Sunday, December 02, 2012

Rise and Rise of the Indian Nutra Market

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.

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.