SlideShare a Scribd company logo
Drug Regulatory Authority
of Pakistan (DRAP)
Act,2012
Contents
• History
• DRAP
• Composition of DRAP
• Function of DRAP
• Policy board
• Funds and budget of DRAP
• Real picture of DRAP
• Other agencies
• References
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.
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
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
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.
Composition of DRAP
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.
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.
• 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
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
• 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
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
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

More Related Content

Similar to Drug Regulatory Authority of Pakistan (DRAP).pptx

International Regulatory agencies
International Regulatory agenciesInternational Regulatory agencies
International Regulatory agencies
Beena Maddi
 
Regulatory agencies
Regulatory agenciesRegulatory agencies
Regulatory agencies
Beena Maddi
 
2023.08.15_National Drug Polices_3rd years.pptx
2023.08.15_National Drug Polices_3rd years.pptx2023.08.15_National Drug Polices_3rd years.pptx
2023.08.15_National Drug Polices_3rd years.pptx
FranciKaySichu
 
Cdsco
CdscoCdsco
Drugs and cosmetics act 1940 and rules 1945 swa
Drugs and cosmetics act 1940 and rules 1945 swaDrugs and cosmetics act 1940 and rules 1945 swa
Drugs and cosmetics act 1940 and rules 1945 swa
Suvarta Maru
 
Regulatory affairs by Aneela Saleem
Regulatory affairs by Aneela SaleemRegulatory affairs by Aneela Saleem
Regulatory affairs by Aneela Saleem
AneelaSaleem
 
Regulatory agencies
Regulatory agenciesRegulatory agencies
Regulatory agencies
Shaik Sana
 
Bodies regulating indian pharmaceutical sector, cdsco
Bodies regulating indian pharmaceutical sector, cdscoBodies regulating indian pharmaceutical sector, cdsco
Bodies regulating indian pharmaceutical sector, cdsco
chiranjibi68
 
Regulatory Control in Pharmaceutical Analysis
Regulatory Control in Pharmaceutical AnalysisRegulatory Control in Pharmaceutical Analysis
Regulatory Control in Pharmaceutical Analysis
Dr Duggirala Mahendra
 
Regulatory affairs, Regulatory requirements for drug approval.pptx
Regulatory affairs, Regulatory  requirements for drug  approval.pptxRegulatory affairs, Regulatory  requirements for drug  approval.pptx
Regulatory affairs, Regulatory requirements for drug approval.pptx
PawanDhamala1
 
Regulatory bodies & CRO
Regulatory bodies & CRORegulatory bodies & CRO
Regulatory bodies & CRO
Suraj Choudhary
 
Role of Drug Regulatory agencies in Clinical Research.
Role of Drug Regulatory agencies in Clinical Research.Role of Drug Regulatory agencies in Clinical Research.
Role of Drug Regulatory agencies in Clinical Research.
ClinosolIndia
 
regulatory approval process of drug, cosmetic and herbals in canada
regulatory approval process of drug, cosmetic and herbals  in canada regulatory approval process of drug, cosmetic and herbals  in canada
regulatory approval process of drug, cosmetic and herbals in canada
Richa Patel
 
Organizaton chart of us fda.
Organizaton chart of us fda.Organizaton chart of us fda.
Organizaton chart of us fda.
Rovil Goel
 
The Drugs and Cosmetics Act and Rules
The Drugs and Cosmetics Act and RulesThe Drugs and Cosmetics Act and Rules
The Drugs and Cosmetics Act and Rules
Jobin Kunjumon Vilapurathuu
 
The drug and cosmetic act and rules
The drug and cosmetic act and rulesThe drug and cosmetic act and rules
The drug and cosmetic act and rules
Jobin Kunjumon Vilapurathuu
 
DGDA-DIU-akt.pptxMajor steps of a Drug Registration
DGDA-DIU-akt.pptxMajor steps of a Drug RegistrationDGDA-DIU-akt.pptxMajor steps of a Drug Registration
DGDA-DIU-akt.pptxMajor steps of a Drug Registration
USAYATUNMAHERA2
 
