whether it can be a mass solution. I hope this article will give the layperson some understanding of these, and the situation that a firm producing genuine Ayurvedic products faces. The information shared below is based on observations, anecdotes, past discussions with experts in herbals and Ayurveda medicine, some of the entrepreneurs in this space and on my experience as a development manager.

Statistical validity:  Ancient Ayurveda recipes and processes were written for batches made in small scale, with localized sourcing of raw materials and applications.  Even if we assume that the starting material is GRAS, at least the equivalent of Phase II/III/IV need to be done.  These trials are very expensive and time-consuming.  Ayurveda medicines are currently approved in India on the basis of limited, short duration trials which do not match the scale & rigor that allopathy medicines go through (note – whether such extensive trials for allopathy are warranted or not is beyond my knowledge.)These limited trials would not be acceptable in developed countries.

 Scale-up: There are several challenges to this.  a) To supply to a billion plus people, these kitchen-size production batches would need to be scaled up to large reactor size.  These are now sometimes carried out in 0.5T batches.  No one seems to have done a proper study of scale-up; i.e. how the process, its conditions and operations are to be adapted to get the same resulting product ( a typical ChemEngg problem).  Then comes the question of demonstrating that the product of scale-up has statistically valid clinical results (as above).   b)  Herbal raw materials which are used have hundreds of natural chemicals, some of these chemicals have mutual synergistic effects, and some suppress side effects and toxicity of other components.  If not in proportion these natural chemicals can be toxic to varying degrees.  (These studies have been done for very few ayurvedic formulations in research labs).  c) Raw material sourced from different locations within the country (even within a state) have different natural chemical proportions, which can sometimes change seasonally.  Before such different RMs can be used for identical processes, someone has to establish the acceptable limits of each chemical component in the recipe (typical specification setting).   This will require extensive study, from a process, toxicity, safety, consistency, repeatability, stability & clinical stand-point.  The alternative is to have uniform RMs, which does not seem to be feasible.

Ancient Ayurveda recipes and processes were written for batches made in small scale, with localized sourcing of raw materials and applications.

 Dosage: As an example, a grandma’s recipe is to take some methi seeds soaked overnight in the morning.  The active components in Fenugreek which help in sugar control has been identified.  However, there is a minimum dosage for these to be effective.  The quantity of seeds which have to be taken twice a day for effectiveness makes the seeds a meal by themselves.  A local Ayurveda can make a formulation for his local patients for quick consumption, and recommend a dosage.  When the scale-up happens as described above, the dosage may have to be changed since the RM is different due to variations in constituent concentrations.

Cost: Supply to a billion people will require large Ayurvedic factories, with complex sourcing, processing and operations of acceptable GMP and FDA standards.  This requires large fixed capital investment.  Clinical studies to establish safety & efficacy will be needed every time the RM going into the blend is different.  This implies high R&D costs.   Perhaps scale effects will help mitigate the impact of fixed costs.  Given the yields (input-output ratio) in some formulations, very large quantities of RM will be needed.  This implies high variable costs.  The price of the RM (plant-based) will increase as the demand increases.  Add testing, packaging, distribution, inventory & marketing costs, and then add reasonable profit margins.  Low dosage cost will be a challenge.  My experience has been that efficacious ayurvedic medicines sourced from a reliable Ayurveda cost more than allopathic medicines when used as a curative for common ailments.  Due to lower side-effects (is it scientifically established?) perhaps the total cost over a lifespan may be low,  but this reasoning would only apply for a person who can afford the dosage in the first place.

As a Development Manager:  Some companies sell products on the goodness of “naturals” for health effects.  Often their products contained active naturals at the motive level, not efficacious levels i.e, the gas chromatograph would show the component at above minimum detection limits so that the claims of incorporating could not be challenged.  There may not be any clinical studies to support efficacious claims.  Incorporating active naturals at an efficacious level often exceeds customer willingness to pay by orders of magnitude.  In addition, establishing a consistent, repeatable supply chain is often not feasible for large volumes.  Active naturals are often restricted to some very premium products.

To summarize, Ayurveda still seems to have a long way to go before the medicines become cost-effective, statistically and clinically proven, consistent  and  repeatable for mass supply and consumption.