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Evidence-based marketing with clinical trial data key in nutra: Expert
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Monday, 21 September, 2020, 08 : 00 AM [IST]
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Nandita Vijay, Bengaluru
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Nutraceuticals industry is following the pharmaceutical industry in several areas including, quality, regulations, labelling and packaging. The current trend is towards evidence-based marketing by generating clinical trial data, according to Dr Anish Desai, founder, IntelliMed Healthcare.
“The clinical trials for nutraceuticals are designed to evaluate and substantiate specific marketing claims, while drug trials document the safety and efficacy of a specific drug for a specific indication,” he stated.
“Further, nutraceuticals trials may be more pragmatic as they document human experiences with specific foods in the context of the human diet while drug trials evaluate the safety and efficacy of a drug in a specific disease. These trials may include both healthy and high risk people while drug trials include patients with a specific disease needing the treatment,” stated Dr Desai while speaking to FnB News.
Basically, Ethics Committee approvals from institutions and informed consent from patients need to be taken according to Good Clinical Practice (GCP) guidelines. Time to approval depends on submission of documents and duration of clinical trial.
Consumers see nutraceuticals are absolutely safe as they are natural and available over-the-counter. This kind of marketing not only has a competitive advantage over products with unsubstantiated claims but also maintains higher quality. “This trend will go a long way in establishing the credibility of nutraceuticals in the minds of medical fraternity and consumers,” he stated.
There is a large patient pool available for participation in India for these studies. However, it depends on the investigators and the institution where the clinical study is undertaken. It is also dependent on the protocol and the follow-up needed for the study. Data needed to justify the claim as the FSSAI guidelines Clause 4 highlighting ‘Claims’ will be essential.
Covid-19 has increased the awareness of health, preventive care and immunity. The increased awareness will continue to drive the importance of nutraceuticals in healthcare and disease management. Nutricosmetics, nutrigenetics, nutrigenomics, food polymers are also emerging in the global market. Innovations in product manufacturing, inactive ingredients, packaging and storage are on the rise.
Nutraceuticals companies look for product differentiation with novel formulations to increase consumer appeal. Tablets, gummies and gels are commonly available. Novel differentiating formulations include beverages, drinks, shots, biscuits, cookies, effervescent tablets, granules, sachets and mouth dissolving tablets.
Clinical substantiation of the claim is important from a regulatory and consumer perspective. Harmonisation of regulations will be important for the industry. Developing and marketing differentiated product is critical.
The Indian nutraceuticals market will see a 21% YOY CAGR to touch $10 billion by 2022. It is the Food Safety and Standards Act, 2006, which has reinforced regulations for nutraceuticals, creating a regulated space for these companies to conduct business.
In the coming years, nutraceuticals will be prominent in medicinal therapy. The success will be dictated by purity, efficacy, safety and innovation. Considering the facts and data, the Indian nutraceuticals market is poised for an unprecedented growth and will play an important role globally, according to Desai.
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