|
Controversial issue of classifying products as ‘nutraceutical’ or ‘drug’ referred to DGHS for further review
|
|
Shardul Nautiyal, Mumbai
July 04 , 2017
|
|
|
The highly controversial issue of classifying products as
‘nutraceutical’ or ‘drug’ in the wake of some pharmaceutical firms
marketing drugs as food supplements to evade price control has finally
been referred to the Director General Health Services (DGHS) for further
review.
Following review of the case by a high level joint
committee comprising experts of Central Drugs Standard Control
Organisation (CDSCO) and the Food Safety and Standards Authority of
India (FSSAI) to classify products as ‘nutraceutical’ or ‘drug’, the
ministry has finally referred the case to the DGHS for further review,
Drugs Controller General of India (DCGI) said.
There were some
borderline issues with claims that multi-vitamin products are not
properly labelled. In order to expedite the case, new experts were
subsequently appointed in the committees set up earlier to arrive at
science based evaluation.
However, experts from CDSCO and FSSAI
jointly reviewed the case on the long pending issue to help determine
efficacy of a product either as ‘nutraceutical’ or as ‘drug’. The
committee was formed to seek clarity whether the labelling on products
is a marketing gimmick or is proper as per the requirements for its
intended use to be defined as a drug or food.
A senior CDSCO official said that the regulatory authorities want a science based evaluation on the matter which is taking time.
DCGI
has also sought clarity on the matter with reference to examining the
validity of claims made on the labels of some vitamin supplements.
The
blurred line between drug and food 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 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.
The industry
says, “If vitamins are removed from health supplements, it will have
far reaching effects on the health of the consumers. The submission
recommends that vitamins should be allowed both in food as well as drug,
depending on the dosages employed.”
Submissions made by the
industry, however, 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.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|