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
biologicals etc.
 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