NEPAL PHARMACY COUNCIL REGULATION, 2059 (2002)
In exercise of power conferred by Section 36 of the Pharmacy Council Act, 2057 (2000), the
Nepal Pharmacy Council has framed the Rules as follows.
The document summarizes the Pharmacy Act of 1948 in India. It establishes the Central Council of Pharmacy to regulate the profession of pharmacy by prescribing minimum education standards. The Council maintains a central register of pharmacists. The Act also creates State Pharmacy Councils to oversee pharmacists at the state level and issue registrations. Its objectives are to regulate and raise the standards of pharmacy education and practice across India.
This document outlines regulations regarding drug registration and licensing in Nepal. It establishes rules for obtaining recommendation letters to establish drug industries, product licenses to manufacture drugs, registration of drugs prior to sale and distribution, import registration of drugs, recommendation letters for drug export or import, registration of names and shops selling drugs, licenses for drug advertising, clinical trials of new drugs, renewal fees, and duplicate copies of licenses and certificates. The regulations are administered by Nepal's Department of Drugs Administration and include various application formats and fees schedules.
Hospital Formulary - presentation gives the detail idea about Hospital formulary, its advantage, disadvantage, how to prepare Hospital formulary and much more. this will be useful for Pharm.D-IV YEAR students, which was in their Hospital pharmacy subject. regards APOLLOJAMES
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.
The document summarizes the constitution and functions of key organizations under the Drugs and Cosmetics Act of 1940 and Rules of 1945 in India. The Drugs Technical Advisory Board (DTAB) advises the central and state governments and consists of 18 ex-officio and nominated members. The Drugs Consultative Committee (DCC) advises on securing uniformity and consists of central and state government representatives. The Central Drugs Laboratory (CDL) in Kolkata analyzes drug and cosmetic samples sent by courts and customs and maintains reference standards.
The document summarizes the key aspects of the Medicinal and Toilet Preparations Act and Rules, 1955 in India. The objectives of the act are to provide for excise duties on medicinal and toilet preparations containing alcohol, narcotics or drugs and to control their manufacture and misuse. The act defines relevant terms and outlines the licensing process and requirements for the manufacture of such preparations both within bonded premises and outside. It also describes the duties and powers of excise officers, search and seizure procedures, offenses and penalties. The schedule lists the categories of dutiable goods and applicable rates of duty.
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
Drugs and cosmetics act 1940 and rules 1945Anoop Singh
Secretary - Drugs Controller, India
30
Functions of DTAB:
1. Advise the Central Government and the State Governments on technical
matters arising out of the administration of this Act.
2. Advise on any matter referred to it by the Central Government.
3. Carry out the functions assigned to it by or under this Act.
4. Perform such other functions as may be prescribed.
31
Drugs Consultative Committee(DCC)
1. The Central Government may constitute one or more Drugs Consultative
Committees to advise it, inter alia, on technical matters arising out of the
administration of this Act and to carry out the functions assigned to
The document summarizes the Pharmacy Act of 1948 in India. It establishes the Central Council of Pharmacy to regulate the profession of pharmacy by prescribing minimum education standards. The Council maintains a central register of pharmacists. The Act also creates State Pharmacy Councils to oversee pharmacists at the state level and issue registrations. Its objectives are to regulate and raise the standards of pharmacy education and practice across India.
This document outlines regulations regarding drug registration and licensing in Nepal. It establishes rules for obtaining recommendation letters to establish drug industries, product licenses to manufacture drugs, registration of drugs prior to sale and distribution, import registration of drugs, recommendation letters for drug export or import, registration of names and shops selling drugs, licenses for drug advertising, clinical trials of new drugs, renewal fees, and duplicate copies of licenses and certificates. The regulations are administered by Nepal's Department of Drugs Administration and include various application formats and fees schedules.
Hospital Formulary - presentation gives the detail idea about Hospital formulary, its advantage, disadvantage, how to prepare Hospital formulary and much more. this will be useful for Pharm.D-IV YEAR students, which was in their Hospital pharmacy subject. regards APOLLOJAMES
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.
The document summarizes the constitution and functions of key organizations under the Drugs and Cosmetics Act of 1940 and Rules of 1945 in India. The Drugs Technical Advisory Board (DTAB) advises the central and state governments and consists of 18 ex-officio and nominated members. The Drugs Consultative Committee (DCC) advises on securing uniformity and consists of central and state government representatives. The Central Drugs Laboratory (CDL) in Kolkata analyzes drug and cosmetic samples sent by courts and customs and maintains reference standards.
The document summarizes the key aspects of the Medicinal and Toilet Preparations Act and Rules, 1955 in India. The objectives of the act are to provide for excise duties on medicinal and toilet preparations containing alcohol, narcotics or drugs and to control their manufacture and misuse. The act defines relevant terms and outlines the licensing process and requirements for the manufacture of such preparations both within bonded premises and outside. It also describes the duties and powers of excise officers, search and seizure procedures, offenses and penalties. The schedule lists the categories of dutiable goods and applicable rates of duty.
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
Drugs and cosmetics act 1940 and rules 1945Anoop Singh
Secretary - Drugs Controller, India
30
Functions of DTAB:
1. Advise the Central Government and the State Governments on technical
matters arising out of the administration of this Act.
2. Advise on any matter referred to it by the Central Government.
3. Carry out the functions assigned to it by or under this Act.
4. Perform such other functions as may be prescribed.
31
Drugs Consultative Committee(DCC)
1. The Central Government may constitute one or more Drugs Consultative
Committees to advise it, inter alia, on technical matters arising out of the
administration of this Act and to carry out the functions assigned to
Nepal Pharmacy Council Model Questions with Answer keysBashant Kumar sah
MCQS, most probable questions compiled from the GPAT old exam questions, old council and LokSewa questions, pharmacology, jurisprudence, pharmaceutics, pharmacognosy, chemistry, hospital pharmacy.
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
This document outlines the formation and functions of Nepal's Drugs Advisory Council and Drugs Advisory Committee according to the Drugs Advisory Council and Drugs Advisory Committee Formation Rules of 2037(1980). The Council and Committee provide advice to the Government of Nepal on various matters related to drugs, including policies, programs, standards, research and regulation. The Council is chaired by the Minister for Forests and consists of representatives from various ministries and experts in drugs. The Committee is chaired by the Secretary of the Ministry of Forests and consists of medical, pharmaceutical and regulatory representatives who advise on technical drug issues. Both groups are responsible for meeting as needed to discuss drugs and making decisions recorded in meeting minutes.
Technology transfer, also called transfer of technology (TOT), is the process of transferring (disseminating) technology from the places and ingroups of its origination to wider distribution among more people and places. It occurs along various axes: among universities, from universities to businesses, from large businesses to smaller ones, from governments to businesses, across borders, both formally and informally, and both openly and surreptitiously
(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
Function of community pharmacy, Organization and structure of retail and wholesale drug store, Legal requirement for establishment, Maintenance of records
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
The document discusses the Pharmacy and Therapeutics Committee (PTC), which is constituted in hospitals to ensure rational drug use. The PTC is composed of physicians, pharmacists and other healthcare professionals. It plays an advisory, educational and drug safety monitoring role. It develops hospital formularies, monitors adverse drug reactions and provides education to staff. Regular meetings are held to review drug use policies and safety issues. The PTC aims to promote optimal drug therapy through its various functions.
