This document discusses regulatory requirements for herbal drugs from a global perspective. It outlines challenges countries face in regulating herbal medicines, including assessing safety and efficacy, quality control, and monitoring adverse effects. Regulations vary significantly between countries and regions. Europe implemented strict regulations after an herbal supplement mix-up caused kidney failure in thousands of women. The US regulates herbal supplements as dietary supplements rather than drugs. Other countries discussed include India, Malaysia, Singapore, China, the Philippines, Nigeria, Saudi Arabia, Australia, Canada, and Japan. The conclusion emphasizes the need for standardized, strengthened global regulation of herbal medicines given increased use and reports of adverse effects.
This document discusses herbal cough remedies and regulation of herbal medicines. It provides epidemiological data showing widespread use of herbal medicines globally, with up to 80% of the population in Africa using traditional herbal medicine. Herbal medicines account for a significant portion of the pharmaceutical market. The document then reviews WHO guidelines for quality, safety and efficacy assessment of herbal medicines and compares regulation standards between countries like Germany, Egypt, and the United States. It also lists some common herbal cough remedies available in Egypt.
Regulatory requirement for setting herbal drug industryRAGHAV DOGRA
The World Health Organization (WHO) estimates that 80 percent of the population of some Asian and African countries presently use herbal medicine for some aspect of primary health care.Pharmaceuticals are prohibitively expensive for most of the world's population, half of whom lived on less than $2 U.S. per day in 2002. In comparison, herbal medicines can be grown from seed or gathered from nature for little or no cost
patent (/ˈpætənt/ or /ˈpeɪtənt/) is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention. An invention is a solution to a specific technological problem and is a product or a process. Patents are a form of intellectual property.
1) Herbal medicines are widely used globally but can cause adverse drug reactions. Pharmacovigilance, or monitoring the safety of medicines, is important for herbal drugs.
2) Challenges in herbal pharmacovigilance include regulation, quality control, and recording identities due to chemical complexity of herbs. Adverse reactions must be reported using forms submitted to regulatory authorities.
3) The WHO established guidelines for herbal pharmacovigilance to build safety information and protect public health. Improved monitoring can restore confidence in herbal medicines.
This document discusses the importance of pharmacovigilance for herbal medications. It notes that herbal medicines are widely used globally but can also cause adverse reactions. A systematic approach to monitoring the safety of herbal medicines is needed to understand their risks and benefits. The challenges include regulating herbal medicines, ensuring quality control, monitoring safety, and standardized identification of herbal ingredients. Pharmacovigilance practices can help evaluate potential adverse effects, identify safety issues, and promote the safe use of herbal therapies.
The herbal healthcare industry is growing globally but India only contributes $1 billion of the $47 billion market. India has a rich history of using herbal medicines through Ayurveda but needs modern testing and characterization to develop effective products. The domestic herbal market is estimated at Rs. 2500-3000 crores and growing at 25% annually. Major opportunities exist in chronic conditions treated by herbal medicines which are safe, convenient and cost-effective alternatives to modern drugs. Standardization, validation and cooperation across medical systems can help protect national interests in herbal medicine.
Effects of herbal drugs on clinical laboratories testing Swati Wadhawan
This document discusses the regulation of herbal medicines. It states that herbal medicines should be regulated to ensure their quality, safety and efficacy through mechanisms like licensing, good manufacturing practices, and pharmacovigilance. Manufacturers must adhere to standards and provide detailed product information for registration. Countries should establish regulatory systems and procedures appropriate to their situations to manage the use of herbal medicines.
This chapter discusses various drug information resources available to pharmacy technicians. It covers primary, secondary, and tertiary literature references as well as common references like Drug Facts and Comparisons, USP DI, Martindale, and AHFS. Other reference types discussed include textbooks, newsletters, indexes, the FDA Orange Book, and Material Safety Data Sheets. The chapter also reviews resources available through the internet, personal digital assistants, and pharmacy technician organizations.
This document discusses herbal cough remedies and regulation of herbal medicines. It provides epidemiological data showing widespread use of herbal medicines globally, with up to 80% of the population in Africa using traditional herbal medicine. Herbal medicines account for a significant portion of the pharmaceutical market. The document then reviews WHO guidelines for quality, safety and efficacy assessment of herbal medicines and compares regulation standards between countries like Germany, Egypt, and the United States. It also lists some common herbal cough remedies available in Egypt.
Regulatory requirement for setting herbal drug industryRAGHAV DOGRA
The World Health Organization (WHO) estimates that 80 percent of the population of some Asian and African countries presently use herbal medicine for some aspect of primary health care.Pharmaceuticals are prohibitively expensive for most of the world's population, half of whom lived on less than $2 U.S. per day in 2002. In comparison, herbal medicines can be grown from seed or gathered from nature for little or no cost
patent (/ˈpætənt/ or /ˈpeɪtənt/) is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention. An invention is a solution to a specific technological problem and is a product or a process. Patents are a form of intellectual property.
1) Herbal medicines are widely used globally but can cause adverse drug reactions. Pharmacovigilance, or monitoring the safety of medicines, is important for herbal drugs.
2) Challenges in herbal pharmacovigilance include regulation, quality control, and recording identities due to chemical complexity of herbs. Adverse reactions must be reported using forms submitted to regulatory authorities.
3) The WHO established guidelines for herbal pharmacovigilance to build safety information and protect public health. Improved monitoring can restore confidence in herbal medicines.
This document discusses the importance of pharmacovigilance for herbal medications. It notes that herbal medicines are widely used globally but can also cause adverse reactions. A systematic approach to monitoring the safety of herbal medicines is needed to understand their risks and benefits. The challenges include regulating herbal medicines, ensuring quality control, monitoring safety, and standardized identification of herbal ingredients. Pharmacovigilance practices can help evaluate potential adverse effects, identify safety issues, and promote the safe use of herbal therapies.
The herbal healthcare industry is growing globally but India only contributes $1 billion of the $47 billion market. India has a rich history of using herbal medicines through Ayurveda but needs modern testing and characterization to develop effective products. The domestic herbal market is estimated at Rs. 2500-3000 crores and growing at 25% annually. Major opportunities exist in chronic conditions treated by herbal medicines which are safe, convenient and cost-effective alternatives to modern drugs. Standardization, validation and cooperation across medical systems can help protect national interests in herbal medicine.
