Nutraceutical Product Development Challenges
                     CHALLENGES 
IN  INDIAN  
NUTRACEUTIC
AL  PRODUCT  
DEVELOPMENT
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, 
FoodResearchLab  Group: www.foodresearchlab.com
Email: [email protected]
TOPIC 
DISCUSSION
Introduction
Nutraceutical Product  
Development 
Challenges
Solutions
Introductio
n
Nutraceutical product development has numerous benefits 
but  still faces many challenges in India, and the food research 
lab  intends to address these issues.
Nutraceutical formulations are thought to provide 
physiological  benefits or immunity against subsequent 
diseases such as stress,  cardiovascular disorders, diabetes, 
cancer, Parkinson's and  Alzheimer's, neurological, pulmonary 
and respiratory disorders,  and may act as 
immunomodulators.
Contd...
Although it may be simple for a nutraceutical product  develo
pment contract R&D to create pharmaceutical tablets,  
powders, capsules, suppositories and so on incorporating 
bioactive  food, obtaining sufficient bioavailability for such 
nutraceuticals is  extremely difficult.
Nutraceutical product development and functional meals 
with  different characteristics have the potential to 
provide unique  goods to the globe at large.
Contd...

Nutraceutical formulations experience many problems 
that limit  their efficacy.
Better-characterized and research-proven goods made 
by  nutraceutical contract manufacturing will assist in 
boosting  customer confidence in nutraceutical and 
functional food items  worldwide.
Nutraceutical Product Development 
Challenges
Nutraceuticals appear to be distinguishable from 
functional foods  in a variety of ways that challenge the 
regulatory ideas of food and  pharmaceuticals.
There are two obvious concerns to the nutraceutical 
formulation  industry: regulatory uncertainty and the 
trustworthiness of  labelling claims. Regulatory 
ambiguity arises both nationally,  providing the 
regulatory quagmire in which the nutraceutical  
contract manufacturing are now surviving, and in 
export markets  due to a lack of international 
agreement on how to label  nutraceuticals.
Contd...
Several plants have varying degrees of the same 
medicinal activity.  For example, more than 100 plants 
have been found to have anti-  diabetic or hypoglycemia 
effects in India.
Nutraceutical contract manufacturing companies 
delays in  identifying such compounds due to lack of 
communication and  indigenous knowledge.
The limited solubility, stability, and permeability of the 
bioactive  component in the gastrointestinal tract 
frequently jeopardise  bioavailability
Contd...
Curcumin, for example, has low oral bioavailability due 
to shallow  blood levels, restricted tissue distribution, 
apparent quick  metabolism, and a short circulation 
half-life.
Another example is probiotics encapsulation technology 
(PET),  which has recently been developed as a 
mechanism for probiotic  delivery. Biomaterial selection, 
solvent type, and toxicity are all  factors that 
contribute to cell survival.
The selection of appropriate technology is 
critical in the  formulation of probiotics.
Contd...
Drug delivery refers to the process of efficiently 
and safely  introducing an active medicinal 
component into the body.
The introduction of innovative delivery systems into 
the  nutraceutical sector has been delayed due to 
their complexity,  high cost, and time consumption.
As a result, conventional forms have been utilised for 
many years,  yet, as previously stated, they have several 
flaws. Nutraceutical  contract manufacturing and 
nutraceutical product development  dwells under this 
issues.
Contd...
Traditional herbal dosage formulae have been created for many years. Permeation 
enhancers,  surface modifiers, prodrugs, colloidal lipid carriers, and other new carriers, for 
example, have been  created.
The inherent powderiness of free phytosterols due to their crystalline form is another 
problem for  food ingredient manufacturers. The particle size of solid components has a 
significant impact on  organoleptic characteristics of meals such as taste and feel.
Insoluble particles may contribute grittiness and coarseness, which contribute to the 
overall  mouth-feel of meals.
Contd...
One difficulty that has been overlooked is raising public awareness about the need of 
making  healthy eating choices.
Individual choosing is the single most important driving element in the food souk's 
expansion. It is  now possible to assume that individual customers eat what they choose.
Solutio
ns
The worldwide approach to 
nutraceutical
regulation and marketing is very 
diversified.
This is mostly due to the difficulties in  
classifying such items, the lack of an  
adequate regulatory class for these 
hybrid  products, and varying perspectives 
on what is  regarded to be sufficient 
scientific proof to  conclude their 
functionality.
Contd...
The unified approach to breaking this barrier can help create a universally acceptable 
definition.  India recently put its definition on the FSSAI site, and the FDA and EU have 
bought in their  regulatory changes.
When the ethnobotanical method is used for drug development, information available 
from  traditional knowledge holders is shared.
Respecting the intellectual property rights of a certain cultural group, tribe, or local people in 
a  place where plants are harvested based on their ethnomedical expertise is vital.This can 
help lead  to understanding more and extracting the right and new sources.
Contd...
The introduction of nanotechnology for pharmaceutical uses 
has  created a new route for improving the stability, solubility, 
or  permeability of problematic nutraceuticals.
The purpose is to promote health and wellness as people's 
average  ages increase.
The addition of generics into the market may reduce the price 
of a  few nutraceuticals, but people's reliance on such goods 
and their  expanding reach indicate that market growth will 
remain constant.
Conclusio
n
The global use of nutraceuticals is 
quickly  increasing, owing to their 
stated safety and  efficacy.
The use of sophisticated nanosized 
drug  delivery systems as a 
platform for  nutraceutical 
composition has recently  gained 
popularity.
Contd..
.
This is inspired by the encouraging findings for the nutraceuticals evaluated in 
bioavailability,  safety, targeting, and stability.
As a result, numerous drug delivery methods, such as nanoparticles, liposomes, 
dendrimers,  phytosomes, nanoemulsions, and others, were developed.
However, there are several obstacles associated with nutraceutical formulation regarding 
efficacy,  safety, and regulatory compliance.
Concerned institutions have not identified a worldwide definition. Globally, regulatory 
agencies  have not been established to control and regulate nutraceuticals.
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