The document provides an overview of the Drugs and Cosmetics Act of 1940 and its rules of 1945 in India. Some key points:
- The Act was enacted in 1940 to regulate drugs and cosmetics in India and ensure they are safe, effective, and meet quality standards. It has since been amended several times.
- The Drugs and Cosmetics Rules were promulgated in 1945 and provide detailed rules for implementation of the Act regarding manufacturing, distribution, labeling, and other aspects of drugs and cosmetics.
- The objectives of the Act are to regulate the import, manufacture, and sale of drugs and ensure they are produced and sold by qualified persons and meet standards of treatment
The 1940 Drugs and Cosmetic Act was established to regulate the import, manufacture, and sale of drugs and cosmetics in India through a licensing system. The objectives of the act were to ensure drugs and cosmetics are produced and sold by qualified persons to prevent substandard drugs and regulate Ayurvedic, Siddha, and Unani medicines. The act established agencies like the Drugs Technical Advisory Board and Drugs Consultative Committees to advise on technical matters and amended over time to expand regulation and oversight of traditional medicines.
All the schedules of Drugs & Cosmetics Act ,1940 as well the Rules,1945 are detailed described. Also the history, objectives, role, all the amendments & orders of the D & C Act are described in most simplified way.
The document discusses the Drug and Cosmetic Act of 1940 and Rules of 1945 in India. It outlines the objectives of regulating drug manufacture, import, and sale. It describes the key definitions in the act, such as drugs, cosmetics, misbranded drugs, and adulterated drugs. It also explains the roles of organizations established under the act, including the Drugs Technical Advisory Board, Drugs Control Laboratories, and powers of the Government Analyst.
Introduction & Objectives
Schedules of the Act.
Schedules of the Rule
Definitions
Administrative bodies
Import & Registration.
Manufacture of drugs
Sale of drugs
Labeling & packaging of drugs
Conditions for grant of licenses
Detailed study of schedules g, h, M, N, P, T, U,V, X & Y
The document summarizes the Drugs and Cosmetics Act of 1940 and Rules of 1945 in India. Some key points:
- It was enacted to regulate the import, manufacture, distribution and sale of drugs and cosmetics through a licensing system. Only qualified persons can manufacture, distribute and sell drugs and cosmetics.
- It covers definitions of drugs and cosmetics. Provisions relate to import, manufacture, sale, labeling and packaging of drugs. It describes schedules to the act and amendments made over time.
- The act is administered through various advisory committees and authorities like the Drugs Technical Advisory Board and Drugs Control Laboratories. It outlines licensing, manufacturing and sale requirements for different drug categories
The document summarizes key aspects of the Drugs and Cosmetics Act, 1940 and its rules regarding the import and manufacture of drugs in India. It outlines objectives like preventing substandard drugs and controlling import/manufacture through licensing. Important definitions are provided for terms like drug, cosmetic, Ayurvedic drugs etc. It also describes schedules to the act classifying drugs, licensing requirements for import/manufacture, conditions for licenses, and penalties for offences. In summary, it covers the legal framework for regulation and control of drugs in India.
Drugs and cosmetics act 1940, rule 1945 by dr. izhar ahmadIzhar Ahmad
This document provides an overview of the Drugs and Cosmetics Act of 1940 in India. Some key points:
[1] It was passed to regulate the import, manufacture, and sale of drugs and cosmetics in India following reports of poor drug quality during British rule.
[2] The Act established bodies like the Drugs Technical Advisory Board and Drugs Consultative Committees to advise on drug standards and administration of the Act.
[3] It defines terms like "drugs", "cosmetics", and covers areas like licensing for drug manufacture, inspection, penalties for violation, and standards that drugs must meet.
[4] The Act was amended over time, including
The 1940 Drugs and Cosmetic Act was established to regulate the import, manufacture, and sale of drugs and cosmetics in India through a licensing system. The objectives of the act were to ensure drugs and cosmetics are produced and sold by qualified persons to prevent substandard drugs and regulate Ayurvedic, Siddha, and Unani medicines. The act established agencies like the Drugs Technical Advisory Board and Drugs Consultative Committees to advise on technical matters and amended over time to expand regulation and oversight of traditional medicines.
All the schedules of Drugs & Cosmetics Act ,1940 as well the Rules,1945 are detailed described. Also the history, objectives, role, all the amendments & orders of the D & C Act are described in most simplified way.
The document discusses the Drug and Cosmetic Act of 1940 and Rules of 1945 in India. It outlines the objectives of regulating drug manufacture, import, and sale. It describes the key definitions in the act, such as drugs, cosmetics, misbranded drugs, and adulterated drugs. It also explains the roles of organizations established under the act, including the Drugs Technical Advisory Board, Drugs Control Laboratories, and powers of the Government Analyst.
Introduction & Objectives
Schedules of the Act.
Schedules of the Rule
Definitions
Administrative bodies
Import & Registration.
Manufacture of drugs
Sale of drugs
Labeling & packaging of drugs
Conditions for grant of licenses
Detailed study of schedules g, h, M, N, P, T, U,V, X & Y
The document summarizes the Drugs and Cosmetics Act of 1940 and Rules of 1945 in India. Some key points:
- It was enacted to regulate the import, manufacture, distribution and sale of drugs and cosmetics through a licensing system. Only qualified persons can manufacture, distribute and sell drugs and cosmetics.
- It covers definitions of drugs and cosmetics. Provisions relate to import, manufacture, sale, labeling and packaging of drugs. It describes schedules to the act and amendments made over time.
