Regulatory aspects of Ayurvedic Research.pptxRiaSikder
The document discusses regulatory aspects of Ayurvedic research and drug development. It outlines that Ayurvedic drugs play an important role in public health and the economy, so they must be regulated to ensure safety, efficacy, and quality. Regulatory requirements drive the need for drug analysis to assure standards are met. Key functions of regulatory agencies include product registration and evaluation, manufacturing and distribution regulation, and adverse reaction monitoring. The main goal is to guarantee safe, effective, and quality drugs for public use. The drug regulatory system in India is governed by both central and state authorities under the Drugs and Cosmetics Act of 1940. The guidelines are intended to help promote better research, evaluation, and understanding of Ayurvedic
Central Drugs Standard Control Organization (CDSCO)KapilKumar198
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It functions under the Directorate General of Health Services and regulates drug approval, clinical trials, manufacturing standards, and import of drugs. CDSCO has six zonal offices, four sub-zonal offices, and seven drug testing laboratories. It is headed by the Drug Controller General of India, who is responsible for approving licenses for certain drug categories and setting quality standards for drug manufacturing and distribution in India.
The drug regulatory authority develops and implements legislation and regulations regarding pharmaceuticals to ensure drug quality, safety and efficacy. It establishes rules for drug manufacture, distribution, clinical trials and more. The key agencies are the Ministry of Health and Family Welfare, Central Drugs Standard Control Organization, Indian Pharmacopoeia Commission and National Pharmaceutical Pricing Authority. The CDSCO regulates drugs and medical devices in India under the Ministry of Health. State drug control organizations like the FDA Maharashtra enforce drug laws at the local level.
central and state Regulatory bodies in Indiasonaliph
The document discusses the central and state drug regulatory bodies in India. It outlines that the key regulatory bodies are the Ministry of Health and Family Welfare, Central Drug Standard Control Organization, Indian Pharmacopoeial Commission, Drug Controller General of India, and National Pharmaceutical Pricing Authority. These bodies regulate drug manufacturing, import, distribution, pricing and ensure drug quality, safety and efficacy. The document also provides details on roles of state drug regulatory authorities like the Food and Drug Administration of Maharashtra.
The document discusses India's regulatory requirements for drugs. It outlines the key regulatory bodies that oversee drug approval and quality control in India, including the Central Drugs Standard Control Organization (CDSCO) and the National Pharmaceutical Pricing Authority (NPPA). The roles of the central and state governments in drug regulation are also summarized. Processes such as new drug approval, licensing, and quality testing are explained.
The document discusses regulatory bodies and agencies that approve drugs. It provides information on the drug development process and regulatory roles of various agencies around the world such as the FDA in the US and CDSCO in India. It describes the functions of regulatory agencies which include product registration, drug evaluation, monitoring safety and efficacy, and adverse reaction monitoring. The challenges regulatory bodies face in promoting public health and protecting people from harmful drugs are also mentioned.
Regulatory aspects of Ayurvedic Research.pptxRiaSikder
The document discusses regulatory aspects of Ayurvedic research and drug development. It outlines that Ayurvedic drugs play an important role in public health and the economy, so they must be regulated to ensure safety, efficacy, and quality. Regulatory requirements drive the need for drug analysis to assure standards are met. Key functions of regulatory agencies include product registration and evaluation, manufacturing and distribution regulation, and adverse reaction monitoring. The main goal is to guarantee safe, effective, and quality drugs for public use. The drug regulatory system in India is governed by both central and state authorities under the Drugs and Cosmetics Act of 1940. The guidelines are intended to help promote better research, evaluation, and understanding of Ayurvedic
Central Drugs Standard Control Organization (CDSCO)KapilKumar198
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It functions under the Directorate General of Health Services and regulates drug approval, clinical trials, manufacturing standards, and import of drugs. CDSCO has six zonal offices, four sub-zonal offices, and seven drug testing laboratories. It is headed by the Drug Controller General of India, who is responsible for approving licenses for certain drug categories and setting quality standards for drug manufacturing and distribution in India.
