This presentation will give General overview about Indian Regulatory Requirements for cosmetics.
This ppt contains information about latest cosmetics rules 2020 and D& C Act 1940
Cosmetics regulatory: includes Regulatory provision relating to manufacture of cosmetics, Schedule M (II) of D & C rule 1945 deals with requirements for the factory premises for the manufacture of cosmetic, requirement of plant & equipment, conditions of licencing, regulatory provision on sale of cosmetics, loan licence, Regulatory provision relating to import of cosmetics, offences & penalties, List of amending Act and adaptation orders.
Penetration Enhancers in Transdermal Drug Delivery SystemSimranDhiman12
Penetration Enhancers in Transdermal Drug Delivery System
Permeation enhancers are substances that reduce the skin barrier's ability to make skin more permeable and allow drug molecules to cross the skin at a faster rate
advantages and disadvantages
types of penetration enhancers
techniques
physical and chemical enhancers
Cosmetics regulatory: includes Regulatory provision relating to manufacture of cosmetics, Schedule M (II) of D & C rule 1945 deals with requirements for the factory premises for the manufacture of cosmetic, requirement of plant & equipment, conditions of licencing, regulatory provision on sale of cosmetics, loan licence, Regulatory provision relating to import of cosmetics, offences & penalties, List of amending Act and adaptation orders.
Penetration Enhancers in Transdermal Drug Delivery SystemSimranDhiman12
Penetration Enhancers in Transdermal Drug Delivery System
Permeation enhancers are substances that reduce the skin barrier's ability to make skin more permeable and allow drug molecules to cross the skin at a faster rate
advantages and disadvantages
types of penetration enhancers
techniques
physical and chemical enhancers
Adhesion describes the attractive forces between a biological material and mucus or mucous membrane. 1. Mucous membranes adhere to epithelial surfaces such as the gastrointestinal tract (GI-tract), the vagina, the lung, the eye, etc. They are generally hydrophilic as they contain many hydrogen macromolecules due to the large amount of water (approximately 95%) within its composition. However, mucin also contains glycoproteins that enable the formation of a gel-like substance. 1. Understanding the hydrophilic bonding and adhesion mechanisms of mucus to biological material is of utmost importance in order to produce the most efficient applications. For example, in drug delivery systems, the mucus layer must be penetrated in order to effectively transport micro- or nanosized drug particles into the body. 2 Bioadhesion is the mechanism by which two biological materials are held together by interfacial forces.
Introduction-notes-classification-manufacturing process-outline-composition-sources of fragrances-EU Regulations for perfumes-natural and synthetic allergens to human
1. Structure of skin.
2. Skin relating problems :
a. Dry skin
b. Acne
c. Pigmentation
d. Prickly heat
e. Wrinkles
f. Body odour
3. Structure of hair.
4. Hair growth cycle.
Regulatory provision related to manufacture of cosmeticManish Rajput
cosmetic, regulatory provision, schedule M, condition of licence, schedule U, prohibition of certain cosmetics, misbranded and spurious cosmetics, loan licence, offences and penalties,
DATION OF EQUIPMENT ICH AND WHO GUIDELINES FOR CALIBRATION AND VALIDATION OF ...deepalisanap31
Introduction to equipment
Calibration
ICH guidelines for calibration of equipment
WHO guidelines for calibration of equipment
Example for calibration of UV
Validation
ICH guidelines for validation of equipment
WHO guidelines for validation of equipment
Example for validation of tablet compression machine
Myself Omkar Tipugade , M pharm , Shree Santkrupa College of Pharmacy , Ghogaon , Karad ( Maharashtra).
I upload the presentation on sun protection & type of Skin and sun screen agent depend on skin type , and also brief information about the cosmetic & cosmeceutical product.