A medication history interview is used to collect detailed information about all medications a patient is currently taking or has taken in the past. This provides insights into allergic reactions, adherence, and use of alternative medicines. The goals are to obtain complete information to compare to medical records, verify histories, and inform care. Key information includes current and past medications, reactions, effectiveness, adherence, and sources like patients, families, and records. Patient counseling then aims to improve understanding of treatment, side effects, and self-management through a structured introduction, discussion, and conclusion.
This document outlines various legal requirements for starting a community pharmacy in India. It discusses the minimum area required, rent agreements, refrigeration requirements, and that an in-charge qualified pharmacist is necessary. It also summarizes legal aspects of contracts, payment terms regarding time, place and mode of payment. Pricing considerations for bulk drugs and drug formulations are defined by law. Various license forms are specified according to the category of drugs to be sold and qualified person requirements.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
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.
The document discusses pharmaceutical legislation in India. It outlines the origin of pharmaceutical companies in India in the early 19th century. In 1931, the Drug Enquiry Committee was appointed to investigate the drug market and make recommendations. The committee recommended establishing drug control departments, a central drug laboratory, and pharmacy councils. This led to the Drug Act of 1940 and subsequent acts regulating drug import, manufacture, and sale. The objective of pharmaceutical legislation is to ensure public access to safe, effective drugs.
Patient counseling involves providing patients with information about their medications, including how to take them properly, potential side effects, and lifestyle changes. The goal is to improve patient understanding and adherence to treatment regimens. Effective counseling establishes a relationship of trust, assesses the patient's needs and concerns, and ensures they comprehend key points about managing their condition and medications. The counseling process involves private discussions that cover topics like dosage, benefits, interactions, and storage in a way patients can understand.
A presentation aimed at providing information with regards to the Pharmacy Act, 1948.
-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
The document summarizes the key aspects of the Drug Price Control Order (DPCO) Acts of 1995 and 2013 in India. It provides definitions of important terms, explains how prices of bulk drugs and formulations are determined, and outlines the powers of the government to fix prices. Some of the key points covered are:
- The DPCO Acts aim to ensure adequate drug production and equitable distribution at fair prices.
- The Acts define terms like bulk drugs, formulations, and ceiling prices and explain how manufacturing costs are considered in price determinations.
- The government has powers to direct manufacturers on bulk drug sales and fix retail prices of scheduled drugs and formulations.
Community pharmacy provides pharmaceutical care and serves the public's need for medicines. In India, community pharmacies are privately owned medicine shops that serve local communities. Community pharmacists play an important role in providing patients access to healthcare by managing their medication needs. They are regulated under the Pharmacy Act of 1948 and must maintain certain legal records. To run a pharmacy properly, pharmacists must select an appropriate site, design an effective layout, stock medicines correctly, hire qualified staff, and keep various financial and legal records.
The document discusses India's Drug Price Control Order (DPCO) which allows the government to regulate prices of essential drugs. The objectives of the DPCO are to ensure adequate production and supply of drugs at fair prices through equal distribution. It defines key terms like bulk drugs, formulations, and ceiling prices. The DPCO specifies how maximum retail prices are calculated and requires manufacturers to provide drug cost information to the government annually. It also outlines penalties for violating the order, such as increasing prices without approval or selling drugs in unlabeled split quantities.
This document outlines the Nepal Pharmacy Council Act from 2000. Some key points:
- It establishes the Nepal Pharmacy Council to regulate the pharmacy profession through certification, education standards, and registration of pharmacists and assistants.
- The Council is an autonomous body that regulates pharmacy education, recognizes degrees, determines qualifications, and maintains a registration book.
- It lays out the composition of the Council including representatives from the government, educational institutions, and professional associations.
- The Council is responsible for setting standards for pharmacy education, recognizing degrees, registering qualified pharmacists and assistants, and removing names from the registration for violating conduct standards.
This document establishes the Nepal Pharmacy Council through the Nepal Pharmacy Council Act. The key points are:
- It establishes the Nepal Pharmacy Council to regulate the pharmacy profession in a scientific manner.
- The Council will consist of 11 members including pharmacists, educators, and government officials. It will register pharmacists and assistants and recognize educational degrees.
- Only registered pharmacists and assistants can practice pharmacy after one year. The Council will register qualified applicants, inspect educational institutions, and remove recognition if standards decline.
- The Council will establish qualifications, register professionals, delete names for misconduct, and re-register names under certain conditions. It aims to manage pharmacy in a systematic way through registration and oversight
Nepal Pharmacy Council Model Questions with Answer keysBashant Kumar sah
MCQS, most probable questions compiled from the GPAT old exam questions, old council and LokSewa questions, pharmacology, jurisprudence, pharmaceutics, pharmacognosy, chemistry, hospital pharmacy.
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
This document outlines the formation and functions of Nepal's Drugs Advisory Council and Drugs Advisory Committee according to the Drugs Advisory Council and Drugs Advisory Committee Formation Rules of 2037(1980). The Council and Committee provide advice to the Government of Nepal on various matters related to drugs, including policies, programs, standards, research and regulation. The Council is chaired by the Minister for Forests and consists of representatives from various ministries and experts in drugs. The Committee is chaired by the Secretary of the Ministry of Forests and consists of medical, pharmaceutical and regulatory representatives who advise on technical drug issues. Both groups are responsible for meeting as needed to discuss drugs and making decisions recorded in meeting minutes.
Technology transfer, also called transfer of technology (TOT), is the process of transferring (disseminating) technology from the places and ingroups of its origination to wider distribution among more people and places. It occurs along various axes: among universities, from universities to businesses, from large businesses to smaller ones, from governments to businesses, across borders, both formally and informally, and both openly and surreptitiously
(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
Function of community pharmacy, Organization and structure of retail and wholesale drug store, Legal requirement for establishment, Maintenance of records
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
The document discusses the Pharmacy and Therapeutics Committee (PTC), which is constituted in hospitals to ensure rational drug use. The PTC is composed of physicians, pharmacists and other healthcare professionals. It plays an advisory, educational and drug safety monitoring role. It develops hospital formularies, monitors adverse drug reactions and provides education to staff. Regular meetings are held to review drug use policies and safety issues. The PTC aims to promote optimal drug therapy through its various functions.
A medication history interview is used to collect detailed information about all medications a patient is currently taking or has taken in the past. This provides insights into allergic reactions, adherence, and use of alternative medicines. The goals are to obtain complete information to compare to medical records, verify histories, and inform care. Key information includes current and past medications, reactions, effectiveness, adherence, and sources like patients, families, and records. Patient counseling then aims to improve understanding of treatment, side effects, and self-management through a structured introduction, discussion, and conclusion.
This document outlines various legal requirements for starting a community pharmacy in India. It discusses the minimum area required, rent agreements, refrigeration requirements, and that an in-charge qualified pharmacist is necessary. It also summarizes legal aspects of contracts, payment terms regarding time, place and mode of payment. Pricing considerations for bulk drugs and drug formulations are defined by law. Various license forms are specified according to the category of drugs to be sold and qualified person requirements.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
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.
The document discusses pharmaceutical legislation in India. It outlines the origin of pharmaceutical companies in India in the early 19th century. In 1931, the Drug Enquiry Committee was appointed to investigate the drug market and make recommendations. The committee recommended establishing drug control departments, a central drug laboratory, and pharmacy councils. This led to the Drug Act of 1940 and subsequent acts regulating drug import, manufacture, and sale. The objective of pharmaceutical legislation is to ensure public access to safe, effective drugs.