The drug regulatory authority develops and implements legislation and regulations regarding pharmaceuticals to ensure drug quality, safety and efficacy. It establishes rules for drug manufacture, distribution, clinical trials and more. The key agencies are the Ministry of Health and Family Welfare, Central Drugs Standard Control Organization, Indian Pharmacopoeia Commission and National Pharmaceutical Pricing Authority. The CDSCO regulates drugs and medical devices in India under the Ministry of Health. State drug control organizations like the FDA Maharashtra enforce drug laws at the local level.
central and state Regulatory bodies in Indiasonaliph
The document discusses the central and state drug regulatory bodies in India. It outlines that the key regulatory bodies are the Ministry of Health and Family Welfare, Central Drug Standard Control Organization, Indian Pharmacopoeial Commission, Drug Controller General of India, and National Pharmaceutical Pricing Authority. These bodies regulate drug manufacturing, import, distribution, pricing and ensure drug quality, safety and efficacy. The document also provides details on roles of state drug regulatory authorities like the Food and Drug Administration of Maharashtra.
The document discusses India's regulatory requirements for drugs. It outlines the key regulatory bodies that oversee drug approval and quality control in India, including the Central Drugs Standard Control Organization (CDSCO) and the National Pharmaceutical Pricing Authority (NPPA). The roles of the central and state governments in drug regulation are also summarized. Processes such as new drug approval, licensing, and quality testing are explained.
The document discusses regulatory bodies and agencies that approve drugs. It provides information on the drug development process and regulatory roles of various agencies around the world such as the FDA in the US and CDSCO in India. It describes the functions of regulatory agencies which include product registration, drug evaluation, monitoring safety and efficacy, and adverse reaction monitoring. The challenges regulatory bodies face in promoting public health and protecting people from harmful drugs are also mentioned.
The document provides an overview of drug regulation systems in India, the United States, and other countries. It discusses the key functions of drug regulatory agencies, which include product registration, regulating drug manufacturing and distribution, monitoring drug safety and efficacy, and regulating drug promotion and information. The main regulatory bodies in India are the Central Drugs Standard Control Organization and other organizations like the Indian Council of Medical Research. In the US, the main regulatory agency is the Food and Drug Administration, which aims to promote health by reviewing research and ensuring drugs are safe. The document also discusses regulatory agencies in other countries like Japan.
The document provides an overview of drug regulation systems in India, the US, Japan, and the EU. It discusses the key drug regulatory agencies and their functions in each region. In India, the main regulatory bodies are the Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, and other organizations like the Indian Council of Medical Research. The US FDA is the primary drug regulatory agency, while in Japan it is the Ministry of Health, Labor and Welfare. The EU coordinates drug regulation between member states through legislation and guidelines.
2023.08.15_National Drug Polices_3rd years.pptxFranciKaySichu
The document summarizes Zambia's national drug policy. Key points include:
- The policy aims to ensure equitable access to safe, effective and affordable essential medicines through regulation, quality control, education, and rational drug use.
- Key stakeholders in developing the policy are the Ministry of Health and other government departments.
- The policy addresses legislation, drug selection, procurement, storage, distribution, financing, local production, human resources and challenges like stockouts and irrational use.
- Implementation of the policy requires strengthening various institutions like the drug regulatory authority and improving challenges around staffing and funding.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices. It is responsible for approving new drugs, licensing manufacturing facilities, and monitoring drug quality. CDSCO's vision is to protect and promote public health in India. It has headquarters in New Delhi and offices across India. CDSCO regulates clinical trials, biosimilars, medical devices, and investigational new drugs. It also oversees state licensing authorities and provides guidance on drug regulation.
Drugs and cosmetics act 1940 and rules 1945 swaSuvarta Maru
The document summarizes the history and objectives of the Drugs and Cosmetics Act of India. It was established in 1940 to regulate drugs and cosmetics in India by licensing manufacturers and sellers. The act has been amended several times since 1955 to update regulations. Key agencies established include the Drugs Technical Advisory Board, Drugs Control Laboratories, and positions for Government Analysts to enforce the act through inspections, testing, and investigations.
Hi, everyone i am providing you the best presentation about the Pakistan relate Drug regulatory affairs and the concept of regulatory affairs of Pharmaceuticals
The document discusses various drug regulatory authorities around the world including the FDA, TGA, CDSCO, and ICMR. It provides an overview of the roles and responsibilities of these agencies in regulating drugs and pharmaceutical products to ensure public health and safety. Key functions of regulatory authorities that are described include evaluating new drugs, inspecting manufacturing facilities, monitoring adverse events, and establishing product standards.
