Writing for NutraIngredients-Asia recently, Amit Srivastava, founder of the Nutrify India project, suggested the industry should come under the remit of the Ministry of Food Processing Industries (MoFPI)
He advocated a centralised ownership so that companies need not “run from ministries to ministries”, since the nutraceutical sector is currently under the charge of a number of ministries, including the FSSAI and Ministry of Health.
In his proposal, MoFPI would own and drive the nutraceutical sector’s development, including overseeing the biodiversity laws from the Ministry of Environment, Forest, and Climate Change (MoEF) and Natural Biodiversity Authority (NBA).
However, other industry players fear that placing the nutraceuticals sector under the remit of MoFPI would risk products being regarded as food for nutrition instead of products with specific health benefits.
Dilip Ghosh, the director of Nutriconnect and advisor to Mumbai-based Health Foods and Dietary Supplements Association (HADSA), voiced his disagreements, preferring the status quo, having consulted leading figures and academicians from the nutraceutical industry.
“MoFPI is more about addressing the technical issues and less so on the regulations. To put nutraceuticals under the purview of MoFPI would be counterproductive as it would tend to tackle nutraceuticals as food for nutrition instead of products providing specific health benefits which is what a nutraceutical product is about,” he said.
To let MoFPI govern nutraceuticals would mean that there is a constant need to regulate nutraceuticals health claims and an inter-ministerial team might be required for performing this particular function, which he believes is counterproductive.
The other alternative, he said, was to emulate the success of Pharmaceuticals Export Promotion Council of India (Pharmexcil) and develop a council for the nutra and ayurveda sector. The Pharmexcil was set up by the Ministry of Commerce and Industry.
The industry players on his camp include Dr CK Katiyar, who is the CEO Technical (Health Care Division) of health and wellness firm Emami Ltd and also sits on the editorial board of the Journal of Ethnopharmacology, Sanjaya Mariwala, MD at nutraceutical firm OmniActive, and ayurveda scientist Dr DB Anantha Narayan.
“Nutraceuticals fall between food and drug and therefore are always intended to claim certain health benefits.
“The examination of health benefit claims falls under the domain of FDAs worldwide as in the case of USFDA, Health Canada, and Australia's Therapeutic Goods Administration,” he said.
There are already ongoing suggestions on opening a special division termed “therapeutic nutraceuticals” within the Ministry of Health to focus on evidence-based nutraceuticals, he added.
Industry challenges
A number of factors plaguing India’s nutraceutical sector – which was officially recognised as a category only five years ago – has been identified.
One problem is the inter-ministerial tussle that has limited the types of ingredients – especially ayurvedic herbs – that could be used in nutraceuticals.
“One may ask, now that FSSAI has allowed use of ayurvedic herbs in nutraceuticals, why is it that the sector is not booming as expected?
“A reason is the inter-ministerial tussle between the FSSAI and the Ministry of AYUSH. While ayurvedic herbs have been permitted for use in nutraceuticals, it comes with the condition that they have to be used in the particular dose listed in schedule IV to make a health claim.
“But doing so means that the organoleptic characteristics of the ayurvedic herbs will go haywire,” Ghosh said.
On the other hand, India’s nutraceutical exports, including ingredients and formulation, are worth slightly lower than US$250m.
Asked the reasons behind low nutraceutical exports, he cited reasons such as the fear of non-compliance to laws of the importing countries, as well as the large amount of investment required to create manufacturing facilities that comply with the USFDA or Good Manufacturing Practice (GMP) standards.
Other factors include little knowledge of consumption habits in other countries and a lack of investment in quality testing labs.
Nonetheless, he believes that exports would increase in the years to come as new regulations are being passed.
“After the new regulation was published in 2017, there is significant improvement in manufacturing quality as well as investment in clinical trials.
“We all believe that within a few years, evidence-based nutraceutical product export from India would increase significantly,” he said.