Patient counseling involves providing patients with information about their medications, including how to take them properly, potential side effects, and lifestyle changes. The goal is to improve patient understanding and adherence to treatment regimens. Effective counseling establishes a relationship of trust, assesses the patient's needs and concerns, and ensures they comprehend key points about managing their condition and medications. The counseling process involves private discussions that cover topics like dosage, benefits, interactions, and storage in a way patients can understand.
A presentation aimed at providing information with regards to the Pharmacy Act, 1948.
-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
The document summarizes the key aspects of the Drug Price Control Order (DPCO) Acts of 1995 and 2013 in India. It provides definitions of important terms, explains how prices of bulk drugs and formulations are determined, and outlines the powers of the government to fix prices. Some of the key points covered are:
- The DPCO Acts aim to ensure adequate drug production and equitable distribution at fair prices.
- The Acts define terms like bulk drugs, formulations, and ceiling prices and explain how manufacturing costs are considered in price determinations.
- The government has powers to direct manufacturers on bulk drug sales and fix retail prices of scheduled drugs and formulations.
Community pharmacy provides pharmaceutical care and serves the public's need for medicines. In India, community pharmacies are privately owned medicine shops that serve local communities. Community pharmacists play an important role in providing patients access to healthcare by managing their medication needs. They are regulated under the Pharmacy Act of 1948 and must maintain certain legal records. To run a pharmacy properly, pharmacists must select an appropriate site, design an effective layout, stock medicines correctly, hire qualified staff, and keep various financial and legal records.
The document discusses India's Drug Price Control Order (DPCO) which allows the government to regulate prices of essential drugs. The objectives of the DPCO are to ensure adequate production and supply of drugs at fair prices through equal distribution. It defines key terms like bulk drugs, formulations, and ceiling prices. The DPCO specifies how maximum retail prices are calculated and requires manufacturers to provide drug cost information to the government annually. It also outlines penalties for violating the order, such as increasing prices without approval or selling drugs in unlabeled split quantities.
This document outlines the Nepal Pharmacy Council Act from 2000. Some key points:
- It establishes the Nepal Pharmacy Council to regulate the pharmacy profession through certification, education standards, and registration of pharmacists and assistants.
- The Council is an autonomous body that regulates pharmacy education, recognizes degrees, determines qualifications, and maintains a registration book.
- It lays out the composition of the Council including representatives from the government, educational institutions, and professional associations.
- The Council is responsible for setting standards for pharmacy education, recognizing degrees, registering qualified pharmacists and assistants, and removing names from the registration for violating conduct standards.
This document establishes the Nepal Pharmacy Council through the Nepal Pharmacy Council Act. The key points are:
- It establishes the Nepal Pharmacy Council to regulate the pharmacy profession in a scientific manner.
- The Council will consist of 11 members including pharmacists, educators, and government officials. It will register pharmacists and assistants and recognize educational degrees.
- Only registered pharmacists and assistants can practice pharmacy after one year. The Council will register qualified applicants, inspect educational institutions, and remove recognition if standards decline.
- The Council will establish qualifications, register professionals, delete names for misconduct, and re-register names under certain conditions. It aims to manage pharmacy in a systematic way through registration and oversight
A pharmacist is defined as someone with a 4-year university degree in pharmacy who has passed licensing exams. The document outlines the registration process and requirements for pharmacists and pharmacy technicians to be listed on Register A or Register B. It discusses qualifications including degree and exam requirements. The Council issues registration certificates and oversees the registration process. Registered pharmacists and technicians must notify the Council of address or practice changes and only use qualifications they have earned.
This document outlines the Nepal Medical Council Act of 2020 (1964) which established the Nepal Medical Council to regulate medical practice and registration of medical practitioners in Nepal. Some key points:
- It establishes the Nepal Medical Council as an autonomous body to manage medical qualifications and registration of practitioners.
- The Council has 17 members including medical practitioners, deans, consumers, and nominees of the government and dental association.
- The Act defines terms related to medical practice and registration. It also covers functions of the Council like recognizing medical colleges, determining medical policy, and maintaining a register of practitioners.
- A Registrar is appointed to maintain the register, register qualified practitioners, and remove names as required. Rules
2.The Drugs Registration Regulation, 2038(1981 and Medicine Registration Guid...Purbanchal University
The document summarizes the key rules and regulations regarding drug registration and pharmacy registration in Nepal as outlined in the Drugs Registration Regulation of 2038 and the Medicine Registration Guidance of 2073. Some of the main points covered include that one must obtain recommendation letters to establish a drug industry or for export/import of drugs. A product license must be obtained to manufacture drugs and drugs must be registered prior to sale, distribution, or importation. Pharmacies must also register and only certified individuals can operate pharmacies or sell/distribute medicines. Regulations further specify renewal fees, duplicate licenses, observance of codes, and the power of the government to alter schedules.
The document outlines the Pharmacy Council of India and regulations regarding pharmacy education and practice in India. Key points include:
- The Pharmacy Act of 1948 established the Pharmacy Council of India to regulate pharmacy education and practice.
- Minimum education requirements were established, including a Diploma in Pharmacy and Bachelor of Pharmacy degrees.
- The Council maintains a central register of pharmacists and sets standards for pharmacy education that institutions must meet to be approved.
- State pharmacy councils were also established to register pharmacists and regulate the profession at a local level.
The document defines key terms related to pharmacy practice and business in Tanzania. It discusses the Pharmacy Act of 2011 and Pharmacy Practice Regulations of 2012, outlining several important sections regarding registration and licensing of pharmacy premises. These include requirements for premises location, design, layout, and storage facilities. The summary also mentions sections related to expiration dates for registration certificates and business permits.
The document outlines new rules for drugs and clinical trials in India established by the Ministry of Health and Family Welfare in 2019. Key aspects include:
- Establishing authorities like the Central Licensing Authority to oversee drug approval and clinical trials.
- Requiring Ethics Committee approval and registration for clinical trials and bioavailability/bioequivalence studies.
- Detailing processes for approval and oversight of clinical trials, including applications, inspections, and suspending trials.
- Establishing compensation amounts in cases of injury or death in clinical trials based on risk factors and disability percentages.
The New Drugs and Clinical Trials (Amendment) Rules, 2023. ClinosolIndia
The latest rules for the registry of Clinical Research Organisations (CRO) in India were issued in The New Drugs and Clinical Trials (Amendment) Rules, 2023. These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies.
The registration process requires the CRO to submit an application with all the necessary details about the clinical trial or study, including the name and address of the sponsor, the name and qualifications of the principal investigator, details of the investigational drug, and other relevant information.
Once the application is submitted, the Central Licensing Authority will examine it to ensure that all necessary information has been provided and that the CRO has the necessary infrastructure, personnel, and equipment to conduct the study safely and effectively. If the Authority is satisfied with the application, it will grant registration to the CRO, after which it can conduct the clinical trial or study as per the approved protocol.
These rules are a significant step forward in ensuring the safety and ethical conduct of clinical trials and studies in India, and in providing greater accountability and transparency in the research process.
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.
