The Food Safety and Standards Authority of India (FSSAI) regulates the import, manufacture, and sale of nutraceuticals in India under the Food Safety and Standard Act 2006. FSSAI requires licenses for all parties involved in the food sector and has established regulations for product evaluation, analysis, health claims and other aspects of importing, manufacturing and selling nutraceuticals. Licenses include basic registration for small retailers, state licenses for medium businesses, and central licenses for large manufacturers. FSSAI regulations aim to standardize and ensure safety of the nutraceutical industry in India.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
This presentation contains the legal or regulatory aspects of nutraceuticals Nutraceuticals first coined by Stephen De Felice, Founder and chairman of Innovation in medicine.
Regulatory aspects of nutraceuticals in India governed by FSSAI
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
Nutraceuticals have been gaining importance to combat the associated life style diseases. That's added a new expansion business of the Pharmaceutical Industry.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
This presentation contains the legal or regulatory aspects of nutraceuticals Nutraceuticals first coined by Stephen De Felice, Founder and chairman of Innovation in medicine.
Regulatory aspects of nutraceuticals in India governed by FSSAI
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
Nutraceuticals have been gaining importance to combat the associated life style diseases. That's added a new expansion business of the Pharmaceutical Industry.
the overall summary of regulation of herbal drugs in India and what document required for getting approval and summary of GMP, GCP guideline with labelling requirement.
Regulatory requirements for herbal medicines: Herbal medicines are different from other types of medicines. The approval process is also different from other medicines. AYUSH Ministry given guidelines for approval of herbal medicines.
Query Solved
1. Regulatory requirements for herbal medicines
2. Herbal Medicines ke liye regulatory requirements
3. AYUSH ka important role in Herbal medicines launch
4. D and C act role in Herbal medicines
5. What are important steps to launch herbal medicines
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
presentation about Nutraceutical
The term “nutraceutical” combines the word “nutrient” (a nourishing food or food component) with “pharmaceutical”(a medical drug). The word “nutraceutical” has been used to describe a broad list of products sold under the premise of being dietary supplements (i.e. a food), but for the expressed intent of treatment or prevent of disease.
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
Presented by A.K. Singla to the ILRI workshop on safety of animal source foods with an emphasis on the informal sectors, New Delhi, India, 8 February 2011
the overall summary of regulation of herbal drugs in India and what document required for getting approval and summary of GMP, GCP guideline with labelling requirement.
Regulatory requirements for herbal medicines: Herbal medicines are different from other types of medicines. The approval process is also different from other medicines. AYUSH Ministry given guidelines for approval of herbal medicines.
Query Solved
1. Regulatory requirements for herbal medicines
2. Herbal Medicines ke liye regulatory requirements
3. AYUSH ka important role in Herbal medicines launch
4. D and C act role in Herbal medicines
5. What are important steps to launch herbal medicines
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
presentation about Nutraceutical
The term “nutraceutical” combines the word “nutrient” (a nourishing food or food component) with “pharmaceutical”(a medical drug). The word “nutraceutical” has been used to describe a broad list of products sold under the premise of being dietary supplements (i.e. a food), but for the expressed intent of treatment or prevent of disease.
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
Presented by A.K. Singla to the ILRI workshop on safety of animal source foods with an emphasis on the informal sectors, New Delhi, India, 8 February 2011
Food Safety and Standards Authority of India is a statutory body established under the Ministry of Health & Family Welfare, Government of India. The FSSAI has been established under the Food Safety and Standards Act, 2006, which is a consolidating statute related to food safety and regulation in India.
-The Central Drug Standard Control Organization (CDSCO) is the main regulatory body of
India for regulation of Pharmaceutical, medical and clinical trials.
➢ The head office of CDSCO is located in New Delhi and it is functioning under the Control
of Directorate General of Health Services, Ministry of Health and Family Welfare,
Government of India.
➢ The CDSCO works with the World Health Organization to promote Good Manufacturing
Practice (GMP) and international regulatory harmony.
➢ It is the central drug authority for discharging functions assigned to the Central Government
under the Drug and Cosmetics Act.
Using versatile analytical techniques for complying with FSSAI, Food Safety a...Saurabh Arora
This presentation describes the regulatory requirements for food testing under the Food Safety and Standards Act. 2006 and Food Safety and Standards Regulations 2011. It also covers the various analytical techniques which can be used to meet the requirements.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
2. 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.”
2
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
3. 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.
4. REGULATORY AUTHORITY
4
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
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
5. 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.
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
5
6. 6
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
Benefits of the FSSAI
Alignment of international regulations
Science-based standards
Clarity and uniformity on novel food areas
Help to curb corruptions
7. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
7
Regulatoryrequirementsfor entryin India
Product
evaluation.
Product
Analysis.
Licenses
Health and label
claims
8. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
8
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.
9. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
9
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.
13. 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.
14. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
14
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
15. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
15
APPROVAL PROCESS FOR SITE REGISTRATION AND
MANUFACTURING LICENSE
17. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
17
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
18. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
18
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
19. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
19
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.
20. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
20
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.
21. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
21
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.
22. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
22
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
23. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
23
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
24. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
24
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.
25. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
25
STATUTORY FEES
FEESTRUCTURE FOR CENTRAL LICENSE
26. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
26
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
27. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
27
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
28. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
28
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
29. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
29
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.