Effects of herbal drugs on clinical laboratories testing Swati Wadhawan
This document discusses the regulation of herbal medicines. It states that herbal medicines should be regulated to ensure their quality, safety and efficacy through mechanisms like licensing, good manufacturing practices, and pharmacovigilance. Manufacturers must adhere to standards and provide detailed product information for registration. Countries should establish regulatory systems and procedures appropriate to their situations to manage the use of herbal medicines.
This chapter discusses various drug information resources available to pharmacy technicians. It covers primary, secondary, and tertiary literature references as well as common references like Drug Facts and Comparisons, USP DI, Martindale, and AHFS. Other reference types discussed include textbooks, newsletters, indexes, the FDA Orange Book, and Material Safety Data Sheets. The chapter also reviews resources available through the internet, personal digital assistants, and pharmacy technician organizations.
This document provides guidance on requirements for starting a herbal medicine business in India. It outlines key considerations such as conducting market research to understand target customers and trends, gaining knowledge of herbs and their properties, obtaining necessary licenses and registrations from regulatory authorities, selecting an appropriate business location, and implementing marketing strategies. The herbal medicine industry in India is regulated under laws and agencies that govern manufacturing, labeling, and safety of Ayurvedic, Siddha, and Unani herbal products.
This slide contains what is generic drug, what is advantages & disadvantages,reason behind unpopularity of generic drug in India, why generic drugs are important in India, why there is a need of generic drug policy, who are the regulatory authority, what are the act & laws, what policy existing in India for generic drug then Conclusion.
The document summarizes the scope of pharmacy education. It discusses how pharmacy involves the art and science of manufacturing and dispensing drugs to cure diseases and promote health. Pharmacy encompasses various fields like pharmaceutical chemistry, pharmaceutics, pharmacology, and pharmacognosy. The document outlines career opportunities for pharmacy graduates in industries, hospitals, research, academia, government, and more. It emphasizes that the pharmaceutical industry is large and growing in India, offering jobs, business opportunities, and a promising future for pharmacy graduates.
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.
The document discusses international guidelines for herbal drugs. The International Council for Harmonization (ICH) brings together regulatory bodies and the pharmaceutical industry to achieve greater harmonization of standards for safe, effective, and high-quality medicines worldwide. While ICH does not have separate guidelines for herbal drugs, development, testing, and clinical trials of herbal medicines follow ICH standards. The World Health Organization also provides information and guidelines regarding traditional and herbal medicines, as over 60% of the world's population uses some form of traditional medicine.
The document introduces an herbal medicine product called Herbicure and discusses plans to market it in England. It notes Herbicure contains natural ingredients that treat various diseases without side effects. Regulations for herbal medicines in England require products to be manufactured under good practices and allow medicinal claims on labels. The alternative medicine market in the UK is growing and competition comes from Chinese and Indian herbal companies. Distribution plans involve partnering with an existing herbal company in England. Sales and promotion will use TV, print media, and offers to retailers. England is seen as a way to enter the larger EU market due to its population and interest in herbal remedies.
This document defines key terms related to phytopharmaceuticals and herbal medicine. It describes phytopharmaceuticals as plant-based drugs containing at least four bioactive compounds that are purified and standardized for human or animal use. Active ingredients are the therapeutic components of herbal medicines. Botanical drug substances, herbal preparations, and finished herbal products are other terms defined. The document also discusses regulatory affairs, traditional medicine, pharmacovigilance, and pharmacoeconomics as they relate to herbal products.
Herbs, Herbal Drugs
Present Scope of Herbal Drug Industry
Scope of Herbal Drug Medicine and Industry
Indian Herbal Industry
International Scope of Herbal Medicines
World Wide Herbal Trade
Overview on plant based industries and research institutions in India
List of few herbal drug industries in India
List of few herbal research institution/ centres in India
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and
aromatic plants in India.
Pharmacy is the science and art of preparing and dispensing medications. Pharmacists play an important role in public health by providing drug information to patients and acting as experts on medications. The document outlines the diverse career opportunities available to pharmacists in fields like hospitals, clinics, community pharmacies, the pharmaceutical industry, government services, and more. Key roles of pharmacists include preparing medications, ensuring quality control, dispensing drugs, and counseling patients.
Noble pharmacy profession for an ever glowing career ppt final 04 10-2021BhanuSagar3
The document provides a history of pharmacy from ancient times to the present. It discusses how pharmacy has evolved from early practices of using natural materials to cure illnesses, to the modern era of evidence-based drug development and patient care. Key events highlighted include the documentation of early remedies in texts like the Ebers Papyrus, advances made by Greek and Roman philosophers, the rise of pharmacy as a separate profession during the Renaissance, the industrialization and standardization of drug production, and today's focus on biotechnology, genetics and clinical practice. The document also outlines the diverse career opportunities now available to pharmacists in fields like the pharmaceutical industry, hospitals, research, education, and regulatory affairs.
Scope of Pharmacy 1 Prof morning Batch 2021Tehmina Adnan
The document provides an overview of various areas of pharmacy including hospital pharmacy, clinical pharmacy, industrial pharmacy, retail pharmacy, and pharmacy education. It discusses the roles and responsibilities of pharmacists in different settings such as hospitals, industry, and retail. It also outlines the scope of pharmacy practice and career opportunities available to pharmacists in areas like academics, marketing, research, and government.
This document provides an overview of an online pharmacy class for first year pharmacy students globally. It introduces topics like the different fields of pharmacy practice such as hospital, retail, and industrial pharmacy. It defines key pharmacy terms like pharmaceutics, drug, and nomenclature of drugs. The document outlines the scope of pharmacy which includes compounding, dispensing, and patient care services. It also lists opportunities for pharmacists in various settings like the pharmaceutical industry, hospitals, retail pharmacies, academia, and more. The next lecture will cover the history and literature of pharmacy.