Lesson 21 Legal Framework Governing Company Secretaries : Company Law By dipt...Dipti Dhakul
Chapter V of the Company Secretaries Act, 1980 (the Act). 21, 21A, 21B, 21C and 22 and First and Second Schedule to the Act and Rules
Disciplinary Directorate, Board of Discipline, Disciplinary Committee, Appeal to Authority and GUIDELINES FOR ADVERTISEMENT BY COMPANY SECRETARY IN PRACTICE
The document summarizes key aspects of the Pharmacy Act and Pharmacy Council of India (PCI). It discusses that the Pharmacy Act established the PCI to regulate pharmacy education and practice in India. The PCI frames Education Regulations to set minimum standards for pharmacy qualifications and approves courses and institutions. It also maintains the Central Register of pharmacists. State Pharmacy Councils are constituted to handle registration of pharmacists at the state level. The document outlines qualifications and processes for registration as a pharmacist in India.
This act gives an idea about the constitution and functions of PCI. Brief about Education Regulation in India. Registration procedure for the pharmacist in India.
The aim of presentation is to provide information related to pharmacy Act, 1948.
Introduction
Definition
Pharmacy Council of India
State pharmacy Council
Registration of pharmacists
Offences and penalties
This document provides an overview of pharmacy law and regulatory affairs in the United Arab Emirates (UAE). It includes the table of contents for an orientation course on pharmacy law, which covers topics like the UAE Federal Law on pharmaceutical professions and institutions, guidelines for good pharmacy practice, codes of conduct, and policies from the Health Authority of Abu Dhabi. The document provides details on licensing requirements for pharmacists, assistants, pharmacies, drug stores, medicine factories and scientific offices. It also outlines regulations regarding prescriptions, controlled substances, and the duties and prohibited acts of pharmacists.
This document is the Republic Act No. 5921 which regulates the practice of pharmacy in the Philippines. Some key points:
- It creates the Council of Pharmaceutical Education to set standards for pharmaceutical education and accredit colleges of pharmacy. It also establishes the Board of Pharmacy to examine and register pharmacists.
- The Board is composed of a chairman and two members appointed by the President. It has the power to examine applicants, issue registration certificates, and reprimand, suspend or revoke certificates for various misconduct.
- To be a registered pharmacist, one must pass theoretical and practical exams administered by the Board. The exams cover various subjects like chemistry, biology, and pharmacy. A degree from an accredited college
The document summarizes key aspects of the Pharmacy Act of 1948 in India. It established the Pharmacy Council of India as the central regulatory body to oversee pharmacy education and practice. The PCI sets minimum education standards, approves courses and institutions, and maintains a central register of pharmacists. The Act also provides for the establishment of State Pharmacy Councils to register pharmacists and regulate practice at the state level. The objectives of the Act are to regulate the pharmacy profession and raise its status in India.
1. This Decree provides for pharmacy practice certificate; pharmacy business; export and import of drugs; registration of herbal ingredients, excipients, capsule shells; assessment of overseas drug manufacturers; power, method and procedures for recalling medicinal ingredients; handling of recalled medicinal ingredients; documents and procedures for issuance of certification of drug advertisement and drug price management.
2. This Decree applies to organizations and individuals in Vietnam and overseas whose operation involves pharmacy in Vietnam.
The Pharmacy Act of 1948 aims to regulate the profession of pharmacy in India. It established the Pharmacy Council of India (PCI) and State Pharmacy Councils (SPC) to oversee pharmacy education and registration of pharmacists. The PCI frames regulations for pharmacy education, approves courses and institutions, and maintains the central register of pharmacists. SPCs prepare and maintain state registers. The Act also defines qualifications for registration as a pharmacist and penalties for offenses like practicing pharmacy without registration.
The document discusses the history and regulations around pharmacy practice and education in India. It describes how the Pharmacy Council of India was established in 1949 to regulate the profession through various functions like maintaining central registers of pharmacists, setting minimum education standards, and approving pharmacy courses and institutions. State pharmacy councils were also formed and are responsible for registering pharmacists within each state based on educational qualifications. The regulations and qualifications for registration have evolved over time as the profession became more formalized.
Similar to NEPAL PHARMACY COUNCIL REGULATION, 2059 (2002) (20)
Classification of Drugs in Nepal under Samuha 'KA' Samuha 'KHA' Samuha 'GA'Nabin Bist
This document classifies drugs into categories and subcategories. Category A includes narcotic drugs and substances related to narcotics. It lists 121 narcotic drugs. Category B includes antibiotics, antiseptics, anesthetics, and other drugs. It lists 147 drugs. Category C establishes percentage limits for certain drugs listed in Categories A and B, including narcotics like codeine, morphine, and other controlled substances.
Instant Hand sanitizer (Alcohol Based ) औषधि ब्यबस्था बिभागNabin Bist
This document outlines requirements and testing methods for alcohol-based instant hand sanitizers. It defines hand sanitizers and lists normative references. Key requirements include acceptable odor/color, liquid or gel form, and compliance with specifications for alcohol content, microbicidal activity, and permissible excipients. Raw materials must meet purity standards. Packaging and detailed labeling are also specified. Methods of analysis involve testing for alcohol content and microbicidal activity using pharmacopeial or validated methods. A one-year shelf life is indicated.
This document discusses carbohydrates. It defines carbohydrates as polyhydroxyaldehydes, ketones, or compounds that produce them on hydrolysis. Carbohydrates are classified as monosaccharides, oligosaccharides, or polysaccharides based on the number of sugar units. Monosaccharides include aldoses and ketoses. Carbohydrates participate in energy storage and structure. Common carbohydrates discussed include starch, glycogen, cellulose, and glycoproteins.
Drug Resistant Tuberculosis Management GuidelineNabin Bist
This document provides national guidelines for drug resistant tuberculosis (DR-TB) management in Nepal. It outlines the background and burden of multi-drug resistant TB (MDR-TB) worldwide and in Nepal. Key points include an estimated 558,000 incident cases of MDR-TB globally in 2017, with treatment success at only 55%. In Nepal, around 1500 cases of DR-TB occur annually, though only 350-450 are notified. The guidelines cover diagnosis, treatment regimens, management, and monitoring of DR-TB.
The WHO Pharmaceuticals Newsletter provides regulatory updates and safety information on medicines from various national regulatory authorities and WHO. This issue includes regulatory actions and safety warnings issued by authorities in countries such as Japan, Ireland, UK, New Zealand, and others. Warnings included updated risks of non-melanoma skin cancer with hydrochlorothiazide, hypoglycemia with direct-acting antivirals for hepatitis C, tendon damage and neurological effects with fluoroquinolone antibiotics, and thromboembolic events with irinotecan. It also provides signals identified in WHO's global pharmacovigilance database and updates on WHO initiatives in India and Thailand.
World Health Organization Model List of Essential Medicines 21st List 2019Nabin Bist
World Health Organization Model List of Essential Medicines 21st List 2019
WHO updates global guidance on medicines and diagnostic tests to address health challenges, prioritize highly effective therapeutics, and improve affordable access
This document discusses the management of diarrhea and constipation. For diarrhea, it focuses on rehydration through oral rehydration solution or intravenous fluids depending on severity. Maintaining nutrition and use of antimicrobial drugs for specific causes of infectious diarrhea are also covered. For constipation, nonpharmacological treatments including diet and lifestyle changes are recommended first. If those fail, various classes of laxatives are discussed including bulk forming, osmotic, and stimulant laxatives.
L-arginine is a semi-essential amino acid that plays an important role in nitric oxide production. Nitric oxide is involved in vascular regulation, immune activity, and other physiological processes. While humans can synthesize L-arginine, dietary intake is important for maintaining adequate plasma levels. L-arginine supplementation has been studied for conditions like hypertension, preeclampsia, erectile dysfunction, and more due to its role in nitric oxide production and vasodilation. Studies have found L-arginine reduces risks of preeclampsia and preterm birth in at-risk women. Further research is still needed but L-arginine may help prevent and treat preeclampsia. Typical effective doses range from 1
WHO Pharmaceuticals NEWSLETTER , 2019 No.2.