Drug regulatory authority
Drug regulatory authority Drug regulatory authority
Drug regulatory authority
Rahul Gawande
 
Laws and Guidelines on Clinical Trials in India.pptx
Laws and Guidelines on Clinical Trials in India.pptxLaws and Guidelines on Clinical Trials in India.pptx
Laws and Guidelines on Clinical Trials in India.pptx
mehulsarathy
 
OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN
OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN
OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN
Arul Packiadhas
 

Similar to Drug Regulatory Authority of Pakistan (DRAP).pptx (20)

International Regulatory agencies
International Regulatory agenciesInternational Regulatory agencies
International Regulatory agencies
 
Regulatory agencies
Regulatory agenciesRegulatory agencies
Regulatory agencies
 
2023.08.15_National Drug Polices_3rd years.pptx
2023.08.15_National Drug Polices_3rd years.pptx2023.08.15_National Drug Polices_3rd years.pptx
2023.08.15_National Drug Polices_3rd years.pptx
 
Cdsco
CdscoCdsco
Cdsco
 
Drugs and cosmetics act 1940 and rules 1945 swa
Drugs and cosmetics act 1940 and rules 1945 swaDrugs and cosmetics act 1940 and rules 1945 swa
Drugs and cosmetics act 1940 and rules 1945 swa
 
Regulatory affairs by Aneela Saleem
Regulatory affairs by Aneela SaleemRegulatory affairs by Aneela Saleem
Regulatory affairs by Aneela Saleem
 
Regulatory agencies
Regulatory agenciesRegulatory agencies
Regulatory agencies
 
Bodies regulating indian pharmaceutical sector, cdsco
Bodies regulating indian pharmaceutical sector, cdscoBodies regulating indian pharmaceutical sector, cdsco
Bodies regulating indian pharmaceutical sector, cdsco
 
Regulatory Control in Pharmaceutical Analysis
Regulatory Control in Pharmaceutical AnalysisRegulatory Control in Pharmaceutical Analysis
Regulatory Control in Pharmaceutical Analysis
 
Regulatory affairs, Regulatory requirements for drug approval.pptx
Regulatory affairs, Regulatory  requirements for drug  approval.pptxRegulatory affairs, Regulatory  requirements for drug  approval.pptx
Regulatory affairs, Regulatory requirements for drug approval.pptx
 
Regulatory bodies & CRO
Regulatory bodies & CRORegulatory bodies & CRO
Regulatory bodies & CRO
 
Role of Drug Regulatory agencies in Clinical Research.
Role of Drug Regulatory agencies in Clinical Research.Role of Drug Regulatory agencies in Clinical Research.
Role of Drug Regulatory agencies in Clinical Research.
 
regulatory approval process of drug, cosmetic and herbals in canada
regulatory approval process of drug, cosmetic and herbals  in canada regulatory approval process of drug, cosmetic and herbals  in canada
regulatory approval process of drug, cosmetic and herbals in canada
 
Organizaton chart of us fda.
Organizaton chart of us fda.Organizaton chart of us fda.
Organizaton chart of us fda.
 
The Drugs and Cosmetics Act and Rules
The Drugs and Cosmetics Act and RulesThe Drugs and Cosmetics Act and Rules
The Drugs and Cosmetics Act and Rules
 
The drug and cosmetic act and rules
The drug and cosmetic act and rulesThe drug and cosmetic act and rules
The drug and cosmetic act and rules
 
DGDA-DIU-akt.pptxMajor steps of a Drug Registration
DGDA-DIU-akt.pptxMajor steps of a Drug RegistrationDGDA-DIU-akt.pptxMajor steps of a Drug Registration
DGDA-DIU-akt.pptxMajor steps of a Drug Registration
 
Drug regulatory authority
Drug regulatory authority Drug regulatory authority
Drug regulatory authority
 