- The act is administered through various advisory committees and authorities like the Drugs Technical Advisory Board and Drugs Control Laboratories. It outlines licensing, manufacturing and sale requirements for different drug categories
The document summarizes key aspects of the Drugs and Cosmetics Act, 1940 and its rules regarding the import and manufacture of drugs in India. It outlines objectives like preventing substandard drugs and controlling import/manufacture through licensing. Important definitions are provided for terms like drug, cosmetic, Ayurvedic drugs etc. It also describes schedules to the act classifying drugs, licensing requirements for import/manufacture, conditions for licenses, and penalties for offences. In summary, it covers the legal framework for regulation and control of drugs in India.
Drugs and cosmetics act 1940, rule 1945 by dr. izhar ahmadIzhar Ahmad
This document provides an overview of the Drugs and Cosmetics Act of 1940 in India. Some key points:
[1] It was passed to regulate the import, manufacture, and sale of drugs and cosmetics in India following reports of poor drug quality during British rule.
[2] The Act established bodies like the Drugs Technical Advisory Board and Drugs Consultative Committees to advise on drug standards and administration of the Act.
[3] It defines terms like "drugs", "cosmetics", and covers areas like licensing for drug manufacture, inspection, penalties for violation, and standards that drugs must meet.
[4] The Act was amended over time, including
The document summarizes key aspects of the Drug and Cosmetic Act and Rules in India, including:
- The Acts and Rules regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
- Important definitions are provided for terms like "drug", "cosmetic", "manufacture" and others.
- Drugs and cosmetics can be deemed "misbranded", "adulterated" or "spurious" if they do not meet certain standards.
- The Rules contain 18 parts and 26 schedules providing detailed requirements and guidelines for drugs and cosmetics.
- Key agencies like the Drugs Technical Advisory Board help administer the Acts and
The document summarizes key aspects of the Drug and Cosmetic Act and Rules in India, including:
- The Acts and Rules regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
- Important definitions are provided for terms like "drug", "cosmetic", "manufacture" and others.
- Drugs and cosmetics can be deemed "misbranded", "adulterated" or "spurious" if they do not meet certain standards.
- The Rules contain 18 parts and 26 schedules providing detailed requirements and guidelines for drugs and cosmetics.
- Key agencies like the Drugs Technical Advisory Board help administer the Acts and
This document provides an overview of drug legislation in the United States and India. It discusses key acts passed in the US in 1906, 1938, 1962, and more that established regulations around drug safety and efficacy. For India, it outlines the Drugs and Cosmetics Act of 1940, the Pharmacy Act of 1948, and others that were enacted to regulate drug quality following reports of adulteration. The regulatory bodies for drugs are the US FDA and India's Central Drugs Standard Control Organization (CDSCO).
OTC drugs (Amended rules) Drug and Cosmetic Act, 1940 & Rules,1945Yamini Shah
The document provides an overview of over-the-counter (OTC) drugs in India, including their history, regulation, and classification. It discusses key amendments to drug laws in India in 1972, 2017, 2018, and 2019. These aimed to clarify the difference between OTC and prescription drugs, establish an OTC drug review process, and create a separate schedule for OTC drugs. The document also lists common OTC drug categories in India like analgesics, antacids, antihistamines, and proposes an initial list of OTC drugs.
This document provides an overview of the legal status of Ayurvedic, Siddha, and Unani medicines in India according to the Drugs and Cosmetics Act of 1940. Some key points:
- Ayurvedic, Siddha, and Unani medicines are defined under the act and regulated similarly to other drugs. They must be manufactured according to formulae from authoritative texts of the respective systems.
- Various bodies like the Drugs Technical Advisory Board provide recommendations for regulating these traditional medicines. Their manufacture, import, and quality control fall under the purview of the Drugs and Cosmetics Act.
- The act defines terms like "drug", "cosmetic", and "
A brief description of history,drugs and cosmetics acts and rules, various drug schedules included in the act and rules, brief description of drug schedules, Recent amendments, etc.
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
This document provides an overview of the Drugs and Cosmetics Act of 1940 and its rules from 1945. It discusses how the act was passed to control the import, manufacture, distribution and sale of drugs and cosmetics in India. It then defines several key terms used in the act, such as drug, cosmetic, manufacturer, and government analyst. Finally, it outlines the various schedules included in the act and rules, which classify drugs, specify standards, and provide licensing requirements and guidelines on manufacturing practices.
The Drugs and Cosmetics Act of 1940 and its subsequent amendments aim to regulate and ensure safety and quality of drugs and cosmetics in India. Key provisions include licensing requirements for import, manufacture, and sale of drugs and cosmetics. The act establishes regulatory bodies like the Drugs Technical Advisory Board and Drugs Control Committees. It defines terms like misbranded, adulterated, and spurious drugs and cosmetics. The schedules to the act and rules classify drugs based on their use and safety.
Drugs and Cosmetics Act, 1940 and its rules 1945:
Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
The Drugs and Cosmetics Act of 1940 and its rules of 1945 aim to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. Key objectives are to ensure the safety, efficacy and quality of drugs available to people and cosmetics marketed. The act defines various terms related to drugs and cosmetics and establishes schedules that classify drugs and outline manufacturing standards. It prohibits import of certain drugs or misbranded, spurious or adulterated products and allows import of other drugs under license. Licenses can be suspended or cancelled for non-compliance with conditions.
This document discusses the field of pharmacy. It begins by defining pharmacy as the science of preparing and dispensing drugs. It then discusses the history and development of pharmacy in India. Key events included the establishment of early pharmaceutical companies in the early 1900s, the Drug Enquiry Committee report in 1931 recommending the professionalization of pharmacy, and various laws passed between 1940-1985 to regulate the drug industry and practice of pharmacy. The document then covers topics within pharmacy including pharmaceutics, biopharmaceutics, and the code of ethics for pharmacists in India.