Bodies regulating indian pharmaceutical sector, cdscochiranjibi68
This document provides an overview of the major regulatory bodies that govern the Indian pharmaceutical sector, with a focus on the Central Drugs Standard Control Organization (CDSCO). It begins with background on drug regulation and the need for effective regulation. It then discusses various international and Indian regulatory bodies. The bulk of the document describes the roles and functions of CDSCO and the Drug Controller General of India as the central drug authorities that approve clinical trials, marketing authorization, and licenses for certain drug categories. It also briefly discusses the National Pharmaceutical Pricing Authority and deficiencies in India's drug regulatory system.
Regulatory control of pharmaceuticals aims to ensure drug safety, efficacy and quality. Key aspects of regulation include drug evaluation and licensing, manufacturing standards, import/export controls, and adverse event monitoring. The main regulatory bodies in India are the Central Drugs Standard Control Organization, which oversees drug approvals, good manufacturing practices and quality control, and the Drugs Controller General of India. Indian drug laws and policies are guided by organizations like the Indian Pharmacopoeia Commission, which establishes drug standards.
Role of Drug Regulatory agencies in Clinical Research.ClinosolIndia
Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
The document discusses the organization of the US Food and Drug Administration (FDA). It describes that the FDA regulates food, drugs, medical devices, cosmetics, and tobacco. It is organized into six product centers that regulate specific areas, a research center, and two offices. The centers regulate drugs, biologics, devices, food, veterinary medicine, and tobacco. The Office of Regulatory Affairs conducts inspections and investigations. The Office of the Commissioner provides leadership. Employment in 2013 totaled 14,589 across the various centers and offices.
The document summarizes key aspects of the Drug and Cosmetic Act and Rules in India, including:
- The Acts and Rules regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
- Important definitions are provided for terms like "drug", "cosmetic", "manufacture" and others.
- Drugs and cosmetics can be deemed "misbranded", "adulterated" or "spurious" if they do not meet certain standards.
- The Rules contain 18 parts and 26 schedules providing detailed requirements and guidelines for drugs and cosmetics.
- Key agencies like the Drugs Technical Advisory Board help administer the Acts and
The document summarizes key aspects of the Drug and Cosmetic Act and Rules in India, including:
- The Acts and Rules regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
- Important definitions are provided for terms like "drug", "cosmetic", "manufacture" and others.
- Drugs and cosmetics can be deemed "misbranded", "adulterated" or "spurious" if they do not meet certain standards.
- The Rules contain 18 parts and 26 schedules providing detailed requirements and guidelines for drugs and cosmetics.
- Key agencies like the Drugs Technical Advisory Board help administer the Acts and
DGDA-DIU-akt.pptxMajor steps of a Drug RegistrationUSAYATUNMAHERA2
monitors and regulates all the activities of these 858 companies. The chief of the Directorate, designated as the Director General, is also empowered by the Govt. to act as the Licensing Authority (LA) of drugs for the purpose of issuing licenses to manufacture, store, sell, import and export drugs and medicines. At present, there are 55 district offices of the Directorate in the country. All officers of the Directorate function as "Drug Inspector" pursuant to the Drug Laws and assist the Licensing Authority for properly discharging his responsibilities. Besides, a number of Committees, such as
Drug Control Committee (DCC),
Standing Committee for procurement and import of raw materials and finished drugs,
Pricing Committee and a number of other relevant Committees,
which comprise of experts, are there to advise the Licensing Authority and to recommend to him matters related to drugs and medicines.
Major steps of a Drug Registration
The document summarizes the drug regulatory system in India. The key points are:
- The Central Drugs Standard Control Organization (CDSCO) regulates pharmaceuticals and medical devices under the Ministry of Health and Family Welfare.
- CDSCO's functions include ensuring drug safety, efficacy and quality; approving new drugs and clinical trials.
- The Drugs Controller General of India heads CDSCO and is advised by the Drug Technical Advisory Board and Drugs Consultative Committee.
- State drug control administrations enforce drug regulation at the state level under the central Drugs and Cosmetics Act.
