Drug Regulatory Authority of Pakistan (DRAP) [Autosaved].pptx

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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. 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.

5. 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

6. 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.

7. Composition of DRAP

8. 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.

9. 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.

10. 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 

11. 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

12. 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

13. 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

14. 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

15. DRAP and Alternative medicine and Health Products Enlistment Rules 2014 S.R.O . 412 (I)/2014.-  In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with prior approval of the Federal Government, is pleased to make the following rules, namely :- Short title and commencement.- (1). These rules may be called the Alternative Medicines and Health Products (Enlistment) Rules, 2014.

16. DRAP and Alternative medicine act 2012 Alternative medicine” means medicinal product which include,indiginous or Unani medicines, imported medicinal products, homeopathic medicnes,new medicines with “therapeutic food. Herbal Preparation, herbal substnaces,herbal medicinal product,phytomdeinces or any others products meant for therapeutic or preventive use which have been derived from plants, animals or animals ingredients alone or their combination but does not contain chemically defined synthetic ingredients, "therapeutic claim” Nutraceutical /Food supplements “pro-biotic

17. Alternative Medicines a.Herbal Medicinal Product or Phyto - medicine or Phyto -pharmaceuticals b. Imported Medicine c. Homeopathic Medicines. d. Bio-chemic Medicines. e. Herbal oils / Balms. f. Herbal preparations g. Any other alternate/ complementary medicines.

18. Health and OTC Products a. Food supplements ( Neutraceuticals or dietary or health supplements). b. Nutritional supplements, pro- biotics and pre- biotics . c. Baby Milks and Foods (infant or baby formulae, follow up formulae, formulae for special medical purposes or complementary foods intended for infants). d. Disinfectants. e. Medicated shampoos containing natural ingredients. f. Medicated Soaps natural ingredients g. Tooth pastes/mouthwashes/throat lozenges/gargles natural ingredients. h. Medicated cosmetics / Derma-care products / Balms / patches / medicate            i. oils natural ingredients

19. Alternative Medicine Practices/ approches Acupuncture Clinics : These clinics specialized in traditional Chinese medicine techniques like acupuncture and acupressure, aimed at restoring balance and promoting healing through the stimulation of specific points on the body. Herbal Medicine Stores : Providing natural remedies and supplements, herbal medicine stores offered alternatives to conventional pharmaceuticals, harnessing the power of plants for various health benefits. Naturopathic Clinics : Naturopathic clinics focused on holistic healing, employing a combination of herbal medicine, nutrition, lifestyle counseling, and other natural therapies to address underlying causes of illness. Chiropractic Clinics : Chiropractors utilized manual techniques to adjust the spine and musculoskeletal system, aiming to alleviate pain, improve mobility, and enhance overall well-being without the use of drugs or surgery.

20. Ayurvedic Centers : Rooted in ancient Indian healing traditions, Ayurvedic centers provided personalized approaches to health through herbal remedies, dietary recommendations, and lifestyle adjustments based on individual constitutions. Homeopathic Clinics : Homeopathy practitioners employed highly diluted substances to stimulate the body's self-healing mechanisms, addressing physical, emotional, and mental health concerns through a gentle and holistic approach. Holistic Health Centers : Offering a comprehensive array of alternative therapies such as massage, energy work, meditation, and yoga, holistic health centers focused on treating the whole person—mind, body, and spirit—for optimal wellness. Traditional Medicine Practitioners : Traditional healers and indigenous medicine practitioners preserved and offered culturally rooted healing modalities, drawing on centuries-old knowledge and practices specific to their communities