Nutraceuticals — “To be or not to be”

Neha, a university student in her twenties, came across an Instagram ad featuring a girl who claimed that the pack of effervescent tablets in her hand fully treated her acne. Struggling with acne herself, she was persuaded to give it a try. The package arrived in a few days. While aesthetically appealing, it thoroughly outlined the ingredients and their benefits. It made her hopeful, as it could be the solution she longed for.

Just when she was about to try it out, her mother noticed the box.

Confused, her mother asked, “What’s this?”

“It’s collagen,” Neha explained. “It helps with acne. Finally, something that will work!”

Mother immediately said, “Who recommended this to you?”

“No one”

“Why not consult a dermatologist? It’s been a while now.” Her mother suggested.

“I don’t want to take medicines for this.”

“Then what’s this you’re taking?”

“It’s not medicine,” she clarified. “It’s only collagen and vitamins to help with my skin.”

“What do you mean? Aren’t vitamins medicine?”

This may not have been the perspective of a college-going student a few years ago. The rise of social media influencers, doctors and/or content creators has led to increased awareness and health curiosity. Consumers today are health-conscious, well-informed, and have more disposable income to invest in their well-being.

Gen Z consumers have adopted traditional herbs like curcumin, ashwagandha, neem, clove, and many more in their modernized avatars. They seek ways to enhance their health, do more, and perform better. They are far more proactive in recognizing indicators when they are feeling low and seek advice to improve their health.

To appeal to these modern Indian consumers, supplements have evolved to innovative formats. Consumers don’t want to feel like they are consuming a ‘medicine.’ If one looks up “iron supplement” on Amazon, they will find effervescent tablets, gummies, mouth-dissolving strips, syrups, oral drops, powders, & even milkshakes! A decade ago, probiotics were not even a common recommendation from doctors, but today, there are hundreds of probiotic products listed on Amazon!

Despite this, nutraceuticals remain a relatively new concept. Let’s take a closer look at how it all began.

The evolution of the true nutraceuticals... diverging away from herbal remedies...

Traditional healing systems like Ayurveda, Siddha, and Unani have used natural resources for centuries, treating the body, mind, and spirit as interconnected entities. However, scientific acceptance was limited by a lack of standardisation and reproducibility. Modern technology has revolutionized identification, isolation, and standardisation, leading to the extraction of bioactive compounds from plants like turmeric, green tea, and garlic. Curcumin is widely used as an anti-inflammatory and antioxidant; EGCG (Epigallocatechin gallate) for cancer prevention; and allicin for diabetes and gout management. It is, in fact, a transition from observation-based remedies (using whole foods) to evidence-based specific supplements/therapeutics. This is resonated by Dr. Stephen De Felice, who first coined the term ‘nutraceuticals’ 35 years ago, essentially referring to “bioactive components derived from food sources that offer health benefits beyond basic nutrition.”

In India, nutraceuticals have travelled a road of twists and turns; despite this, the market has grown 4.5 times from 2012 to 2023, in an 11-year span, reaching a 1.5% share of the global market. ^1,8

As per Kearney’s report, “India’s nutraceuticals sector has attracted more interest from venture capitalists, with investments surging by 2.5x from 2020–2023 compared with 2016–2019, while the global market only saw a 1.7x increase during the same period.” ⁸

A country where micronutrient deficiencies are highly prevalent (66.4% of women in India are anemic,⁹ 80-90% of Indians suffer from vitamin D deficiency,¹⁰ and so on), the market progression is still slower considering India’s rich resources, history, and knowledge.

The modern era is witnessing an evolution of multimodal treatment plans combining traditional medicine, pharmaceuticals, and nutraceuticals. The Ministry of AYUSH promotes holistic treatment through research councils and national institutes to maximize patient QoL.⁷ However, there is a lack of collaboration among experts from different sciences, preventing full implementation of this discipline. This is due to the absence of formal training in nutraceuticals or herbal medicines in allopathic courses, preventing confidence in recommending medicines from these disciplines. (evident from a comment by an eminent specialist answering a query to his patient, “We didn’t read Nutra or Herbal in our course; hence, I can’t recommend.”)

Nutra can play a critical role in every stage of the healthcare spectrum:

Image 1: Healthcare Spectrum showing 5 stages (conceptualised by and ©copyright of Green Bark Consulting)

In a nutshell 

• There is always the right supplement for every purpose & stage of life
• Awareness of disease and understanding of the role Nutra plays is the most critical factor for the population to accept, consume and spread the confidence 
• Progressively, people look for ways to avoid high-cost hospitalisation (preventive) and loss of productive time (productivity)

The regulatory landscape...

Though the FSSAI of India has governed Nutra products so far, recent discussions have emerged about transferring regulatory oversight to the CDSCO, which regulates pharmaceuticals. This potential shift has sparked debates on whether nutraceuticals warrant pharmaceutical-level scrutiny or can be counterproductive!

An inter-ministerial committee suggested that supplements claiming to cure or mitigate any specific disease should be considered a drug and, therefore, come under the purview of the Central Drug Standards Control Organisation (CDSCO)²

Therefore, the intent of CDSCO control is understandable: to improve safety and efficacy evaluations for brands claiming therapeutic benefits, curb misleading claims, and strengthen India's position as a global hub. It could also attract consumers who may be skeptical about the genuineness of the products.³

Consumer freedom may also pose a risk.