Laws and Guidelines on Clinical Trials in India.pptxmehulsarathy
Diving into the Regulatory Framework: Navigating Clinical Trial Laws & Guidelines in India. This academic presentation offers an in-depth analysis of the legal landscape governing clinical research in India. Delve into the intricate web of regulations, ethical principles, and participant protection measures outlined by the Drugs and Cosmetics Act, ICMR guidelines, and recent amendments.
OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN Arul Packiadhas
The document provides an overview of drug regulatory agencies in India, the US, Europe, and Japan. It discusses the common functions of drug regulation including ensuring drug safety, licensing, inspections, and adverse event monitoring. For each region, it outlines the key regulatory bodies and their responsibilities. In India, the main agencies are CDSCO, NIHFW, DTAB, ICMR, and CDTL. In the US, the FDA oversees drug approval and safety. The key European agencies are EDQM and EMA, while Japan's PMDA regulates pharmaceuticals.
The document provides an overview of drug regulation systems in India, the United States, and other countries. It discusses the key functions of drug regulatory agencies, which include product registration, regulating drug manufacturing and distribution, monitoring drug safety and efficacy, and regulating drug promotion and information. The main regulatory bodies in India are the Central Drugs Standard Control Organization and other organizations like the Indian Council of Medical Research. In the US, the main regulatory agency is the Food and Drug Administration, which aims to promote health by reviewing research and ensuring drugs are safe. The document also discusses regulatory agencies in other countries like Japan.
The document provides an overview of drug regulation systems in India, the US, Japan, and the EU. It discusses the key drug regulatory agencies and their functions in each region. In India, the main regulatory bodies are the Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, and other organizations like the Indian Council of Medical Research. The US FDA is the primary drug regulatory agency, while in Japan it is the Ministry of Health, Labor and Welfare. The EU coordinates drug regulation between member states through legislation and guidelines.
2023.08.15_National Drug Polices_3rd years.pptxFranciKaySichu
The document summarizes Zambia's national drug policy. Key points include:
- The policy aims to ensure equitable access to safe, effective and affordable essential medicines through regulation, quality control, education, and rational drug use.
- Key stakeholders in developing the policy are the Ministry of Health and other government departments.
- The policy addresses legislation, drug selection, procurement, storage, distribution, financing, local production, human resources and challenges like stockouts and irrational use.
- Implementation of the policy requires strengthening various institutions like the drug regulatory authority and improving challenges around staffing and funding.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices. It is responsible for approving new drugs, licensing manufacturing facilities, and monitoring drug quality. CDSCO's vision is to protect and promote public health in India. It has headquarters in New Delhi and offices across India. CDSCO regulates clinical trials, biosimilars, medical devices, and investigational new drugs. It also oversees state licensing authorities and provides guidance on drug regulation.
Drugs and cosmetics act 1940 and rules 1945 swaSuvarta Maru
The document summarizes the history and objectives of the Drugs and Cosmetics Act of India. It was established in 1940 to regulate drugs and cosmetics in India by licensing manufacturers and sellers. The act has been amended several times since 1955 to update regulations. Key agencies established include the Drugs Technical Advisory Board, Drugs Control Laboratories, and positions for Government Analysts to enforce the act through inspections, testing, and investigations.
Hi, everyone i am providing you the best presentation about the Pakistan relate Drug regulatory affairs and the concept of regulatory affairs of Pharmaceuticals
The document discusses various drug regulatory authorities around the world including the FDA, TGA, CDSCO, and ICMR. It provides an overview of the roles and responsibilities of these agencies in regulating drugs and pharmaceutical products to ensure public health and safety. Key functions of regulatory authorities that are described include evaluating new drugs, inspecting manufacturing facilities, monitoring adverse events, and establishing product standards.
Bodies regulating indian pharmaceutical sector, cdscochiranjibi68
This document provides an overview of the major regulatory bodies that govern the Indian pharmaceutical sector, with a focus on the Central Drugs Standard Control Organization (CDSCO). It begins with background on drug regulation and the need for effective regulation. It then discusses various international and Indian regulatory bodies. The bulk of the document describes the roles and functions of CDSCO and the Drug Controller General of India as the central drug authorities that approve clinical trials, marketing authorization, and licenses for certain drug categories. It also briefly discusses the National Pharmaceutical Pricing Authority and deficiencies in India's drug regulatory system.
