The document discusses regulation and marketing of nutraceuticals in India. It notes that the nutraceutical market in India was worth Rs 18.75 million in 2008 and is growing at 21.23% annually. Key drivers of growth include increasing affluence, awareness, and accessibility of products. However, the regulatory framework and lack of credibility present impediments. The Food Safety and Standards Authority of India regulates nutraceuticals and requires licenses, product evaluation, and India-specific health and label claims for market entry. Globalization presents challenges due to regulatory variance between countries.

1. Regulation and Marketing of nutraceuticals
Submitted to : Mr. Rahul Thory
Submitted by : Pritika (14msft01)

2. Nutraceuticals
• The term nutraceuticals is a hybrid or
contraction of nutrition and pharmaceutical
reportedly, it was coined in 1989 by DeFelice.
• Any substance that may be considered a food
or part of a food and provides medical or
health benefits, including the prevention and
treatment of disease. Such products may
range from isolated nutrients, dietary,
supplements and diets to genetically
engineered ‘designer’ foods, herbal products,
and processed foods such as cereals, soups,
and beverages.”

3. Market of nutraceuticals
• In 2008 ,the Nutraceuticals market in India
was Rs 18.75 million.
• It is growing at CAGR of 21.23%.
• India’s nutritional supplement market is
expected to more than double to Rs 9,500
crore by 2013.

4. Drivers for growth of Nutraceuticals
• Affluence of working population with
changing lifestyles.Affluence :
• Reducing affordability of sick care,
driving consumers towards wellness.Affordability
• Increasing physician awareness and
media penetration.Awareness
• Increased accessibility due to
emergence of new channels.Accessibility

5. Critical impediments for
nutraceuticals
• Regulatory framework
• Resources of enforcement
• Lack of credibility
• Prices of nutraceuticals

6. FSSA & Nutraceuticals
• Chapter IV section 22 of the act addresses
nutraceuticals, functional foods, dietary
supplement.
• Acc. To it “ foods for special dietary uses or
functional foods for nutraceuticals or health
supplements” means :

7. foods which are specially processed or formulated to
satisfy particular dietary requirements and the
composition of these foodstuffs must differ
significantly from the composition of ordinary foods
of comparable nature, if such ordinary foods exist .

8. Regulatory requirements for India
entry
• As the nutraceuticals regulation is evolving in India,
with FSSA getting recently
• implemented there is a possibility that some of the
content is conflicting / confusing, but for Indian
industry to take a shape, these have to be
streamlined.
• In order to enter Indian nutraceuticals market, some
of the very important areas
• to focus include product evaluation, actual product
analysis, procuring licenses
• and developing India specific health and label claims.

9. 1. Product evaluation
In Indian conditions, the formulations behave
very funnily and get mixed up in
classifications. Hence, the due-diligence in
terms of carving a specific amount for each
ingredient and the combination of ingredients
becomes very crucial.

10. The Food Safety and Standards Rules, 2011
highlights regulatory enforcement
structure and procedures which Central
Government proposes to make. The
structure has a hierarchy from commissioner of
Food Safety to number of
officers like designated officer, food safety
officer, food analyst, etc. who will
be involved in the product analysis process at
different points.

11. Various steps in the product analysis include :
• Developing extracts of documents and
authenticating the same by concerned authority.
• Sample collection (in the presence of witnesses)
• Sample dispatch to concerned authority
(different process for bulk package and single
package)
• Food analysis
• If analysis is not complete within stipulated
period of time, further action plan by designated
officer
• Adjudication proceedings (holding enquiry,
appeal procedure, hearing, etc.)

12. 2. Licenses
Though new FSSA promises to simplify Licensing and
Registration processes for nutraceuticals, the actual
process vary depending on number of parameter
To get the product registered in India, number of
licenses (almost 4-5)will be required depending on the
actual product status like -
• Whether company wants to sell bulk drug or finished
formulation
• Whether company is importing finished product or
bulk ingredient?
• Whether product to be imported is with or without
India specific label and will the claims be developed in
India?

13. • Whether the company has packaging license?
• Whether it requires manufacturing license?
• Whether it requires marketing license?

14. 3. Health and label claims
• Developing health and label claims specific to Indian
regulatory guidelines is the major element to be
focused while entering Indian market.
• International as well as national clients have number
of questions about
• Indian labelling and packaging requirements
• Packing of consignment
• Need for sample material and declaration for
registration
• Composition of consignment and approach for the
same
• Label contend
• Structure-function claim and label claim

15. conclusion
Globalization of the nutraceuticals and
functional food industry presents
significant challenges to stakeholders, not the
least of which is the regulatory
variance between countries active in the
marketplace. Nutraceuticals are
playing crucial role in developments of future
therapeutics but it depends on
control of purity, efficacy and safety.