Ethical Nutraceuticals: Need of the hour

As the world grappled with the COVID-19 pandemic, and now continues to deal with its aftermath, ‘immunity’ has become the new buzzword and the demand for nutraceuticals across the globe has increased manifold. This, in turn, has opened a huge opportunity for the nutraceuticals industry globally and India is uniquely positioned to become one of the most formidable players in this segment, with a projected $100 billion valued market by 2030. (Read: https:// www.expresspharma.in/six-reasons-why-india-is-poised-to-be-aglobal-leader-in-nutraceuticals/)

However, even as this industry booms and newer players enter the market, serious concerns are being raised about the research, regulation, development and consumption of these nutraceuticals. So, timely and pertinent measures are of essence to leverage the tremendous growth potential and eliminate bottlenecks that hinder the industry’s progress.

Express Pharma- Nutrify Today Boardroom series In a bid to examine and understand the prerequisites for the next leg of growth in nutraceuticals, Nutrify Today and Express Pharma came together to launch the Express Pharma- Nutrify Today Boardroom series. The aim was to create and build a platform for pharma industry leaders to initiate a dialogue that would assist the pharma industry to leverage growth through ethical nutraceuticals. It is also an endeavour to enable government bodies to shape effective policies that would help the growth of the ethical nutraceuticals industry in India through effective engagement with the pharma industry.

The first edition of the Express Pharma – Nutrify Today Boardroom series, held recently in Mumbai, offered a platform for meaningful dialogues on the vast ocean of opportunities for the Indian pharma sector to be reaped in nutraceuticals, provided the right course is set for long and sustainable growth.

An eminent panel of pharma experts and leaders came together to explore approaches to build an ecosystem for developing scientifically proven, evidence-based nutraceutical products. Dr Meenakshi Singh, Secretary Nutraceuticals Task Force under chairmanship to PSA to Government of India; Rahul Kulshreshtha, Strategic Alliances – Office of the Principal Scientific Adviser to the Government of India; Aditi Kare-Panandikar, MD, Indoco Remedies; Anand Swaroop, President, Cepham Inc; Rajaram Sankaran, Chief Strategy Officer – India, Torrent Pharmaceuticals; Shriram Balasubramanian, Director Marketing and Business Development, Zuventus Healthcare and Amit Srivastava, Chief Catalyst, Nutrifytoday.com were the participants in this round table moderated by Viveka Rowchowdhury, Editor, Express Pharma & Express Healthcare.

As the experts dived deep into the challenges in this field and the measures needed to enhance ethical standards in nutraceutical research, industry practices, and use, they also examined how a pharma-like approach in terms of regulation, quality assessment and safety profiles could benefit the nutraceuticals industry.

This article is a summation of the inferences drawn and lessons learnt from the views, concerns and insights shared by experts on this knowledge-sharing platform. And, we understand that gaining success through ethical nutraceuticals will largely hinge on the following factors:

◆ A clear and comprehensive regulatory framework: Experts emphasised that it is inadvisable to let nutraceuticals evolve without a clear regulatory framework since the lack of uniform, consistent or standardised regulations can prove detrimental to arrest the growth and adversely impact the credibility of this segment. Therefore, creating a separate set of laws and regulations to guarantee that nutraceutical products are safe, efficacious and meet high standards of quality is very critical. They asserted that strict guidelines and improved techniques must be adopted to ensure that there is enough evidence to validate the health claims made by different products, especially in terms of purity and safety. Discussing various aspects of dietary supplements, nutraceutical supplementation and pharmacological nutrition, experts stressed that while there have been some measures to improve the regulatory landscape in nutraceuticals, there are limitations and bottlenecks to overcome.

◆ A centralised regulatory body: Underpinning the importance of single-point ownership in the nutraceuticals sector, the experts pointed out that as the sector has often come under the ambit of different regulatory bodies like FSSAI, AYUSH, DCGI, MoFPI etc, grey areas continue to dog the progress of the sector. Time and again, there has been a call for setting up a centralised authority or creating a body like Pharmexcil to integrate government bodies to serve nutraceuticals. As the experts at this round table also discussed the need for such a centralised body, Srivastava, who was part of a meeting held by the Nutraceutical Task Force, informed that the formation of a nutraceutical panel in the Ministry of Commerce to ensure a nutraceutical industry-specific agenda is underway.