This document provides an overview of the textbook "The Pharmacy Technician 4th Edition" by Dr. Bisrat Hailemeskel. It discusses the origins of pharmacy dating back thousands of years, how medicine has evolved over time, and key developments in the 20th century like antibiotics and the establishment of the FDA. It also describes the role of pharmacists today, the education and licensing process, and how computers are now used extensively in pharmacy settings to manage patient profiles, billing, prescribing, and labeling.
The document provides an overview of the history and development of pharmacy and healthcare. It describes how ancient civilizations first looked to magic and religion to explain illness before adopting more scientific approaches. Key developments included ancient Greek and Roman physicians establishing early medical practices, the identification of active compounds from plants in the Middle Ages, and major advances in the 19th-20th centuries like vaccines, antibiotics, and new drug development. The modern pharmacy profession developed alongside new regulations with the growth of pharmaceutical drugs in the 20th century.
This document outlines the Philippine National Drug Policy and provides information about the 7th edition of the Philippine National Drug Formulary (PNDF) Volume I. The five pillars of the Philippine National Drug Policy are described which aim to ensure drug quality, promote rational drug use, develop local pharmaceutical industry, implement targeted government drug procurement, and empower the public. The PNDF Volume I is the country's essential medicines list and is regularly updated by the National Formulary Committee. Key details provided in this document include acknowledgements, definitions, guidelines, and statistics related to the 7th edition of the PNDF Volume I.
1. Pharmacy is a health profession that links health sciences with pharmaceutical sciences to ensure safe and effective use of drugs.
2. Pharmacists work in various settings like hospitals, retail pharmacies, the pharmaceutical industry, and academia. They are responsible for interpreting prescriptions, compounding and dispensing medications, providing drug information to patients and healthcare professionals, and ensuring appropriate drug use.
3. Pharmacy education involves studying both prerequisite sciences and professional pharmacy courses over several years to become an expert in medicines who can optimize patient outcomes.
The document provides an overview of the field of pharmacy, including:
- Pharmacy is defined as the science of preparing, dispensing, and reviewing drugs and providing additional clinical services to ensure safe and effective medication use.
- Key areas of pharmacy practice are described, including hospital pharmacy, retail pharmacy, industrial pharmacy, and forensic pharmacy.
- The roles and responsibilities of pharmacists are outlined, emphasizing their role in optimizing patient outcomes through medication management.
- Pharmacy education and the various specializations within the field are summarized.
Pharmaceutics is the area of study concerned with the formulation,
manufacturing stability and effectiveness of pharmaceutical dosage form. In
the previous unit various communicable, non-communicable disorders were
described. In this unit we will study how the drugs are administered in the body
to be effective. Drugs are rarely used alone. They are used as a part of a
formulation with other non-drug substances. These non-drug substances or
additives serve specific function. The drugs presented in the dosage form are
given in a specific quantity i.e. dose for a specific period. These dosage forms
are available in various forms as required for a specific disease condition.
Packaging of dosage form is another important aspect as the dosage form
should not degrade during storage. A good packaging is necessary to protect
the drug component from any type of deterioration till it reaches the consumer.
The importance of medicinal plants in the treatment of a variety of human ailments man has been dependent on the higher plants as a source of food and medicine.
This document discusses pharmacy as a career. It describes pharmacy as the science of medicines and the art of compounding and dispensing drugs. It notes that India has a large and developed pharmaceutical industry, being the world's third largest by volume and exporting $11 billion in generic drugs in 2012. The document outlines the scope of pharmacy work, including jobs in government organizations, pharma industries, hospitals, research institutes, and more. It provides examples of prominent pharmaceutical companies in Gujarat, India and describes roles in areas like industrial pharmacy, clinical research, drug regulatory affairs, community pharmacy, and hospital pharmacy.
This document discusses pharmacovigilance as it relates to herbal medications. It defines pharmacovigilance and outlines its goals of improving patient safety, public health, and risk assessment of medicines. It then discusses specific challenges in monitoring the safety of herbal medicines, including quality control issues due to their complex chemical profiles. Several methods for herbal pharmacovigilance are described, including spontaneous adverse event reporting, prescription event monitoring, and reporting by herbal practitioners. Some herbs with known safety risks are highlighted as examples.
The document discusses regulations for herbal drugs and quality standards. It outlines World Health Organization guidelines for authentication, contaminants testing, and other quality control of herbal drugs. It then describes regulations for herbal drugs in India, the United States, Australia, Canada, and the European Union. It also discusses Schedule T of the Indian Drugs and Cosmetics Act, which lays out good manufacturing practices, and potential interactions between herbal medicines and conventional drugs.
This document provides guidance on requirements for starting a herbal medicine business in India. It outlines key considerations such as conducting market research to understand target customers and trends, gaining knowledge of herbs and their properties, obtaining necessary licenses and registrations from regulatory authorities, selecting an appropriate business location, and implementing marketing strategies. The herbal medicine industry in India is regulated under laws and agencies that govern manufacturing, labeling, and safety of Ayurvedic, Siddha, and Unani herbal products.
This slide contains what is generic drug, what is advantages & disadvantages,reason behind unpopularity of generic drug in India, why generic drugs are important in India, why there is a need of generic drug policy, who are the regulatory authority, what are the act & laws, what policy existing in India for generic drug then Conclusion.
The document summarizes the scope of pharmacy education. It discusses how pharmacy involves the art and science of manufacturing and dispensing drugs to cure diseases and promote health. Pharmacy encompasses various fields like pharmaceutical chemistry, pharmaceutics, pharmacology, and pharmacognosy. The document outlines career opportunities for pharmacy graduates in industries, hospitals, research, academia, government, and more. It emphasizes that the pharmaceutical industry is large and growing in India, offering jobs, business opportunities, and a promising future for pharmacy graduates.
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.
The document discusses international guidelines for herbal drugs. The International Council for Harmonization (ICH) brings together regulatory bodies and the pharmaceutical industry to achieve greater harmonization of standards for safe, effective, and high-quality medicines worldwide. While ICH does not have separate guidelines for herbal drugs, development, testing, and clinical trials of herbal medicines follow ICH standards. The World Health Organization also provides information and guidelines regarding traditional and herbal medicines, as over 60% of the world's population uses some form of traditional medicine.