NIOSOMES , GENERAL CHARACTERISTICS OF NIOSOME , TYPES OF NIOSOMES , OTHERS TYPES OF NIOSOMES , NIOSOMES VS LIPOSOMES , COMPONENTS OF NIOSOMES , Non-ionic surfactant , Cholesterol , Charge inducing molecule , METHOD OF PREPARATION , preparation of small unilamellar vesicles , Sonication , Micro fluidization , preparation of large unilamellar vesicles , Reverse Phase Evaporation , Ether Injection , preparation of Multilamellar vesicles , Hand shaking method , Trans membrane pH gradient drug uptake process (remote loading) , Miscellaneous method :Multiple membrane extrusion method , The “Bubble” Method , Formation of Niosomes From Proniosomes , SEPARATION OF UNENTRAPPED DRUGS , Gel Filtration , Dialysis , Centrifugation , FACTORS AFFECTING THE PHYSICOCHEMICAL PROPERTIES OF NIOSOMES , Membrane Additives , Temperature of Hydration , PROPERTIES OF DRUGS , AMOUNT AND TYPE OF SURFACTANT
Structure of Surfactants , Resistance to Osmotic Stress , Characterization of niosomes ,Therapeutic applications of Niosomes , For Controlled Release of Drugs , To Improve the Stability and Physical Properties of the Drugs , For Targeting and Retention of Drug in Blood Circulation , Proniosomes , Aspasomes , Vesicles in Water and Oil System (v/w/o) ,Bola - niosomes , Discomes , Deformable niosomes or elastic niosomes , According to the nature of lamellarity ,Small Unilamellar vesicles (SUV) 25 – 500 nm in size.,Large Unilamellar vesicles (LUV) 0.1 – 1μm in size , Multilamellar vesicles (MLV) 1-5 μm in size , According to the size:Small Niosomes (100 nm – 200 nm) , Large Niosomes (800 nm – 900 nm),Big Niosomes (2 μm – 4 μm)
Adhesion describes the attractive forces between a biological material and mucus or mucous membrane. 1. Mucous membranes adhere to epithelial surfaces such as the gastrointestinal tract (GI-tract), the vagina, the lung, the eye, etc. They are generally hydrophilic as they contain many hydrogen macromolecules due to the large amount of water (approximately 95%) within its composition. However, mucin also contains glycoproteins that enable the formation of a gel-like substance. 1. Understanding the hydrophilic bonding and adhesion mechanisms of mucus to biological material is of utmost importance in order to produce the most efficient applications. For example, in drug delivery systems, the mucus layer must be penetrated in order to effectively transport micro- or nanosized drug particles into the body. 2 Bioadhesion is the mechanism by which two biological materials are held together by interfacial forces.
Introduction-notes-classification-manufacturing process-outline-composition-sources of fragrances-EU Regulations for perfumes-natural and synthetic allergens to human
1. Structure of skin.
2. Skin relating problems :
a. Dry skin
b. Acne
c. Pigmentation
d. Prickly heat
e. Wrinkles
f. Body odour
3. Structure of hair.
4. Hair growth cycle.
Regulatory provision related to manufacture of cosmeticManish Rajput
cosmetic, regulatory provision, schedule M, condition of licence, schedule U, prohibition of certain cosmetics, misbranded and spurious cosmetics, loan licence, offences and penalties,
DATION OF EQUIPMENT ICH AND WHO GUIDELINES FOR CALIBRATION AND VALIDATION OF ...deepalisanap31
Introduction to equipment
Calibration
ICH guidelines for calibration of equipment
WHO guidelines for calibration of equipment
Example for calibration of UV
Validation
ICH guidelines for validation of equipment
WHO guidelines for validation of equipment
Example for validation of tablet compression machine
Myself Omkar Tipugade , M pharm , Shree Santkrupa College of Pharmacy , Ghogaon , Karad ( Maharashtra).
I upload the presentation on sun protection & type of Skin and sun screen agent depend on skin type , and also brief information about the cosmetic & cosmeceutical product.
