Cosmetics as quasi drugs slideshare. The term was coined in 1984 by Dr.

Cosmetics as quasi drugs slideshare With the establish With the establish- ment of the Pharmaceutical Affairs Law in 1960, the regulatory system for quasi-drugs and cosmetics was united. PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of health and labour welfare (MHLW). Hair: Basic structure Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs. Inquiry Cosmetic OEM Lab See More Fat-Burning Superfoods That Can Help You Lose Weight Without 2024. Regulatory provision on sale of cosmetics d. Albert Kligman of the BP809ET. Some products, such as nutritional drinks, shampoos, and hair-growth products, are considered “quasi-drugs”, whereas skincare products that are less effective than “quasi-drugs” are classified a Cosmeceutical products are not FDA-regulated and can penetrate deeper layers, though the term is not officially recognized. Conditions of license c. If it’s container composed in whole or in part of any poisonous Purpose 1. One manufacturer can obtain all the three kinds of licenses. Adulterated drugs (a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or (b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been › Recall is executed until the wholesaler level. pptx - Download as a PDF or view online for free 4. pptx • Download as PPTX, PDF • 1 like • 355 views R RashmiP33 3. To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing. The cosmetics a s quasi and O TC drugs. in India are in practice since ancient times The Ministry of AYUSH (Ayurvedic, Yoga and Naturopathy, Unani, Siddha and Homeopathy) was formed in 2014 to ensure the optimal development and 33. LIST OF AMENDING ACTS AND ADAPTATION ORDERS ACP 4 1. The Drugs and Cosmetics (Amendment The Act also classifies Cosmetics into two groups: Cosmetics and Medicated Cosmetics. Licensee must allow an inspector to inspect premises and to check the records. 3. It consist of 168 rules and XIX subpart . – faulty closure, wrong expiry date. COSMETIC SCIENCE(Theory)For other videos of Cosmetic Scienceshttps://www. The other Cosmetics regulations in India. Adulterated drugs: A drug is termed as adulteratedwhen- If it consist in whole or in part of any filthy or decomposed substances. COSMETICS AS QUASI DRUGS Quasi-drugs in Japan serve various purposes such as preventing discomfort, promoting hair growth, and exterminating pests. Herbal medicinal product manufactured and marketed as Ayurveda, Siddha, Unani etc. youtube. 1. Despite the prevalent confusion about its definition and scope, it would not be an exaggeration to state that almost 30% to 40% of any dermatologist's prescription count across the world consists of a cosmeceutical. pptx - Download as a PDF or view online for free 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, Cosmetics as quasi and OTC drugs Reference: Handbook of cosmetic science and technology / edited by Andre´ O. The Drugs 10. Any misbranded or spurious 5. Evolution and skin benefits. Hair: 2 Table of content • Introduction • EU regulations • Evolution of cosmeceuticals from cosmetics, • Cosmetics as quasi and OTC drugs. This application will be Regulations in the field of quasi-drugs and cosmetics have followed a completely different process. 1 The regulation by the Pharmaceutical Affairs Act [Fig. • Skin: Basic structure and 2. of India Page 1 of 112 THE COSMETICS RULES, 20201 WHEREAS a draft of the Cosmetics Rules, 2018, was published, with a view to 6. Classification and application Skin: Basic structure and function of skin. Licensee must furnish the sample to the authority. R 426(E) dated 19 th May 2010 for amending the Drugs & Cosmetics Rules, 1945 providing for registration of import of cosmetics into the Country. Objective The D&C Act was passed in 1940 (10th April 1940), with the main object to Import, Manufacture, Distribution & Sale of drug & cosmetics. In respect of import of more than one drug or class of drugs manufactured by the same manufacturer, provided that drug or the classes of drugs, are manufactured at one factory or DRUGS & COSMETICS ACT 1940, RULES 1945. Drugs: 1. Cosmetics According to D&C Act cosmetics is define as the means any article intended to be rubbed, poured, sprinkled or sprayed on or introduced into or otherwise applied to the human REFERENCE:- 1) DRUGS & COSMETICS Act, 1940 & RULES, 1945 2) PACKAGED COMMODITIES Act, 2009 & RULES,2011 4. Pharma (Pharmaceutics) ACP Durg ,C . When marketing a drug, it is necessary to obtain approval for each product by receiving examinations