The document discusses the Drugs and Cosmetics Act of 1940 in India. It was established to regulate the import, manufacture, and sale of drugs and cosmetics through licensing. The Act created advisory bodies like the Drugs Technical Advisory Board and Drugs Consultative Committee. It also established the Central Drugs Laboratory. The Act defines key terms and sets provisions around import, manufacture, sale, labeling, and packaging of drugs and cosmetics. It prohibits the import of misbranded, spurious, substandard, or banned drugs and sets penalties for violations.
This document provides an overview of the Drugs and Cosmetics Act of 1940 and its rules of 1945 in India. It discusses the history and objectives of the act, key definitions, schedules, provisions around importing and manufacturing drugs, licensing requirements, and offenses and penalties. The act was implemented to regulate the drug industry and ensure safety, quality and standards through licensing and inspection. It covers allopathic, ayurvedic, siddha and unani medicines.
Drugs and Cosmetics Act 1940, 1945 Unit-I as per B. Pharm Pharmaceutical Juri...Sagarpamu123
This PPT covers the B. Pharm, Pharmaceutical Jurisprudence Unit-I topics with Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
Drugs and cosmetics act 1940 and rules 1945 swaSuvarta Maru
The document summarizes the history and objectives of the Drugs and Cosmetics Act of India. It was established in 1940 to regulate drugs and cosmetics in India by licensing manufacturers and sellers. The act has been amended several times since 1955 to update regulations. Key agencies established include the Drugs Technical Advisory Board, Drugs Control Laboratories, and positions for Government Analysts to enforce the act through inspections, testing, and investigations.
The document discusses key provisions of the Drugs and Cosmetics Act related to Ayurvedic, Siddha, and Unani (ASU) drugs in India. It outlines (1) how ASU drugs were included under the Act in 1964 with the insertion of Chapter IVA, (2) the roles of bodies established under the Act such as the ASU Drugs Technical Advisory Board and Drugs Consultative Committees, and (3) definitions and penalties related to misbranded, adulterated, and spurious ASU drugs. The schedules list authoritative books and standards for ASU drugs covered under the Act.
Drugs and cosmetics act, 1940 and rulesRavish Yadav
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
The document discusses key aspects of the Drugs and Cosmetics Act of India, including its history, objectives, definitions, administration, and provisions. Specifically, it aims to regulate the import, manufacture, distribution and sale of drugs and cosmetics through licensing to ensure quality and prevent substandard drugs. Key bodies established under the Act include the Drugs Technical Advisory Board, Drugs Control Laboratories, and offices of Government Analysts and Licensing Authorities.
Drugs and Cosmetics Act 1940 and Rules 1945 - Objectives, Legal definitionMd Altamash Ahmad
The document summarizes the Drugs and Cosmetics Act of 1940 and Rules of 1945 in India. It was introduced to regulate the import, manufacture, distribution and sale of drugs and cosmetics in the country. Some key points:
- It defines terms like drugs, cosmetics, misbranded and adulterated drugs.
- It aims to prevent entry of spurious drugs, allow only trained personnel to sell drugs, and prohibit manufacture of substandard drugs.
- It describes powers of drug inspectors to inspect premises and take samples to check quality standards.
- The act is administered through advisory boards, analytical laboratories, and executive authorities like licensing bodies and drug inspectors.
The document discusses various aspects of intellectual property (IP) laws in India, including the types of IP, governing acts, terms of protection, and infringement issues. It covers patents, trademarks, copyrights, and introduces the governing bodies of WIPO and IP law firms. Key points include:
1) Patents protect inventions and are governed by the Patents Act, 1970. The patent term is 20 years from filing and covers functional/technical inventions.
2) Trademarks protect symbols, logos, designs used in commerce and are governed by the Trademarks Act, 1999. Rights are reserved for 10-17 years and renewed.
3) Copyright protects literary, artistic, and musical works and
Fermentation is a process that uses microorganisms to produce food, pharmaceuticals, and alcoholic beverages on an industrial scale. There are three main types of fermentation processes: batch, fed-batch, and continuous. Batch fermentation involves adding all nutrients at once and allowing the microbes to grow until maximum product concentration is reached. Fed-batch fermentation involves regularly adding fresh media without removing culture. Continuous fermentation continuously removes and replenishes culture media and products to maintain steady conditions. Fermenters come in various sizes and designs including surface, submerged, stirred tank, airlift, and bubble column fermenters. Proper media formulation providing carbon, nitrogen, minerals and other nutrients is essential for microbial growth
The document summarizes key aspects of the Drug and Cosmetic Act and Rules in India, including:
- The Acts and Rules regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
- Important definitions are provided for terms like "drug", "cosmetic", "manufacture" and others.
- Drugs and cosmetics can be deemed "misbranded", "adulterated" or "spurious" if they do not meet certain standards.
- The Rules contain 18 parts and 26 schedules providing detailed requirements and guidelines for drugs and cosmetics.
- Key agencies like the Drugs Technical Advisory Board help administer the Acts and
The document summarizes key aspects of the Drug and Cosmetic Act and Rules in India, including:
- The Acts and Rules regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
- Important definitions are provided for terms like "drug", "cosmetic", "manufacture" and others.
- Drugs and cosmetics can be deemed "misbranded", "adulterated" or "spurious" if they do not meet certain standards.
- The Rules contain 18 parts and 26 schedules providing detailed requirements and guidelines for drugs and cosmetics.
- Key agencies like the Drugs Technical Advisory Board help administer the Acts and
This document provides an overview of drug legislation in the United States and India. It discusses key acts passed in the US in 1906, 1938, 1962, and more that established regulations around drug safety and efficacy. For India, it outlines the Drugs and Cosmetics Act of 1940, the Pharmacy Act of 1948, and others that were enacted to regulate drug quality following reports of adulteration. The regulatory bodies for drugs are the US FDA and India's Central Drugs Standard Control Organization (CDSCO).
