The Indian Nutra market contributes 0.9% of the $117 billion
global Nutra market. Estimated at $1 billion and growing with a CAGR of
18%, it makes the Indian Nutra Market one of the fastest growing markets
globally. Since a while now regulations pertaining to Nutraceuticals were quite
unclear in most of the countries barring a few like US, EU and Japan who have
had a clear regulatory framework for nutritional supplements. The Indian
industry has now followed suit. The
Food Safety and Standards Authority of India (FSSAI) which has been
established under Food Safety and Standards Act, 2006 which consolidates
various acts & orders that have hitherto handled food related issues in
various Ministries and Departments. FSSAI has been created for laying down
science based standards for articles of food and to regulate their manufacture,
storage, distribution, sale and import to ensure availability of safe and wholesome food
for human consumption. "The
Food Safety and Standards Regulations, 2011” has been notified in the Gazette
of India dated 5th May 2011. With the implementation of these guidelines supplement
manufacturers would now have to comply with the Indian regulatory requirements
right from Product evaluation, to licenses, manufacturing & claims.
Sunday, December 02, 2012
Ongoing Clinical Trials at Vedic
Health Condition: Osteoarthritis
Sponsor Location: Hong Kong
Study: An exploratory, randomized, controlled, crossover study to
investigate the efficacy and tolerability of the novel investigational product
in patients with pain in the knee joint due to mild and moderate Osteoarthritis
Status: Study Start up
Phase
Health Condition: Blood Circulation
Sponsor Location: Hong Kong
Study: An exploratory, open-label, single arm study to assess the effect
of local application patch on blood circulation
Status: Study Start up Phase
Health Condition: Stem Cells Therapy in Type II Diabetes
Mellitus
Sponsor Location: India
Study: An open-label, single arm, prospective study to evaluate
the safety and efficacy of Allogenic stem cell transplantation as an adjunct to
exogenous insulin therapy in patients with type ii diabetes mellitus
Status: On Hold
Health Condition: NA (Healthy Volunteers)
Sponsor Location: United
States
Study: Assessment of the effect of herbal supplement on the levels
of circulating endothelial progenitor cells and hematopoietic stem cells in
human subjects
Status: Study Start up
Phase
60M NutrAssist Program
Product Development Process
has always been a challenge for innovator companies. With stiff market
competition and stricter regulations dietary supplement or nutraceutical
companies always want to be fully sure that their product development plan is
in accordance to the regulatory requirements of the land. Myriad costs crop up
from the word go in the product development process. Some companies would
resort to seek the right consultant to guide them in understanding and
following regulations. Finding such an expert in the supplement industry is not
only time-consuming but come with their own cost structures. This is a
compelling reason for companies to shy away from such consulting firms. A lack
of direction and no proper guidance often leads to a break in the product
development process. To combat such irregularities and challenges, Vedic offers
a unique opportunity to all supplement manufacturing/marketing companies who
want to make sure that the path chosen by their organization is going to
optimally help the product positioning into the markets.
Presenting 60M NutrAssist Program, the 60 minutes
FREE consultation given by Vedic Lifesciences Product Development Experts.
FDA enforcement: An injunction for disease claims
An Oregon herb and supplement manufacturer has been slapped with a permanent injunction for disease claims on products.
Claim substantiation is one of the major concerns in the
successful clinical development of a nutraceutical/ dietary product. It is a
critical component in the process as false or misleading claims made by
supplement manufacturers are subjected to judicial action. Often manufacturers
find themselves at crossroads due to their lack of knowledge of correct label
claims. They prefer to set these claims by relying on information which most of
the times may come in from dubious sources and try to avoid consultants who are
experts in the field. Result; Product Recall or in the above case a permanent
injunction. How do you avoid such a situation? First and foremost one needs to
identify the product correctly in accordance to the therapeutic benefits
accrued from its ingredients. An overzealous effort to claim what doesn’t exist
or relate to certain health conditions can even cause fatalities. Specific
Claims need substantiation and cannot be stated without clinical evidence.
Consult a right consultant with experience and expertise in the field of Nutra
product research. Such consultants will guide you in understanding your product
potential and will assist you in drawing up correct and relevant claims and
then substantiate the same. Vedic offers a simple and scientific environment to
substantiate your claims. Let us help you deliver your promise of good health.
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