India’s nutrition market “heats up” with FSSAI approval

Published: 10-Oct-2022

Those closely involved with this approval process believe "there’s huge potential for nutraceuticals backed by extensive science"

India may be the next huge market for sports nutraceuticals that are supported by safety and scientific data. The recent registration approval of TSI’s PEAK ATP by the Food Safety and Standards Authority of India (FSSAI), granting India’s GCV Life (GCVL) an unprecedented exclusivity, is an indicator of a major market shift. 

GCVL Founder and Director Shailesh Gadre said: “Previously there was only a small penetration of sports nutrition products in India. But since the pandemic, the middle class has begun to understand the importance of preventive healthcare and sports nutrition. The number of people who have become health conscious, physically active and who are consuming products to support their active lifestyles has gone up considerably.” 

Gadre continued: “We are already exploring new product concepts, and discussing how we will educate consumers about the PEAK ATP’s benefits.The Indian consumer will now have a choice between pure energy supplement (PEAK ATP) and traditional energy and sugar drinks.” 

TSI Group President Larry Kolb said: “Until now, most sports nutrition ingredients have been imported into India from the U.S., Europe and Australia. Now, Indian sports nutrition companies will be moving forward. This also represents an incredibly exciting opportunity for our U.S. customers using PEAK ATP to export their finished products to India.” 

Human clinical research confirms the immediate benefits of PEAK ATP for athletes, weekend warriors and everyday exercisers. It can help anyone make the most of time spent exercising

India’s market is very complex, with no single national distributors. Kolb and Gadre expect their collaboration to specifically benefit smaller, innovative entrepreneurs. “GCVL is structured to benefit innovators. The sports nutrition segment has already grown more than 25% in India. Some companies are talking about doubling their business in the next two to three years,” says Gadre. “TSI and GCVL are drawn together by a shared vision of helping innovators tap into these opportunities and benefit the Indian consumers to become healthier.” 

Indian regulators are increasingly looking at new ingredients and delivery systems from a stronger scientific perspective. “The partnership between TSI and GCVL was a very important part of the registering process. GCVL’s expertise was critical to earning approval,” said John C. Fuller, Jr., Ph.D., TSI Group’s Director of Regulatory. It was essential to establish the importance of ATP to the market; and the criteria were stringent. 

“FSSAI evaluated ATP based on manufacturing, analysis of safety and history of use. To do this, they analysed preclinical safety studies, human clinical studies, and prior approvals and marketing in other countries like Canada and the U.S. They looked at PEAK ATP in comparison with the ATP monograph. Along with this analysis of the compound itself for safety, they looked at manufacturing practices to ensure they follow Good Manufacturing Practices and supply to ensure that PEAK ATP will consistently meet specifications and analysis for hazards. 

“PEAK ATP was also independently analysed in an Indian laboratory to verify the product meets specifications. They also looked at the stability of Peak ATP and formulations with Peak ATP,” Fuller said.

TSI’s scientific and regulatory work supports our global vision, which is to give consumers throughout the world access to our innovative ingredients

TSI’s multi-patented PEAK ATP is a non-stimulant energy source that fuels muscles and powers the body’s movement. PEAK ATP is a clinically validated and patented form of adenosine 5’-triphosphate (ATP) disodium that is identical in structure to ATP produced and used by the human body. ATP is the body’s preferred energy source as it drives the biological reactions that allow cells to function and life to exist. PEAK ATP being vegetarian/vegan-friendly will appeal to India’s largely vegetarian population. 

“Human clinical research confirms the immediate benefits of PEAK ATP for athletes, weekend warriors and everyday exercisers. It can help anyone make the most of time spent exercising,” said Kolb. “Many companies are looking for the right product to launch in India. This is an example of the right ingredient becoming available at the right time, with the right certification and through right partnership.” 

Gadre added: “Companies weren’t launching new products during the pandemic. Now the pipelines are cleared and this is a good time to bring PEAK ATP to market.” GCVL has also represented TSI’s myHMB for more than three years. 

“TSI’s scientific and regulatory work supports our global vision, which is to give consumers throughout the world access to our innovative ingredients,” said Kolb. “Our goal is to replicate this regulatory approval for PEAK ATP in other countries, much as we are doing with our expanded access to myHMB.”  

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