Transintegra Healthacare Hong kong Pharmaceutical products registration poisins board
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Hong Kong Pharmaceutical Products which are not subject to Registration with Pharmacy & Poisons Board
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Schedules
THIS IS ABOUT SCHEDULES AND RULES IMPLEMENTED FOR MANUFACTURING, IMPORT, EXPORT, PRESCRIPTION, STORAGE OF ALLOPATHY, AYURVEDIC AND UNANI DRUGS.THERE IS DIFFERENT SCHEDULE FOR DIFFERENT KIND OF DRUGS LIKE BIOLOGICAL PRODUCTS, NARCOTIC DRUGS ETC.
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The document outlines various schedules under the Drugs and Cosmetics Act of 1940 and Rules of 1945 in India. The key schedules include:
- Schedule M which outlines Good Manufacturing Practice requirements for manufacturing premises, equipment, and operations.
- Schedule D which lists drugs that are exempt from certain import provisions.
- Schedule P which specifies the maximum permitted shelf-life periods for drugs.
The schedules provide standards and guidelines for drugs, cosmetics, surgical materials, and pharmaceutical manufacturing facilities in India.
Regulatory requirements for herbal medicines
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
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2. Herbal Medicines ke liye regulatory requirements
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Schedules
THIS IS ABOUT SCHEDULES AND RULES IMPLEMENTED FOR MANUFACTURING, IMPORT, EXPORT, PRESCRIPTION, STORAGE OF ALLOPATHY, AYURVEDIC AND UNANI DRUGS.THERE IS DIFFERENT SCHEDULE FOR DIFFERENT KIND OF DRUGS LIKE BIOLOGICAL PRODUCTS, NARCOTIC DRUGS ETC.
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This document summarizes various laws governing Ayurvedic drugs in India, including the Drug & Cosmetic Act of 1940, Drug & Magic Remedies Act of 1954, Prevention of Food Adulteration Act, Food Standards and Safety Act of 2006, and Narcotic Drugs and Psychotropic Substances Act of 1985. It provides details on key parts of acts like the Drug & Cosmetic Rules of 1945 and amendments made for regulation of Ayurvedic drugs. The document also lists some scheduled poisons and permitted excipients in Ayurvedic medicines.
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Schedule c
This document outlines standards and testing requirements for biological products and special products intended for parenteral administration in Schedule C. It discusses that these products must use proper names on labels and be sealed in sterile containers. It also requires labeling to meet Indian standards. Products must be tested for sterility, strength, quality, purity, abnormal toxicity, and pyrogens to ensure safety before the expiration date listed on the container.
Drugs & Cosmetics Act 1940 Part IV
This presentation describes various important schedules in the Drugs & Cosmetic Act. Schedules includes G,H,N,P,U,V,X,Y,F, Part-XII-B & DMR (OA).
Schedules of Pharmacy
The document outlines various schedules under the Drugs and Cosmetics Act of 1940 and Rules of 1945 in India. The key schedules include:
- Schedule M which outlines Good Manufacturing Practice requirements for manufacturing premises, equipment, and operations.
- Schedule D which lists drugs that are exempt from certain import provisions.
- Schedule P which specifies the maximum permitted shelf-life periods for drugs.
The schedules provide standards and guidelines for drugs, cosmetics, surgical materials, and pharmaceutical manufacturing facilities in India.
Regulatory requirements for herbal medicines
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
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The document discusses Thailand's drug control and registration system. It outlines the organization of the Drug Control Division within the Thai Food and Drug Administration and describes the drug licensing and registration processes. The drug registration system classifies drugs into new drugs, new generic drugs, and generic drugs and details the review process for new drug and new generic drug registration applications. It also discusses Thailand's safety monitoring program for new drugs and efforts to harmonize regulations with ASEAN standards.
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Drugscosmeticsact1940 120826115235-phpapp02.pptx-1
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This document discusses the Drugs and Cosmetics Act of 1940 and associated schedules in India. It provides an overview of the act's objectives to ensure drugs sold in India are safe and effective. It describes the various schedules which classify and regulate drugs based on their potential risks and how they must be labeled, prescribed, and sold. Key points covered include the roles of regulatory authorities, licensing requirements, and standards that drugs must meet to be imported or manufactured in India.