Laws and Guidelines on Clinical Trials in India.pptx
Laws and Guidelines on Clinical Trials in India.pptxLaws and Guidelines on Clinical Trials in India.pptx
Laws and Guidelines on Clinical Trials in India.pptx
 
OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN
OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN
OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN
 

More from ShafaatHussain20

Food spoilage lecccc micro org nutri.pptx
Food spoilage lecccc micro org nutri.pptxFood spoilage lecccc micro org nutri.pptx
Food spoilage lecccc micro org nutri.pptx
ShafaatHussain20
 
Bacteria Lec 33333333333333333rd sem.pptx
Bacteria Lec 33333333333333333rd sem.pptxBacteria Lec 33333333333333333rd sem.pptx
Bacteria Lec 33333333333333333rd sem.pptx
ShafaatHussain20
 
Virus Leccccccccccccccccccccccccccc.pptx
Virus Leccccccccccccccccccccccccccc.pptxVirus Leccccccccccccccccccccccccccc.pptx
Virus Leccccccccccccccccccccccccccc.pptx
ShafaatHussain20
 
Food Spoilage Agents Enzymtic spoilage.pptx
Food Spoilage Agents Enzymtic spoilage.pptxFood Spoilage Agents Enzymtic spoilage.pptx
Food Spoilage Agents Enzymtic spoilage.pptx
ShafaatHussain20
 
Biochemical and clinical Nutrition Assessment.pptx
Biochemical and clinical Nutrition Assessment.pptxBiochemical and clinical Nutrition Assessment.pptx
Biochemical and clinical Nutrition Assessment.pptx
ShafaatHussain20
 
Nutrient mmmmmmmmmmmmmmmmmmmdensity.pptx
Nutrient mmmmmmmmmmmmmmmmmmmdensity.pptxNutrient mmmmmmmmmmmmmmmmmmmdensity.pptx
Nutrient mmmmmmmmmmmmmmmmmmmdensity.pptx
ShafaatHussain20
 
Group society aaaaaaaaand community.pptx
Group society aaaaaaaaand community.pptxGroup society aaaaaaaaand community.pptx
Group society aaaaaaaaand community.pptx
ShafaatHussain20
 
Halassssssssssssl foo dietary laws.pptx
Halassssssssssssl foo dietary  laws.pptxHalassssssssssssl foo dietary  laws.pptx
Halassssssssssssl foo dietary laws.pptx
ShafaatHussain20
 
sssssssssssssssssssssssssssssssssssssssf.pptx
sssssssssssssssssssssssssssssssssssssssf.pptxsssssssssssssssssssssssssssssssssssssssf.pptx
sssssssssssssssssssssssssssssssssssssssf.pptx
ShafaatHussain20
 
Socio lec 1 updkkkkkkkkkkkkkkkkkated.pptx
Socio lec 1 updkkkkkkkkkkkkkkkkkated.pptxSocio lec 1 updkkkkkkkkkkkkkkkkkated.pptx
Socio lec 1 updkkkkkkkkkkkkkkkkkated.pptx
ShafaatHussain20
 
Lecture_11_Socialization_and_Personality.pptx
Lecture_11_Socialization_and_Personality.pptxLecture_11_Socialization_and_Personality.pptx
Lecture_11_Socialization_and_Personality.pptx
ShafaatHussain20
 
Ethnocentrismkkkkkkkkkkkkkkkkkkk_new.ppt
Ethnocentrismkkkkkkkkkkkkkkkkkkk_new.pptEthnocentrismkkkkkkkkkkkkkkkkkkk_new.ppt
Ethnocentrismkkkkkkkkkkkkkkkkkkk_new.ppt
ShafaatHussain20
 
Pure Foodd-Laws lec 4th sem updated.pptx
Pure Foodd-Laws lec 4th sem updated.pptxPure Foodd-Laws lec 4th sem updated.pptx
Pure Foodd-Laws lec 4th sem updated.pptx
ShafaatHussain20
 
