10.06.22
The Food Safety Standards Authority of India (FSSAI) recently approved an ingredient marketed by TSI as Peak ATP, granting what TSI describes as an “unprecedented exclusivity” to GCV Life, a distributor in India which has a partnership with TSI.
According to GCV Life founder and director Shailesh Gadre, the approval comes as sports nutrition products are becoming popular in India.
“Previously there was only a small penetration of sports nutrition products in India,” Gadre said. “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. We are already exploring new product concepts, and discussing how we will educate consumers about the Peak ATP’s benefits.”
“Until now, most sports nutrition ingredients have been imported into India from the U.S., Europe, and Australia,” said Larry Kolb, TSI Group president. “Now, Indian sports nutrition companies will be moving forward. This also represents an exciting opportunity for our U.S. customers using Peak ATP to export their finished products to India.”
Gadre noted that there are no single national ingredient distributors in India, and its market is relatively complex, and that he expects the collaboration to mainly benefit smaller, more innovative supplement brands.
The FSSAI Process
Indian regulators are looking at new ingredients and delivery systems with a stronger scientific perspective in mind, according to TSI.
“FSSAI evaluated ATP based on manufacturing, analysis of safety and history of use,” said John C. Fuller Jr., PhD, TSI Group’s regulatory director. “To do this, they analyzed 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 analyzed in an Indian laboratory to verify the product meets specifications,” Fuller continued. “They also looked at the stability of Peak ATP and formulations with Peak ATP.”
Vegetarian/Vegan-friendly Credentials Are a Strong Point
Peak ATP, a patented form of adenosine 5’-triphosphate (ATP) disodium, is identical in structure to ATP produced and used by the human body, and is used as an energy source in cellular biological reactions. Its lack of animal sources will be a selling point to India’s largely vegetarian population, according to the company.
“This is an example of the right ingredient becoming available at the right time, with the right certification, and through the right partnership,” said Kolb, who noted that this is part of the company’s expansion plan to replicate regulatory approval for Peak ATP in other countries.
According to GCV Life founder and director Shailesh Gadre, the approval comes as sports nutrition products are becoming popular in India.
“Previously there was only a small penetration of sports nutrition products in India,” Gadre said. “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. We are already exploring new product concepts, and discussing how we will educate consumers about the Peak ATP’s benefits.”
“Until now, most sports nutrition ingredients have been imported into India from the U.S., Europe, and Australia,” said Larry Kolb, TSI Group president. “Now, Indian sports nutrition companies will be moving forward. This also represents an exciting opportunity for our U.S. customers using Peak ATP to export their finished products to India.”
Gadre noted that there are no single national ingredient distributors in India, and its market is relatively complex, and that he expects the collaboration to mainly benefit smaller, more innovative supplement brands.
The FSSAI Process
Indian regulators are looking at new ingredients and delivery systems with a stronger scientific perspective in mind, according to TSI.
“FSSAI evaluated ATP based on manufacturing, analysis of safety and history of use,” said John C. Fuller Jr., PhD, TSI Group’s regulatory director. “To do this, they analyzed 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 analyzed in an Indian laboratory to verify the product meets specifications,” Fuller continued. “They also looked at the stability of Peak ATP and formulations with Peak ATP.”
Vegetarian/Vegan-friendly Credentials Are a Strong Point
Peak ATP, a patented form of adenosine 5’-triphosphate (ATP) disodium, is identical in structure to ATP produced and used by the human body, and is used as an energy source in cellular biological reactions. Its lack of animal sources will be a selling point to India’s largely vegetarian population, according to the company.
“This is an example of the right ingredient becoming available at the right time, with the right certification, and through the right partnership,” said Kolb, who noted that this is part of the company’s expansion plan to replicate regulatory approval for Peak ATP in other countries.