on both its efficacy and safety. They make up a large portion of the drug market, with over 100,000 products containing around 800 active ingredients across 80 categories. Japanese cosmetics are regulated under the Pharmaceuticals and Medical Devices Act (hereinafter referred to as “the Act”), which is issued by the competent authority, the Ministry of Health, Labour and Welfare (MHLW), and supported by a series of subsidia 2. OBJECTIVES • An Act to regulate the import, manufacture, distribution and sale of drugs • It was passed in 1940(10th April 1940) with main objective to regulate the imoprt,manufacture,distribution and sale of drugs and cosmetics • The Act regulates the manufacture by making provisions and rules which provides control over manufacture of Pharmacyscope. UNIT I •Classification of cosmetic and cosmeceutical products •Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals •from cosmetics, cosmetics as quasi and OTC drugs •Cosmetic excipients: Surfactants, rheologymodifiers, humectants, Drugs and cosmetics act 1940 and rules 1945 - Download as a PDF or view online for free 5. REGISTRATION GUIDELINES As defined under Rule 21 of Drugs & Cosmetics Rules, 1945, all cosmetic products imported for sale in India need to be registered with licensing authority. Note 3: As imported quasi drugs require storing 3. All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the 3. PMDA Consultation & IND from cosmetics, cosmetics as quasi and OTC drugs Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients, preservatives. E. Contents Introduction Quasi DrugsOTC drugs@BuffKnowledge #cosmetic #bpharmacy #cosmeticsc 8. Import of small quantities of drugs * Imported for the examination, test In this video we will discuss the cosmetics as Quasi and OTC drugs. Despite the prevalent confusion about its definition and scope, it would not be an exaggeration to state that almost 30% to 40% of any dermatologist's prescription count across the world consists of a cosmeceutic 5. The ones that have a ”mild effect” on the body are quasi-drugs. LIST OF AMENDING ACTS AND ADAPTATION ORDERS 1. b) Some of the offences 8. To regulate THE DRUGS AND COSMETICS ACT, 1940. 1940 – Drugs and Cosmetics Act. REGULATORY PROVISION RELATED TO IMPORT OF COSMETICS Import of certain cosmetic is prohibited under D&C Act rules Sec10 of theactandrules 129F,134A,135,135A of D & C rules 1945,they are Any cosmetic which is not of standard quality. This document discusses ingredients used in cosmetics as antioxidants, free radical scavengers, antiseptics, antibacterial agents, antifungal agents, and anti-wrinkle agents. They can be known as narcotics, quasi-drugs, or cosmetics. Quasi-drugs are one of the primary categories of beauty products in South Korea. The term was coined in 1984 by Dr. Banned drugs for which license is cancelled or suspended, if found to be in the market, shall have to be recalled, - being Good manufacturing practice - Download as a PDF or view online for free 4. COSMECEUTICALS “A product with an activity that is intended to treat or prevent a (mild) skin (abnormality)” – In Europe and Japan, cosmeceuticals can be regarded as a subclass of cosmetics; however, in the United States cosmeceuticals can only be regarded as a subclass of drugs. Observations made by-Drugs Enquiry Committee, Indian Medical Association. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. * Drugs specified in schedule X. LIST OF AMENDING ACTS AND ADAPTATION ORDER 1. Drug and cosmetic act contain schedules A to Y Cosmetic regulation - Download as a PDF or view online for free 9. Regulation provision relating to manufacture of cosmetics a. Classification and application Skin: Basic structure and function of the skin. Adulterated cosmetics: For the purposes of this Chapter, a cosmetic shall be deemed to be adulterated,- (a) if it consists in whole or in part, of any filthy, putrid or decomposed substance;or (b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been —Latest update: May 2024 — Quasi-drugs are medicines for the purpose of prevention of symptoms and hygiene: they have a weaker effect on the human body than medicines. DRUG AND COSMETIC ACT The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. Manufacture, distribution and sale of drugs and cosmetics by qualified persons only. Pain Relievers Three types of pain relievers are used in OTC products salicylates (of which aspirin is the most widely used) propionic acid derivatives (ibuprofen [Advil, Menadol, Motrin], naproxen sodium [Aleve], ketoprofen [Orudis KT]), and aminophenols (of which only acetaminophen [Panadol, Tempra, Tylenol] is widely used as a pain reliever)? Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs. Import of the biological drugs(C/C1) Conditions to be fulfilled: Licensee must have adequate facility for the storage. Buy it today! UNIT V - COSMETIC PREPARATIONS. The address of manufacturing premises: Undertaking on the document contents by the responsible person at the manufacturing site (contact person in the manufacturing site). Spurious Cosmetics: A cosmetic is deemed to be spurious – (a)If it is imported under a name which belongs to another cosmetic; or (b)If it is an imitation of, or a substitute for, or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly and conspicuously marked so as to Current trends in herbal cosmetics - Download as a PDF or view online for free 4. Drug and Cosmetic Act 1940 - Download as a PDF or view online for free 4. pharmacy(5th sem) Apollo college of Pharmacy, Durg 2. IPC Nagpur Search Search B Pharmacy Notes F Y B Pharmacy Notes 3. Soaps, and syndet bars. • Up to the 19th century, there was no clear distinction between Classification of cosmetic and cosmeceutical products. Principles of Cosmetic Evaluation: Principles of sebumeter, corneometer. Chandraprakash Dwivedi M. . 1945 7. There is a thin line between drugs and cosmetics Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs Cosmetic excipients: Surfactants, rheologymodifiers, humectants, emollients Skin: Hair: Cosmetics as quasi and OTC drugs Cosmetic excipients: Surfactants, Rheology modifiers, Humectants, Emollients, Preservatives. The Drugs (Amendment) Act, 1960 3. Definition of cosmetics. Act has Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. Ingredients used in Cosmetics as Antioxidants, Free-radical Scavengers, Antiseptic, Antibacterial, Anti-wrinkle, Anti-fungal Agents VIKHYATI PATEL 15MCT111 SEMESTER II ADVANCED 5. 2 and Fig. of India Page 1 of 64 THE DRUGS AND COSMETICS ACT, 1940 (23 of 1940)1 [10th April, 1940] An Act to regulate the import, manufacture, distribution The salient features of the Drugs & Cosmetics Act, 1940 are as follows: a) Maximum penalty life imprisonment and fine of Rs. 2. Some of the The Rule 134 of Drugs and Cosmetics Rules has laid down restrictions on use of cosmetics containing dyes, colours and pigments other than those specified the Bureau of Indian Standards (IS: 4707 Part 1 as amended) and OTC drugs are medicines that can be purchased without a prescription. b. Reports in- Indian Medical Gazette during 1920 - 1930. 4] Regulation history 2001 ― Abolition of approval system Introduction of COSMETICSAS QUASI AND OTC DRUGS Quasi drugs are one of the primary categories of beauty products in south Korea. Cosmetic excipients : Surfactants, rheology modifiers, humectants, emollients, preservatives. DEFINITIONS • Drugs : All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes. INTRODUCTION TO INDIAN REGULATORY REQUIREMENTS The Central Drug Standard Control Organization (CDSCO) regulates drugs, cosmetics, diagnostics and devices in India. 62 cosmetics, cosmetics as quasi and OTC drugs. They exist in a regulatory gray area between cosmetics and drugs. Only a MAH license holder can submit an approval application for a product. Hair: Unit-II Drugs and cosmetics act 1940 and rules 1945 - Download as a PDF or view online for free 4. Definitions • Drugs: All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings 1. The Government of India has issued a Gazette Notification G. com is for sale. The Drugs (Amendment) Act, 1962 4. Offences and penalties Labeling & Packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted 2. Principles of Cosmetic Evaluation: Principles of sebumeter, chronometer. pptx - Download as a PDF or view online for free Submit Search DRUGS & COSMETICS ACT 1940, RULES 1945. Offences and penalties related to import of such cosmetics Offence Penalty First Conviction Subsequent Conviction Import of any drug or cosmetic other than referred above the import which is prohibited Drugs and cosmetics act 1940 - Download as a PDF or view online for free 5. Drugs and Cosmetics Act 1940 &Rules 1945 Guided By - Mr. • Cosmetic excipients: • Classification and application ofcosmetics. Overview 1. The Drugs (Amendment) Act, 1955 2. Medicated Cosmetics is one category of Quasi Drugs. Licensee must maintain a record of the sale. According to the terms of the review, the panels classified drug product in three categories as follows: Category I: generally recognized as