Lpids(Fats) Lec Nukkkkkktrition FSt.pptx
Lpids(Fats) Lec Nukkkkkktrition FSt.pptxLpids(Fats) Lec Nukkkkkktrition FSt.pptx
Lpids(Fats) Lec Nukkkkkktrition FSt.pptx
ShafaatHussain20
 
Probiotics In Humankkkkkkkk Health-1.pptx
Probiotics In Humankkkkkkkk Health-1.pptxProbiotics In Humankkkkkkkk Health-1.pptx
Probiotics In Humankkkkkkkk Health-1.pptx
ShafaatHussain20
 
(6) Guidlinedddddddddddddddddddds SC.ppt
(6) Guidlinedddddddddddddddddddds SC.ppt(6) Guidlinedddddddddddddddddddds SC.ppt
(6) Guidlinedddddddddddddddddddds SC.ppt
ShafaatHussain20
 
(7) Cliniccccccccccccccal (Pictures).ppt
(7) Cliniccccccccccccccal (Pictures).ppt(7) Cliniccccccccccccccal (Pictures).ppt
(7) Cliniccccccccccccccal (Pictures).ppt
ShafaatHussain20
 
lipidsbykkkkkkkkksagar-210928141113.pptx
lipidsbykkkkkkkkksagar-210928141113.pptxlipidsbykkkkkkkkksagar-210928141113.pptx
lipidsbykkkkkkkkksagar-210928141113.pptx
ShafaatHussain20
 
Lecture n1- History and Introduction.ppt
Lecture n1- History and Introduction.pptLecture n1- History and Introduction.ppt
Lecture n1- History and Introduction.ppt
ShafaatHussain20
 
Good-manufacturi Lecjjjjjjjjjjjjj new.ppt
Good-manufacturi Lecjjjjjjjjjjjjj new.pptGood-manufacturi Lecjjjjjjjjjjjjj new.ppt
Good-manufacturi Lecjjjjjjjjjjjjj new.ppt
ShafaatHussain20
 

More from ShafaatHussain20 (20)

Food spoilage lecccc micro org nutri.pptx
Food spoilage lecccc micro org nutri.pptxFood spoilage lecccc micro org nutri.pptx
Food spoilage lecccc micro org nutri.pptx
 
Bacteria Lec 33333333333333333rd sem.pptx
Bacteria Lec 33333333333333333rd sem.pptxBacteria Lec 33333333333333333rd sem.pptx
Bacteria Lec 33333333333333333rd sem.pptx
 
Virus Leccccccccccccccccccccccccccc.pptx
Virus Leccccccccccccccccccccccccccc.pptxVirus Leccccccccccccccccccccccccccc.pptx
Virus Leccccccccccccccccccccccccccc.pptx
 
Food Spoilage Agents Enzymtic spoilage.pptx
Food Spoilage Agents Enzymtic spoilage.pptxFood Spoilage Agents Enzymtic spoilage.pptx
Food Spoilage Agents Enzymtic spoilage.pptx
 
Biochemical and clinical Nutrition Assessment.pptx
Biochemical and clinical Nutrition Assessment.pptxBiochemical and clinical Nutrition Assessment.pptx
Biochemical and clinical Nutrition Assessment.pptx
 
Nutrient mmmmmmmmmmmmmmmmmmmdensity.pptx
Nutrient mmmmmmmmmmmmmmmmmmmdensity.pptxNutrient mmmmmmmmmmmmmmmmmmmdensity.pptx
Nutrient mmmmmmmmmmmmmmmmmmmdensity.pptx
 
Group society aaaaaaaaand community.pptx
Group society aaaaaaaaand community.pptxGroup society aaaaaaaaand community.pptx
Group society aaaaaaaaand community.pptx
 