The document introduces an herbal medicine product called Herbicure and discusses plans to market it in England. It notes Herbicure contains natural ingredients that treat various diseases without side effects. Regulations for herbal medicines in England require products to be manufactured under good practices and allow medicinal claims on labels. The alternative medicine market in the UK is growing and competition comes from Chinese and Indian herbal companies. Distribution plans involve partnering with an existing herbal company in England. Sales and promotion will use TV, print media, and offers to retailers. England is seen as a way to enter the larger EU market due to its population and interest in herbal remedies.
This document defines key terms related to phytopharmaceuticals and herbal medicine. It describes phytopharmaceuticals as plant-based drugs containing at least four bioactive compounds that are purified and standardized for human or animal use. Active ingredients are the therapeutic components of herbal medicines. Botanical drug substances, herbal preparations, and finished herbal products are other terms defined. The document also discusses regulatory affairs, traditional medicine, pharmacovigilance, and pharmacoeconomics as they relate to herbal products.
Herbs, Herbal Drugs
Present Scope of Herbal Drug Industry
Scope of Herbal Drug Medicine and Industry
Indian Herbal Industry
International Scope of Herbal Medicines
World Wide Herbal Trade
Overview on plant based industries and research institutions in India
List of few herbal drug industries in India
List of few herbal research institution/ centres in India
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and
aromatic plants in India.
Pharmacy is the science and art of preparing and dispensing medications. Pharmacists play an important role in public health by providing drug information to patients and acting as experts on medications. The document outlines the diverse career opportunities available to pharmacists in fields like hospitals, clinics, community pharmacies, the pharmaceutical industry, government services, and more. Key roles of pharmacists include preparing medications, ensuring quality control, dispensing drugs, and counseling patients.
Noble pharmacy profession for an ever glowing career ppt final 04 10-2021BhanuSagar3
The document provides a history of pharmacy from ancient times to the present. It discusses how pharmacy has evolved from early practices of using natural materials to cure illnesses, to the modern era of evidence-based drug development and patient care. Key events highlighted include the documentation of early remedies in texts like the Ebers Papyrus, advances made by Greek and Roman philosophers, the rise of pharmacy as a separate profession during the Renaissance, the industrialization and standardization of drug production, and today's focus on biotechnology, genetics and clinical practice. The document also outlines the diverse career opportunities now available to pharmacists in fields like the pharmaceutical industry, hospitals, research, education, and regulatory affairs.
Scope of Pharmacy 1 Prof morning Batch 2021Tehmina Adnan
The document provides an overview of various areas of pharmacy including hospital pharmacy, clinical pharmacy, industrial pharmacy, retail pharmacy, and pharmacy education. It discusses the roles and responsibilities of pharmacists in different settings such as hospitals, industry, and retail. It also outlines the scope of pharmacy practice and career opportunities available to pharmacists in areas like academics, marketing, research, and government.
This document provides an overview of an online pharmacy class for first year pharmacy students globally. It introduces topics like the different fields of pharmacy practice such as hospital, retail, and industrial pharmacy. It defines key pharmacy terms like pharmaceutics, drug, and nomenclature of drugs. The document outlines the scope of pharmacy which includes compounding, dispensing, and patient care services. It also lists opportunities for pharmacists in various settings like the pharmaceutical industry, hospitals, retail pharmacies, academia, and more. The next lecture will cover the history and literature of pharmacy.
This document provides an overview of the textbook "The Pharmacy Technician 4th Edition" by Dr. Bisrat Hailemeskel. It discusses the origins of pharmacy dating back thousands of years, how medicine has evolved over time, and key developments in the 20th century like antibiotics and the establishment of the FDA. It also describes the role of pharmacists today, the education and licensing process, and how computers are now used extensively in pharmacy settings to manage patient profiles, billing, prescribing, and labeling.
The document provides an overview of the history and development of pharmacy and healthcare. It describes how ancient civilizations first looked to magic and religion to explain illness before adopting more scientific approaches. Key developments included ancient Greek and Roman physicians establishing early medical practices, the identification of active compounds from plants in the Middle Ages, and major advances in the 19th-20th centuries like vaccines, antibiotics, and new drug development. The modern pharmacy profession developed alongside new regulations with the growth of pharmaceutical drugs in the 20th century.
This document outlines the Philippine National Drug Policy and provides information about the 7th edition of the Philippine National Drug Formulary (PNDF) Volume I. The five pillars of the Philippine National Drug Policy are described which aim to ensure drug quality, promote rational drug use, develop local pharmaceutical industry, implement targeted government drug procurement, and empower the public. The PNDF Volume I is the country's essential medicines list and is regularly updated by the National Formulary Committee. Key details provided in this document include acknowledgements, definitions, guidelines, and statistics related to the 7th edition of the PNDF Volume I.
1. Pharmacy is a health profession that links health sciences with pharmaceutical sciences to ensure safe and effective use of drugs.
2. Pharmacists work in various settings like hospitals, retail pharmacies, the pharmaceutical industry, and academia. They are responsible for interpreting prescriptions, compounding and dispensing medications, providing drug information to patients and healthcare professionals, and ensuring appropriate drug use.
3. Pharmacy education involves studying both prerequisite sciences and professional pharmacy courses over several years to become an expert in medicines who can optimize patient outcomes.
The document provides an overview of the field of pharmacy, including:
- Pharmacy is defined as the science of preparing, dispensing, and reviewing drugs and providing additional clinical services to ensure safe and effective medication use.
- Key areas of pharmacy practice are described, including hospital pharmacy, retail pharmacy, industrial pharmacy, and forensic pharmacy.
- The roles and responsibilities of pharmacists are outlined, emphasizing their role in optimizing patient outcomes through medication management.
- Pharmacy education and the various specializations within the field are summarized.
Pharmaceutics is the area of study concerned with the formulation,
manufacturing stability and effectiveness of pharmaceutical dosage form. In
the previous unit various communicable, non-communicable disorders were
described. In this unit we will study how the drugs are administered in the body
to be effective. Drugs are rarely used alone. They are used as a part of a
formulation with other non-drug substances. These non-drug substances or
additives serve specific function. The drugs presented in the dosage form are
given in a specific quantity i.e. dose for a specific period. These dosage forms
are available in various forms as required for a specific disease condition.
