1. Pharmacovigilance of Nutraceutical Products
Dr Aditya Kaushik
Head-Medical Governance & Regulatory Affairs
GlaxoSmithKline Consumer Healthcare Limited.

2. 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…

3. Let food be thy medicine…
Nutraceuticals
Then… I came across a quote from
Hippocrates as below
Let food be thy medicine…

4. The term "nutraceutical" was coined from
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.

5. 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.

6. Such products may range from isolated nutrients,
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

7. Ingredients of Nutraceutical Products
Vitamin & minerals
Antioxidants
Herbal/ Phytochemicals
Enzymes , Aminoacids
Probiotics / Prebiotics

8. Regulations on Nutraceutical Products
Ministry Of Health, Govt. Of India is currently
formulating Rules, which shall regulate
manufacture , sale and promotion of such
products.

9. Adverse Events with Nutraceutical Products
Now the question is…
Can Food and Food Supplements cause
Adverse Events?

10. The answer is not difficult…

11. Adverse Events with Nutraceuticals
Examples…
A consumer suffered from allergic reaction
including heavy sneezing after consuming a
Dietary Food Supplement.

12. Adverse Events with Foods
A consumer suffered from allergic reaction
including abdominal upset after consuming
Noodles preparation…

13. 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.

14. So, the answer is…
Adverse event with such products happen,
But, get reported less often

15. Pharmacovigilance for Nutraceuticals ?
So… What is the status?
At present, Nutraceuticals are not on radar of
Pharmacovigilance in any country including
India.

16. And the question to all stakeholders is… Is it necessary to include Nutraceuticals for Pharmacovigilance?

17. I think a debate and consensus between all stakeholders would give us the right answer and way forward… Thank You…