OTC drugs (Amended rules) Drug and Cosmetic Act, 1940 & Rules,1945Yamini Shah
The document provides an overview of over-the-counter (OTC) drugs in India, including their history, regulation, and classification. It discusses key amendments to drug laws in India in 1972, 2017, 2018, and 2019. These aimed to clarify the difference between OTC and prescription drugs, establish an OTC drug review process, and create a separate schedule for OTC drugs. The document also lists common OTC drug categories in India like analgesics, antacids, antihistamines, and proposes an initial list of OTC drugs.
This document provides an overview of the legal status of Ayurvedic, Siddha, and Unani medicines in India according to the Drugs and Cosmetics Act of 1940. Some key points:
- Ayurvedic, Siddha, and Unani medicines are defined under the act and regulated similarly to other drugs. They must be manufactured according to formulae from authoritative texts of the respective systems.
- Various bodies like the Drugs Technical Advisory Board provide recommendations for regulating these traditional medicines. Their manufacture, import, and quality control fall under the purview of the Drugs and Cosmetics Act.
- The act defines terms like "drug", "cosmetic", and "
A brief description of history,drugs and cosmetics acts and rules, various drug schedules included in the act and rules, brief description of drug schedules, Recent amendments, etc.
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
This document provides an overview of the Drugs and Cosmetics Act of 1940 and its rules from 1945. It discusses how the act was passed to control the import, manufacture, distribution and sale of drugs and cosmetics in India. It then defines several key terms used in the act, such as drug, cosmetic, manufacturer, and government analyst. Finally, it outlines the various schedules included in the act and rules, which classify drugs, specify standards, and provide licensing requirements and guidelines on manufacturing practices.
The Drugs and Cosmetics Act of 1940 and its subsequent amendments aim to regulate and ensure safety and quality of drugs and cosmetics in India. Key provisions include licensing requirements for import, manufacture, and sale of drugs and cosmetics. The act establishes regulatory bodies like the Drugs Technical Advisory Board and Drugs Control Committees. It defines terms like misbranded, adulterated, and spurious drugs and cosmetics. The schedules to the act and rules classify drugs based on their use and safety.
Drugs and Cosmetics Act, 1940 and its rules 1945:
Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
The Drugs and Cosmetics Act of 1940 and its rules of 1945 aim to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. Key objectives are to ensure the safety, efficacy and quality of drugs available to people and cosmetics marketed. The act defines various terms related to drugs and cosmetics and establishes schedules that classify drugs and outline manufacturing standards. It prohibits import of certain drugs or misbranded, spurious or adulterated products and allows import of other drugs under license. Licenses can be suspended or cancelled for non-compliance with conditions.
This document discusses the field of pharmacy. It begins by defining pharmacy as the science of preparing and dispensing drugs. It then discusses the history and development of pharmacy in India. Key events included the establishment of early pharmaceutical companies in the early 1900s, the Drug Enquiry Committee report in 1931 recommending the professionalization of pharmacy, and various laws passed between 1940-1985 to regulate the drug industry and practice of pharmacy. The document then covers topics within pharmacy including pharmaceutics, biopharmaceutics, and the code of ethics for pharmacists in India.
The document discusses the Drugs and Cosmetics Act of 1940 in India. It was established to regulate the import, manufacture, and sale of drugs and cosmetics through licensing. The Act created advisory bodies like the Drugs Technical Advisory Board and Drugs Consultative Committee. It also established the Central Drugs Laboratory. The Act defines key terms and sets provisions around import, manufacture, sale, labeling, and packaging of drugs and cosmetics. It prohibits the import of misbranded, spurious, substandard, or banned drugs and sets penalties for violations.
This document provides an overview of the Drugs and Cosmetics Act of 1940 and its rules of 1945 in India. It discusses the history and objectives of the act, key definitions, schedules, provisions around importing and manufacturing drugs, licensing requirements, and offenses and penalties. The act was implemented to regulate the drug industry and ensure safety, quality and standards through licensing and inspection. It covers allopathic, ayurvedic, siddha and unani medicines.
Drugs and Cosmetics Act 1940, 1945 Unit-I as per B. Pharm Pharmaceutical Juri...Sagarpamu123
This PPT covers the B. Pharm, Pharmaceutical Jurisprudence Unit-I topics with Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
Drugs and cosmetics act 1940 and rules 1945 swaSuvarta Maru
The document summarizes the history and objectives of the Drugs and Cosmetics Act of India. It was established in 1940 to regulate drugs and cosmetics in India by licensing manufacturers and sellers. The act has been amended several times since 1955 to update regulations. Key agencies established include the Drugs Technical Advisory Board, Drugs Control Laboratories, and positions for Government Analysts to enforce the act through inspections, testing, and investigations.
The document discusses key provisions of the Drugs and Cosmetics Act related to Ayurvedic, Siddha, and Unani (ASU) drugs in India. It outlines (1) how ASU drugs were included under the Act in 1964 with the insertion of Chapter IVA, (2) the roles of bodies established under the Act such as the ASU Drugs Technical Advisory Board and Drugs Consultative Committees, and (3) definitions and penalties related to misbranded, adulterated, and spurious ASU drugs. The schedules list authoritative books and standards for ASU drugs covered under the Act.
Drugs and cosmetics act, 1940 and rulesRavish Yadav
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
The document discusses key aspects of the Drugs and Cosmetics Act of India, including its history, objectives, definitions, administration, and provisions. Specifically, it aims to regulate the import, manufacture, distribution and sale of drugs and cosmetics through licensing to ensure quality and prevent substandard drugs. Key bodies established under the Act include the Drugs Technical Advisory Board, Drugs Control Laboratories, and offices of Government Analysts and Licensing Authorities.