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The Drug and Cosmetic Act of 1940 and Rules of 1945 regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. The objectives are to prevent the import or manufacture of substandard drugs and cosmetics, and ensure they are only distributed by trained professionals. The Act defines key terms like "drug", "cosmetic", and categories of drugs like Ayurvedic and Homeopathic. It establishes standards for quality, prohibits misbranding and adulteration, and defines spurious drugs. Schedules list authoritative texts for Ayurvedic/Siddha/Unani medicines, quality standards, and classify drugs as prescription-only or over-the-counter. The Act aims to
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Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
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1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
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This document discusses labels for pharmaceutical products. It defines a label and describes two main types - manufacturer labels and dispensing labels. Manufacturer labels contain drug information for medical professionals and must include the name, strength, dosage form, quantity, instructions, precautions, registration number, batch number, dates and manufacturer details. Dispensing labels are affixed by pharmacists and include the patient's name, prescription number, directions for use, pharmacy information and sometimes interactions. Labels provide important information to ensure drugs are used safely and effectively.
Drugs & cosmetics act 1940
(i) Not below the rank of Deputy Drugs Controller
(ii) Qualification as prescribed for licensing authority
Functions:
(i) Grant/renewal/suspension/cancellation of licences
(ii) Inspection of premises
(iii) Collection of samples
(iv) Prosecution of offenders
SJTPC 25
Controlling authority
Qualification:
(i) Graduate in Pharmacy or Pharmaceutical
Chemistry or Medicine with specialization in
clinical pharmacology or microbiology
Functions:
(i) Co-ordination and unification of the activities of all
licensing authorities under it.
(ii) Appellate authority against the orders
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This document summarizes regulations regarding the import of drugs and cosmetics into India. It defines key terms like drugs, cosmetics, misbranded drugs, adulterated drugs, spurious drugs, misbranded cosmetics, and spurious cosmetics. It outlines rules for importing drugs under a license, including for Schedule C, C1, and X drugs. It also discusses importing drugs for personal use, importing new drugs, and importing drugs by government hospitals. Exceptions to import rules are provided. Finally, penalties for contravening import provisions are stated.
drug and cosmetic act
The document outlines the definitions, regulatory bodies, and provisions around the import, manufacture, and sale of Ayurvedic drugs and cosmetics under the Drugs and Cosmetics Act of India. It describes the roles of organizations like the Drugs Technical Advisory Board and Drug Consultative Committees in advising the government on these matters. It also summarizes the rules for licensing, inspection, sampling, and testing of imported, manufactured, and sold drugs and cosmetics to ensure quality standards are maintained.
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This document discusses the import of drugs and cosmetics into India. It begins by defining import, drug, and cosmetic. It then discusses that imported drugs and cosmetics must meet quality standards and cannot be misbranded, adulterated, or spurious. Misbranded drugs do not have proper labels, adulterated drugs contain decomposed substances or were prepared in unsanitary conditions, and spurious drugs are fake versions of other drugs. Certain drugs and cosmetics are prohibited from import if they do not meet these standards or are not properly labelled and packaged. Some drugs can be imported under license, including those in Schedules C, C1, and X or small quantities for testing or personal use
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This document provides an overview of basic information on pharmaceutical dosage forms and drug delivery systems. It discusses active drug substances and the need for dosage forms to deliver drugs effectively. Common dosage forms are described for oral, rectal, and other systemic routes of administration. These include tablets, capsules, liquids, and suppositories. Immediate and controlled release solid oral dosage forms are also covered. The document aims to familiarize readers with common dosage forms and factors influencing drug delivery through different systems.
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This document discusses the regulation of herbal drugs in India. It begins by providing background on traditional Indian medicine systems like Ayurveda, Siddha, Unani, Naturopathy and Homeopathy. It then explains that herbal drugs are regulated under the Drug and Cosmetic Act of 1940 and Rules of 1945 in India. The Department of AYUSH is the regulatory authority that issues manufacturing licenses and enforces good manufacturing practices. The document outlines the application process for licenses, facility requirements, and clinical trial guidelines for herbal drugs. It also discusses issues like intellectual property protection of traditional knowledge and the growth of the herbal drug industry in India.