Halassssssssssssl foo dietary laws.pptx
Halassssssssssssl foo dietary  laws.pptxHalassssssssssssl foo dietary  laws.pptx
Halassssssssssssl foo dietary laws.pptx
 
sssssssssssssssssssssssssssssssssssssssf.pptx
sssssssssssssssssssssssssssssssssssssssf.pptxsssssssssssssssssssssssssssssssssssssssf.pptx
sssssssssssssssssssssssssssssssssssssssf.pptx
 
Socio lec 1 updkkkkkkkkkkkkkkkkkated.pptx
Socio lec 1 updkkkkkkkkkkkkkkkkkated.pptxSocio lec 1 updkkkkkkkkkkkkkkkkkated.pptx
Socio lec 1 updkkkkkkkkkkkkkkkkkated.pptx
 
Lecture_11_Socialization_and_Personality.pptx
Lecture_11_Socialization_and_Personality.pptxLecture_11_Socialization_and_Personality.pptx
Lecture_11_Socialization_and_Personality.pptx
 
Ethnocentrismkkkkkkkkkkkkkkkkkkk_new.ppt
Ethnocentrismkkkkkkkkkkkkkkkkkkk_new.pptEthnocentrismkkkkkkkkkkkkkkkkkkk_new.ppt
Ethnocentrismkkkkkkkkkkkkkkkkkkk_new.ppt
 
Pure Foodd-Laws lec 4th sem updated.pptx
Pure Foodd-Laws lec 4th sem updated.pptxPure Foodd-Laws lec 4th sem updated.pptx
Pure Foodd-Laws lec 4th sem updated.pptx
 
Lpids(Fats) Lec Nukkkkkktrition FSt.pptx
Lpids(Fats) Lec Nukkkkkktrition FSt.pptxLpids(Fats) Lec Nukkkkkktrition FSt.pptx
Lpids(Fats) Lec Nukkkkkktrition FSt.pptx
 
Probiotics In Humankkkkkkkk Health-1.pptx
Probiotics In Humankkkkkkkk Health-1.pptxProbiotics In Humankkkkkkkk Health-1.pptx
Probiotics In Humankkkkkkkk Health-1.pptx
 
(6) Guidlinedddddddddddddddddddds SC.ppt
(6) Guidlinedddddddddddddddddddds SC.ppt(6) Guidlinedddddddddddddddddddds SC.ppt
(6) Guidlinedddddddddddddddddddds SC.ppt
 
(7) Cliniccccccccccccccal (Pictures).ppt
(7) Cliniccccccccccccccal (Pictures).ppt(7) Cliniccccccccccccccal (Pictures).ppt
(7) Cliniccccccccccccccal (Pictures).ppt
 
lipidsbykkkkkkkkksagar-210928141113.pptx
lipidsbykkkkkkkkksagar-210928141113.pptxlipidsbykkkkkkkkksagar-210928141113.pptx
lipidsbykkkkkkkkksagar-210928141113.pptx
 
Lecture n1- History and Introduction.ppt
Lecture n1- History and Introduction.pptLecture n1- History and Introduction.ppt
Lecture n1- History and Introduction.ppt
 
Good-manufacturi Lecjjjjjjjjjjjjj new.ppt
Good-manufacturi Lecjjjjjjjjjjjjj new.pptGood-manufacturi Lecjjjjjjjjjjjjj new.ppt
Good-manufacturi Lecjjjjjjjjjjjjj new.ppt
 

Recently uploaded

USE OF AI in sensory evolution of food.pptx
USE OF AI in sensory evolution of food.pptxUSE OF AI in sensory evolution of food.pptx
USE OF AI in sensory evolution of food.pptx
saeedusama485
 
A Review on Recent Advances of Packaging in Food Industry
A Review on Recent Advances of Packaging in Food IndustryA Review on Recent Advances of Packaging in Food Industry
A Review on Recent Advances of Packaging in Food Industry
PriyankaKilaniya
 