Drugs and Cosmetics Act 1940 and Rules 1945 - Objectives, Legal definitionMd Altamash Ahmad
The document summarizes the Drugs and Cosmetics Act of 1940 and Rules of 1945 in India. It was introduced to regulate the import, manufacture, distribution and sale of drugs and cosmetics in the country. Some key points:
- It defines terms like drugs, cosmetics, misbranded and adulterated drugs.
- It aims to prevent entry of spurious drugs, allow only trained personnel to sell drugs, and prohibit manufacture of substandard drugs.
- It describes powers of drug inspectors to inspect premises and take samples to check quality standards.
- The act is administered through advisory boards, analytical laboratories, and executive authorities like licensing bodies and drug inspectors.
The document discusses various aspects of intellectual property (IP) laws in India, including the types of IP, governing acts, terms of protection, and infringement issues. It covers patents, trademarks, copyrights, and introduces the governing bodies of WIPO and IP law firms. Key points include:
1) Patents protect inventions and are governed by the Patents Act, 1970. The patent term is 20 years from filing and covers functional/technical inventions.
2) Trademarks protect symbols, logos, designs used in commerce and are governed by the Trademarks Act, 1999. Rights are reserved for 10-17 years and renewed.
3) Copyright protects literary, artistic, and musical works and
Fermentation is a process that uses microorganisms to produce food, pharmaceuticals, and alcoholic beverages on an industrial scale. There are three main types of fermentation processes: batch, fed-batch, and continuous. Batch fermentation involves adding all nutrients at once and allowing the microbes to grow until maximum product concentration is reached. Fed-batch fermentation involves regularly adding fresh media without removing culture. Continuous fermentation continuously removes and replenishes culture media and products to maintain steady conditions. Fermenters come in various sizes and designs including surface, submerged, stirred tank, airlift, and bubble column fermenters. Proper media formulation providing carbon, nitrogen, minerals and other nutrients is essential for microbial growth
This document discusses herbal cosmetics and ingredients used for hair care. It describes various hair care products including shampoos, rinses, conditioners, and hair dyes. It provides details on important herbal materials used in hair care like amla, almond oil, shikakai, henna, neem, and others. The document also discusses formulations and evaluation methods for herbal hair conditioners, dyes, and shampoos. Key herbal ingredients and their benefits for hair care are emphasized.
The document discusses the mechanisms of innate and adaptive immunity. It describes the three lines of defense in the immune system: physical and chemical barriers, nonspecific resistance, and specific resistance. The mechanisms of innate immunity include epithelial surfaces, antibacterial substances, cellular factors, inflammation, fever, and acute phase proteins. Adaptive immunity involves B cells, T cells, and immunological memory. The humoral immune response involves antibody production by B cells, while cell-mediated immunity involves T cell activation and cytotoxic T cells destroying infected cells.
The document summarizes the key aspects of the Pharmacy Act of 1948 in India. It established the Pharmacy Council of India to regulate the profession of pharmacy, including prescribing minimum education standards and maintaining a central register of pharmacists. The Act also provides for state pharmacy councils to register pharmacists, inspect premises, and hear cases regarding removal from the register. The overall objective was to regulate and raise the standards of pharmacy practice in India through uniform education, training and control over entry into the profession.
Schedule P of the Drugs and Cosmetics Act, 1940 and its Rules 1945 outlines regulations for drugs. It establishes requirements for drug labeling including the expiration or shelf life of drugs. Manufacturers must display the date until which the drug is expected to meet specifications and remain safe and effective.
Antioxidants are compounds that terminate chain reactions initiated by free radicals, protecting cells from damage. They help protect skin from sun damage and signs of aging by guarding cells from free radical attack. Common antioxidant-rich foods include berries, citrus fruits, green tea, garlic, and herbs like ginkgo biloba and Asian ginseng. Preservatives prevent spoilage by being effective over a product's shelf life while being safe, non-toxic and not interacting with other ingredients. Common natural preservatives include tea tree oil, thyme oil, grapefruit seed extract, lemon, honey, and bee propolis.
Evaluation of the efficiency of sterilization methods.pptxmonika kaurav
Sterilization methods must be strictly evaluated to ensure products labeled as sterile are free of viable microorganisms. Controls include monitoring the sterilization process using sterility indicators and testing the sterility of final products. Effective controls are essential to guarantee the absence of microbes from sterilized medical supplies and equipment.
Herbal excipients and herbal formulationsmonika kaurav
This document discusses herbal excipients used in pharmaceutical formulations. It defines excipients as substances used as carriers for active pharmaceutical ingredients. Several herbal excipients are described, including starches, gums, cellulose, which are used as binding agents, disintegrants, coatings, and more. The advantages of herbal excipients are their renewable source, biodegradability, and lower cost compared to synthetic excipients. Challenges include potential variation in composition and contamination. Colorants, sweeteners, and binders are also discussed as classes of herbal excipients.
How to Build a Module in Odoo 17 Using the Scaffold MethodCeline George
Odoo provides an option for creating a module by using a single line command. By using this command the user can make a whole structure of a module. It is very easy for a beginner to make a module. There is no need to make each file manually. This slide will show how to create a module using the scaffold method.
This document provides an overview of wound healing, its functions, stages, mechanisms, factors affecting it, and complications.
A wound is a break in the integrity of the skin or tissues, which may be associated with disruption of the structure and function.
Healing is the body’s response to injury in an attempt to restore normal structure and functions.