Packaging of dosage form is another important aspect as the dosage form
should not degrade during storage. A good packaging is necessary to protect
the drug component from any type of deterioration till it reaches the consumer.
The importance of medicinal plants in the treatment of a variety of human ailments man has been dependent on the higher plants as a source of food and medicine.
This document discusses pharmacy as a career. It describes pharmacy as the science of medicines and the art of compounding and dispensing drugs. It notes that India has a large and developed pharmaceutical industry, being the world's third largest by volume and exporting $11 billion in generic drugs in 2012. The document outlines the scope of pharmacy work, including jobs in government organizations, pharma industries, hospitals, research institutes, and more. It provides examples of prominent pharmaceutical companies in Gujarat, India and describes roles in areas like industrial pharmacy, clinical research, drug regulatory affairs, community pharmacy, and hospital pharmacy.
This document discusses pharmacovigilance as it relates to herbal medications. It defines pharmacovigilance and outlines its goals of improving patient safety, public health, and risk assessment of medicines. It then discusses specific challenges in monitoring the safety of herbal medicines, including quality control issues due to their complex chemical profiles. Several methods for herbal pharmacovigilance are described, including spontaneous adverse event reporting, prescription event monitoring, and reporting by herbal practitioners. Some herbs with known safety risks are highlighted as examples.
The document discusses regulations for herbal drugs and quality standards. It outlines World Health Organization guidelines for authentication, contaminants testing, and other quality control of herbal drugs. It then describes regulations for herbal drugs in India, the United States, Australia, Canada, and the European Union. It also discusses Schedule T of the Indian Drugs and Cosmetics Act, which lays out good manufacturing practices, and potential interactions between herbal medicines and conventional drugs.
This document summarizes the progress of globalizing traditional Chinese medicines (TCM). It discusses how several TCM herbal monographs have been adopted by the United States Pharmacopoeia and over 45 by the European Pharmacopoeia. The first TCM product was registered in the Netherlands as a traditional medicine. Currently, nine TCM products are in clinical trials with the US FDA, with one in Phase III trials. However, no TCM products have been approved as drugs by the FDA yet. The document also reviews the registration pathways for herbal medicines in Europe and the classifications of traditional use, well-established use, and full marketing authorization.
The use of herbal drugs for the prevention and treatment of various health ailments has been in practice from time immemorial. Generally it is believed that the risk associated with herbal drugs is very less, but reports on serious reactions are indicating to the need for development of effective marker systems for isolation and identification of the individual components.Standards for herbal drugs are being developed worldwide but as yet there is no common consensus as to how these should be adopted. Standardization, stability and quality control for herbal drugs are feasible, but difficult to accomplish. Further, the regulation of these drugs is not uniform across countries. There are variations in the methods used across medicine systems and countries in achieving stability and quality control. The present study attempts to identify the evolution of technical standards in manufacturing and the regulatory guideline development for commercialization of herbal drugs.
Keywords: survey was conducted to obtain primary data on challenges faced during production, commercialization, and marketing approval for traditional or herbal drugs in India and abroad. Responses were collected from companies by email, telephone, and in-person interviews and were analyzed to draw appropriate conclusions.The use of plants, parts of plants and isolated phytochemicals for the prevention and treatment of various health ailments has been in practice from time immemorial. It is estimated that about 25% of the drugs prescribed worldwide are derived from plants and 121 such active compounds are in use. Of the total 252 drugs in WHO's essential medicine list, 11% is exclusively of plant origin The use of plants, parts of plants and isolated phytochemicals for the prevention and treatment of various health ailments has been in practice from time immemorial. It is estimated that about 25% of the drugs prescribed worldwide are derived from plants and 121 such active compounds are in use. Of the total 252 drugs in WHO's essential medicine list, 11% is exclusively of plant origin .
This document provides guidelines for monitoring the safety of herbal medicines. It discusses the importance of including herbal medicines in pharmacovigilance systems to understand adverse effects from combined herbal and conventional medicine use. Sources of safety reports include healthcare professionals, consumers, hospitals, and manufacturers. National regulatory agencies are responsible for communicating safety information through various channels to facilitate safe and effective herbal medicine use.
Herbal products in canada how safe are theyNazeer Mohd
Herbal products sold in Canada are largely unregulated as they are exempt from the drug review process if not registered as drugs. This places consumers at risk of side effects from adulterated or ineffective herbal products. While perceived as natural and safe, herbal therapies can be harmful, especially when used to replace conventional medical treatment. Physicians need to be aware of potential issues with herbal product use in order to advise patients.
The document discusses herbal medicines and natural products. It introduces pharmacognosy as the study of medicinal plants and natural products used as medicines. Herbal medicines contain complex mixtures of compounds derived from plants, while pure natural products contain single or a few active compounds. Quality control and production processes are important for both herbal medicines and pure natural products to ensure safety and efficacy. Regulations provide frameworks for traditionally used herbal medicines.
Herbal pharmacovigilance: India vs global outlook
Proper training for pharmacovigilance
If people had been trained on how, why, what and where to report such unwanted reactions, they would have certainly helped the regulatory authority to help themselves. Even if the National Pharmacovigilance Programme has heartened accounting of all suspected drug-related adverse events including those caused by herbal/traditional/alternative medicines, the integer of reports related to herbal drugs has been extremely bad. A great many challenges, which rule out the identification and reporting of adverse reactions to herbal drugs can be identified in terms of detection, assessment and deterrence. This includes falling short of quality assurance and control in the manufacture of herbal preparations, which in turn becomes confusing and deters the spotting of adverse reactions. However, patients get allopathic medicines at the same time, which might also be contributing to those unexpected reactions. The gist of the matter is that a person skilled in PV
This document discusses the growth of herbal drugs as over-the-counter products. It notes that while India is the birthplace of Ayurveda, a popular form of herbal medicine, the domestic herbal drug market in India is much smaller than in Western countries. Herbal drugs can be a safe alternative to prescription drugs for minor illnesses if properly regulated, but lack of standardization and control can pose risks to consumers. Education is needed around the proper use of herbal medications as over-the-counter products to ensure their safe and effective use.