NIOSOMES , GENERAL CHARACTERISTICS OF NIOSOME , TYPES OF NIOSOMES , OTHERS TYPES OF NIOSOMES , NIOSOMES VS LIPOSOMES , COMPONENTS OF NIOSOMES , Non-ionic surfactant , Cholesterol , Charge inducing molecule , METHOD OF PREPARATION , preparation of small unilamellar vesicles , Sonication , Micro fluidization , preparation of large unilamellar vesicles , Reverse Phase Evaporation , Ether Injection , preparation of Multilamellar vesicles , Hand shaking method , Trans membrane pH gradient drug uptake process (remote loading) , Miscellaneous method :Multiple membrane extrusion method , The “Bubble” Method , Formation of Niosomes From Proniosomes , SEPARATION OF UNENTRAPPED DRUGS , Gel Filtration , Dialysis , Centrifugation , FACTORS AFFECTING THE PHYSICOCHEMICAL PROPERTIES OF NIOSOMES , Membrane Additives , Temperature of Hydration , PROPERTIES OF DRUGS , AMOUNT AND TYPE OF SURFACTANT
Structure of Surfactants , Resistance to Osmotic Stress , Characterization of niosomes ,Therapeutic applications of Niosomes , For Controlled Release of Drugs , To Improve the Stability and Physical Properties of the Drugs , For Targeting and Retention of Drug in Blood Circulation , Proniosomes , Aspasomes , Vesicles in Water and Oil System (v/w/o) ,Bola - niosomes , Discomes , Deformable niosomes or elastic niosomes , According to the nature of lamellarity ,Small Unilamellar vesicles (SUV) 25 – 500 nm in size.,Large Unilamellar vesicles (LUV) 0.1 – 1μm in size , Multilamellar vesicles (MLV) 1-5 μm in size , According to the size:Small Niosomes (100 nm – 200 nm) , Large Niosomes (800 nm – 900 nm),Big Niosomes (2 μm – 4 μm)
Definition of cosmetic products as per Indian regulation. Indian regulatory requirements for labeling of cosmetics .Regulatory provisions relating to import of cosmetics ,Misbranded and spurious cosmetics. Regulatory provisions relating to manufacture of cosmetics – Conditions for obtaining license, prohibition of manufacture and sale of certain cosmetics, loan license, offences and penalties.
pharmacy, cosmetics, regulatory provisions related to manufacturing, import, sell and distribution of cosmetics as per drug and cosmetics act and rules 1940&1945
A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.
Definition of cosmetics.
Regulation provision relating to manufacture of cosmetics
a. How to obtain license
b. Conditions of license
c. Regulatory provision on sale of cosmetics
d. Loan license
Offences and Penalties
M Pharm Pharmacognosy Semester 2, HERBAL COSMETICS UNIT 1, Herbal/natural cosmetics, Classification &
Economic aspects. Regulatory Provisions relation to manufacture of cosmetics: -
License, GMP, offences & Penalties, Import & Export of
Herbal/natural cosmetics, Industries involved in the production of
Herbal/natural cosmetics.
Regulatory Prohivision M. Pharm (Pharmaceutics).pptxPrachi Pandey
Drug and Cosmetics Act, 1940, defined “cosmetics” as-
“Any article intended to be rubbed, poured sprinkled or sprayed on or intended into or applied to any part of the human body for cleansing, beautifying, promoting attractiveness & altering appearance, and includes any article intended for use as a components of cosmetics”.
- Generally, cosmetics consisting misbranded, spurious & adulterated cosmetics products.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
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.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
1. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 1
SVKM’s Institute of Pharmacy , Dhule
F.Y. Pharm. , Branch Pharmaceutics
Mr. Saurabhasing J. Rajput
PRN No: 2254482817012
Indian Regulatory Requirements For Cosmetics
Presented by :
Dr. Babasaheb Ambedkar Technological University
Lonere-402103 Tal. - Mangaon, Dist. - Raigad (M.S.) India
(MPH204T) COSMETICS & COSMECEUTICALS
Guided by :
Dr. Aarti Belgamwar
2. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 2
Points to be discussed :
Definition of cosmetics
Cosmetics regulation in INDIA & Chapters
List of Categories of Cosmetics
Types of License for cosmetics
Regulatory requirements for mfg. of Cosmetics
Regulatory requirements for Labelling of Cosmetics
New Schedules & Forms
Reference
3. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Cosmetic Products (as per Indian regulation)
Cosmetic is defined under section 3(aaa) of the Drugs and
Cosmetics Act, 1940 as, any article intended to be rubbed, poured,
sprinkled or sprayed on, or introduced into, or otherwise applied
to, the human body or any part thereof for cleansing, beautifying,
promoting attractiveness or altering the appearance, and includes
any article intended for use as a component of cosmetic
3
4. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Cosmetics Regulation In INDIA
• Cosmetic Legislation is driven in INDIA through Drugs and
Cosmetics Act 1940 & rules 1945, and the legislative body is
CDSCO headed by DCGI
• Import of cosmetics is regulated under a system of registration
by CDSCO who is the main authority to regulate activities
relating to cosmetics.
