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Govt to amend Schedule V of Drugs and Cosmetics Act to clear confusion between vitamins and drugs
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Shardul Nautiyal, Mumbai
September 28 , 2017
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Government is mulling over to amend Schedule V of the Drugs and
Cosmetics Act, 1940 to clear the confusion between dietary supplements,
multi-vitamins and drugs. However, submissions made by the industry 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).
As of
today, Schedule V under the Drugs and Cosmetics Act covers proprietary
medicines and patented drugs. Schedule V stipulates standards for patent
or proprietary medicines, containing vitamins for prophylactic,
therapeutic or paediatric use. As per the standards, it shall contain
the vitamins in quantities not less than and not more than those
specified in single or in two divided daily doses.
This comes at a
time when Central Drug Standards Control Organisation (CDSCO) has
formed a high level committee of subject matter experts to frame an
exclusive schedule of over-the-counter (OTC) drugs.
A high level
joint committee comprising of experts from Central Drugs Standard
Control Organisation (CDSCO) and the Food Safety and Standards Authority
of India (FSSAI) had also been set up to classify products as
‘nutraceutical’ or ‘drug’, the case which is now being referred to
Director General of Health Services (DGHS) for further review in the
wake of some pharmaceutical firms marketing drugs as food supplements to
evade price control.
The committee was formed to address
borderline issues with claims that multi-vitamin products are not
properly labelled. This was also aimed at determining 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.
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
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.”
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TOPICS
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