India has passed the FSS Act in 2006, under this act FSSAI has been established

1. UNIT-III (MRA204T)
REGULATIONS FOR IMPORT, MANUFACTURE AND
SALE OF NEUTRACEUTICALS IN INDIA
Presented by:
Ms.Bhanu Mounika
Reg. No.: 222310
I. M. Pharmacy
Shri Vishnu College of Pharmacy
Under the Guidance of:
Dr. Lakshmi Prasanthi Nori
Professor
Department of Regulatory Affairs

2. INTRODUCTION
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.”

3. THE FOOD SAFETY AND STANDARDS
AUTHORITY OF INDIA (FSSAI)
India has passed the Food Safety and Standard Act 2006, Under this act The Food Safety
and Standards Authority of India (FSSAI) has been established.
FSSAI has been created for laying down science based standards for articles of food and to
regulate their manufacture, storage, distribution, sale and import to ensure availability of safe
and wholesome food for human consumption.
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.

4. The Food Safety and Standard Act of 2006 emphasizes the necessity to regulate
nutraceuticals, functional foods, and dietary supplements so that anyone can
manufacture, sell, distribute, or import these products
The nutritional supplements should follow all Food Safety Regulations, 2011
standards for residues, toxins, and contaminations
To operate a nutraceutical organization, the company owners must obtain a
license from the producers specified by the Food Safety and Standards Regulations
of 2011.

5. REGULATORY REQUIREMENTS FOR
ENTRY IN INDIA
Product
evaluation.
Product
Analysis.
Licenses
Health and label claims

6.  No person shall import any unsafe or misbranded or substandard food.
 Foreign Trade (Development and Regulation) Act 1992.
 This act was adopted to provide for the development and control of foreign
commerce by facilitating imports into India
IMPORT OF NUTRACEUTICALS

7.  NISG is assisting the central authority operationalize food import clearance, at 14
ports of entry.
The Central Licensing Authority has engaged the National Institute of Smart
Government (NISG) under the Ministry of Communications and Information Technology.
As per India Import data, Nutraceutical import shipments in India stood at 1.1K,
imported by 85 India Importers from 157 Suppliers.
India imports most of its Nutraceutical from United States and Russia is the largest
importer of Nutraceutical in the World.
The top 3 importers of Nutraceutical are India with 1,150 shipments followed
by Myanmar with 713 and Sri Lanka at the 3rd spot with 601 shipments.

8. IMPORT PROCEDURE

11.  FSSAI – Regulation that standardised manufacture of 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.
 Neutraceuticals should be manufactured should contain ingredients specified in
schedule
MANUFACTURE

12. 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

13. APPROVAL PROCESS FOR SITE REGISTRATION AND MANUFACTURING LICENSE

14. Licenses issued by
the FSSAI
– 3 types.
Central
License
State License Basic Registration
SALE OF NUTRACEUTICALS
For sale of nutraceuticals 3 types of licenses issued by the FSSAI

15.  FSSAI Central License (Large Food Business) – Turnover above Rs.20Cr in
case of manufacturing or trading.
FSSAI State License (Medium Food Business) – Turnover between Rs.12 Lac
to Rs. 20 Cr annually/additionally. The turnover limit is same for FSSAI State
trading license or FSSAI State Manufacturing license.
Basic FSSAI Registration (Petty Food Business) – Turnover upto 12Lacks
It is also known as Basic FSSAI License. The turnover of such business should
not exceed the limit of Rs.12 lac per annum.

16. 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
For Obtaining an FSSAI Basic Registration
DOCUMENTS REQUIRED FOR FSSAI REGISTRATION

17. 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

18. 1. Write about Import of Neutraceuticals and it’s Procedure?
2. Write about the Approval Process for site registration and Manufacturing License ?

19. 1. Overview of Dietary Supplements Merck Manual Professional version By Melissa G.
Marko, Ph.D., Senior Clinical Scientist, Nestle Nutrition; Ara DerMarderosian, Ph.D.,
Professor Emeritus of Biology and Pharmacognosy, University of the Sciences.
2. Ganesh G.N.K, Ramachandran A, Suresh KR, Senthil V, BaviyaPriyadharshini R.
Nutraceuticals – A Regulatory review. International Journal of Drug Regulatory Affairs;
2015, 3(2), 22-29 ISSN: 2321 – 6794.
3. Food Safety and Standards Authority of India, Regulations, Notification on The
Gazette of India (2015).http://fssai.gov.in/home/imports/import-
regulations.htmlAccessed on January 2018
4. Namdeo Shinde, Bhaskar Bangar, Sunil Deshmukh, Pratik Kumbhar. Nutraceuticals:
A review on current status. Research J. Pharm. And Tech.
References

20. 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.