These days, the demand for special food items like
neutratceuticals and dietary supplements has increasingly been
growing by leaps and bounds. The FSSAI had recently constituted
Task Force to device a regulatory framework for regulating
supply of these products in the market. Task Force's
recommendations primarily comprise guidelines for the approval of
dietary supplements and neutraceuticals that are manufactured
and marketed across the country. Once the recommendations get a nod
from the FSSAI, all the manufacturers across the country will have
to seek NOC from the Centre prior to manufacturing
PSA view - As of date, there are no laws to
regulate this segment of the market. A lot of incidents have been
reported regarding the adverse effects that the
"so-called" ayurvedic and Unani products have on people.
We are hoping that the new regulations have enough teeth to check
the capability of neutraceuticals' manufacturers who claim to
churn health related products. Since these products aren't
usually recommended by doctors and are purchased over the counter,
the constituency and effects/side-effects must be clearly written
on the packaging, as in case of allopathic drugs. As of now, let us
wait and watch!
mechanism programme for medical device industry to be introduced
The Union Health Ministry
("Ministry") as a step to regularize the
medical device industry has proposed to introduce the
Materio-Vigilance Programme of India
("MvPI") in 3 months to create a
mechanism ensuring safety of medical devices among the public. MvPI
programme will be specific to the medical device industry and is
intended to function in tune with the existing PvPI programme and
The Ministry wishes to kick-start the programme by setting up
MvPI cells in 10 medical colleges. The proposed programme primarily
focuses on creating a system for reporting medical device
associated adverse events, create awareness among the health care
professionals on reporting requirements, formulate system for data
collection and storage and provide a platform to stakeholders to
access to its recommendations.
PSA view - The Ministry's decision to
formulate a vigilance mechanism specific to medical device industry
is a step in the right direction. Lately, the Ministry has
introduced several amendments in the pharma related legislations to
promote and protect the medical device industry and hence, this
step to create strict reporting and vigilance mechanism will assist
in effective implementation of these legislation. Hence, the MvPI
programme is a welcome move.
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The food processing industry one of the largest industries in India is widely recognized as a 'sunrise industry' in India having huge potential for uplifting the agricultural economy, creation of large scale processed food manufacturing and food chain facilities, and the resultant generation of employment and export earnings.
One of the potential threats for manufacturing and sale of food/health supplements such as "Dietary food supplement", "Food supplements", "Nutritional supplements", "Health supplements", is its categorization in the category of "Food" or "Drugs", as there is a very thin line between "drugs/ medicines" and "nutritional supplements".
In its Cabinet Note in December, 2014, the Government of India proposed significant amendments to the Consolidated Foreign Direct Investment Policy, 2014 (''FDI Policy'') with respect to India's medical device industry.
Although in countries like the United States of America and New Zealand, drugs to be prescribed by medical practitioners are allowed to be advertised directly to consumers/patients and are regulated by the respective department of the Government in charge of drugs in the country, the same practice is not followed or encouraged in India.
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