The authorities have also involved industry stakeholders, including companies and industry associations, in the discussion.
Health Foods and Dietary Supplements Association (HADSA) is one of the associations involved.
Earlier in February, we reported that the Indian government has formed a five-member panel to examine the possibility of shifting nutraceutical regulatory oversight from the Food Safety and Standards Authority of India (FSSAI) to the Central Drugs Standard Control Organisation (CDSCO).
The intent is said to address regulatory challenges and promote consumer safety.
Since April, there has been discussions held fortnightly to assess the possibility and other options.
One of the options raised, is to let the Drugs Controller General of India (DCGI) take over the control of vitamins and minerals with dosage levels above one RDA and upper limit, Dr. Vaibhav Kulkarni, honorary secretary and board member of HADSA, told NutraIngredients-Asia.
Dr. Vaibhav, who was previously the head of regulatory affairs with Abbott Nutrition, is also the founder and director of nutraceutical start-up Zantus Lifesciences.
At the moment, vitamins and minerals with dosage levels above one RDA or upper limit will be considered as pharmaceuticals.
However, there are exceptions for Foods for Special Medical Purpose (FSMP) and Foods for Special Dietary Use (FSDU).
According to the FSSAI, FSMP products, for example, may have nutrients at levels higher than the RDA, but not exceeding the limits of vitamins and minerals as specified in Schedule III of the nutraceutical regulations.
There has been an influx of applications for FSMP and FSDU, and this has called for greater expertise to look into this area, Dr. Vaibhav said.
For instance, there has been concerns around hypervitaminosis – abnormally high storage levels of vitamins – raised by doctors in the scientific panel formed to assess these applications.
“The scientific panel looks into the data that the company has submitted for that particular level. At the same time, you have doctors in the panels who suggest that hypervitaminosis is also a big issue.
“The authority has opened up and said that the regulation needed to be looked into again, and we will have to see whether it is logical to keep this thing in entirety with the food authority, or could it be shifted to the DCGI. That’s where the discussion is still ongoing,” he said.
Other reasons for involving the DCGI include enforcing GMP, hygiene and safety standards for pharmaceutical companies that are also manufacturing nutraceuticals in their facilities. One of the aims is to ensure that nutraceuticals are not contaminated with pharmaceutical substances during the manufacturing process.
Asked the timeline, he said that the rate at which the discussion and changes would be pushed would depend on how eager the minster was in driving this forward.
NutraIngredients-Asia has contacted the DCGI for comments.
All nutraceuticals should be overseen by food regulator – HADSA
HADSA, in this case, is of the view that all nutraceuticals should continued to be overseen by the FSSAI.
It is involved in one of the panels that looks at why nutraceuticals should remain under the purview of the food regulator.
It will also assess the possibility for disease or risk reduction claims for food, as well as enforcing Good Manufacturing Practice (GMP).
The panel is also made up of ex-government officials, private companies, and research institutes.
Dr. Vaibhav said HADSA was of the view that nutraceuticals – even those that were above one RDA and upper limits – should be regulated by the FSSAI in order to drive innovation forward.
“A lot of the industry players feel that if the regulatory control of nutraceuticals goes under DCGI, the possibility of the growth rates that I've told you may not happen, or may get down,” he said.
He also pointed out concerns around price control as seen in the pharma industry.
“If nutraceuticals come under price control, then automatically, a lot of players will get discouraged, because they will not get the profits the way they want to, and this may also stifle innovation.
“In a sense, it can slow down our industry. So all these points need to be considered so that there is a minimal hit to the industry if they are moving nutraceuticals under the DCGI.
“We want to protect nutraceutical innovation but we are happy to discuss the other possible arrangements as well.”
India’s nutraceutical industry has expanded swiftly in the past decade.
It now has a market size of more than US$5bn and in the next one to two years, it is poised to grow by 22 to 25 per cent.
“It is expected that by the end of 2025 or early 2026, the market, the sales of nutraceuticals is going to touch US$18bn. From a global perspective, India will grow from a market share of two per cent to 3.5 per cent just in a few years’ time," Dr. Vaibhav said.