Regulatory control of pharmaceuticals aims to ensure drug safety, efficacy and quality. Key aspects of regulation include drug evaluation and licensing, manufacturing standards, import/export controls, and adverse event monitoring. The main regulatory bodies in India are the Central Drugs Standard Control Organization, which oversees drug approvals, good manufacturing practices and quality control, and the Drugs Controller General of India. Indian drug laws and policies are guided by organizations like the Indian Pharmacopoeia Commission, which establishes drug standards.
Role of Drug Regulatory agencies in Clinical Research.ClinosolIndia
Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
The document discusses the organization of the US Food and Drug Administration (FDA). It describes that the FDA regulates food, drugs, medical devices, cosmetics, and tobacco. It is organized into six product centers that regulate specific areas, a research center, and two offices. The centers regulate drugs, biologics, devices, food, veterinary medicine, and tobacco. The Office of Regulatory Affairs conducts inspections and investigations. The Office of the Commissioner provides leadership. Employment in 2013 totaled 14,589 across the various centers and offices.
The document summarizes key aspects of the Drug and Cosmetic Act and Rules in India, including:
- The Acts and Rules regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
- Important definitions are provided for terms like "drug", "cosmetic", "manufacture" and others.
- Drugs and cosmetics can be deemed "misbranded", "adulterated" or "spurious" if they do not meet certain standards.
- The Rules contain 18 parts and 26 schedules providing detailed requirements and guidelines for drugs and cosmetics.
- Key agencies like the Drugs Technical Advisory Board help administer the Acts and
The document summarizes key aspects of the Drug and Cosmetic Act and Rules in India, including:
- The Acts and Rules regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
- Important definitions are provided for terms like "drug", "cosmetic", "manufacture" and others.
- Drugs and cosmetics can be deemed "misbranded", "adulterated" or "spurious" if they do not meet certain standards.
- The Rules contain 18 parts and 26 schedules providing detailed requirements and guidelines for drugs and cosmetics.
- Key agencies like the Drugs Technical Advisory Board help administer the Acts and
DGDA-DIU-akt.pptxMajor steps of a Drug RegistrationUSAYATUNMAHERA2
monitors and regulates all the activities of these 858 companies. The chief of the Directorate, designated as the Director General, is also empowered by the Govt. to act as the Licensing Authority (LA) of drugs for the purpose of issuing licenses to manufacture, store, sell, import and export drugs and medicines. At present, there are 55 district offices of the Directorate in the country. All officers of the Directorate function as "Drug Inspector" pursuant to the Drug Laws and assist the Licensing Authority for properly discharging his responsibilities. Besides, a number of Committees, such as
Drug Control Committee (DCC),
Standing Committee for procurement and import of raw materials and finished drugs,
Pricing Committee and a number of other relevant Committees,
which comprise of experts, are there to advise the Licensing Authority and to recommend to him matters related to drugs and medicines.
Major steps of a Drug Registration
The document summarizes the drug regulatory system in India. The key points are:
- The Central Drugs Standard Control Organization (CDSCO) regulates pharmaceuticals and medical devices under the Ministry of Health and Family Welfare.
- CDSCO's functions include ensuring drug safety, efficacy and quality; approving new drugs and clinical trials.
- The Drugs Controller General of India heads CDSCO and is advised by the Drug Technical Advisory Board and Drugs Consultative Committee.
- State drug control administrations enforce drug regulation at the state level under the central Drugs and Cosmetics Act.
Laws and Guidelines on Clinical Trials in India.pptxmehulsarathy
Diving into the Regulatory Framework: Navigating Clinical Trial Laws & Guidelines in India. This academic presentation offers an in-depth analysis of the legal landscape governing clinical research in India. Delve into the intricate web of regulations, ethical principles, and participant protection measures outlined by the Drugs and Cosmetics Act, ICMR guidelines, and recent amendments.
OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN Arul Packiadhas
The document provides an overview of drug regulatory agencies in India, the US, Europe, and Japan. It discusses the common functions of drug regulation including ensuring drug safety, licensing, inspections, and adverse event monitoring. For each region, it outlines the key regulatory bodies and their responsibilities. In India, the main agencies are CDSCO, NIHFW, DTAB, ICMR, and CDTL. In the US, the FDA oversees drug approval and safety. The key European agencies are EDQM and EMA, while Japan's PMDA regulates pharmaceuticals.