The WHO Pharmaceuticals Newsletter provides you
with the latest information on the safety of medicines
and legal actions taken by regulatory authorities around
the world. It also provides signals based on information
derived from the WHO global database of individual
case safety reports
1) Rabies is a viral disease transmitted primarily through bites from rabid animals.
2) It is transmitted through saliva, usually via bites, but can also be transmitted through scratches or licks on broken skin or mucous membranes.
3) In Southeast Asia, 96% of human rabies cases are caused by dog bites. Other animals like monkeys, cats, foxes, bats and rodents can also transmit rabies.
1) The document summarizes recommendations from the 18th International Conference of Drug Regulatory Authorities held in Dublin, Ireland in 2018.
2) Key themes of discussion included promoting regulatory collaboration, convergence and harmonization; improving coordination and reliance; enabling access to innovative medical products; and strengthening regulatory systems.
3) Recommendations called on WHO and member states to finalize guidance on good regulatory practices, harmonize application formats, consider conditional approvals during public health emergencies, and improve communication on risk and benefits of medical products.
Nepal Pharmacy Council License Exam Model set II (Pharmacist)Nabin Bist
Nepal Pharmacy Council License Exam Model set II (Pharmacist)
Based on Nepal Pharmacy Council License Syllabus
Prepared By Pramila Ghimire & Nabin Bist
Guidelines for Drug Donation to Nepal (DDA)Nabin Bist
1. This document provides guidelines for drug donations in Nepal to ensure donated drugs meet national requirements and are based on expressed needs.
2. Key guidelines include that donated drugs must be approved for use in Nepal, have sufficient shelf life remaining, come from reliable sources that meet quality standards, and be appropriately packaged and labeled.
3. The recipient organization is responsible for informing donors of needs and ensuring proper storage, handling, and administration of donated drugs.
This document presents Nepal's National Health Policy 2071. It discusses the background and history of health initiatives in Nepal. Some key achievements over the past decades include controlling many infectious diseases and reducing maternal and child mortality rates. However, challenges remain in ensuring quality health services reach all citizens, especially vulnerable groups. The policy aims to build on past gains, address current and emerging issues, and fulfill Nepal's constitutional commitment to health as a fundamental right. It outlines visions, goals and strategies to guide the health sector over the coming years through efficient use of resources and responsive management.
The document summarizes several important drug regulatory news and safety updates from regulatory authorities including Health Canada and the US FDA. It provides warnings and updates to healthcare professionals in Nepal about potential drug interactions and risks, including:
1) The risk of high anion gap metabolic acidosis with concomitant use of flucloxacillin and paracetamol.
2) The possible risk of hypothyroidism in infants given iodine-containing contrast agents.
3) The removal of a boxed warning about asthma deaths for medicines containing inhaled corticosteroids and long-acting beta agonists.
4) The rare risk of subacute cutaneous lupus erythematosus with proton
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
1. NEPAL PHARMACY COUNCIL REGULATION,
2059 (2002)
Approved by
His Majesty's Government on
2059-4-21 (Aug. 6, 2002)
In exercise of power conferred by Section 36 of the Pharmacy Council Act, 2057 (2000), the
Nepal Pharmacy Council has framed the Rules as follows.
Chapter - 1
Preliminary
1.1 Short title and commencement : (1) These Rules may be called as "Nepal Pharmacy
Council Regulation, 2059 (2002)".
(2) This Regulation shall come into force immediately.
1.2. Definition : Unless the subject or context otherwise requires, in this Regulation,-
(a) "Act" means the Nepal Pharmacy Council Act, 2057 (2000).
(b) "Pharmacy Professionalist" means Pharmacist or Pharmacy
assistant.
(c) "Institution" means educational institution or any institution
relating to Pharmacy profession and this shall include any type of
institution which provides pharmacy service.
(d) "Educational Institution" means any educational or training institute
established with the objective to provide or cause to provide study,
training relating to Pharmacy Subject (Medical Science) and it shall
include educational or training institution established in any name
relating to Pharmacy for such purpose.
[1]
2. (e) "Employee" means the employee who render service in the act of
the Council.
Chapter - 2
Provision Relating to Name Registration
2.1 Name registration and re-name registration fee : (1) For the purpose of name
registration of Pharmacy professionalist in the Council, the fee as prescribed under
Schedule-1 shall be required to be paid.
(2) If the name of any person has been removed from the registration book of
the Council after name registration pursuant to Clause (a), (b) or (c) of Section 18 of
the Act, the fee as equivalent to the initial name registration shall be required to pay
for re-registration of the name.
2.2 Application to be made for name registration : (1) Any person holding pharmacy
profession wish to register his name in the registration book to carry out Pharmacy
profession, such person shall be required to submit an application to the Council in the
format prescribed in Schedule-2.
(2) While submitting an application pursuant to Sub-rule (1), a copy of the
educational qualification or degree and the document issued by authoritative authority
as regards to such educational qualification or degree, name registration fee
determined pursuant to Sub-rule 2.1, Affidavit pursuant to Schedule-3 and other
document prescribed by the Council and the certificate of Nepalese citizenship in the
case of Nepalese citizen and in the case of non-Nepalese, a copy of his identify issued
by governmental body showing his passport or identity and the recommendation letter
issued by the head of the institution in which he has desired to work for registration of
his name stating therein causes for his to work, period of work etc. shall be required to
be enclosed therewith.
2.3 Period of the recommendation, investigation, inquiry against the application :
Generally, the total period of investigation by the Registrar against the application
submitted by the applicant and the inquiry and recommendation to be made by the
[2]
3. Subject Committee relating to thereof to the Council shall not exceed than three
months.
2.4 Decision of registration of name, renewal of registration and registration book : (1)
The Registrar having registered the name of person bearing pharmacy professionalist
whose name has been decided to register by the Council pursuant to Section 15 of the
Act in the registration book in the format pursuant to Schedule-4 shall be required to
issue a name registration certificate to such Pharmacy Professionalist in the format
pursuant to Schedule-5.
(2) If any non-Nepalese pharmacy professionalist has to carry out pharmacy
profession in any institute throughout the Kingdom of Nepal such Pharmacy
professionalist shall be required to register their name in the registration book.
(3) Non-Nepalese Pharmacy professionalist shall be entitled to carry out
pharmacy profession up to the period and limit prescribed by the Council.
(4) While making name registration of non-Nepalese Pharmacy Professionalist
pursuant to Sub-rule (2), a decision shall be required to be made to register the name
in the Council authorizing to carry out the Pharmacy profession throughout the
Kingdom of Nepal for a period of two years in maximum.
(5) If any non-Nepalese Pharmacy Professionalist whose name has been
registered specifying the time frame pursuant to Sub-rule (4), wish to renew his name,
such professionalist shall be required to submit an application before the Council at
least 35 days in advance of the expiry of the time frame enclosing therewith the fee so
prescribed in Schedule-1 and the Council if so deems necessary may make a decision
for renewal of name registration of such person not exceeding one year once after
submission of such application.
(6) It shall be deemed to have been expired automatically the name registration
of Pharmacy professionalist in case where the registered non-Nepalese Pharmacy
professionalist has not submitted an application for renewal of name registration
before the Council 35 days in advance of expiry of time frame of his name registration
[3]
4. or his period of service has been terminated in the institution where he is serving prior
to the expiry of time frame of renewal of registration or he has left to work in such
institution.