Healing can occur in two ways: Regeneration and Repair
There are 4 phases of wound healing: hemostasis, inflammation, proliferation, and remodeling. This document also describes the mechanism of wound healing. Factors that affect healing include infection, uncontrolled diabetes, poor nutrition, age, anemia, the presence of foreign bodies, etc.
Complications of wound healing like infection, hyperpigmentation of scar, contractures, and keloid formation.
Strategies for Effective Upskilling is a presentation by Chinwendu Peace in a Your Skill Boost Masterclass organisation by the Excellence Foundation for South Sudan on 08th and 09th June 2024 from 1 PM to 3 PM on each day.
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
This presentation includes basic of PCOS their pathology and treatment and also Ayurveda correlation of PCOS and Ayurvedic line of treatment mentioned in classics.
Leveraging Generative AI to Drive Nonprofit InnovationTechSoup
In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
Liberal Approach to the Study of Indian Politics.pdf
UNIT-1-L-1,2,3-converted.pptx
1.
2. MONIKA KAURAV
ASSISTANT PROFESSOR
KIET SCHOOL OF PHARMACY
KIET GROUP OF INSTITUTIONS
DELHI NCR GHAZIABAD
DRUGS AND COSMETICS
ACT,1940AND ITS RULES
1945
(HISTORY, OBJECTIVES&
LEGAL DEFINITIONS)
3. The word jurisprudence derives from the Latin term juris prudentia, which
means "the study, knowledge, or science of law." Jurisprudence commonly
means the philosophy of law
. The third type of jurisprudence seeks to reveal
the historical, moral, and cultural basis of a particular legal concept.
Pharmaceutical jurisprudence is the study of laws regulating the profession
of pharmacy in India. It includes all the acts and rules thereof mentioned in the
constitution of India. E.g. drug and Cosmetics act and rules, pharmacy act, MTP
act, magic remedies act, etc.
5. British misrule-Providing poor healthcare system to Indian citizens
Observations made by-Drugs Enquiry Committee, Indian Medical
Association
Reports in- Indian Medical Gazette during 1920-30
1940 – Drugs and Cosmetics Act
1945 – Rules under the Act
Extended to whole ofIndia……
HISTORY
6. HISTORY
The Parliament of India formed an Act which regulates the import,
manufacture and distribution of drugs in India
The primary objective of the Act is to ensure that the drugs and cosmetics
sold in India are safe, effective and conform to prescribed quality
standards
The Drugs Act was formulated in 1940 in pursuance of recommendations of
Chopra Committee constituted in 1930 by Government of India
The drugs under the Drugs and Cosmetic Act cover wide varieties of
therapeutic substances, diagnostics and medical devices
7. HISTORY
The Act has been further amended as Drugs (amendment) Act 1964 to
include Ayurvedic and Unani drugs
The Drugs Act, as enacted in1940, has since been amended several
times and is now titled as “The Drugs and Cosmetics Act, 1940”.
8. HISTORY
The drug rules were promulgated in December 1945 and enforcement of
these rules started in 1947
The Rules have also been amended time to time to meet the needs of the time
and to rectify any deficiencies noticed during the implementation
The responsibility of enforcing the various Acts vests with the Central
government and State/Union Territory (UT) governments
Under the Drugs and Cosmetics Act, the drugs are classified in schedules
and regulations are laid down for their storage, display, sale, dispensing,
leveling, prescribing etc.
9. OBJECTIVES
To regulate the import, manufacture, distribution and sale of drugs
and cosmetics through licensing.
manufacture distribution and sale of drugs and cosmetics by qualified persons
only
To prevent sub standard in drugs for maintaining high standards of medical
treatment.
To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs
To establish Drugs Technical Advisory Board and Drugs
Consultative Committee for allopathic and allied drugs and cosmetics.
10. The salient features of the Drugs &Cosmetics Act, 1940 are
as follows:
Maximum penalty life imprisonment and fine of Rs. 10 lakhs or 3 times
the value of the confiscated goods, whichever is more.
Some of the offences cognizable and non-bailable.
Besides officers from the Drug Controller’s Office, other gazette officers
also authorized to launch prosecution under the Act;
Specially designated courts for trial of offences covered under the Act;
Provision for compounding of minor offences.
11. ABBREVIATIONS
• Adaptation of Laws Order,1950
• Clause
• Inserted
• Page
• Part
• Regulation
• Repealed
• Section
• Schedule
• Section
• Substituted
• with effectfrom
A.O.1950
Cl.
Ins.
P
.
Pt.
Reg.
Rep.
S.
Sch.
Sec.
Subs.
w.e.f.
