Nutraceutical or a drug
Dr KK Aggarwal
President CMAAO and HCFI
Experts from Central Drugs food Standard Control Organisation
(CDSCO) and the Food Safety and Standards Authority of India (FSSAI) are
debating how to decide a product as a drug or food. Most companies like to
launch a food supplement to escape the price control.
The blurred line between drug and supplements surfaced in
2009 when the drug price regulator National Pharmaceutical Pricing Authority
(NPPA) said that pharma firms are marketing drugs as food supplements to escape
the price control.
The joint expert committee of CDSCO and FSSAI formed is
meant to ascertain whether the products and ingredients marketed are labelled
on the basis of their intended effects on the human body and further to be
classified as drugs, vitamins or food.
Submissions be experts say that vitamins need to be allowed
both in health and nutritional supplements if they are
within the recommended dietary allowance (RDA) stipulated by Indian Council of
Medical Research (ICMR).
It further elaborates that the issue is more of recognizing
RDA as the basis and not the ceiling in daily intakes of nutrients.
The submission recommends that vitamins should be allowed
both in food as well as drug, depending on the dosages employed. [Pharmabitz]