Vitamin supplement overconsumption in the U.S. has raised concerns about hypervitaminosis, with fat-soluble vitamins at higher risk of accumulation. ¹¹ Manufacturers have been left to make product claims without stringent regulatory oversight, leading to misleading claims and misguided choices. For example, collagen-based beauty products often claim universal benefits, but their efficacy varies from person to person. Consumers may struggle to determine the product's suitability and potentially worsen existing skin conditions.

On the contrary... Are we focusing on the real issue?

We know price control is one of the inevitable consequences of CDSCO regulation. India puts NLEMs (National List of Essential Medicines) under price control because they are considered essential drugs for public health, and to ensure affordability and accessibility, the government regulates their prices.

It’s believed that nutraceuticals aren't supposed to be used to treat or cure any disease or condition; they can only be used to support or "help prevent" the onset or progression of a disease or condition. On the other hand, they are being considered for regulation by CDSCO, which could eventually control prices in the same way that other essential medicines are (as resonated in the cover story of Nuffoods Spectrum, Jan 2025)

If access is the prime objective to pose nutraceuticals under price control in their entirety, there will be many grey areas that would demand in-depth debate...

• Nutraceuticals are diverse (like drugs); a particular preventive or supportive purpose can be served by many nutraceutical compounds of a range of costs (e.g., vitamin minerals—the common and economical nutraceuticals vs. more specific non-vitamin nutraceuticals, which are relatively lesser known and expensive). Therefore, people can achieve their preventive or supportive purpose without spending exorbitantly using well-understood common vitamin minerals. On the other hand, those who have understanding and are able to afford it will experience the exclusive non-vitamin-specific purpose or targeted options. Therefore, the imposition of price control is not compulsory to facilitate preventive healthcare in India.
• Another set of critical considerations are awareness, understanding, and knowledge. The pharma professionals must have observed substantial resistance from the specialists to recommend the exclusive non-vitamin high-profile specific nutra since the pharma-like clinical evidence with statistical significance is not available in most of the cases. In fact, there are many such highly beneficial compounds that need education and the generation of real-world evidence to realize their true potential. On the other hand, through the D2C route, high-profile nutra compounds can never reach the consumers since it requires in-depth understanding. Here lies the paradox of the logic of bringing in control to the entire Nutra ‘en-masse’. Without enhancement and the spread of the science of Nutra, no augmented usage can be expected. Supportive healthcare or preventive medication or supplements were never consumed in India even if they were affordable. After all, the word 'medicine’ is still driven by dire necessity and considered a spend out of compulsion. Proactive positive health spending is still nascent in India, hovering around a very basic understanding of multivitamins and minerals, along with some basic proteins and amino acids.
• Moreover, let us not overlook the fact that despite substantial progress, India is still a country where health spending is mostly out-of-pocket (OOP) with a minimalistic approach to treatment, delayed diagnosis, mostly taking recourse to empirical therapies, poor compliance with NCDs/chronic therapies, and grossly inadequate access to health facilities with a lack of skilled primary care HCPs. Leaving aside all these prime challenges, a sudden priority to preventive health through price-aiding nutraceutical baffles justification. 
• India should progress toward a holistic therapeutic regimen through a planned approach (as has been suggested by many experts). Medical education, at first, has to embrace such a multimodal approach and be open to multi-disciplinary therapies/Rx. Here, critical medicines would be combined with Nutra /therapies from other disciplines to allow a ‘cure–support–prevent’ model. Such a futuristic approach may integrate various faiths of remedies to empower holistic management better for our country of huge diversity.
• The nutraceutical industry is currently at a pivotal point in exploring its vast horizon beyond just traditional vitamins and minerals. It’s time to invest resources, effort, and time to build evidence, which has so far been the reason for disbelief in nutraceuticals. Nuances of ‘nutrikinetics’ and ‘nutridynamics’, comparative efficacy, and safety to be researched and published. Strong evidence will encourage KOLs of various therapy areas to explore, leading to the emergence of real-world use cases. 
• Needless to mention, such research and innovations are not cost-friendly. Intending access and not building the science background will definitely dissociate experts from this science. Thus, directly or indirectly, constraining research and innovation will simply wipe out the nutraceutical dream from India.

Finally, even if the common vitamins (having mass usage) are considered for a price cap to enhance access, we must remember that many of these vitamins in their therapeutic concentrations already under price cap. Will there be any additional gain by putting Nutra/RDA dosage under regulation? On the other hand, the high-profile specific nutra compounds are not yet being used by the critical mass, and conceptually they are still in their nascent stage, where regulation will be futile. Hence, the key question, “To be or not to be.” What’s your take on this?

References

1. Nutraceuticals market in India, Oct 2018 report by Deloitte.

2. The Times of India: Bring health supplements under drug control watch, suggests panel Nov 16, 2024, 03.20 AM IST

3. Nuffoods Spectrum, January 2025

4. PubMed Central: Omega-3 fatty acids and dementia by Greg M Cole et. al 

5. Harvard Health Publishing (Harvard Medical School): The Gut-Brain Connection; 18 July 2023

6. Gut: The Inside Story Of Our Body’s Most Under-Rated Organ; Giulia Enders

7. Press Information Bureau GOI: Holistic Treatment under AYUSH, 12 Feb 2021

8. Nutraceuticals in India: capitalizing on the shift toward preventive healthcare, Kearney 2024

9. A micro review of a nutritional public health challenge: Iron deficiency anaemia in India; P Natekar et al 2022 via Science Direct

10. Vitamin D deficiency in India; P Aparna et al PMID: 30090772

11. Hypervitaminosis: A Global Concern; Manouchehr Saljoughian; Published in uspharmacist.com; 15 Oct 2021