12. PART 1 :DRUG AND COSMETIC ACT,1940
Chapter 1 • Introductory
Chapter 2
• The drugs TechnicalAdvisory Board,The
Central Drug Laboratory, The Drugs
Consultative Committee
Chapter 3 • Import of Drugs and Cosmetics
Chapter 4
• Manufacturing ,Sales and Distribution of Drugs
and Cosmetics
Chapter 4A
• Provisions relating to Ayurvedic ,Siddha and
Unani Drugs
Chapter 5 • Miscellaneous
13. PART 2 :DRUG AND COSMETIC RULES,1945
Part1 • Preliminary
Part2 • The Central Drugs Laboratory
Part3 • Rules 9to 20
Part4 • Import and Registration
Part5
• Government Analysts,Inspectors,Licensing
Authorities andcontrolling authorities
Part6 • Sale of Drugs other than Homeopathic
Medicines
Part6A • Sale of Homeopathic Medicines
Part7 • Manufacture for sale or for distribution of
Drugs other than Homeopathic Medicines
14. PART 2 :DRUG AND COSMETIC RULES,1945
Part 8
Part9 • Labelling and Packing of Drugs Other Than
Homeopathic Medicines
Part10
• Special Provisions Relating to Biological and
Other Special Products
Part10A
• Import of Manufacture of New Drug for Clinical
Trials or Marketing
Part10B
• Requirements for the collection , storage ,
processing and distribution of whole Human
Blood, Human Blood Components by Blood
Banks and Manufacture of Blood Products
• M anufacture for Examination, T
est or
Analysis
15. PART 2 :DRUG AND COSMETIC RULES,1945
Part 11
Part 12
Part 13
Part14
• Manufacture of Cosmetic for Sale or For
Distribution
Part15 • Labelling,Packing and Standards of Cosmtics
Part16
• Manufacture for sale of ayurvedic (including
Siddha) or Unani Drugs
• Exemptions
• Standards
• Import ofcosmetics
16. PART 2 :DRUG AND COSMETIC RULES,1945
Part17 • Labelling,Packing, Limit of Alcohol in
Ayurvedic (Including Siddha) or Unani Drugs
Part18 • Government Analysts and Inspectors for
Ayurvedic (Including Siddha) or Unani Drugs
Part19 • Standards of Ayurvedic ,Siddha and Unani
Drugs
17. PRESCRIBED APPENDICES
Appendix 1
• Data required to be submitted with application for the permission to
market a newdrug.
Appendix 2
• Format for submission of clinical trial reports.
Appendix 3
• Animal toxicity requirement for clinical trials and marketing of a new drug.
Appendix 4
• Number of animals for long term toxicity studies
Appendix 5
• Patients consent form for participating in a Phase I clinical trial
Appendix 6
• Four groups of fixed dose combination and their data requirement
18. The Drug and Cosmetics act, 1940 was enacted by the Department of Health
under the Ministry of Health and Family Welfare after receiving the assent of the
Governor General on April 10, 1940 and came into force on April 1, 1947
FIRST SCHEDULE:
list of ayurvedic, siddha and unani books.
SECOND SCHEDULE:
standards to be compiled with by imported drugs and by
drugs manufactured for sale, sold, stocked or exhibited for
sale or distributed.
It contains 168 rules from 1 to 168 and 25 Schedules from Schedule
A to ScheduleY.
19. LEGAL DEFINITIONS
Drug includes :
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
such substances (other than food) intended to affect the structure or any function of the
human body or intended to be used for the destruction of vermin or insects which cause
disease in human beings or animals, as may be specified from time to time by the Central
Government by notification in the Official Gazette
20. LEGAL DEFINITIONS
Drug includes :
all substances intended for use as components of a drug including empty gelatin
capsules;and
such devices intended for internal or external use in the diagnosis, treatment,
mitigation or prevention of disease or disorder in human beings or animals, as
may be specified from time to time by the Central Government by notification in
the Official Gazette, after consultation with the Board
21. LEGAL DEFINITIONS
Cosmetic includes :
Any article intended to be rubbed, poured, sprinkled or sprayed on, 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.
22. Misbranded drugs :
if it is so colored, coated, powdered or polished that damage is
concealed
if it is not labelled in the prescribed manner; or
if its label or container or anything accompanying the drug bears any
statement, design or device which makes any false claim for the drug or
which is false or misleading in any particular.
LEGAL DEFINITIONS
23. Adulterated drug :
if it consists, in whole or in part, of any filthy, putrid or decomposed
substance;
or
if it has been prepared, packed or stored under insanitary conditions whereby
it may have been contaminated with filth or whereby it may have been
rendered injurious to health; or
if its container is composed in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health.
LEGAL DEFINITIONS
24. Spurious drugs :
if it is imported under a name that belongs to another drug; or
if it is an imitation of, or a substitute for, another drug or
resembles another drug in a manner likely to deceive or bears
upon it or upon its label or container the name of another drug,
or
if it has been substituted wholly or in part by another drug or
substance.
LEGAL DEFINITIONS
25. LEGAL DEFINITIONS
Patent or Proprietary Medicine means :
in relation to Ayurvedic, Siddha or Unani Tibb systems of
medicine all formulations containing only such ingredients mentioned in the
formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems
of medicine specified in the First Schedule, but does not include a medicine which is
administered by parenteral route and also a formulation included in the authoritative
books as specified in clause (a);
in relation to any other systems of medicine, a drug which is a remedy or prescription
presented in a form ready for internal or external administration of human beings or
animals and which is not included in the edition of the Indian Pharmacopoeia for the time
being or any other Pharmacopoeia authorized in this behalf by the Central Government
after consultation with the Drugs Technical Advisory Board constituted under section 5
26. LEGAL DEFINITIONS
Registered Medical Practitioner means a person :
holding a qualification granted by an authority specified or notified under Section 3 of the Indian
Medical Degrees Act, 1916, or specified in the Schedules to the Indian Medical Council Act,
1956;or
registered or eligible for registration in a medical register of a State meant for the registration of
persons practicing the modern scientific system of medicine [excluding the Homoeopathic
system of medicine];or
registered in a medical register other than a register for the registration of Homoeopathic
practitioners of a State, who although not falling within sub- clause (i) or sub-clause (ii) is
declared by a general or special order made by the State Government in this behalf as a person
practicing the modern scientific system of medicine for the purposes of this Act ;or
registered or eligible for registration in the register of dentists for a State under the Dentists Act,
1948;or
who is engaged in the practice of veterinarymedicine and who possesses qualifications
approved by the State Government
27. LEGAL DEFINITIONS
HOMOEOPATHIC MEDICINES
It includes any drug whose therapeutic efficacy has been established through
long clinical experience as recorded in authoritative Homeopathic literature,
prepared according to the techniques of Homeopathic pharmacy. It does not
include medicines, administered by the parenteral route.