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it includes all the description regarding the cosmetics,its manufacture , labelling, import and all other regulations.
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This document discusses the Drugs and Cosmetics Act of 1940 and associated schedules in India. It provides an overview of the act's objectives to ensure drugs sold in India are safe and effective. It describes the various schedules which classify and regulate drugs based on their potential risks and how they must be labeled, prescribed, and sold. Key points covered include the roles of regulatory authorities, licensing requirements, and standards that drugs must meet to be imported or manufactured in India.
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The Drug and Cosmetic Act of 1940 and Rules of 1945 regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. The objectives are to prevent the import or manufacture of substandard drugs and cosmetics, and ensure they are only distributed by trained professionals. The Act defines key terms like "drug", "cosmetic", and categories of drugs like Ayurvedic and Homeopathic. It establishes standards for quality, prohibits misbranding and adulteration, and defines spurious drugs. Schedules list authoritative texts for Ayurvedic/Siddha/Unani medicines, quality standards, and classify drugs as prescription-only or over-the-counter. The Act aims to
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Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Drug approval process in japan
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
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This document discusses labels for pharmaceutical products. It defines a label and describes two main types - manufacturer labels and dispensing labels. Manufacturer labels contain drug information for medical professionals and must include the name, strength, dosage form, quantity, instructions, precautions, registration number, batch number, dates and manufacturer details. Dispensing labels are affixed by pharmacists and include the patient's name, prescription number, directions for use, pharmacy information and sometimes interactions. Labels provide important information to ensure drugs are used safely and effectively.
Drugs & cosmetics act 1940
(i) Not below the rank of Deputy Drugs Controller
(ii) Qualification as prescribed for licensing authority
Functions:
(i) Grant/renewal/suspension/cancellation of licences
(ii) Inspection of premises
(iii) Collection of samples
(iv) Prosecution of offenders
SJTPC 25
Controlling authority
Qualification:
(i) Graduate in Pharmacy or Pharmaceutical
Chemistry or Medicine with specialization in
clinical pharmacology or microbiology
Functions:
(i) Co-ordination and unification of the activities of all
licensing authorities under it.
(ii) Appellate authority against the orders
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This document summarizes regulations regarding the import of drugs and cosmetics into India. It defines key terms like drugs, cosmetics, misbranded drugs, adulterated drugs, spurious drugs, misbranded cosmetics, and spurious cosmetics. It outlines rules for importing drugs under a license, including for Schedule C, C1, and X drugs. It also discusses importing drugs for personal use, importing new drugs, and importing drugs by government hospitals. Exceptions to import rules are provided. Finally, penalties for contravening import provisions are stated.
drug and cosmetic act
The document outlines the definitions, regulatory bodies, and provisions around the import, manufacture, and sale of Ayurvedic drugs and cosmetics under the Drugs and Cosmetics Act of India. It describes the roles of organizations like the Drugs Technical Advisory Board and Drug Consultative Committees in advising the government on these matters. It also summarizes the rules for licensing, inspection, sampling, and testing of imported, manufactured, and sold drugs and cosmetics to ensure quality standards are maintained.
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Fees and form for the submission of application.
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The document outlines India's regulations for new drugs. It defines new drugs and explains that they must demonstrate safety and efficacy through clinical trials before approval. It describes the general process which involves obtaining a license to manufacture test batches and approval from the Drugs Controller General of India to conduct clinical trials. Four phases of clinical trials are required to generate the necessary data for marketing authorization. The types of new drugs are defined and the documents required at each stage of clinical trials and for final marketing approval are detailed.
