Regulatory Administrative Institutions MPA 517

1. Regulatory Administrative InstitutionsMPA 517 Lecture-30

2. Recap I. Monitoring and evaluation of programmes being carried out of the Commissionerate Afghan Refugees Lahore, Peshawar, Quetta, International Organizations and the NGOs etc through periodical visits/inspections by the Chief Commissioner Afghan Refugees and other officers in the Chief Commissionerate for Afghan Refugees. II.  Issuance of NOCs for vehicles imported by UN Agencies, NGOs and Afghan Tanzeemats for disposal etc. III.     Issuance of exemption certificates for relief goods meant for Afghan Refugees. IV. Maintenance of warehouse funded by the United Nations High Commission for Refugees (UNHCR). V.   Preparation of Reconciliation Statement of wheat supply to Afghan Refugees with Provincial Food Department.  VI.   Coordination for repatriation of Afghan Refugees.

3. RAZMAK CADET COLLEGE • Cadet College, Razmak, North Waziristan Agency is an autonomous body of Ministry of SAFRON and is located in the heart of FATA. The College is providing quality education to the poor tribal candidates up to Intermediate. The College was established under Presidential Regulation-II of 1977. • FATA Secretariat, Peshawar sponsors the financial liabilities of the college. The Finance Division allocates funds in the regular budget of FATA Secretariat, Peshawar as “ grant in-aid”. • The funds are released to the college on the monthly basis. The Board of Governors manages the affairs of the College.  • The College started functioning in 1978 with strength of 100 students which has now been increased to 500 students. The College is providing educational facilities from 7th to 12th classes.

4. The Council Of Islamic Ideology • The Council of Islamic Ideology is a constitutional body that advises the legislature whether or not a certain law is repugnant to Islam, namely to the Qur'an and Sunna. • The Council of Islamic Ideology was established as Advisory Council of Islamic Ideology on August 1, 1962 under Article 199 of the Constitution of the Islamic Republic of Pakistan 1962, which provided for the constitution of the Council (Articles 199 - 203), its functions (Article 204), rules of procedure (Article 205), and the establishment of Islamic Research Institute (Article 207). 

5. Vision 2025 • The Vision 2025 is the country’s long–term development blueprint which aims to create a globally competitive and prosperous country providing a high quality of life for all its citizens. • It aspires to transform Pakistan into an industrialized and knowledge based middle income country by 2025. Themes/ Priority Areas • Integrated Energy • Modernization of Infrastructure • Indigenous Resource Mobilization • Institutional Reforms and Governance • Value-addition in Commodity Producing Sectors • Export promotion and Private Sector Led Growth • Social Capital

6. Today’s Lecture • Drug Regulatory Authority of Pakistan • Ministry of Defence

7. Drug • A drug is, in the broadest of terms, a chemical substance that has known biological effects on humans or other animals. Foods are generally excluded from this definition, in spite of their physiological effects on animal species. • In pharmacology, a drug is "a chemical substance used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being." Drugs may be used for a limited duration, or on a regular basis for chronic disorders. • Recreational drugs are chemical substances that affect the central nervous system. Alcohol, nicotine, and caffeine are the most widely consumed psychotropic drugs worldwide. • They may be used for effects on perception, consciousness, personality, and behavior. Many recreational drugs are also used in medicine. • Some drugs can cause addiction and habituation and all drugs have side effects. Many drugs are illegal for recreational purposes and international treaties such as the Single Convention on Narcotic Drugs exist for the purpose of legally prohibiting certain substances.

8. Drug addiction symptoms or behaviors • Feeling that you have to use the drug regularly — this can be daily or even several times a day • Failing in your attempts to stop using the drug • Making certain that you maintain a supply of the drug • Spending money on the drug, even though you can't afford it • Doing things to obtain the drug that you normally wouldn't do, such as stealing • Feeling that you need the drug to deal with your problems • Driving or doing other risky activities when you're under the influence of the drug • Focusing more and more time and energy on getting and using the drug

9. Drug addicts in Pakistan • Almost 5.8 per cent of the adult population, approximately 6.4 million persons or one in every 27 persons in Pakistan is using drugs, while nearly 25 per cent of the youth population is involved in some form of drug abuse in Pakistan. • Drug abuse is most prevalent in Khyber-Pakhtunkhwa, where 11 per cent of the population uses drugs, followed by Sindh where 6.5 per cent of the population is drug addict. • In Balochistan, almost five per cent population uses drugs while in Punjab, 4.8 per cent of the population is drug addict. • Drug addicts are also more prone to accidents and are at higher risk of HIV/AIDS, hepatitis B & C, tuberculosis, suicide, overdose deaths and cardiovascular diseases.