The document discusses drug registration processes and formats used in ASEAN countries. It provides information on the individual drug registration systems of each ASEAN member state, which countries have their own formats versus following the common ASEAN CTD format. Export of Indian AYUSH products to ASEAN countries has increased significantly between 2004-2008. The common ASEAN CTD format is described in detail with its section headings.
Issues and constraints in medicicinal plants in pakistan A Presentation by Mr...Mr.Allah Dad Khan
Medicinal plants remain crucial for healthcare in developing countries, though over-exploitation and lack of regulation harm their sustainability. Issues with herbal medicines in Pakistan include poverty limiting access to costly modern drugs, lack of awareness of herbal benefits, quality concerns without standards, and policy gaps without herbal medicine registration or licensing. Potential solutions involve integrating herbal medicine into the national health policy and mainstream medical education to validate its therapies and conserve plant resources.
The document discusses over-the-counter (OTC) drugs in India. It states that OTC drugs do not require a prescription and include drugs not listed as prescription-only. Prescription-only drugs are listed in Schedules H and X and require medical supervision. Drugs in Schedule G require labels stating they are dangerous without medical oversight. The Indian OTC market was worth $1.8 billion in 2009 and is projected to grow 10-12% over 5 years. Common OTC products include digestives, analgesics, and vitamins.
Herbal drug regulations and standardisationRavish 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.
Herbal products, also known as botanical products or phytomedicines, are products made from plants to treat diseases or maintain health.
Herbal products are made by extracting active ingredients from plant parts, such as leaves, bark, roots, seeds, or flowers.
Herbal products, including dietary supplements, are regulated by the FDA. However, unlike pharmaceutical drugs, they do not require pre-market approval. Instead, manufacturers are responsible for ensuring the quality and safety of their products.
The FDA establishes Good Manufacturing Practices (GMP) regulations for dietary supplements to ensure quality control during manufacturing.
The safety of herbal products in the USA is overseen by various regulatory agencies, primarily the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
To ensure a high degree of safety and effectiveness of herbal products and quality control standards during the manufacturing of herbal supplements and medicines, AHPA published GACP (Good Agriculture and Collection Practices) guideline in the American Herbal Pharmacopoeia.
Following file comprises of information about interactions taking place between herbs-drug, herbs-herbs, it also highlights some of the cases of clinical laboratory test interactions taking place due to use of herbal medicines.
Pharmacovigilance is the science of monitoring the effects of pharmaceutical products after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions. Herb-drug interactions can occur when herbs are taken concurrently with prescription or over-the-counter medications. Some common herb-drug interactions include garlic increasing the breakdown of antiviral drugs, green tea increasing the side effects of oral contraceptives, and liquorice decreasing the effectiveness of antihypertensives. It is important to report any suspected adverse reactions to medications to help ensure safe and effective use of drugs and herbs.
Hi Friends , This ppt contains some information related to herbal formulation .This topic mainly abstracted from Pharmacognosy subject of FY.D.pharmacy.so i hope you like my slide and if you like my slide then like ,share and follow me.
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2. Introduction
In 2005, the WHO global survey on National Policy on
Traditional Medicine and Regulation of Herbal Medicines
pointed out that there has been increasing use of
complementary and alternative medicines (CAM) in many
developed and developing countries. The safety and efficacy of
traditional medicine, complementary and alternative medicines,
as well as quality control, have become important concerns for
both Health Authorities and the public.
3.
4. Herbal
supplements,
sometimes called
botanicals, are
one type of
dietary
supplement
available for
purchase. Herbal
supplements
aren't new —
plants have been
used for
medicinal
purposes for
thousands of
years..
Herbal supplements generally haven't been subjected to the
same scientific scrutiny and aren't as strictly regulated as
medications.
Makers of herbal supplements must follow good manufacturing
practices (GMP) — to ensure that supplements are processed
consistently and meet quality standards.
Don't have to get approval from the Food and Drug
Administration (FDA) before putting their products on the
market.
However, Europe has very firm regulation for the registration and
marketing of herbal supplement.
5. Challenges
Countries face major challenges in the development and implementation
of the regulation of traditional, complementary /alternative and herbal
medicines.
- Challenges are: Regulatory status, assessment of safety
and efficacy, quality control, safety monitoring and lack of knowledge
about TM/CAM within the national drug regulatory authorities.
6. 1. Challenges related to the regulatory status of herbal medicines: A
single medicinal plant may be defined as a food, a functional food, a dietary
supplement, or an herbal medicine in different countries
2. Challenges related to the assessment of safety and efficacy
Requirement and methods for research and evaluation for safety and efficacy.
3. Challenges related to the quality control of herbal medicines
Quality of source of raw materials used in their production and GMP (IPQC and FPQC)
7. 4. Challenges related to the safety monitoring of herbal medicines
Adverse events arising from the consumption of herbal medicine- due to wrong species of the plant
my mistake, adulteration, undeclared medicine, contamination, overdosage, misuse of herbal
medicine, and concomitant use with other medicine.
5. Lack of knowledge about herbal medicine within national drug
authorities
Lack of knowledge on herbal medicine and challenges on creating /updating the national level
policy
8.
9.
10. In the USA…
There is no registration (with FDA) of herbal medicines and they are not
included in the NEML.
The Dietary Supplement, Health and Education Act of 1994 forms the
National Regulation on herbal medicines.
Manufacturers do not need to analyze the biological and chemical properties
of their herbal products.
US regulations prohibit the claim that any herbal product prevents disease.
11. Cont.…
Manufacturers are responsible to ensure that the information on the herbal
product label is truthful and not misleading,- FDA monitors — alongside
reports of adverse effects from the use of dietary supplements.
Herbal products formulated to treat more serious ailments — a category
that covers many traditional Asian preparations — fall between the
regulatory cracks.
12. Cont.…
Makers of products are marketed as food supplements cannot make
claims about the conditions they aim to treat — thus people suffering
from maladies will be unaware of these potentially beneficial treatments.
To make therapeutic claims, the products must be registered as medicinal
drugs and undergo the FDA’s rigorous, expensive and lengthy drug
approval process — which, like the European regulations, requires
complex biochemical analyses and three phases of clinical trials.