• Manufacturing of cosmetics in India is regulated under a
system of inspection and licensing by the State Drug Control
Department .
4
5. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
New Cosmetics Rule , 2020
The Ministry of Health and Family Welfare notified the
Cosmetics Rules,2020, on December 15, 2020 :-
with an aim to separately codify and update the rules
relating to import, manufacture, labelling, sale and
distribution of cosmetics in India, which were earlier set
out under the Drugs and Cosmetics Rules, 1945
Cosmetic Rules 2020 have been modified vide notification
No. G.S,R. 763 (E) Dated 15- 12-2020 and the same have
come into force from the date of its notification i.e. 15-12-
2020.
5
6. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
New Cosmetics Rule,2020 Chapters :
Chapter 1
• Preliminary
• Definitions & Explanation
Chapter 2
• Licensing Authorities & Officers
• Functions of Central Cosmetics Laboratory
Chapter 3
• Import of Cosmetics
• Import Registration Certificate
Chapter 4
• Manufacture of Cosmetics for sale or
Distribution
Chapter 5
• Permission for Import or Manufacture of New
Cosmetics
6
7. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Chapter 6
• Labelling , Packaging & Standards
for sale or Distribution of Cosmetics
Chapter 7
• Procedure of Sampling for Test
• Analysis, Seizure & Report
Chapter 8
• Approval of Laboratory for carrying
out Tests on Cosmetics & their Raw
Materials
Chapter 9 • Miscellaneous
Continue...
7
8. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 8
List of Categories of Cosmetics for sale in Country:
(A) Powders
(B) Skin Powder for Infants
(C) Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade,
brilliantine, shaving-creams and hair-oils, etc.
(D) Nail Polishes and Nail Lacquers.
(E) Lipsticks and Lip-gloss.
(F) Depilatories
(G) Preparations used for Eyes
1. Eyebrows, Eyelashes, Eyeliners.
2. Kajal and Surma.
(H) Aerosol
(I) Alcoholic Fragrance solutions
( J) Hair Dyes
(K) Tooth-powders and toothpastes, etc.
1. Tooth-powder in General.
2. Tooth pastes.
3. Tooth — Powder (Black).
(L) Toilet Soaps
9. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Central Licensing
Authority
Import of cosmetics is
regulated under a system of
registrationby the CDSCO
State Licenscing
Authority
The State Government
appoints a Licensing
Authority State Drug Control
Department ,who inspect and
provide license for
manufacturing of the
products.
IMPORT LICENSE MANUFACTURING LICENSE
Types of Cosmetics License in INDIA :
9
10. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
As per D&C Act & Rules 1945 certain cosmetics are
prohibited to Import in India:
01
02
03
04
05
06
07
COSEMETICS
CONTAINING
MERCURY
COSMETICS
CONTAINING
LEAD
COSMETICS
CONTAINING
HEXACHLOROPHENE
.
COSMETICS CONTAINING
HARMFUL INGREDIENT
MISBRANDED COSMETICS
SPURIOUS & ADULTRATED
COSMETICS
NOT OF STANDARD QUALITY
10
11. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Regulatory requirements to Import of Cosmetics
• The import of cosmetics is regulated
under a system of registration by
central licensing authority appointed
by central Government
• Require compulsory
registration certificate for
importing from DCGI (CDSCO)
• Cos 1 Application of a product to be
imported made through online
portal on SUGAM Portal by
Importer
11
12. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Regulatory requirements for manufacturing of
Cosmetics :
Loan License :
A person(applicant) who does not have his own
arrangements(factory) for manufacture but who wish to avail the
manufacturing facilities owned by another licensee. Such licenses
are called Loan licenses.
