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Guidelines for mfg & marketing of dietary supplements, nutraceuticals to be issued soon
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Suja Nair Shirodkar
April 28 , 2015
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Task force constituted by the food safety authority to regulate category
of special food items like nutraceuticals and dietary supplements
submitted their recommendations to the Food Safety and Standards
Authority of India (FSSAI) last week. The recommendations basically
comprises of guidelines for the approval of dietary supplements and
nutraceutical products that are manufactured and marketed throughout the
country.
It is understood that the seventeen-member team had
submitted the recommendations based on a detailed study conducted on the
market in consultation with all the stakeholders. It basically
highlights the key regulatory requirements that need to be implemented
to regulate this huge market. Once these recommendations gets the nod
from the FSSAI, all the manufacturers in the country falling under this
category will have to get a no objection certificate (NOC) and approval
from the centre prior to manufacturing and marketing the products.
Dr
Koshia commissioner of Gujarat FDCA who was the part of this task force
informed that the aim behind coming out with these recommendations was
to bring in a regulatory semblance to this highly unregulated segment,
especially considering the adverse health implications it may have on
people if left unchecked.
At present, India does not have any
kind of regulatory guidelines for the approval or monitoring of the
products under this segment. Interestingly, a lot of ayurvedic products
in the country, are sold as nutraceuticals or dietary supplements.
Experts state though there is currently no fixed statistics to show the
size of the market, the scope of the same is huge as it is basically a
direct to consumer segment.
“Implementing these guidelines will
not only help in effectively regulating the market but also maintain a
proper data on the same, which is not the case today. In the recent
past, there has been an increase in the incidents of misuse or improper
manufacturing conditions. Considering the huge health risks it can pose
to the consumers it is high time to concentrate on having an ideal
approval policy that will ensure proper compliance of manufacturing of
all the products that are available in the market,” informed Dr Koshia.
It was in this light that the Centre has constituted the task force
over two and a half month back.
Highly placed sources from the
Centre informed that this move will help in checking a lot of activities
that go unaccounted in the country as of now. It has been observed by
experts that a lot of Ayush products are currently sold under this
segment directly to the consumers. Some cite that certain products
especially those that claim to aid health benefits to the consumers,
having ingredients which usually need to undergo stringent approval
process under the drugs and cosmetics act gets easily available in the
market as a dietary or nutraceutical product.
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