13. First herbal Approved in
2006
Sinecatechins, a tea polyphenol for the
topical treatment of cervical warts.
Registered as a ‘botanical’ — a separate
classification from synthetic, chemically
pure drugs.
14. Veregen® is a topical ointment indicated for the treatment of external
genital and perianal warts (Condylomata acuminata) in immunocompetent
patients of 18 years and older
15. Second herbal Approved
in 2013
Botanical prescription drug approved by the FDA is
crofelemer (Fulyzaq™) to treat diarrhea symptoms
associated with antiretroviral therapy for HIV/AIDs.
Individuals taking antiretroviral drugs frequently
experience side effects such as nausea and diarrhea.
According to the statement issued by the FDA, taking
crofelemer (Fulyzaq™) twice daily may relieve the
associated diarrhea side effects.
16. Crofelemer is derived from the red
sap of the Croton lechleri plant, also
called Sangre de grado.
Sangre de grado - meaning
"blood of the dragon," is a
medium-sized tree that grows
in the upper Amazon region
of Peru, Ecuador, and
Colombia.
17. What made the Europe to adopt a strictest
guidelines on the herbal products?
Aristolochia fangchi Stephania tetrandra
18. Around a third of UK adults use
herbal products.
In the early 1990s, thousands of women attending a slimming clinic in
Belgium were accidentally given a weight-loss treatment containing the
toxic herb Aristolochia fangchi rather than the anti-inflammatory agent
Stephania tetrandra.
For practitioners and adherents of herbal medicine, it was one of their
worst nightmares: more than 100 of the women suffered kidney failure.
Many later developed cancer of the urinary system.
19. Why was that nightmare happened in
Europe?
Mistaken identity.
Chinese herbs are traded using their common names, which can
confuse Western practitioners of traditional medicine.
The term fang ji describes the roots of both A. fangchi and S.
tetrandra.
Western doctors might be unfamiliar with the language and
traditional practice.
20. Cont.…
The Belgian case has prompted the European Medicines Agency (EMA) to create
a new and world strictest regulations on the registration of herbal products.
EMA took utmost care to ensure the efficacy and safety of the herbal products
before they are registered and marketed in Europe.
The Traditional Herbal Medicinal Products Directive (THMPD) came into force
across the European Union (EU) in April 2011.
•aims to protect public health and at the same time secure the free
movement of herbal products within the EU.
21. Cont.…
Under the directive, herbal medicines intended as treatments for minor
health ailments must be registered as traditional-use products with the
regulatory agency in every EU member state in which the product is to
be sold (although each national regulatory agency is supposed to
recognize licenses already granted by other EU members).
This system is designed to make it less likely that a product is sold as a
traditional herbal medicine in one country and as something else in
another.
22. France received 160 applications but has granted only 7 registrations.
Germany is one of the leading Member States in respect of total
registrations, it nevertheless has granted only 154 registrations out of
426 applications.
At the time of the EMA report in 2012, 149 applications were still
under assessment whilst 123 applications had failed or been
withdrawn.
Last 10 years - Registered only a few THMPs - often less than ten
products
23. Cont.…
The THMPD does not cover practitioners of herbal medicine, who
are still permitted to mix herbal remedies from individual components
for personal prescriptions.
Products are eligible for license as a traditional herbal medicine only
if they have been used to treat a specified health complaint for at least
30 years, including a minimum of 15 years in Europe.
Herbal products are held to similar safety and quality standards as
pharmaceutical drugs.
24. India and regulatory status
The Government of India created a separate department known as the
Department of Indian Systems of Medicine and Homeopathy in 1995,
later renamed as the Department of Ayurveda, Yoga, Unani, Siddha
and Homeopathy (AYUSH), to serve as the national office for
T&CM, which is administered under the MoH. The independent
Ministry of AYUSH was formed in 2014.
Adherence to manufacturing information in pharmacopoeias and
monographs is required.
25. Herbal medicines are also included under Schedule E of the Drugs
and Cosmetics Rules.
Licenses given to manufacturing units are renewed every 3 years, to
ensure compliance with GMP.
Herbal medicines categorized as prescription medicines are sold in
pharmacies; herbal medicines categorized as non-prescription
medicines, self-medication or OTC medicines are sold in
pharmacies and other outlets, and by licensed practitioners.
26. Malaysia
Herbal products in Malaysia fall under the category of regulated products.
Any marketer intending to place the herbal products in the market require to
register the product first.
The applicant is required to have a registered with the Malaysia Registrar of
Business or Suruhanjaya Syarikat Malaysia under two classifications:
The product must undergo premarket registration with NPRA, Malaysia
Halal Requirement
27. Cont…
Health Supplements
a) General or Nutritional Claims – Abridge evaluation
b) Functional Claims (Medium) – Abridge evaluation
c) Disease Risk Reduction Claims (High) – Full Evaluation
Natural Products (Includes herbal and traditional products )- Full
Evaluation
28. Cont.
Natural Products
◦ Traditional medicine
◦ Finished Herbal Product (one or more herbs)
◦ Herbal Remedy
◦ Homeopathic Medicine
Food – Drug Interphase
Functional Foods and Foods
29. Singapore - HSA
TM are not subject to approvals and licensing
HSA prohibits the addition of medicinal ingredients such as steroids in
TM.
HSA also sets strict limits on toxic heavy metals in these products.
Dealers (importers, manufacturers, wholesale dealers and sellers) have
the obligation to ensure that their products are not harmful or unsafe,
and that they conform with the following guidelines before supplying
TM into Singapore.
30. Toxic heavy metal limits
Heavy metal Permissible limits
Arsenic 5 parts per million (ppm)
Cadmium 0.3 ppm
Lead 10 ppm
Mercury 0.5 ppm
For existing products imported
or locally manufactured before 1
September 2019, dealers had a
one-year grace period to ensure
compliance to the above revised
limits. With effect from 1
September 2020, all products
sold in Singapore should not
exceed the revised limits.
