Nutraceuticals Regulations 2022 to encourage Pharma Industry

Majority of products under the category of sports nutrition are from western markets and imported by companies including pharmaceuticals.

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Last Updated on April 3, 2022 by The Health Master

The Union government’s latest guidance on nutraceuticals, health supplements, special dietary and medical purports along with pre and probiotics is expected to encourage pharma industry to research & manufacture sports nutrition and medicine products.

The Nutraceuticals Regulations 2022 provides far more clarity and could boost the research and manufacture capabilities in the area of sports medicine and is looking to qualify the same under the Union government productivity linked incentive (PLI) scheme, noted D B Anantha Narayana, CSO, Ayurvidye Trust, chairman, Scientific Panel-Nutraceuticals, FSSAI.

Majority of products under the category of sports nutrition are from western markets and imported by companies including pharmaceuticals.

Following India’s ability to research and manufacture pharmaceuticals which include a slew of vitamins and mineral formulations, companies are confident that they can capitalize contract research and manufacture of sports nutrition products.

According to Narayana, it is high time the industry looks at Atmanirbhar and opt for the PLI scheme for sports nutrition to save the foreign exchange as most of the active ingredients need to be imported.

Sports nutrition products, such as sports drinks, sports food & sports supplements are developed for and consumed by athletes and bodybuilders to improve their overall health, performance, and muscle growth. This category is getting extended to those who do some form of sports & activity including jogging or gyming.

Moreover, India’s anthropometrics are different. Therefore there is a need to either adopt or modify or Indian Centric products to be developed as a supplement, nutraceutical or as a dedicated sports nutrition product under a separate category.

The country already is engaged in the development of vitamins, minerals, amino acids Indian regulations also has ‘botanicals. The recommended dietary allowances RDAs need rethinking for innovations, Dr Narayana stated at the recently concluded national webinar on sports supplements & nutraceuticals.

In order to drive India centric innovations, the Hyderabad-based National Institute of Nutrition (NIN) issued the new RDA Requirements in 2020. It recommends to consider EAR (Estimated Average Requirements) in place of RDA, for all nutrition and nutrition based offerings.

EAR represents the central tendency of the nutrient requirement in the population, namely, the median or mean value which satisfy the requirements of 50% of the nutrient requirement in the population, he said.

The research and development of sports nutrition innovations can also be driven from indigenous sources like botanicals. An eco-system of strong R&D competency, pharma scale up & production capabilities along with pool for qualified scientific resources can accelerate this further, stated Dr Narayana.

In addition it is also an untapped area for pharma and food start-ups, engaged in R&D of nutrition medicine to ascertain the unscientific combinations of botanical concentrates, its bio-availability, interactions, stability and taste.

Lot of scientific data on active ingredients are available. There is also considerable reliance on India for human clinical trials data to decide on ingredient based claims or product based claims and here for sports nutrition, Indian pharma contract researcher companies and clinical trial organisations can push for investments in human study to make reliable strong benefit claims.

This is primarily because improper combinations of vitamins, minerals, amino acids & nutraceuticals can lead to unscientific product manufacture and potential safety concerns, said Dr Narayana.

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