10. Aims & Objectives • To provide effective coordination and enforcement of Drugs Act, 1976 for provision of drugs and therapeutic goods that are safe, effective, quality and economical. 2. To bring harmony in interprovincial trade and commerce of drugs and therapeutic goods.

11. Divisions Pharmaceutical Evaluations and Registration Division • Pharmaceutical Evaluations and Registration Division is responsible for the evaluation, assessment and registration of pharmaceuticals drugs for human beings, animals and to perform other functions connected therewith and assigned by the Board. Drug Licensing Division • Drug Licensing Division shall be responsible for the licensing of the drugs manufacturing facilities and to perform other functions connected therewith. Quality Assurance and Laboratory Testing Division • Quality Assurance and Laboratory Testing Divisionshall be responsible for enforcement of current Good Manufacturing Practices under the Act, and for testing or research of drugs and to perform other functions connected therewith. • The Division will also perform the functions related to post marketing surveillance and shall be responsible for the evaluation, coordination and monitoring of safety, efficacy and quality of registered drugs and inactive materials including the clinical and toxicological study, drug recalls and with drawls, and to perform other functions connected therewith.

12. Divisions Medical Devices and Medicated Cosmetics Division • Medical Devices and Medicated Cosmetics Division shall be responsible for the assessment, enlistment or registration of medical devices and medicated cosmetics, medicated shampoos and medicated soaps for human beings, animals and to perform other functions connected therewith. Biological Drugs Division • Biological Drugs Division shall be responsible for the evaluation, assessment, registration and licensing of Biological for human beings, animals and to perform other functions connected therewith including all the functions of national control authority for biological as required for the prequalification by World Health Organizations of locally manufactured human biological drugs. Controlled Drugs Division • Controlled Drugs Division shall in consultation with the Federal Government be responsible for regulation and allocation of quota of narcotic drugs, psychotropic substances and precursor chemicals and to perform other functions connected therewith.

13. Divisions Pharmacy Services Division • Pharmacy Services Division shall be responsible for the development and promotion of pharmacy services and to perform other functions connected therewith. Health and OTC Products (non-drugs) Division • Health and OTC Products (non-drugs Division shall be responsible for the assessment, licensing and registration of Alternative Medicines such as Ayurvedic, Chinese, Unani and Homeopathy, enlistment or registration of nutritional products and food supplements for human beings, animals and to perform other functions connected therewith. Costing and Pricing Division • Costing and Pricing Division shall be responsible for the costing and pricing of therapeutic goods and to perform other functions connected therewith. Budget and Accounts Division • Budget and Accounts Division shall be responsible for budgetary and financial aspects of the Authority and other daily accounting matters connected therewith or ancillary thereto.

14. Divisions Administration, Human Resource and Logistics Division • Administration, Human Resource and Logistics Division shall be responsible for administration, recruitment, appointment, capacity building and development for the Authority and other matters connected therewith and ancillary there to. Legal Affairs Division • Legal Affairs shall be responsible for legal aspects of the Authority and other matters connected with Drug Court and other court cases therewith or ancillary thereto. Management Information Services Division • Management Information Services Division shall be responsible for development of automation of functions using information technology for the Authority and other matters connected therewith and ancillary there to .

15. REGULATORY SERVICES 1. Drug Registration 2. Biological Registration 3. Medical Devices Registration 4. Health Products Registration 5. Alternative Medicine Registration 6. Licensing of Drug Manufacturing units 7. Licensing of Biological Manufacturing sections and units 8. Licensing of Alternative Medicine manufacturing units

16. Ministry of Defence • Deals with all policy and administrative matters pertaining to all the armed forces engaged in the defence of the country. • The Ministry of Defence is responsible for policy and administrative matters pertaining to the Defence of the Federation and three Armed Forces. • The Defence Division is responsible for policy and administrative matters pertaining to the Defense of the Federation and three Armed Forces. • The responsibility in respect of Inter-national negotiation, agreements and purchases of Defence equipment along with allied accessories are also being handled by this Division. • This Division has eight Attached Departments and three Autonomous Bodies.

