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…

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

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.

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.

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

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…