FARE-Awareness-Teens_2022_Restricted.pptx
FARE-Awareness-Teens_2022_Restricted.pptxFARE-Awareness-Teens_2022_Restricted.pptx
FARE-Awareness-Teens_2022_Restricted.pptx
vikeshblazer
 
Top 12 Best Restaurants in Panchkula city
Top 12 Best Restaurants in Panchkula cityTop 12 Best Restaurants in Panchkula city
Top 12 Best Restaurants in Panchkula city
Tricity help post
 
Heritage Conservation.Strategies and Options for Preserving India Heritage
Heritage Conservation.Strategies and Options for Preserving India HeritageHeritage Conservation.Strategies and Options for Preserving India Heritage
Heritage Conservation.Strategies and Options for Preserving India Heritage
JIT KUMAR GUPTA
 
W.H.Bender Quote 67 - Start with the MENU! The First Step in a Restaurant Sta...
W.H.Bender Quote 67 - Start with the MENU! The First Step in a Restaurant Sta...W.H.Bender Quote 67 - Start with the MENU! The First Step in a Restaurant Sta...
W.H.Bender Quote 67 - Start with the MENU! The First Step in a Restaurant Sta...
William (Bill) H. Bender, FCSI
 
按照学校原版(KCL文凭证书)伦敦国王学院毕业证快速办理
按照学校原版(KCL文凭证书)伦敦国王学院毕业证快速办理按照学校原版(KCL文凭证书)伦敦国王学院毕业证快速办理
按照学校原版(KCL文凭证书)伦敦国王学院毕业证快速办理
vdabso
 
快速办理(Adelaide毕业证书)阿德莱德大学毕业证文凭证书一模一样
快速办理(Adelaide毕业证书)阿德莱德大学毕业证文凭证书一模一样快速办理(Adelaide毕业证书)阿德莱德大学毕业证文凭证书一模一样
快速办理(Adelaide毕业证书)阿德莱德大学毕业证文凭证书一模一样
mmmnvxcc
 
NANOTECHNOLOGY IN FOOD PACKAGING (FOOD TECHNOLOGY)
NANOTECHNOLOGY IN FOOD PACKAGING (FOOD TECHNOLOGY)NANOTECHNOLOGY IN FOOD PACKAGING (FOOD TECHNOLOGY)
NANOTECHNOLOGY IN FOOD PACKAGING (FOOD TECHNOLOGY)
Addu25809
 
FOOD OBESITY IN NORTH AMERICA ( NEW).pptx
FOOD OBESITY IN NORTH AMERICA ( NEW).pptxFOOD OBESITY IN NORTH AMERICA ( NEW).pptx
FOOD OBESITY IN NORTH AMERICA ( NEW).pptx
kevinfrancis63
 
一比一原版(Sheffield毕业证书)谢菲尔德大学毕业证如何办理
一比一原版(Sheffield毕业证书)谢菲尔德大学毕业证如何办理一比一原版(Sheffield毕业证书)谢菲尔德大学毕业证如何办理
一比一原版(Sheffield毕业证书)谢菲尔德大学毕业证如何办理
i990go7o
 
Cacao, the main component used in the creation of chocolate and other cacao-b...
Cacao, the main component used in the creation of chocolate and other cacao-b...Cacao, the main component used in the creation of chocolate and other cacao-b...
Cacao, the main component used in the creation of chocolate and other cacao-b...
AdelinePdelaCruz
 
一比一原版(Bristol毕业证)布里斯托大学毕业证如何办理
一比一原版(Bristol毕业证)布里斯托大学毕业证如何办理一比一原版(Bristol毕业证)布里斯托大学毕业证如何办理
一比一原版(Bristol毕业证)布里斯托大学毕业证如何办理
uhyqho
 

Recently uploaded (13)

USE OF AI in sensory evolution of food.pptx
USE OF AI in sensory evolution of food.pptxUSE OF AI in sensory evolution of food.pptx
USE OF AI in sensory evolution of food.pptx
 
