1. FSSAI issues regulations specifying permissible limits of
toxins in food
The FSSAI has issued a draft notification to amend the Food
Safety and Standards (Contaminants, Toxins and Residues)
Regulation, 2011. The proposed amendment specifies the permissible
levels of toxic metal contaminants including lead, arsenic, tin and
cadmium in food items by introducing the following entries against
each metal toxin/contaminant proposed to be regulated under the
This amendment comes with a view towards fixing the standards in
processed foods with presence of heavy metal contaminants in them,
especially in the backdrop of findings of lead beyond permissible
limits in the instant noodles Maggi, owned by Nestle Group.
PSA view: In light of the hue and cry over
hygiene levels pertaining to food processing and the monitoring of
contaminants in food products in the Indian market, this draft
notification is a much awaited step by the FSSAI towards
harmonizing the Indian food safety standards with the international
standards, like Codex.
2. FSSAI proposes rules on health supplements and
The FSSAI has recently issued a draft of Food Safety and
Standards (Food or Health Supplements, Nutraceuticals, Foods for
Special Dietary uses, Foods for Special Medical Purposes,
Functional Foods, and Novel Foods) Regulations, 2015
("Draft Regulations"). These Draft
Regulations have defined and classified Nutraceuticals, Foods for
Special Dietary Use, Foods for Special Medical Purposes, Foods
containing Probiotic Ingredients, Foods containing prebiotic
ingredients, Specialty Foods containing ingredients based on
Ayurveda, Unani and Siddha and Traditional Health Systems of India
and Novel Foods on the basis of essential composition, labeling,
usage of additives, contaminants and toxins, besides claims on
health and nutritional values. The Draft Regulations further
mandate manufacturers to label such foods as "food or health
supplement" and to prominently display on such labels, the
phrase "not for medicinal use", and specify the quantity
one must intake and that the product does not intend to cure any
disease etc. These labeling requirements are in addition to the
existing requirements under Food Safety and Standards (Packaging
and Labeling) Regulations, 2011.
PSA view: While separating items like health
supplements and nutraceuticals from medicines in terms of
classification may make it easier for the FSSAI to regulate the
manufacture, processing and sale of such foods, the additional
labeling requirements may complicate compliance for food business
operators who now have to comply with specific packaging and
labeling requirements for different food categories in addition to
the existing requirements under the Food Safety and Standards
(Packaging and Labeling) Regulations, 2011.
3. IPC makes ADR reporting easy
IPC has made a strategic move to promote involvement of the
healthcare professionals in strengthening the Pharmacovigilance
Programme of India. IPC has recently released suspected adverse
drug reaction ("ADR") reporting forms
for voluntary reporting of adverse drug reactions by healthcare
professionals. With this form, all healthcare professionals
including clinicians, dentists, pharmacists and nurses can report
ADRs to IPC. The form empowers healthcare professionals to notify
IPC which acts as the national coordination centre for the PvPI
programme of India on any suspected cases of ADRs. With this form,
healthcare professionals can report adverse reactions due to herbal
products as well as non-serious reactions too. The form so
collected shall be periodically forwarded to the global
pharmacovigilance database managed by WHO Uppsala Monitoring Centre
PSA view: It is high time that a mechanism is
devised wherein pharma covigilance is made mandatory on drug
manufacturers and doctors. The form is indeed a laudable step and a
welcome move as far as patient safety and drug monitoring is
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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".
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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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