Registered Homoeopathic medical practitioner meansa
person who is registered in the Central Register or a State Register of
Homoeopathy
28. LEGAL DEFINITIONS
Ayurvedic, Siddha Or Unani Drugs includes all medicines : intended for
internal or external use for or in the diagnosis, treatment, mitigation or
prevention of disease or disorder in human beings or animals, and
manufactured exclusively in accordance with the formulae described in, the
authoritative books of [Ayurvedic, Siddha and Unani Tibb systems of
medicine], specified in the First Schedule.
Manufacture in relation to any drug or cosmetic includes : any process or part
of a process for making, altering, ornamenting, finishing, packing, labelling,
breaking up or otherwise treating or adopting any drug or cosmetic with a
view to its sale or distribution but does not include the compounding or
dispensing of any drug, or the packing of any drug or cosmetic in the ordinary
course of retail business
29. LEGAL DEFINITIONS
Government Analyst means :
in relation to Ayurvedic, Siddha or Unani drug, a Government Analyst appointed by
the Central Government or a State Government under section 33F;and
in relation to any other drug or cosmetic, a Government Analyst appointed by the Central
Government or a State Government under section 20
Inspector means :
in relation to Ayurvedic, Siddha or Unani drug, an Inspector appointed by the Central Government
or a State Government under section 33G; and
in relation to any other drug or cosmetic, an Inspector appointed by the Central
Government or a State Government under section 21
30. LEGAL DEFINITIONS
Central Licence Approving Authority means the Drugs Controller of India,
or the Joint Drugs Controller (India) or the Deputy Drugs Controller
(India) appointed by the Central Government
Director means the Director of the Central Drugs Laboratory
Form means a form set forth in Schedule A
Laboratory means the Central Drugs Laboratory
31. LEGAL DEFINITIONS
Retail Sale means a sale other than a sale by way of wholesale
dealing; whether to a hospital, or a dispensary, or a medical,
educational or research institute or to any other person
Sale by way of wholesale dealing means sale to a person for the
purpose of selling again and includes sale to a hospital, dispensary,
medical, educational or research institution
Poisonous Substance means a substance specified in Schedule E
32. SCHEDULE/ GUIDELINES RULE
A : Forms and formats of letters for applications of licensing etc.
B : Fee structure for drug analysis by CDL (Central Drug Laboratory) or by
the Govt. Analyst
C : Biological and special products for parenteral administration. Examples: Antibiotics,
Vitamins, Bacteriophages, Surgical dressings and Opthalmic preparations whose import,
manufacture, sale and distribution are governed by special provisions.
C(I) : Other special products for non-parenteral administration. Examples: Digitalis drugs,
Ergot drugs, Adrenaline, Fish liver oil, Hormonal preparations whose import, manufacture,
sale and distribution are governed by special provisions.
33. SCHEDULE/ GUIDELINES RULE
D : Exemptions that have been granted to drugs and importers of drugs from complying with
the requirements of import of the drugs and also the condition for such exemptions.
E(I) : List of poisonous substance under Ayurvedic, Siddha and Unani system of medicine
F and F(I): Special provisions applicable for the production, testing, storage,
packing and labelling of biological and other special products.
F(II):Standards of surgical dressings.
F(III):Standards of sterilized umbilical tapes.
FF: Standards for ophthalmic preparations.
34. SCHEDULE/ GUIDELINES RULE
G : List of substances that are required to be used under only medical supervision
and which are to be labelled accordingly. Ex. Metformin, Anti Histaminic, …etc
H : List of prescribed drugs that should be sold by retail only on prescriptionsof
R.M.P. Ex. Atenolol, Lorazepam, Dapson etc.
J : Disease or ailments which a drug may not purport to prevent or cure Ex.
Cancer, AIDS, Cataract, Diabetes…etc
K : Drugs exempted from certain provisions relating to the manufacture ofthe
drugs.
35. SCHEDULE/ GUIDELINES RULE
M : Good manufacturing practice (GMP) requirements of factory premises, plants
and equipments
M(I) : Requirements of factory premises for manufacturing of homeopathic
preparation.
M(II) : Requirements of factory premises for manufacturing of cosmetics.
M(III) : Requirements of factory premises for manufacturing of medical
devices
36. SCHEDULE/ GUIDELINES RULE
N : List of minimum equipments for efficient running of a pharmacy.
O : Standard for disinfectant fluids. Ex… Phenol, H2O2, alcohol etc
P : Life period of the drugs. Ex. Insulin Inj. – 24 months
P(I) : Pack size of the drugs
37. SCHEDULE/ GUIDELINES RULE
Q
Part-I : List of coaltar colours, dyes and pigments permitted in cosmetics and
soaps.
Part-II : List of colours permitted in soaps
Ex. Caramel, TiO2, Toney red
R : Standards for condoms which are made up of rubber latex intended for
single use and other mechanical contraceptives.
R(I) : Standards for medical devices
S : Various cosmetics and toiletries, and directs the
manufacturers of cosmetics to confirm to the latest
BSI (Bureau of Indian Standards) requirements.
38. SCHEDULE/ GUIDELINES RULE
• T : Requirement of factory premises and hygienic condition for Ayurvedic
(including Siddha) and Unani drugs.
• U : Particulars to be shown in manufacturing, raw material and analytical record of
thedrugs
• U(I) : Particulars to be shown in manufacturing, raw material and analytical record of
the cosmetics
• V : Standard for patent or proprietary medicines
39. SCHEDULE/ GUIDELINES RULE
W : List of drugs which can be marketed under generic names only.
X : Names of narcotic and psychotropic drugs for which special
control measure have been laid down
Y : Requirements and guidelines on clinical trials for import and
manufacture of the new drugs