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This document provides an overview of semi-solid dosage forms. It defines semi-solids as products that tend to alleviate or treat pathological conditions when applied to the skin or mucous membranes. Ideal properties include a smooth texture, elegant appearance, and non-irritating qualities. Common types are ointments, creams, pastes, gels, and suppositories. Formulation involves selecting appropriate bases, preservatives, and other excipients. Methods of preparation include size reduction, levigation, mixing, homogenization, and filling. Evaluation tests physical properties, drug release, and stability.
dosage forms and route of drug administration
The document discusses different dosage forms and routes of drug administration. It describes how drugs are formulated with excipients into various dosage forms for efficacious delivery. The main dosage forms covered are solid forms like powders, granules, tablets, capsules; semi-solid forms like ointments, creams; and liquid forms like syrups, suspensions, emulsions. Each dosage form has unique characteristics depending on factors like physical appearance, how it is administered, and frequency of dosing. Common routes of administration include oral, topical, and injectable forms.
Pharmaceutical Suspensions and Emulsions
A detailed description about Pharmaceutical Suspensions and Emulsions or Disperse systems was given in this ppt
Semi solid dosage form
This document discusses semisolid dosage forms including ointments, creams, and gels. It defines these forms, describes common ingredients used in their preparation such as bases, preservatives, and gelling agents. Methods of preparation including fusion and emulsification are outlined. The document also discusses ideal properties and how these forms are evaluated based on parameters like penetration, release of active ingredients, and irritation potential.
Quality control of pharmaceutical products
This document discusses quality control of medicinal products. It defines quality control as procedures to ensure identity and purity of pharmaceuticals, ranging from simple chemical tests to complex pharmacopoeial standards. The document outlines types of counterfeit medicines that may have incorrect ingredients or dosages. It also discusses analytical processes for quality control, including standard methods, field tests, and ensuring precision and accuracy. Quality assurance involves four phases from evaluating new methods to external audits.
stability tests for pharmaceutical products
These documents provide guidance on stability testing and evaluation for pharmaceutical products. The purpose of stability testing is to provide evidence on how a drug product's quality varies over time under various environmental conditions. Key aspects addressed include testing the drug substance and finished product under different timepoints and storage conditions to establish or extend a product's shelf life. The documents outline best practices for conducting long-term, accelerated, and intermediate stability studies to evaluate the impact of factors like temperature, humidity, and light on a product's physical, chemical, biological, and microbiological properties over time.
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The Drugs & Cosmetics Act of 1940 established rules for licensing authorities, drug inspectors, and controlling authorities to regulate the import and sale of drugs and cosmetics in India. Key provisions include requirements for licensing authorities and inspectors to have qualifications in pharmacy or medicine. Inspectors are responsible for inspecting licensed establishments, ensuring license conditions are followed, investigating complaints, and maintaining records. The import of certain drug classes like misbranded, substandard, or spurious drugs is prohibited. Conditions for licensing the import of biological, narcotic, and Schedule X drugs as well as drugs for examination, personal use, and manufacturing are outlined. Cosmetics containing harmful ingredients or exceeding limits for heavy metals are also prohibited
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DRUG AND COSMETIC ACT,1940 AND ITS RULES 1945.pptx
The Drug and Cosmetic Act of 1940 and its Rules of 1945 were passed to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. The Act defines drugs and cosmetics and establishes schedules that list regulated substances. It provides for licensing of sales and imports, sets labeling and packaging requirements, and qualifies government analysts and drug inspectors to enforce the Act.
Indian pharmacopoeia from initial to latest edition
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This presentation provide you the basic knowledge about the Pharmacopoeia and later about the Indian Pharmacopoeia. Details about the Indian Pharmacopoeia i.e Who publish it? When first edition was published? Published Addendum? Latest edition and its Addendum? Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
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MANUFACTURING OF DRUGS AND COSMETICS
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The document summarizes the regulation of drug imports under the Drugs and Cosmetics Act of 1940 in India. It outlines that certain drugs cannot be imported if they are not of standard quality, misbranded, spurious, adulterated, or do not have an import license. Drugs specified in Schedules C and C1 can be imported under license, excluding those in Schedule X. An import license application requires a fee and must be accompanied by information about the drug. Licenses are valid until the end of the year issued and can be suspended or cancelled for non-compliance. Personal imports of drugs are allowed if for exclusive personal use and declared to customs.
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