◆ Robust R&D and manufacturing policies: Speaking on the need for policies and regulations-led interventions to ease the growth of this industry, stakeholders of the pharma and nutra industry also discussed the value of incentives to encourage research in ingredients and formulations to drive ethical nutraceuticals. Apart from addressing the need to design and implement policies that encourage product standardisation, minimise product adulteration, and ensure that recommended daily allowance (RDA) and Tolerable Upper Limit (TUL) are met, the experts also discussed how the government’s plan to introduce a Research Linked Incentive (RLI) Scheme and Production Linked Incentive (PLI) scheme in nutraceuticals could give an added impetus to the sector’s growth by enabling sizeable investments.

◆ A robust nutrivigilance system: The experts at the round table unanimously believe that indiscriminate access and consumption of nutraceuticals without the support of the medical fraternity could turn into a huge health disaster. This view is supported by studies published in reputed journals like PubMed and BMJ that reveal that over 30,000 patients annually are admitted to the emergency ward due to the adverse impact of nutraceuticals. This, in turn, led to a discussion on the role and importance of a surveillance system akin to the pharma industry to monitor and record adverse events associated with nutraceuticals. The experts at the round table vociferously supported setting up a dedicated nutrivigilance system which can promote and implement a systematic, scientific and consistent approach to assess the risk–benefit ratio of nutra products, build up scientific evidence and proof of concepts, as well as initiate and chart risk alleviation strategies.

◆ Evidence-based practices: The dearth of precise scientific data or raison d’être for the use of dietary supplements and nutraceuticals can have an adverse impact, caution industry experts. They recommend stringent guidelines to collect and propagate validated data on the safety, efficacy and claims made on the labels of nutraceuticals products. Long-term studies for clinical validation of ingredients or formulations in nutraceuticals, effective approaches to understanding the toxicology of active ingredients, interactions between drugs and dietary supplements, purity, and bioavailability of nutraceuticals etc are also imperative to drive ethical growth in the sector. Drawing comparisons between R&D and manufacturing practices in the pharma and nutra sectors, the experts said that nutraceutical manufacturers should ensure that only potent ingredients with the right dosages backed by clinical studies are used in their products. Better standardisation, cGMP practices and evidence-based approaches to ensure better product quality, stability, functionality, safety, solubility and acceptance among patients will be vital to the advancement of this sector. This, in turn, will help the nutra sector deal with increased scrutiny and surveillance from global regulatory agencies as well.

◆ Effective use of technology: Emerging technologies will play a crucial role in shaping the discovery, design and development of responsible and ethical nutraceutical products, opined the panellists at the first edition of Express PharmaNutrify Today Board Room series. They also examined how technology can be leveraged and effectively deployed to provide specific dosages and ingredients as per patients’ varying needs. For instance, AI can be deployed to select ingredients by matching data points from studies on nutrition and nutraceuticals and provide insights into commercial patterns, industry trends, etc. Automation and IIoT can enhance efficiency, cut costs and get products to market faster. A case-in-point discussed at the round table was Torrent Pharmaceuticals;’s NutrifyGenie, an AI-powered engine that can prioritise safety, efficacy and traceability in nutraceuticals.

India Pharma Inc’s tryst with nutraceuticals

Thus, amid the clarion call for better regulations, a clear road map and empirical data to validate claims of efficacy and safety made by the slew of products entering the market to build a clear and robust roadmap for the nutraceuticals sector in India, India Pharma Inc, backed by its science and research-oriented approach, has several comparative advantages when it came to nutraceuticals. Especially, since ensuring transparency and ethical approaches to making and marketing nutraceuticals will be pivotal to the long-term growth of the sector.

However, over the last few years, the pharma industry’s forays and experiments with nutraceuticals have evinced a mixed bag of results. The sector looks at the nutraceutical segment as an avenue to expand product portfolios by leveraging scientific credibility. But, the excitement to leverage the growth potential in nutraceuticals has been countered by challenges like the lack of an effective approach/guideline for clinical proofs, clinical trials, factory audit standards, bioactive standardisation, method validations, etc.

Companies like Dr Reddy’s, Sun Pharma, La Renon, and Zuventus have made sizeable investments and witnessed noteworthy growth in their nutraceuticals portfolio, but many others are still struggling to find the best approach to succeed in this space.

But, armed with the right partners and a robust entry strategy, the nutra space offers a great opportunity for the pharma sector to fill gaps for certain health conditions and problems, improve profit margins, increase customer base and grow in new markets.

However, pharma players, industry bodies and policymakers need to align and adopt a cohesive approach to bring more clarity to this industry and make it mainstream to make the most of its tremendous potential.