(7) If the registration has been canceled pursuant to Sub-rule (6), the name
registration or renewal registration fee so paid shall not be refunded.
(8) Other provision relating to name registration and renewal registration of
non-Nepalese Pharmacy Professionalist shall be as prescribed by the Council.
2.5 Notice of name registration to be given : If the Council, owing to any reason has made
decision not to register the name of such applicant while making proceeding into the
application so submitted for name registration, the Registrar shall be required to give
information thereof to the concerned applicant in the format prescribed in Schedule-6.
2.6 Fee not to be refended : If the Council has made decision not to register the name of
the applicant in the registration book pursuant to Rule 2.5, the fee so paid by the
applicant for name registration shall not be refended.
Chapter - 3
Provision Relating to Professional Code of Conduct
3.1 Professional code of conduct : (1) For the purpose of Clause (e) of Section 9 and
Clause (c) of Sub-section (1) of Section 18 of the Act, the professional code of
conduct to be observed by the registered Pharmacy Professionalist while carrying out
the Pharmacy profession shall be as follows:-
(a) No discrimination be made on the basis of religion race, sex and
social cast and custom or any means against any person while
exercising professional knowledge and skill.
(b) Acts to be carried out only on to the subject of study or knowledge
and skill obtained by him.
[4]
5. (c) No undue financial benefit of any type shall be obtained other than
the remunearation, allowance and other facilities in lieu of serivce
through publicity of pharmacy service or no undue activity of any
type which damage the image of Pharmacy pforession be carried
out or caused to be carried out.
(d) Responsibility of each act relating to Pharmacy profession to be
performed by them shall be required to be taken and performed
personally.
(c) Each registered Pharmacy professionalist shall be required to
update their name.
(2) The code of conduct to be observed by the Pharmacy Professionalist other
than as referred to in Sub-rule (1), shall be as prescribed by the Council from time to
time.
(3) It shall be the duty and responsibility of all so concerned to observed or
cause to observe the professional code of conduct.
3.2 Deemed to be treated as the professional code of conduct has not followed : If the
registered Pharmacy Professionalist has not observed the code of conduct so
determined pursuant to Rule 3.1, it shall be treated that the professional code of
conduct has not been observed.
Chapter - 4
Procedure Relating to Removal of Name from the Registration Book, Suspension and
Re-registration the Name
4.1 Inquiry Committee : If the matter appeares to the notice of the Council by any means
that any registered Pharmacy professionalist has not observed the professional code of
conduct pursaunt to Rule 3.1 or registered the name in the registration book pursuant
to Clause (e) of Sub-section (1) of Section 18 of the Act, the Council may constitute a
[5]
6. one or three members Inquiry Committee on the convenorship of any member of the
Council to have inquiry an required and submit a report thereof.
4.2 To take statement and cause to submit proof and evidence : The Inquiry Committee
may, take the statement of the person charged in the crime of non-observation of the
professional code of conduct or registered the name pursuant to Clause (e) of Sub-
section (1) of Section 18 of the Act and cause to submit proof and evidence against the
charge so made to him.
4.3 Opportunity of defence to be given : (1) During the process of investigation of the
person against whom the charge of non-observation of professional conduct or
registered the name pursuant to Clause (e) of Sub-section (1) of Section 18 of the Act
has been made, the Council shall be required to give an opportunity of his defence as
regards to that by providing reason for such action to such person at least 35 days in
advance.
(2) While giving an opportunity of defence pursuant to Sub-rule (1), the charge
against him shall be required to be clearly indicated and the facts and grouds on which
each charge is based.
(3) The concerned person shall be required to submit his defence within the
time frame so given for defence pursuant to Sub-rule (1).
4.4 Suspension may be made : (1) The Inquiry Committee may, suspend a registered
Pharmacist or Pharmacy assistant from the date of initiation of inquiry against whom
the charge of non-observation of professional conduct or registered the name pursuant
to Clause (e) of Sub-Section (1) of Section 18 of the Act has been made.
Provided that generally suspension shall not be made unless the following
circumstance exist:-
(a) If there appears a possibility of collecting false evidence concealing
the evidence agaisnt him if he is not suspended and allowed to carry
out Pharmacy Professions, or
[6]
7. (b) If there appeares a possibility of loss and damage to such profession
or consumer if he is not suspended and allowed to carry out
Pharmacy profession.
(2) While suspending any Pharmacy professionalist pursuant to Sub-rule (1),
he shall not be suspended ordinarily for more than two months. The proceedings
against him shall be required to be completed within the said period. If such
proceedings cannot be completed within the said period owing to extraordinary
circumstance and the period of suspension has to be extended, the period of
suspension can be extended for maximum of one month with the prior approval of the
Council.
(3) The information of suspension pursuant to Sub-rule (1) or extension of the
period of suspension pursuant to Sub-rule (2) shall be required to be given to the
Pharmacy professionalist so concerned and the institution, if he has been serving in
any institution. After obtaining the information of suspension of any Pharmacy
Professionalist, such institution shall be required to suspend the Pharmacy
Professionalist so concerned from the service of its institution.
4.5 An opportunity of clarifiaction to be given : (1) If the defence has not been made
within the time frame so given to defense pursuant to Rule 4.3 or if the defense so
submitted is not satisfactory, a notice at least of 15 days shall be required to be given
as regards to ask such person to submit clarification that why his name should not be
removed from the registration book.
(2) The Pharmacy professionalist shall be required to submit clarification
within the time frame so given in cases where an opportunity of clarification has been
given pursuant to Sub-rule (1).
4.6 Report of the Inquiry Committee : (1) The Inquiry Committee shall be required to
submit its report before the Council after completion of the act of inquiry.
(2) The report to be submitted pursuant to Sub-rule (1), shall be required to be
enclosed therewith the opinion of the Committee whether the name of any person be
[7]
8. removed from the registration book or not and all proof and evidence obtained
thereon.
4.7 Decision to be made by the Council : The Council shall be required to make decision
by studying the report submitted by the Inquiry Committee pursuant to Rule 4.6 and
mentioning explicit reasons upon proper evaluation of the defense, clarification
submitted by the person so charged and available proof and evidence after having
checked whether or not the person so charged has been given enough opportunity of
defense and clarification pursuant to Rule 4.3 and 4.5 respectively and whether or not
factual evaluation and analysis of the defense, clarification submitted by him and
proof, evidences enclosed therewith and the evidences collected by Inquiry
Committee.
4.8 Information of decision : If the Council has made decision to remove the name of any
person from the registration book of the Council pursuant to Rule 4.7 on the ground of
non-observation of professional conduct or charge of the name registration pursuant to
Clause (e) of Sub-section (1) of Section 18 of the Act, the Registrar shall, after giving
the information of such decision to the person so concerned and the institution where
he is serving, require to publish a public notice thereon.
4.9 Termination of Suspension : If the charge made against any person for non-
observation of professional conduct or registration of the name pursuant to Clause (e)
of Sub-section (1) of Section 18 of the Act has been proved pursuant to Rule 4.7 or not
proved by the Council and if such person has been suspended pursuant to Rule 4.4,
such suspension shall ipso facto, be terminated.
4.10 Re-name registration : If the Council has decided to re-register the name of any
Pharmacy Professionalist pursuant to Sub-section (2) of Section 20 of the Act, the
Registrar shall register the name of such person in the registration book by following
the procedures as referred to in Schedule-2 and issue a certificate thereof.
