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]