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 to address regulatory challenges and promote consumer safety, according to officials.
Pradip Chakraborty, former director at the FSSAI told us, that the development had been hotly debated among industry players.
He said that most companies he spoke with were concerned with the move, as the first set of nutraceutical regulations only came to fruition after years of deliberation, and to change hands could bring uncertainty to the industry’s growth and development.
“Companies that I have spoken with were actually scared of this development…If something new comes along, it will take some time, at least five to six years for a smooth transition and the industry could be in trouble, because nobody knows what is going to happen. There is uncertainty and you do not know what the outcome would be,” he said.
India only managed to introduce its first set of nutraceuticals regulations eight years ago known as the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations or the FSS Regulations 2016. The FSSAI later operationalised a new set of regulations in 2022.
Sandeep Gupta, chief founder and director of the Expert Nutraceutical Advocacy Council (ENAC), is also not supportive of moving nutraceuticals under the control of CDSCO.
He said that there has been a lack of interaction between the government and industry over the latest developments, saying that the government had “taken the decision (of forming the panel and conducting the review) in isolation.”
Moreover, moving nutraceuticals under the purview of CDSCO could be a fatal move for the industry, he said.
“If nutraceuticals were to come under the purview of the CDSCO, this industry will die.
“This is because whatever efforts that the food business operators have brought in for the growth, expansion, and the innovation to bring the best of products into this country and to make the best of innovation through their research, will all go into the drain.
“The industry will become very conservative, thereby impacting the economics of the industry, and leading to the loss of jobs and layoffs, because this will curb the growth and expansion of the industry, which I feel will be a very negative impact.”
He believes that the government and the panel should involve the “right experts”, including the FSSAI and standard review groups.
“I believe both the government and the industry should come together to discuss and deliberate, understand the background of what has been designed so far for nutraceuticals regulations and to understand what kinds of value these regulations can bring in and put India on a global map.”
Chakraborty added that the Health Foods and Dietary Supplements Association (HADSA) would be discussing the topic in its upcoming meeting next month. Following which, its meeting minutes would be circulated to the ministries involved, Federation of Indian Chambers of Commerce and Industry (FICCI), and the Confederation of Indian Industry (CII).
Long process and extra burden to CDSCO?
Moving nutraceuticals under the ambit of CDSCO is going to be a long-term process and this could be lengthened by the upcoming general elections to be held in April or May, said Chakraborty.
“At this stage, no government will take any decision because the new government will have to take that decision and this will take some time,” he said.
Even without the elections, the usual protocol would require the panel to submit their recommendations that will be put to the Ministry of Health, Prime Minister Office, and subsequently for public consultation and parliamentary debate.
He also noted that CDSCO already has its own sets of issues to handle, and it would be a “very bad move” to let them take charge of nutraceuticals regulatory oversight, as this is going to be an “extra burden” for them.
Non-alignment with global standards
On the other hand, putting FSSAI in charge of nutraceuticals regulations will be more aligned to global standards, as seen in the case of the EU and US, where food regulators are responsible for nutraceuticals.
“Health supplements are regulated in many parts of the world through the food authority, such as Health Canada, US Food and Drug Administration, and EFSA (European Food Safety Authority). We need to think of converging with the other international regulators,” said Chakraborty.
He said that it would be advisable for FSSAI to communicate with the industry body if there’s problems in the interpretation or implementation of regulations.
However, he also noted that there could be officials within the FSSAI that would want to relinquish their control of nutraceuticals, due to a lack of technical expertise and understanding of the nutraceutical regulations.
“We have such a beautiful [nutraceutical] regulation and we should be very proud to have it. [We should develop them] in such a manner [to allow] industry to bring more innovation, and bring the best products to the market in the interest of public health,” added Gupta.
What could be the reasons for the review?
While the actual reasons for the review are unclear, Gupta believes that exaggerated health claims by companies and quality issues could have played a role.
Another reason could be due to the overlap of clause 21 of the FSS regulations and schedule V of The Drugs and Cosmetics Rules concerning the use of patent or proprietary medicines containing vitamins for prophylactic, therapeutic, or paediatric use.
“There are two perspectives to this. If there is concern on the overlap between clause 21 of the FSS regulations with schedule V of The Drugs and Cosmetics Rules, then the CDSCO will need to revisit and revise the levels of prophylactic, therapeutic levels, or eliminate the prophylactic levels, and this will clear all the confusion between the FSSAI and the CDSCO,” he said.
As for overclaims and quality issues, he believes that FSSAI could design stricter regulations to combat the issue, as well as to train food safety officers in having better skills to test product qualities.
