Nutraceuticals ppt (1)

FSSAI REGULATIONSFOR THEIMPORT,
MANUFACTUREANDSALEOF
NUTRACEUTICALSIN INDIA
Sai sree
I/II M Pharmacy; Regulatory Affairs
Under the guidance of :
KOUSHIK YETUKURI M Pharm (PhD
student)

WHAT ARE
NUTRACEUTICALS?
 The term “nutraceutical” combines two words –“nutrient” (a
nourishing food component) and “pharmaceutical” (a medical
drug).
 Stephen DeFelice, defined “nutraceutical” as “a food or part of
food that provides medical or health benefits including the
prevention and treatment of disease.”
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CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES

The Food Safety and Standards Authority of India (FSSAI)
3CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
 India has recently passed the Food Safety and Standard Act 2006, under this act The
Food Safety and Standards Authority of India (FSSAI) has been established. It is a
modern integrated food law to serve as a single reference point in relation to
regulation of food products including nutraceutical, dietary supplements and
functional food.

REGULATORY AUTHORITY
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 Ministry of Health & Family Welfare, Government of India is the Administrative Ministry for the
implementation of FSSAI.
 The FSSAI has its headquarters at New Delhi.
 The current Chairperson for FSSAI - RITA TEOTIA
 The current Chief Executive Officer for FSSAI - PAWAN KUMAR AGARWAL

 Food Safety and Standard Act 2006 consists of 12 chapters. Chapter IV, Article 22 of the act
addresses nutraceutical, functional food, dietary supplements and the need to regulate these products
such that anyone can manufacture, sell, or distribute or import these products.
 Everyone in the food sector is required to get a license or a registration that would be issued by local
authorities.
 The act provides for a graded penalty structure where the punishment depends on the severity of the
violation.
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Benefits of the FSSAI
Alignment of international regulations
Science-based standards
Clarity and uniformity on novel food areas
Help to curb corruptions

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Regulatoryrequirementsfor entryin India
Product
evaluation.
Product
Analysis.
Licenses
Health and label
claims

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IMPORT OF NUTRACEUTICALS
 No person shall import any unsafe or misbranded or substandard food.
 Foreign Trade (Development and Regulation) Act 1992
 All imports will come under Central Licensing.

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 The Central Licensing Authority has engaged the National Institute of Smart Government (NISG) under the
Ministry of Communications and Information Technology.
 NISG is assisting the central authority operationalize food import clearance, at 14 ports of entry.

CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES 1
IMPORT PROCEDURE

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CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES 13
MANUFACTURE
 FSSA, 2016 – Regulation that standardised manufacture of nutraceuticals.
 An FBO may manufacture nutraceuticals from food or non-food sources.
 Nutraceuticals manufactured should contain ingredients specified in Schedules.

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FSSAI Key Requirements for Manufacturing Nutraceuticals
FSSAI has standardized nutraceuticals so they may contain only any of the ingredients as specified in Schedule I or
Schedule II or Schedule IV or Schedule VI or Schedule VII or Schedule VIII of the Nutraceutical regulations.
Schedule I contains a list of Vitamins and minerals
Schedule II contains the list of essential amino acids and other nutrients
Schedule IV List of plant or botanical ingredients
Schedule VI List of ingredients as nutraceuticals
Schedule VII List of strains as probiotics (live micro-organisms)
Schedule VIII List of prebiotic compounds

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APPROVAL PROCESS FOR SITE REGISTRATION AND
MANUFACTURING LICENSE

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SALE OF NUTRACEUTICALS

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Licenses issued
by the FSSAI
– 3 types.
Central
License
State License
Basic
Registration
For sale of Nutraceuticals 3 types of licenses issued by the FSSAI

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1. FSSAI Registration Central License
 Major Manufacturers or FBO’s.
2. FSSAI Registration State License.
 Small to Medium sized manufacturers or FBO’s.
3. Basic Registration.
 Petty or very small sized manufacturers

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Central License (Large Food Business) Turnover More
Than 20 Crore
FSSAI Central License - For Turnover above Rs. 20 Cr in
Case of Manufacturing or Trading or Storage beyond certain
limited as specified by the law.

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State License (Medium Food Business) Turnover 12Lac To 20cr
FSSAI State License - For the food license, Business with turnover between
Rs. 12 Lac to Rs. 20 Cr. annually or/additionally. The turnover limit is the
same for an FSSAI State trading license or an FSSAI State Manufacturing
license.

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Basic Registration (Petty Food Business) Turnover upto 12Lac
Basic FSSAI Registration- Basic FSSAI Registration is required for petty food business
operators. It is also known as the Basic FSSAI License. The turnover of such business
should not exceed the limit of Rs. 12 lac per annum.
A petty retailer, hawker, vendor or temporary stall holder are examples of this category.

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DOCUMENTS REQUIRED FOR FSSAI REGISTRATION
For Obtaining an FSSAI Basic Registration
Photo Identity of FBO
NOC by
Municipality/Panchayat,
Health NOC
Pan card of FBO
Proof of possession of
business premises
Declaration about the
Business details in Form
A

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For Obtaining An FSSAI State & Central License
Form-B Duly completed and signed
Blueprint/layout plan of the processing unit
Form IX
NOCs from Municipality or local body
Source of milk and meat (If applicable)
Food Safety Management System plan and Recall Plan (If applicable)
Proof of possession of premises

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Additional Document for Central License
 Certificate from Ministry of Commerce and Industry, Department of Commerce
for 100% export oriented unit (EOU).
 Supporting document to show the proof of annual turnover.
 NOC document issued by FSSAI department.
 Import Export (IE) Code certificate issued by DGFT.

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STATUTORY FEES
FEESTRUCTURE FOR CENTRAL LICENSE

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Fee structure for State License
For New License
• 2000 to 5000 P.A
(State-wise
variation exists.
For actual fees,
you can make
inquiry from
FSSAI License
consultant)
For Renewal of
License
• Depends on
number of years
selected.
For Duplicate of
License
• 10% of license
fees is applicable

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Fees for Basic Registration
• INR 100/YearFor new registration
certificate
• INR 100/YearFor renewal of
registration certificate
• 10% of the applicable certificate
fee
For duplicate of
registration certificate

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PENALTY FOR NONCOMPLIANCE
PARTICULARS PENALTY
Penalty for sub-standard food. Up to 5 lakh INR
Penalty for misbranded food Up to 3 lakh INR
Penalty for misleading advertisement 10 lakh
Penalty for Food containing extraneous
matter
1 lakh
Food quality not in compliance with act 2 Lakh
Petty manufacturer – 25,000
Compensation in case for injury 1.00 lakh

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CONCLUSION
Although the Food Safety and Standard Act 2006 define functional food/ nutraceutical legally,
there are still further effective regulations; guideline and suitable protocols are required to gain
momentum for effective implementation across the nation. Still there is need to clarify and
formulate the regulatory framework. If substantiation effectively enforced the Food Safety and
Standard Act there is the potential to open up tremendous opportunity for the functional food or
nutraceutical industry.

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1. https://enterslice.com/fssai-registration
2. http://www.businesswindo.com/infocafe/howto-obtain-fssai-license
3. https://www.slideshare.net/SwapnilFernandes1/fssai-regulations-for-the-
import-manufacture-and-sale-of-nutraceuticals-in-india-recommended-
dietary-allowance-rda
4. https://www.researchgate.net/publication/279058372_Nutraceutical_and_Fu
nctional_Food_Regulations_in_India
5. file:///C:/Users/.CLPT11/Downloads/Guidance_Document_Nutraceutical_18_
05_2018.pdf
REFERENCES

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