A Review on Recent Advances of Packaging in Food Industry
A Review on Recent Advances of Packaging in Food IndustryA Review on Recent Advances of Packaging in Food Industry
A Review on Recent Advances of Packaging in Food Industry
 
FARE-Awareness-Teens_2022_Restricted.pptx
FARE-Awareness-Teens_2022_Restricted.pptxFARE-Awareness-Teens_2022_Restricted.pptx
FARE-Awareness-Teens_2022_Restricted.pptx
 
Top 12 Best Restaurants in Panchkula city
Top 12 Best Restaurants in Panchkula cityTop 12 Best Restaurants in Panchkula city
Top 12 Best Restaurants in Panchkula city
 
Heritage Conservation.Strategies and Options for Preserving India Heritage
Heritage Conservation.Strategies and Options for Preserving India HeritageHeritage Conservation.Strategies and Options for Preserving India Heritage
Heritage Conservation.Strategies and Options for Preserving India Heritage
 
W.H.Bender Quote 67 - Start with the MENU! The First Step in a Restaurant Sta...
W.H.Bender Quote 67 - Start with the MENU! The First Step in a Restaurant Sta...W.H.Bender Quote 67 - Start with the MENU! The First Step in a Restaurant Sta...
W.H.Bender Quote 67 - Start with the MENU! The First Step in a Restaurant Sta...
 
按照学校原版(KCL文凭证书)伦敦国王学院毕业证快速办理
按照学校原版(KCL文凭证书)伦敦国王学院毕业证快速办理按照学校原版(KCL文凭证书)伦敦国王学院毕业证快速办理
按照学校原版(KCL文凭证书)伦敦国王学院毕业证快速办理
 
快速办理(Adelaide毕业证书)阿德莱德大学毕业证文凭证书一模一样
快速办理(Adelaide毕业证书)阿德莱德大学毕业证文凭证书一模一样快速办理(Adelaide毕业证书)阿德莱德大学毕业证文凭证书一模一样
快速办理(Adelaide毕业证书)阿德莱德大学毕业证文凭证书一模一样
 
NANOTECHNOLOGY IN FOOD PACKAGING (FOOD TECHNOLOGY)
NANOTECHNOLOGY IN FOOD PACKAGING (FOOD TECHNOLOGY)NANOTECHNOLOGY IN FOOD PACKAGING (FOOD TECHNOLOGY)
NANOTECHNOLOGY IN FOOD PACKAGING (FOOD TECHNOLOGY)
 
FOOD OBESITY IN NORTH AMERICA ( NEW).pptx
FOOD OBESITY IN NORTH AMERICA ( NEW).pptxFOOD OBESITY IN NORTH AMERICA ( NEW).pptx
FOOD OBESITY IN NORTH AMERICA ( NEW).pptx
 
一比一原版(Sheffield毕业证书)谢菲尔德大学毕业证如何办理
一比一原版(Sheffield毕业证书)谢菲尔德大学毕业证如何办理一比一原版(Sheffield毕业证书)谢菲尔德大学毕业证如何办理
一比一原版(Sheffield毕业证书)谢菲尔德大学毕业证如何办理
 
Cacao, the main component used in the creation of chocolate and other cacao-b...
Cacao, the main component used in the creation of chocolate and other cacao-b...Cacao, the main component used in the creation of chocolate and other cacao-b...
Cacao, the main component used in the creation of chocolate and other cacao-b...
 
一比一原版(Bristol毕业证)布里斯托大学毕业证如何办理
一比一原版(Bristol毕业证)布里斯托大学毕业证如何办理一比一原版(Bristol毕业证)布里斯托大学毕业证如何办理
一比一原版(Bristol毕业证)布里斯托大学毕业证如何办理
 

Drug Regulatory Authority of Pakistan (DRAP).pptx

  • 1. Drug Regulatory Authority of Pakistan (DRAP) Act,2012
  • 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.
  • 9.
  • 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

  1. 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.
  2. 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.