Labelling Conditions For Loan License :
Manufactured By
Marketed By
12
13. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Application for grant of loan license & Manufacturing
License to manufacture cosmetics for sale or for
distribution :
13
Any person who
intends to mfg.
cosmetics .
• For Distribution
• Loan license
Online
Application on
SUGAM Portal
• Form COS– 5&6
• Fee 3 rd. Schedule
• 45 Days
State Licensing
Authority
• Site inspection by
officer
• License granted in
form COS 8 & 9
who Issue
How
14. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Conditions of license :
Manufacturing of Cosmetics :
Manufacture of cosmetics shall be conducted under the direction and personal supervision of at least one person who
is a whole-time employee and who possesses any one of the following qualifications.
(i) Holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the
Pharmacy Act, 1948 (8 of 1948), or
(ii) Must beregistered under the Pharmacy Act, 1948 (8 of 1948), or
(iii) Has passed the Intermediate Examination with Chemistry as one of the subjects or an
examination recognized by the Licensing Authority as equivalent to it.
(iv) Holds a bachelor degree in Cosmetic Technology from recognized university.
Factory Premises :
comply with the requirements and conditions specified in the 7 th Schedule.
The manufacturer shall either :
(i) Provide and maintain adequate staff.
(ii) Laboratory equipment approved by the Central Licensing Authority
(i) Documents in respect of the ownership or occupation on rental or other basis of the
(ii) constitution of the firm.
The applicant shall maintain documentary evidence of :
14
15. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Grant & Validity of license :
1) If the Licensing Authority, is satisfied then shall grant a license
in Form COS-8 or Form COS-9 .
2) If the Licensing Authority is not so satisfied, he shall reject the
application with Reason.
3) within a period of 6 months from the rejection of an application
for a license is granted if rejected requirements are fulfilled
4) A license or loan license issued in Form COS- 8 or Form COS- 9
shall remain valid from 5 years from the date of its issue, unless, it
is suspended or cancelled by the State Licensing Authority.
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16. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Requirements of plant and equipment :
Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade,
brilliantine, shaving-creams and hair-oils, etc.-
Equipment’s:
(a) Mixing and storage tanks of suitable materials.
(b) Heating kettle — steam, gas or electrically heated.
(c) Suitable agitator.
(d) Colloidal mill or homogenizer (wherever necessary).
(e) Triple roller mill (wherever necessary).
(f) Filling and sealing equipment.
(g) Weighing and measuring devices.
An area of 25 square metres is recommended.
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17. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Regulatory Requirements for Labelling of
Cosmetics :
Generic or common name of the commodity packed. (Brand Name)
Name and address of the importer if imported .
Net quantity in terms of standard unit of weights and measures. (gm/ml)
Month and year of packing & Expiry Date
Maximum retail sales price (MRP) in INR
Adequate direction for safe use
Full ingredients listing .
Any warning, caution or special direction required to be observed by the consumer
A statement of the names and quantities of the ingredients that are hazardous or poisonous
Batch number starting with “ B ”
Manufacturing license number starting with suffix “ M ”
Import Registration No. (in case of Imports)
QR Code & Bar Code .
Name of the manufacturer with complete address of the premises of the manufacturing place
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18. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
New Schedules Introduced in Cosmetics Rules 2020 :
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19. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
New Schedules Introduced in Cosmetics Rules 2020 :
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20. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Forms comes under New Cosmetics Rules 2020 :
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21. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Forms comes under New Cosmetics Rules 2020 :
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22. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
Forms comes under New Cosmetics Rules 2020 :
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23. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
SUGAM Portal :
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24. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
CDSCO Official Website :
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25. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals
References :
• https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
• https://cdscoonline.gov.in/CDSCO/UserRegistration
• MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health
and Family Welfare) NOTIFICATION New Delhi, the 15th December,
2020 , Cosmetics Rules, 2020.
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26. Vision: To Pursue Excellence in Pharmaceutical Education & Research to Develop Competent Professionals 26