Chapter - 5
Provision Relating to Chairman, Member and Registrar
[8]
9. 5.1 Functions, duties and powers of Chairman : In addition to the functions, duties and
powers as referred to in Section 25 of the Act, the functions, duties and powers of
Chairman shall be all other functions to carry out or cause to carry out as the Chief of
the Council.
5.2 Functions, duties and powers of the Registrar : In addition to the functions, duties and
powers otherwise mentioned in the Act and this Regulation, the function, duties and
powers of the Registrar shall be as follows:-
(a) To carry out all act and actions as the Administrator or Chief of the
Council,
(b) To implement or cause to implement budget, plan and programme
approved by the Council,
(c) To take responsibility of fund of the Council,
(d) To take registration book under its own responsibility,
(e) To carry out other acts designated, directed, delegated and ordered
by the Council and Chairman.
5.3 Remuneration of Registrar : The Council shall give to the Registrar the monthly
remuneration as prescribed in Schedule-7.
5.4 Meeting allowance : Meeting allowance to be obtainable by Chairman, Member,
Registrar and Expert of the Council and Chairman, Member, Member-secretary and
expert of the Subject Committee shall be as prescribed in the Schedule-7.
Chapter - 6
Provision Relating to Post, Number of Positions, Class, Minimum Qualification and
Vacancy Fulfillment of Employee of the Council
6.1 Post, number of positions, class and minimum qualification of employee of the
Council : (1) The post, number of positions, class and the minimum qualification
required for such post shall be as prescribed in the Schedule-8.
[9]
10. (2) If it has been deemed necessary to create new post for the Council other
than as referred to in Sub-rule (1), the Registrar shall be required to submit to the
Council mentioning thereof work load, financial responsibility to be incurred
therefrom and sources thereon.
(3) If submitted for creation of new post pursuant to sub-rule (1), the Council
having considered the work load and also the financial responsibility to be incurred,
deems necessary to create post, shall be required to request before the Ministry of
Health for approval of number of positions.
(4) If the number of positions have been approved by the Ministry of Health as
per request of the Council pursuant to Sub-rule (3), the Council shall create the
number of positions as approved.
(5) Vacancy fulfillment Committee: (1) For the purpose of appointment of
employee to the vacant post of service of the Council and recommend the name of
appropriate candidate before the Chairman having selected such employee on the basis
of principle and method as approved by the Public Service Commission, a Vacancy
Fulfillment Committee shall be constituted as follows:-
(a) Member of the Council designated by
Chairman - Chairman
(b) Member of the Council designated by
Chairman - Member
(c) Registrar - Member-Secretary
(2) The Vacancy Fulfillment Committee may invite the expert so concerned
with the post to be fulfilled as expert in the meeting as and when required.
(3) All proceedings relating to meeting of the Vacancy Fulfillment Committee
shall be as determined by the said Committee.
(4) The meeting allowance to be obtained by Chairman, Member, Member-
Secretary and Expert shall be as prescribed in Schedule-7.
[10]
11. 6.3 Appointment to be made on Contract : (1) The candidate so recommended for new
appointment by the Vacancy Fulfillment Committee shall be given appointment on
contract for maximum of two years at one time within 15 days from the date of
recommendation and the notice thereof shall be required to be given to the candidate
so concerned through the quickest means.
(2) The decision of appointment pursuant to Sub-rule (1) shall be made by
Chairman.
(3) The Council may, if it deems necessary, on the recommendation of the
Registrar, extend the period of contract not exceeding two years at one time of the
employee whose appointment has been made pursuant to Sub-rule (1).
(4) The condition of service, facilities and period of service of employee
appointed pursuant to Sub-rule (1) shall be as referred to in the contract paper.
6.4 No appointment to be made without the post : No one shall be allowed to appoint to
the service of the Council without the post. If it has been found that the appointment
so made, the salary, allowance including other facilities having received by such
employee during the service of the Council shall be realized from the appointing
officer.
Chapter - 7
Miscellaneous
7.1 Seal of the Council : (1) The seal of the Council shall be in the format and design as
referred to in the Schedule -9.
(2) The seal of the Council pursuant to Sub-rule (1) shall be made as per the
size prescribed by the Council and colour to be used in such seal shall be as prescribed
by the Council.
(3) Any document to be issued on behalf of the Council shall bear the seal of
the Council.
[11]
12. 7.2 Notice of leaving profession or change of address to be given : If any registered
Pharmacy professiolist has left Pharmacy Profession or changed the address such
Pharmacy professionalist shall be required to give written notice thereof to the
Registrar within one month.
7.3 Record of name registration required to be maintained up-to-date : (1) The Registrar
shall be required to maintain up-to-date the name of each Pharmacy Professionalist
whose name has been registered in the Council under this Regulation.
(2) The Council shall once in every three years publish publicly the name of
Pharmacy Professionalist which has been maintained
up-to-date pursuant to Sub-rule (1).
7.4 Details required to be made available to maintain up-to-date the record of name
registration : (1) For the purpose of maintaining up-to-date the record of name
registration of each registered Pharmacy Professionalist, the Pharmacy Professionalist
by filling the up-to-date form in the format as prescribed shall be required to made
available to the Council.
(2) The name of Pharmacy Professionalist who has not made available up-to-
date detail form pursuant to Sub-rule (1) shall not be included in the up-to-date list.
7.5 Up to date fee : The Pharmacy Professionalist whose name has been registrered in the
registration book of the Council shall be required to enclose therewith up-to-date fee
so determined in Schedule-1 while sending up-to-date detail pursuant to Rule 7.3.
7.6 Interpretation of Regulation : The power of interpretation of this Regulation shall be
vested with the Council.
7.7 Power to remove difficulties : If any difficulties have been occurred unexpectedly on
to the subject not directed or mentioned clearly as to be done in such way by the Act
or this Regulation, the Council may remove such difficulties having managed proper
provision complied with the provisions as referred to in the Act and this Regulation.
[12]
13. 7.8 Delegation of authority : (1) The Council may delegate some powers from among the
powers conferred to the Council under the Act and this Regulation to the Subject
Committee, Chairman, Member, Registrar and Officer employee of the Council.
(2) The Chairman and Registrar may delegate some powers from among the
powers conferred to the Chairman and Registrar under the Act and this Regulation to
the Registrar and Officer employees of the Council respectively.
7.9 Determination of policy, guideline, procedure, condition, standard and infrastructure
may be made : (1) For the purpose of obtaining the Objective of the Act and this
Regulation, the Council may determine and issue policy, guideline, procedure,
condition, standard and infrastructure as required on the subject as follows :-
(a) Operation of Pharmacy Profession in systematic, scientific and
smooth way,
(b) Standard and infrastructure for the establishment of educational
institution and operation,
(c) Evaluate and review the basis of recognisation of the educational
institution and curricula, conditions of admission, examination
system and other necessary condition and infrastructure relating to
thereof of such institution,
(d) Necessary qualification to carry out Pharmacy Profession and
determination of limitation of work of Pharmacy Professionalist.
(e) Other necessary subject.
(3) It shall be the duty of all so concerned to observe or cause to observe the
policy, guideline, procedure, condition, standard and infrastructure issued pursuant to
Sub-rule (1).
7.10 Power to amend the Schedule : The Council may modify or change in the Schedule of
this Regulation as and when required.