17. Inter-Services Public Relations • The Directorate of Inter-Services Public Relations is an administrative military organization within the Pakistan Defence Forces that coordinates military information with the media and the civil society. The ISPR is now headed by 2-star rank officer i.e. Major General • The public relations requirements of the Armed Forces are looked after by the ISPR Directorate. The ISPR Directorate was established in 1949 as Army's Colonel Shabaz Khan was appointed its first director-general. Commodore MaqboolHussain is the only naval officer of the Pakistan Defence Forces to have privileged to head the directorate. The majority of its executive heads had come from the Army Branch, and as of today, Army's 2 star rank officer is heading the ISPR directorate.

18. In Pakistan's military staff appointments and assignments, the ISPR is one of the most prestigious directorate of Pakistan Armed Forces. • Its executive officer is also a chief military spokesperson of the Pakistan Armed Forces. • The director-general directly reports to Chairman of Joint Chiefs of Staff Secretariat, Chief of Army Staff of Pakistan Army as well the head also directly report to Chief of Air Staff of Air Force, Commandant of Marines, and the Chief of Naval Staff of Navy and the Coast Guard

19. Operations • The ISPR directorate is staffed with combined military of Pakistan Defence Forces alongside with large sum of civilian officers. • It functions as a part of the Joint Chiefs of Staff Secretariat, and its purpose is to garner national support for the Armed Forces and strengthen their resolve to accomplish the assigned mission while undermining the will of the adversary. • It also acts as an interface between the Armed Forces, the media and the public. • It formulates much of the media policy of Pakistan's military, safeguards the Armed Forces from negative influences and monitors both international and domestic media.

20. Inter Services Selection Board • ISSB mission is to Select potential officers for the defence forces of Pakistan who have the requisite mental, moral, social and dynamic qualities to make successful leaders during peace and war.  • The above mission sets a very sacred and tough challenge for the oraganistaion which can only be met with true dedication, selfless devotion and unflinching resolve to set and meet the standards. • Inter Services Selection Board follows a set of time tested protocols to analyse and predict human personality and along the way has earned a respectable name and fame to its credit.

21. SELECTION SYSTEM • Aim of Inter Services Selection Board is to select potential officers for the defence forces of Pakistan who have  the requisite capabilities to successfully complete their course of training at the military academies and also  possess physical, mental, social and dynamic qualities to make successful leaders during peace and war. • Inter Services Selection Board caters for selection of candidates for training as potential officers for all the  three services of Pakistan. Services Headquarters, however, plan the total number of candidates to be  tested/inducted in various courses as per their overall requirement/schedule. • The selection technique followed by the ISSB is three dimensional. • All candidates appearing before the ISSB are to  take three different types of tests, i.e, psych tests, GTO tests and Interview. • The Psychologist Officers, Group Testing Officers and the Deputy Presidents, who are specialists in their respective fields, administer these tests.

22. Pakistan Military Accounts Department • Pakistan Military Accounts Department (PMAD) is an attached Department of Ministry of Defence mainly responsible for making payments to the Armed Forces, maintaining accounts thereof and rendering financial advice to defence authorities. • It also has a well established internal audit mechanism in the form of Local Audit offices functioning under the Controller of Local Audit (Defence Services). • Military Accounts Department deals with payments, accounting and internal audit in respect of three Defence Forces, Defence Production Division and Inter Services Organizations Establishment.

23. Functions • Maintenance of Accounts of Defence Services • Payment of Pay & Allowances to Commissioned Officers, JCOs / ORs and civilians paid from Defence Services Estimates • Audit and Payment of Stores indigenous and imported. • Audit and Payment relating to the Works of Defence Services • Internal Audit • Compilation of Defence Services receipts / Expenditures • Preparation of Appropriation Accounts • Payment of Railway and PIA Claims relating to the Defence Side • The P.M.A.D is performing dual duties i.e. accounting as well as internal auditing

24. Summary • Drug Regulatory Authority of Pakistan • Ministry of Defence

25. Next Lecture • Revision Lecture 1-15