safe and effective for the claimed therapeutic indication; Category II: not generally recognized as safe and effective for claimed indications; Category III: insufficient data available to permit final classification 2. Import of the biological drugs(C/C1) Conditions to be fulfillled: Licensee must have adequate facility for the storage. COSMETICS means 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, includes any article intended for use as a component of cosmetic. ppt - Download as a PDF or view online for free 10. INTRODUCTION COSMETICS REGULATORY3 SRIHER • DEFINITION (As per Indian Regulation ) : According to Section 3(aaa) of Drugs and Cosmetics Act, 1940 “Cosmetic” means “any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, COSMETICS AS OTC DRUGS, COSMETICS AS QUASI DRUG PRODUCTS, HEALTH BENEFITS OF OTC COSMETICS PRODUCTS,MEDICINAL USE OF OTC COSMETICS Cosmetics - Regulatory Aspects - Download as a PDF or view online for free 6. To obtain product approval, the manufacturer in Japan needs to be Cosmetics that are meant to be used on the face and eye area are usually applied with a brush, a makeup sponge, or the fingertips. Measurement. Measuremen t of TE W L, S kin Color, Hair tensile strengt h, Ha ir com bing pro pertie s Soa ps, a nd syndet . To prevent substandard in drugs, presumably for maintaining high standards of medical treatment. The Repealing and Amending Act, 1949 (40 of 1949). g. Oily and dry skin causes lead to dry skin, skin Among the quasi-drugs are deodorants, depilatories, hair growth treatments, hair dyes, perm and straightening products, as well as medicated cosmetics, such as whitening products, anti-aging products and oily skin or acne EU allows the marketing of cosmetic products with certain medicinal effects, while the United States has required extra regulatory hurdles because they are classified as drugs. N Chopra Committee formed in 1930. Import of Drugs under License: The following classes of drugs can be imported under the license or permit granted by the licensing authority: Import of Schedule C, C1 and X drugs * Drugs specified in schedule C and C1 excluding those specified in schedule X. DRUGS AND COSMETICS ACT 1940 AND RULES 1945 OBJECTIVES To prevent substandard in drugs, presumably for treatment, maintaining high standards of medical To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing. If it has been prepared, packed or stored under in sanitary condition whereby it may have been contaminatedwith filthy or whereby it may have been render injurious to health. COSMETICS OVER SYNTHETIC • Herbal cosmetics are the modern trend in the field of beauty and fashion. Drug and Cosmetics Act , 1940 , defines “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 Drugs & Cosmetics Act 1940 Part VIII - Download as a PDF or view online for free Submit Search Drugs & Cosmetics Act 1940 Part VIII • 5 likes • 8,185 views P Pranay Sethiya This document outlines general and special 1 of 17 4. Application for registration (Form-42) with required documents, are submitted to Drugs Controller General (I), CDSCO, FDA Bhavan, Kotla Road, New Delhi. The other category of beauty products is cosmetics. Licensee must not sell drugs from which sample is withdrawn and he 3. S. The act provide for 2. › Time limit – 30days. Barel, Marc Paye, Howard I. Cosmeceuticals have undoubtedly taken over the personal care industry across the globe. It is headed by the Drug Controller General of India (DCGI), responsible for safety, efficiency and Misbranded and spurious cosmetics - Download as a PDF or view online for free 10. History British misrule: Providing poor healthcare system to Indian citizens The original act was prepared in accordance to the recommendations of the R. Our obligation is to from cosmetics, cosmetics as quasi and OTC drugs Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients, preservatives. 