[13]
14. Schedule - 1
(Relating to Sub-rule (1) of Rule 2.1, Sub-rule (5) of Rule 2.4 and Rule 7.5)
Name Registration, Registration Renewal and Updating fee
(a) Licensining Exam Fee Nrs. 1500/-
(b)Name registration fee:
1. For Pharmacist Nrs. 2000/-
2. For Pharmacy assistant Nrs. 1000/-
3. For Non-Nepalese Pharmacist Nrs. 15,000/-
4. For Non-Nepalese Pharmacy assistant Nrs. 10,000/-
(b) Renewal fee :
1. For Non-Nepalese Pharmacist Nrs. 7500/-
2. For Non-Nepalese Pharmacy assistant Nrs. 5000/-
(c) Name registration updating fee :
1. For Pharmacist Nrs. 500/-
2. For Pharmacy assistant Nrs. 300/-
[14]
15. Schedule - 3
(Relating to Sub-rule (2) of Rule 2.2)
AFFIDAVIT
I ……………………… hereby promising to carry out honestly all the functions,
duties and powers and pforessional conduct as to be carried out as a Pharmacist/Pharmacy
assistant in accordance with Nepale Pharmacy Council Act, 2057 (2000) and Nepal Pharmacy
Council Regulation, 2059 (2002) and subject to other prevailing law, submit this affidavit.
Further, I hereby agree to bear action against me as per law in case I have not carried out the
functions, duties and preofessional conduct as to be carried out as a Pharmacist/ Pharmacy
assistant as directed by the Nepal Pharmacy Council Act, Regulation and other Prevailing law.
Signature:-……………
Name:- ………………
Address:- ……………
Date:- ………………
[ 15]
16. Schedule - 4
(Relating to Sub-rule (1) of Rule 2.4)
REGISTRATION BOOK
Photograph of the
applicant
Registration No.:-
Name:-
Permanent address:- Zone: ………………… District: ………………
Village Development Committee/Municipality ………………………
Ward No.: ………… Tole: ……… Village: ……………
Telephone No.:………… Fax No: …………
Temporary address: Zone: ………………… District: ………………
Village Development Committee/Municipality ………………………
Ward No.: ………… Tole: ……… Village: ……………
Telephone No.:………… Fax No: …………
E-mail:
Father's name:
Employed institution and address
[16]
17. Details relating to educational qualification and training:
Ordinary educational qualification
Serial Obtained Faculty of Year Division Remarks
No. educational study
qualification
1.
2.
3.
Professional educational qualifications
Serial Obtained Faculty of Year Division Remarks
No. educational study
qualification
1.
2.
3.
Training
Serial Name of degree Name of Institution Year Division Remarks
No. providing training
1.
2.
3.
[17]
18. Date of decision of the Council:
Signature of the person filling
the details:
Signature of certificate
bearer: Date of registration:
Signature of Registrar:
Amendment and change in the details etc. (to be filled at the time of up dating name
registration)
Date Details Signature of the person Signature of the Remarks
filling details Registrar
[18]
19. Schedule - 5
(Relating to Sub-rule (1) of Rule
2.4) Nepal Pharmacy Council
Photograph of bearer
of name registration
certificate
NAME REGISTRATION CERTIFICATE
Mr. ……………, aged ………, a resident of …………… Zone ……… District
………………, Municipality/Village Development Committee, Ward No. ……… has
completed the prescribed qualification to be completed for registration of name in the
registration book of Nepal Pharmacy Council in accordance with the Nepal Pharmacy Council
Act, 2057 (2000) and Nepal Pharmacy Council Regulation, 2059 (2002), now, therefore, this
certificate has been issued having registered his/her name in the registration book of Nepal
Pharmacy Council as Pharmacist / Pharmacy Assistant as per the decision of Nepal Pharmacy
Council dated …………………
Registration number:
Date of issuance of name registration certificate:
Signature:- ………
Name:-
Note:- In cases where the name registration of non-Nepalese Pharmacist / Pharmacy assistant
has not been renewed, the validity of this certificate shall only be up to the period of
two years from the date of issuance and incases where the renewal of name
registration of such Pharmacist /Pharmacy assistant is to be made, such Pharmacist /
Pharmacy assistant shall be required to submit an application before the Nepal
Pharmacy Council at least 35 days in advance of termination of the validity of this
certificate.
[19]
20. (Particular to be mentioned in the reverse page of name registration certificate)
DETAILS OF RENEWAL OF NAME REGISTRATION
Period of renewal Date of decision Signature of Seal of the Remarks
of name of the Council for Registrar Council
registration renewal of name
_______________ registration
From To
[20]
21. Schedule - 6
(Relating to Rule 2.5)
Subject:- Information of non-registry of name
Mr. ……………………
…………………
Upon taking action into the matter, as per your application to this office dated
………………… for the registration of name in the Registration Book of the Nepal Pharmacy
Council, the Council, by a decision dated ……………, decided not to register your name in
the Registration Book owing to the ground as follows :
Grounds of not registering name
(a)
(b)
(c)
Signature:- ……………
Date:- …………………
Name:- ………………
Registrar
[21]
22. Schedule - 7
(Relating to Rule 5.3, Rule 5,4 and Sub-rule (4) of Rule 6.2)
Meeting Allowance and Remuneration of the Registrar
(a) Meeting allowance (Each meeting)
1. Chairman of the Council Nrs.1000/
2. Member of the Council, Registrar and expert Nrs. 800/-
3. Chairman of the Subject Committee Nrs. 800/-
4. Member of the Subject Committee, Member-Secretary and
expert Nrs. 600/-
5. Chairman of the Vacancy Fulfillment Committee Nrs. 800/-
6. Member of the Vacancy Fulfillment Committee, Member-
Secretary and expert Nrs. 600/-
(b) Remuneration of the Registrar (Each month)
1. If any employee employed in the service of His Majesty's
Government, assigned as the Registrar - Nrs.10000/-
2. If any employee who is not employed in the service of
Government has been assigned as the Registrar, he shall be
entitled equivalent to the salary and allowance if any, entitled by
the officer at least of level eight in accordance with the Nepal
Health Service Act, 2053 (1996).
[22]
23. Schedule - 8
(Relating to Rule 6.1)
Class, designation, position, number of positions and minimum
qualification for Service
Serial No. Designation Class Number of Minimum qualification
position
1. Administrative Third Class 1 (one) Obtained minimum of
Officer Officer Bachelor or the degree
equivalent to that on the
subject of Humanity and
Social Science or
Commerce or Science
and Technology or Law
or education.
2. Office Assistant First Class 1 (one) Passed minimum
Assistant certificate level or the
degree equivalent to that
on the subject of
Humanity and Social
Science or Commerce or
Science and Technology
or Law or Education and
obtained minimum 6
months training relating
to computer operation or
computer diploma.
[23]
24. 3. Sub-accountant Second class 1 (one) Passed S.L.C. or the
assistant degree equivalent to that.
4. Peon Class less 1 (one) Familiar to simple
reading and working
[24]
25. Schedule - 9
(Relating to Rule 7.1)
Details :
There shall appear the words "Nepal Pharmacy Council in Nepali and English at the
top and bottom between the inner and outer Circles and tablet and capsule of drugs at the left
and right side respectively between the said circles and grinder (motor/peshal) marked Rx
shall be placed in the middle of mouth of two wrinkled snakes and the said grinder
(motor/peshal) shall be standed by a stick and there shall be mentioned 2058 and 2001 at the
outer left and right side of wrinkled snakes respectively.
[25]