31. Microbial limits: Oral Products
Microbe Microbial limits
Total aerobic microbial count Not more than 105 CFU per g or ml
Yeast and mould count Not more than 5 x 102 CFU per g or
ml
Escherichia coli, Salmonellae and
Staphylococcus aureus
Absent in 1g
32. Microbial limits: Topical Products
Dealers are encouraged to comply to the ASEAN Guidelines on the Limits of
Contaminants for microbial limits.
Microbe Microbial limits
Total aerobic microbial count Not more than 104 CFU per g or ml
Yeast and mould count
Not more than 5 x 102 CFU per g or
ml
Pseudomonas aeruginosa and
Staphyloccocus aureus
Absent in 1g or ml
33. Singapore ensures…
Labelling requirements
List of Prohibited ingredients
Substances from endangered species - Trade in
Endangered Species of Wild Fauna and Flora (CITES) import
and export permits.
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34. China
Governed by the State Food and Drug Administration (SFDA)
Registered as functional food or drugs.
Regulatory approval of functional food is the responsibility of the
Department of Food License whereas that of Chinese herbal drugs is
controlled by the Division of TCMs & Ethno-Medicines under the
Department of Drug Registration.
Drugs in China cover not just chemical drugs but also traditional
medicines.
35. Cont…
Traditional Chinese Medicines refer to medicinal
substances and their preparations used under the
guidance of traditional Chinese medical theory;
whereas natural medicinal products refer to natural
medicinal substances and their preparations used under
the guidance of modern medical theory.
36. Philippines
At least 5 or more decades as documented in medical, historical, and
ethnological literature are permitted to be marketed under this category.
The Bureau of Food and Drugs (BFAD) mandate registration of the
traditionally used herbal products before manufactured, imported or
marketed.
The extent of control of BFAD includes the brand names of the
traditional herbal products as well, and their prior clearance is required,
before filing for product registration.
37. Cont.
Authentication of the plant specimen needs to be obtained from the
Philippine National Museum or any BFAD recognized taxonomist, and
for imported products, the certificate of authenticity of the plants from
the authorized government agency of the country of origin is accepted.
The quality control requirements further lay down that the
pharmacopoeia standards. BFAD further mandates that product
indications should not require supervision by a physician.
38. Nigeria
The trade of herbal products is regulated by National Agency for Food
and Drug Administration and Control (NAFDAC).
Herbals products are classified as "Herbal Medicines and Related
Products." Premarketing registration of herbal medicines and related
products is mandatory in Nigeria.
All advertisements require a preclearance from NAFDAC.
No advertisement can be made as a cure for any disease conditions
listed in "Schedule 1" to the Food and Drug Act 1990.
39. Saudi Arabia
They are allowed if they have at least 50 consecutive years of traditional use.
Their dose and the method of preparation must be same as those used,
traditionally.
According to the evidence provided, they may fall under the sub-categories:
Pharmacopoeial evidence for traditional products
Nonpharmacopoeial evidence for traditional products.
40. Cont.…
For the former, the medicinal ingredients, quantity, recommended dose, route of administration,
duration of use, dosage form, directions of use, risk information should be same as the
Pharmacopoeia and the method of preparation must be traditional.
For the latter category, any two independent references must be provided to supplement the
evidence supporting the safety and efficacy of the product, from clinical studies, pharmacopoeias,
and textbooks
References, peer-reviewed published articles, data from nonclinical studies on pharmacokinetics,
pharmacodynamics, toxicity information, reproductive effects, and the potential genotoxicity or
carcinogenicity of an ingredient or information based on previous marketing experience of a
finished product.
41. Australia
Medicinal products containing such ingredients as herbs, vitamins, minerals,
nutritional supplements, homoeopathic and certain aromatherapy preparations are
referred to as 'complementary medicines' and are regulated as medicines under the
Therapeutic Goods Act 1989 (the Act).
A complementary medicine is defined in the Therapeutic Goods Regulations 1990
as a therapeutic good consisting principally of one or more designated active
ingredients mentioned in Schedule 14 of the Regulations, each of which has a
clearly established identity and traditional use
42. How complementary medicines are regulated in Australia
Australia has a risk-based approach,
Lower risk medicines can be listed on the Australian Register of Therapeutic Goods (ARTG).
Higher risk medicines must be registered on the ARTG.
Some complementary medicines are exempted from the requirement to be included on the
ARTG, such as certain preparations of homoeopathic medicines.
The TGA Manufacturing Quality Branch inspects manufacturers on an ongoing basis for
compliance with good manufacturing practice.
Post marketing surveillance is required.
43. Canada
All NHPs sold in Canada are subject to the Natural Health Products Regulations
(The Government of Canada, 2003), which came into force on January 1, 2004.
All producers of NHPs need to apply for licenses before selling them in Canada.
To apply for a license, the person or company shall apply to Natural Health
Products Directorate (NHPD), Minister of Health Canada.
It is interesting to note that evidence is not necessarily from clinical trial data but
can also be references to published studies, journals, pharmacopoeias and
traditional resources.
44. Japan
2 overlapping types of traditional herbal medicines coexisted for centuries.
1. The traditional Japanese and Chines medicine- These medical systems were
damaged by the first Medical Care Law in 1874 that proclaimed the
abrogation of traditional Japanese medicine.
2. The second type of herbal medicine used in Japan originated in Europe and
south-east Asia and became popular after the law in 1874 was announced.
Regulation of quality standards of those herbal products was established in
Japanese Pharmacopoeia for more than 90% of them.
45. Cont.…
Kampo medicines are the main traditional herbal medicines in Japan and are
classified as pharmaceuticals.
They are based on ancient Chinese medicine and have evolved to the Japanese
original style over a long period of time.
Kampo medicines are prescription based as well as OTC
Crude drugs and Kampo extracts have been listed in The Japanese Pharmacopoeia.
Pharmaceuticals and Medical Devices Agency (PMDA) under the Ministry of
Health, Labour and Welfare
46. Conclusion
The global acceptance and use of herbal medicines and related products
continue to assume exponential increase.
adverse reactions in recent times are also becoming more vivid.
previous misconception of regarding or categorizing herbal medicinal
products as “safe” because they are derived from “natural” source.
The reality is that “safety” and “natural” are not synonymous.
Therefore, regulatory policies on herbal medicines need to be standardized
and strengthened on a global scale.