Scientific credibility key to next phase of India's nutraceutical growth: Dr. Saurabh Arora, MD, Auriga Research

By: Dr. Saurabh Arora

Last updated : October 03, 2026 12:24 pm



The industry's more rigorous players are likely to pull further ahead over the coming years, not through any single scientific breakthrough, but because their underlying systems are reused and refined with each new launch


India's nutraceutical industry has moved from a niche category into a mainstream part of household health spending. That growth has been built largely on formulation variety and retail reach: new ingredient combinations, new delivery formats, and rapid expansion into e-commerce and modern trade. The scientific depth behind individual products has not kept pace with that expansion. In most cases, a label's claim still reflects an ingredient's reputation rather than a measured, tested effect, and that gap is becoming harder for the industry to ignore.

According to FSSAI, any health claim on a nutraceutical, whether tied to enhanced function, immunity, or disease risk reduction, must rest on adequate documentation drawn from human studies, with claims of curing or preventing disease barred outright. This standard has stood since 2016. The shortfall is not in the rule itself but in the industry's capacity to satisfy it at the pace products are launched. Testing infrastructure and research timelines have not scaled at the speed of product development, and that mismatch is now the industry's defining constraint.

A Shift in Formulation Discipline

A segment of the industry has started to change directions by abandoning the construction of traditional ingredients in favor of a practice much closer to pharmacological formulation, where ingredients are standardized, taken in dosages known to elicit a certain response rather than those selected based on convenience and cost considerations. The difference is fundamental and not merely cosmetic. Botanical extracts have varying levels of actives based on their plant source, growing conditions, and method of extraction; therefore, products using the same ingredient may vary considerably in the actual content they provide to the consumer. It is only through products relying on defined actives in a formulated product that a sufficiently specific claim can be made to warrant defending it. This is a very different goal from increasing the number of ingredients in a formula, because the former involves reducing the list of ingredients in favor of well-characterized ones.

Such discipline amounts to little in the absence of testing that can prove it. Safety testing, involving contaminant and pesticide residue levels and microbiological limitations, is a fairly well-developed area in the industry, mostly due to its overlap with programs food manufacturers have in place. Functionality testing, which entails proving the presence of the right amount of active substances the formulation relies on, lags far behind in development, especially when it comes to complex botanical blends, which are prevalent in this field. Methods that can be used to analyze individual substances cannot be simply translated into analyzing complex blends, and creating methods that can accomplish this takes much effort. This is by far the most obvious weakness in the difference between what can be formulated and what can be tested within the industry.

The Need for Clinical Evidence

The third criteria to be considered is clinical evidence, one which would survive independent scrutiny: protocol design, appropriate sample sizes, Good Clinical Practice, and peer-reviewed publications. This criterion becomes particularly relevant when marketing internationally, because consumers and regulatory bodies look for evidence in a certain form, namely published trial results and peer-reviewed publications, not in-house documentation created by the company that claims credit for the discovery. A peer-reviewed study has already been tested against outside scrutiny before it reaches a foreign buyer's desk. An internal report, however carefully conducted, has not, and is judged accordingly by markets that have other options.

Sourcing, testing, and clinical evidence depend on one another; none substitutes for the others. A rigorous clinical study loses its value if the commercial batch sold at scale no longer matches the material originally tested. Precise analytical testing confirms what a formulation contains but says nothing about what it does in the human body without a clinical study behind it.The quality of clinical research founded upon variable basic ingredients will be undermined by its very foundation whenever there is any variation in sourcing within a batch. The integrity of the industry functions more like a chain than it does a certificate; it extends from the field in which the ingredient grows through to the testing proving its efficacy.

That credibility, once gained, often grows instead of leveling off. A company that has already built validated sourcing and functional testing for one product category can extend that same infrastructure to its next formulation at a fraction of the original cost and time. The industry's more rigorous players are therefore likely to pull further ahead over the coming years, not through any single scientific breakthrough, but because their underlying systems are reused and refined with each new launch, while competitors without that base effectively start over each time they enter a new category.

Building What Endures

The parts of the industry executing this well already point to the model the rest will eventually need to follow: formulations built around identified, quantified actives; testing that verifies both safety and functional potency; and clinical studies designed to hold up to scrutiny well beyond a company's own marketing language. What separates the leading segment from the rest is not ambition but discipline, a willingness to let testing and research run their full course rather than compress them to fit a launch calendar, even when that discipline slows a product's path to market in the short term.

India's nutraceutical sector has already proven that it can scale quickly. The test that remains is whether that scale can be matched by formulations and evidence sturdy enough to stand on their own, wherever in the world they are sold. That is a demanding standard, but the industry's stronger formulators are already showing it is within reach, and their progress is instructive for everyone else building toward the same bar. An industry that meets this standard consistently will have built something that outlasts any single product cycle: a reputation for science that consumers, regulators, and international buyers can trust without asking twice, and a foundation sturdy enough to carry the sector's next decade of growth.

 

About Author

Dr. Saurabh Arora brings over 17 years of experience leading the testing laboratory and research business at Arbro and Auriga. He has established six laboratories across New Delhi, Manesar, Baddi and Bangalore, leading a team of 500+ scientists serving over 10,000 clients annually. From 2017–2019, he oversaw the National Food Laboratory under a public-private partnership with FSSAI. 

*The author’s views are his own and do not necessarily represent those of the publisher.

nutraceuticals clinical FSSAI formulation discovery regulator analytical testing Saurabh Arora Auriga Research human studies

First Published : October 03, 2026 12:00 am