Authorities are also involving industry stakeholders, including companies and industry associations, in the discussions.
The Health Food and Dietary Supplements Association (HADSA) is one of the associations involved.
Earlier in February, we reported that the Indian government had constituted a five-member committee to examine the possibility of transferring regulatory oversight of dietary supplements from the Food Safety and Standards Authority of India (FSSAI) to the Central Drugs Standard Control Organisation (CDSCO).
The purpose is said to be to address regulatory challenges and promote consumer safety.
Discussions have been held every two weeks since April to assess that possibility and other options.
One of the options raised is to entrust the Drugs Controller General of India (DCGI) with controlling the intake of vitamins and minerals above the recommended daily allowance and upper limits, said Dr Vaibhav Kulkarni, honorary secretary and director, HADSA. NutraIngredients – Asia.
Dr. Vaibhav, who previously served as head of regulatory affairs at Abbott Nutrition, is also the founder and director of nutraceutical start-up Xantus Life Sciences.
Currently, vitamins and minerals in doses above 1 RDA or the upper limit are considered medicines.
However, there are exceptions for Foods for Special Medical Purposes (FSMP) and Foods for Special Dietary Uses (FSDU).
According to FSSAI, for example, FSMP products may contain nutrients at levels above the RDA but not exceed the limits for vitamins and minerals specified in Schedule III of the Dietary Supplements Regulations.
There has been a surge in FSMP and FSDU applications and greater expertise is required to investigate this area, Dr Vaibhav said.
For example, doctors on the scientific committee formed to evaluate these uses raised concerns about hypervitaminosis (abnormally high store levels of vitamins).
“The scientific committee will look at the data that the companies have submitted about their specific levels. At the same time, there are doctors on the committee who suggest that vitamin hypervitaminosis is also a big problem.”
“The authorities have made it clear that the regulations need to be revisited and we need to see whether it makes sense to leave the issue entirely to the food authorities or whether it can be transferred to DCGI. Discussions are still on in that regard.” He said.
Other reasons for DCGI’s involvement include enforcing GMP, hygiene and safety standards for pharmaceutical companies that also manufacture nutraceuticals in their own facilities. One of the objectives is to ensure that nutraceuticals are not contaminated with pharmaceutical substances during the manufacturing process.
Asked about the timeline, he said the extent to which discussions and changes are pushed forward will depend on how keen the minister is to push the initiative forward.
Nutrients – Asia DCGI has been contacted for a comment.
All dietary supplements should come under the supervision of food regulatory authorities – HADSA
In this case, HADSA is of the view that all dietary supplements should continue to be overseen by FSSAI.
The company sits on a committee looking at why dietary supplements should come under the purview of food regulators.
They also evaluate foods for potential illness or reduced-risk claims and enforce Good Manufacturing Practices (GMP).
The committee is made up of former government officials, private companies and research institutions.
Dr Vaibhav said HADSA is of the view that dietary supplements, even those that exceed the recommended daily intake or upper limits, should be regulated by the FSSAI to encourage innovation.
“Many in the industry feel that if regulatory control of nutraceuticals comes under the purview of DCGI, the growth rates I have mentioned may not materialise or may decline,” he said. He said.
He also pointed to concerns about price controls in the pharmaceutical industry.
“If dietary supplements were subject to price controls, this would automatically discourage many companies as they would no longer be able to make the profits they would like to make, and this could stifle innovation.”
“In a way, it may slow down the growth of our industry. So, if we are to shift nutraceuticals under DCGI, all these points need to be taken into consideration so that the blow to the industry is minimal.”
“We want to protect our nutritional supplement innovation, but are happy to discuss other possible arrangements.”
The Indian nutraceutical industry has expanded rapidly over the past decade.
The market size is currently over $5 billion and is expected to grow by 22-25% over the next 1-2 years.
“By the end of 2025 or early 2026, the nutraceutical market size is expected to touch USD 18 billion. Globally, India’s market share will grow from 2% to 3.5% in just a few years.” Dr Vaibhav said.
