Pharmacovigilance of Nutraceutical Products

Dr Aditya Kaushik

Head-Medical Governance & Regulatory Affairs

GlaxoSmithKline Consumer Healthcare Limited.

Fortunately, I got a very easy topic to discuss with

you as I could not find any thing which could be

called as concrete on this…

Nutraceuticals

Then… I came across a quote from

Hippocrates as below

Let food be thy medicine…

Background

The term "nutraceutical" was coined from

"nutrition" and "pharmaceutical" in 1989 by

Dr. Stephen DeFelice, MD, founder and chairman

of the Foundation for Innovation in Medicine

(FIM), Cranford, NJ.

According to Dr. Stephen…

'A nutraceutical is any substance that is a

food or a part of a food and provides medical

or health benefits, including the prevention

and treatment of disease.

Cont…

Such products may range from isolated nutrients,

dietary supplements and specific diets to

genetically engineered designer foods, herbal

products, and processed foods.

Sometimes also referred as Functional foods or

Dietary supplements

Ingredients of Nutraceutical Products

Vitamin & minerals

Antioxidants

Herbal/ Phytochemicals

Enzymes , Aminoacids

Probiotics / Prebiotics

Regulations on Nutraceutical Products

Ministry Of Health, Govt. Of India is currently

formulating Rules, which shall regulate

manufacture , sale and promotion of such

products.

Adverse Events with Nutraceutical Products

Now the question is…

Can Food and Food Supplements cause

Adverse Events?

The answer is not difficult…

Adverse Events with Nutraceuticals

Examples…

A consumer suffered from allergic reaction

including heavy sneezing after consuming a

Dietary Food Supplement.

Adverse Events with Foods

A consumer suffered from allergic reaction

including abdominal upset after consuming

Noodles preparation…

Investigation revealed that the consumers were

allergic to additives used in the Food preparations

and the adverse events were due to presence of

FLAVOR AND FLAVOR ENHANCERS used in

the products.

So, the answer is…

Adverse event with such products happen,

But, get reported less often

Pharmacovigilance for Nutraceuticals ?

So… What is the status?

At present, Nutraceuticals are not on radar of

Pharmacovigilance in any country including

India.

And the question to all stakeholders is…

Is it necessary to include Nutraceuticals for

Pharmacovigilance?

I think a debate and consensus between all

stakeholders would give us the right answer and

way forward…

Thank You…