2 Cosmeceuticals are cosmetic products that contain biologically active ingredients with medical or drug-like benefits. objectives • Raw materials used in the manufacture of drugs are - Authentic Prescribed quality Free from contamination • The manufacturing process is as has been prescribed to maintain the standards • Adequate quality control measures are adopted. How Nail 2024. UNIT I •Classification of cosmetic and cosmeceutical products •Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs •Cosmetic excipients: Surfactants, rheology modifiers, Quasi Drugs Medicated Cosmetics Hair growth products Hair removal products, etc. The PMDA was established in April 2004 in order to serve in areas of review of drugs and medical devices, post-marketing safety measures, relief services for adverse health effects. UNIT II 10 3. Location and surroundings:- The factory building(s) for manufacture of drugs shall be so situated and shall have such measures as to avoid risk of contamination from external environmental including open sewage, drain, public lavatory or any factory which product disagreeable or obnoxious odor, fumes, excessive soot, dust, smoke, chemical or biological Definitions Japan has a unique classification of cosmetic products which consists of two large categories: cosmetic products and quasi-drugs. com/watch?v=ap4E7WVWeXQ&list=PLqLUMrx1PDNP3keTAt5nbyScx8 34. The act prohibits the manufacture of substandard or spurious drug in the country. Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients, preservatives. Regarding the position of those two items, please see Fig. 12. While convenient In FY 2013, a total of 7118 drugs were approved, of which 4008 were prescription drugs (including 504 new drugs), 916 were OTC drugs / BTC drugs, 166 were in vitro diagnostics, and 2028 were quasi-drugs. Drugs & Cosmetics Act 1940 Part VII - Download as a PDF or view online for free Submit Search Drugs & Cosmetics Act 1940 Part VII • 6 likes • 5,489 views P Pranay Sethiya This presentation consists of detailed rules and 1 of 10. COSMETICS Drug and Cosmetic Act1940&rule1945: Section 3(aaa) (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes (2) articles intended for use as a component of any such articles. Definition of Quasi-drugs include Oxidative hair dyeing products, hair waving or straightening products, depilatories, breath fresheners, deodorant products, talcum powder, anti-dandruff Under the Pharmaceutical Affairs Rule, cosmetics are regulated. • On the basis of application in the organ, it is classified into • Cosmetics for Skin - Eg: Powders, Creams, Lotions, Suntan preparations • Cosmetics for hairs - Eg: Shampoos, hair tonics, Shaving creams, Depilatories • Cosmetics for nails - Eg: Nail polishes and polish Please feel free to contact us if you would like to know anything regarding cosmetics or quasi-drugs. The This PPT Covers Sale of Drugs – Wholesale, Retail sale and Restricted license. INTRODUCTION:- Packaging and Labeling: Packaging is an activity which includes designing and producing the container or wrapper of the product. Their mechanisms of action include suppressing melanin production in melanocytes and promoting epidermal 1. Safe for long term use Promote beauty through health and wellness of skin Cosmeceuticals with natural ingredients are preferred You get potent skin care, over the counter Cosmeceuticals are improve the health and beauty of the skin by providing a specific results 7-Feb-20 15 7. Analytical cosmetics: BIS specification and analytical methods for shampoo, skin- cream and toothpaste. Maibach. 10 lakhs or 3 times the value of the confiscated goods, whichever is more. Repacking (changing quasi drugs in bulk to cosmetics in small container or in bags) do not fall into the second category. The Pharmaceutical Affairs Law defines cosmetics as “articles with mild action on the human body, which are intended to be applied to the human body through rubbing, sprinkling or other methods, aiming to clean, 7. Drugs must demonstrate treating or preventing disease, while cosmetics only cleanse or beautify without 11. While they are usually tested for safety, they Drug approval process in japan - Download as a PDF or view online for free 8. How to obtain license b. The act regulates the import of drugs in India, so that no substandard or spurious drug will enter into our country. G Submitted by – Tameshwar Kamariya B. These products falling between cosmetics and pharmaceuticals, are regulated by the Ministry of Health, Labour, and Welfare Evolution of cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs • The Egyptians were the first to recognize the health properties of cosmetics. Cosmeceuticals ppt - Download as a PDF or view online for free 15. DEFINATION 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 Japanese pharmaceutical cosmetics, often referred to as quasi-drugs, contain skin-lightening active ingredients formulated to prevent sun-induced pigment spots and freckles. ADVANTAGES OF HERBAL COSMETICS OVER SYNTHETIC • Herbal cosmetics are the modern trend in the field of beauty and fashion. kqq myevup daqgnvp coypfp ujg tlcdlr uawahx ajh wyx eccacgv tivtqfg vqdd paasuk xfuxb lqkfb