Similar to Drug Regulatory Authority of Pakistan (DRAP).pptx (20)
2. Contents
• History
• DRAP
• Composition of DRAP
• Function of DRAP
• Policy board
• Funds and budget of DRAP
• Real picture of DRAP
• Other agencies
• References
3. History
• Before the establishment of DRAP, drug
regulation in Pakistan was managed by various
agencies, including the Drug Control
Organization (DCO), the Central Drugs
Laboratory (CDL), and the Ministry of Health.
However, the fragmented regulatory
framework led to challenges in coordination,
enforcement, and ensuring the quality of
pharmaceuticals.
4.
5. What is Drug Regulatory Authority
• Drug Regulatory Authority of Pakistan (DRAP) has been established in
NOV13,2012 for effective coordination and enforcement of the Drugs Act, 1976
and to bring harmony in inter-provincial trade and commerce of therapeutic
goods. Therapeutic goods regulated by the DRAP include.
• Pharmaceutical and biological drugs for human or veterinary use,
• Medical Devices and Medical Cosmetics
• Health & OTC (non-drugs) also known as alternative medicines such as:
– Ayurvedic
– Chinese
– Unani
– Homeopathy
– Nutritional products
– Food supplements for human beings, animals
• DRAP ensures that therapeutic goods, approved and available in market, meet
prescribed standards of quality, safety and efficacy. The regulatory functions
performed by DRAP include registration and marketing authorization, vigilance,
market surveillance and control, licensing establishments, regulatory inspection,
laboratory testing, clinical trials oversight, pharmacovigilance, and lot release of
6. What is Drug Regulatory Authority…….
• The authority may set up its establishments including sub-
offices and laboratories at province capital and such other
places from time to time.
• The existing Federal Drug Control Administration(FDCA) and
sub offices set up in all provinces are called Central Drug
Laboratory
• For example; • National Control Laboratory on Biological,
Karachi • Federal Drug Surveillance Laboratory, Islamabad
7. Organizational Structure
• The Drug Regulatory Authority of Pakistan is the public institution of
Government of Pakistan.
• The Authority is working as an autonomous body under the
administrative control of Ministry of National Health Services,
Regulation & Coordination.
• The legal basis of DRAP is the Drug Regulatory Authority of Pakistan Act,
2012. The general direction, administration and monitoring of the
Authority is vested to the Policy Board constituted under Section 9 of
the DRAP Act, 2012.
• Drug Regulatory Authority of Pakistan started operation in November,
2012, when the DRAP Act, 2012 came in to force.
• The former Federal Drug Control Administration and its laboratories
were merged in the formation of DRAP.
• The new area of responsibility takes into account the regulation and
quality standards of Medical Devices, Alternative Medicines, Health &
OTC products, in addition to the implementing international
standardization and harmonization to assure the quality, safety and
effectiveness drugs and biological products.
10. Divisions
• The Drug Regulatory Authority of Pakistan (DRAP)
is an autonomous body under the Ministry of
National Health Services, Regulations &
Coordination.
• It operates under the direction of a Policy Board
and has thirteen divisions, each responsible for
specific functions outlined in the DRAP Act of
2012. These divisions, overseen by boards and
committees, are empowered to make decisions
within their designated areas of responsibility.
11. Divisions
• The DRAP has following Divisions:-
• 1. Pharmaceutical Evaluation & Registration
The Pharmaceutical Evaluation & Registration Division evaluates,
assesses, and registers pharmaceutical drugs for humans and animals. It
also approves post-registration variations of these drugs.
• 2. Biological Evaluation & Research
• The Biological Drugs Division evaluates, assesses, registers, and
licenses biological drugs for humans and animals. It also performs
functions necessary for prequalification by the World Health
Organization of locally manufactured human biological drugs.
• 3. Medical Devices & Medicated Cosmetics
The Medical Devices & Medicated Cosmetics Division assesses and
registers medical devices, medicated cosmetics, shampoos, and soaps
for humans and animals, along with related functions.
• Drug Licensing
• Drug Licensing Division is responsible for the licensing of the drugs
manufacturing facilities and to perform other functions connected
therewith.
