Through its manufacturing partner, Zeon Life Sciences, the FSSAI granted the company a licence for the product to be manufactured and sold in India.
This approval will permit Zeon to manufacture and sell SlimBiome as an ingredient to brands, as well as a health product, and in finished products under OptiBiotix's GoFigure range of meal replacement shakes, snack bars, and muesli.
SlimBiome is one of the company's signature products, designed to aid in weight management, satiety, and glucose and appetite regulation, as well as to balance blood sugar and insulin levels. It contains glucomannan, chromium, and prebiotic fibres.
South Asian stepping stone
According to OptiBiotix CEO Stephen O'Hara, the approval also signifies the company's continuing progress in APAC, which began last year with the launch of SlimBiome in Vietnam, the Philippines and Indonesia, through a distribution deal with functional food firm CTC Group.
He added that OptiBiotix had received the approval from the FSSAI in an unexpectedly short time, which itself was a significant achievement, as this was a vital step in completing the supply chain to fulfil orders from corporate partners in India.
Speaking to NutraIngredients-Asia, O'Hara said: "It was a very detailed registration process but surprisingly, it didn't take very long. We started the process in February and we've now achieved approval for SlimBiome and products containing SlimBiome in India. We were not expecting to get approval so quickly, as that is unusual for most companies in India.
"This agreement is another step in a strategy designed to build multiple revenue streams from ingredient sales, and white label and own-label branded consumer and pharmaceutical products across multiple channels with industry partners from around the world."
He added that in addition to selling SlimBiome as an ingredient for foods like bread, yoghurt and muesli, as part of its GoFigure brand, and in a sachet format (approved as a medical food in the EU with the CE mark), OptiBiotix would also be catering specifically to local tastes.
"In India, we are catering the ingredient to more local tastes by including it in foods such as chapati, and we're looking into extending our range to include products like gummies and porridge.
"We also have other agreements in the pipeline with potential partners to produce shakes, bars, muesli pots, and even burger patties.
"Through Zeon, we've met with 30 companies in India, many of which are well-established global firms such Unilever, Abbott Nutrition, Danone, GNC, Decathlon, Herbalife and Sun Pharma that were interested making products such as bars and shakes using SlimBiome."
"In fact, we have more interest in SlimBiome than we could ever hope to meet, though I can't reveal the names of all the interested parties just yet."
APAC navigation
O'Hara said that while its focus was now on India, OptiBiotix would also use its activity in the country to boost its expansion plans in other APAC markets.
"With India being such a large country, there are regional variations in the types of food consumers eat. We are working with local manufacturers because they can identify the most suitable types of products for different areas.
"We will then see if those products are suitable for our markets in the Philippines, Vietnam and Indonesia."
"With SlimBiome, we can create cereals, puffs, flakes and more, and these products are all under development at the moment. They will be available in our APAC markets when they're ready.
"We're also looking at Singapore, Thailand, South Korea, Japan and eventually, China. China is a massive market, and we know we need to build a globally recognised brand before going there."
He also noted the marked differences in terms of regulation and consumer awareness in the different APAC markets, saying it was important to find common trends across demographics and countries.
Japan, for example, is quite a complex market and has a regulatory process more advanced than in many other parts of the world, but OptiBiotix is 'certainly targeting that market', as it considers Japan a 'large, sophisticated market' with many older consumers who are always on the lookout for new innovations.
In comparison, India's market is much younger — around 65% of the population is under 25 — and Japan is far more highly regulated. However, a common trend in both countries, O’Hara said, was the prevalence of chronic lifestyle diseases, such as diabetes and obesity.
"The key is in how we market SlimBiome to these different markets and demographics. We create the science and innovation, build the patents and trademarks, and carry out clinical studies to prove the safety and efficacy of our products, and our distributors and marketers provide the expertise in how best to get those products to market.
"They also influence the types of products sold in different markets — for instance, gummies may be very popular among elderly people in a certain country, while shakes may be less popular. We have to consider what the most appropriate product type and delivery system is for each market."