12. • 5. Health & OTC
• The Health & OTC(Over the counter) Products Division assesses and registers
alternative medicines (Ayurvedic, Chinese, Unani, Homeopathy), as well as
nutritional products and food supplements for humans and animals, among other
related functions.
7. Pharmacy Services
Pharmacy Services Division is responsible for the development and promotion of
pharmacy services and to perform other functions connected therewith.
• 8.Costing & Pricing
Costing and Pricing Division is responsible for the costing and pricing of therapeutic
goods and to perform other functions connected therewith.
• 9.Controlled Drugs
• Controlled Drugs Division in consultation with the Federal Government is responsible
for regulation and allocation of quota of narcotic drugs, psychotropic substances and
precursor chemicals and to perform other functions connected therewith.
• 10. Admin. HR & Logistics
• Administration, Human Resource and Logistics Division is responsible for
administration, recruitment, appointment, capacity building and development for
the Authority and other matters connected therewith and ancillary there to.
• 11. Budget & Accounts
• Budget and Accounts Division is responsible for budgetary and financial aspects of
the Authority and other daily accounting matters connected therewith
13. Power and function of DRAP
• Followings are the main functions of Authority: –
• Administer the DRAP Act 2012 and the Drugs Act 1976 and
advise the Provincial Governments for the laws that are
applicable to the Provinces;
• Monitor the enforcement of drugs laws and collect relevant data
and information;
• Issue guidelines and monitor the enforcement of:-
• Licensing of the manufacture of therapeutic goods;
• Registration of therapeutic goods;
• Regulation for the advertisement;
• Drug specifications and laboratory practices
• Regulation and allocation of quota of narcotic drugs,
psychotropic substances and precursor substances (chemicals) in
consultation with Federal Government
14. • Regulation for pricing and mechanism for fixation of prices of
various therapeutic goods under its ambit
• Determining standards for biological manufacturing and
testing
• Implementation of internationally recognized standards and
guidelines
• Regulation, enforcement and monitoring of advertisement
rule and ban on false advertisement
• Manufacturing of active pharmaceutical ingredients.
• Coordinate, monitor or engage, in conjunction with other
organizations, Provincial Governments and international
agencies, in training, study or project related to therapeutic
goods
15. Strategic Plan
• Strategic Plan sets ambitions for us to achieve our strategic objectives that
contribute towards ensuring availability of quality assured, safe and
effective Therapeutic Goods (TGs) in Pakistan. We are committed to
maximize opportunities of treatment for patients for the people of
Pakistan
• Strategic Plan 2022-2025
• The Strategic Planning of DRAP for the Year 2022-2025 is focused on
following four areas where prioritized activities are identified under each
strategic goal.
• Goal 1: Optimized Regulatory System
• Strengthening of Pharmacovigilance(
-> Monitoring of Antimicrobial Consumption (AMC)
-> International Accreditations
-> Effective regulation of therapeutic goods
16. Strategic Plan
• Goal 2: Better Informed Users
• Safe and Rational use of therapeutic goods
-> Prompt communication with public
-> Improve public awareness
-> Involvement of all stakeholders
• Goal 3: Access to Health Products by All
• Addressing shortages
-> Early access to new treatments
-> Integrity of supply chain
-> MRPs regulation
• Goal 4: Strengthening Internal Capabilities
• Capacity building
-> Automation of Quality Management System (QMS)
-> Financial self-sufficiency
-> Strengthening infrastructure
Editor's Notes
Pharmaceutical drugs are chemical substances formulated to treat, prevent, or alleviate symptoms of diseases and medical conditions. They can include a wide range of medications, such as antibiotics, pain relievers, antidepressants, antihypertensives, and many others.
Biological drugs, also known as biologics, are medications derived from living organisms or their components. These drugs are typically produced using biotechnological processes and include vaccines, hormones, monoclonal antibodies, and cell therapies. Biological drugs often target specific molecules or pathways in the body and are used to treat various diseases, including cancer, autoimmune disorders, and infectious diseases.
Pharmacovigilance is the process of monitoring, evaluating, and assessing the safety and effectiveness of pharmaceutical drugs or medical products once they are on the market. It involves collecting, detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. Pharmacovigilance aims to ensure the safe use of medications by identifying and minimizing risks, improving patient safety, and enhancing public health.
