Introduction_to pharmaceutical regulatory affairs.pptx

pharmaceutical regulatory affairs

1. Scope of Pharmacy in Bangladesh

2. History of Pharmacy in B □ a D e n p a g rt m l a e n d t o e f P s h h armac y starte d it s journe y i n 1964. Prof Kamaluddin Ahmed was the first Chairman of the Dept. of Pharmacy and Dept. of Biochemistry. Only 20 students, a few teachers and fewer physical facilities, lecture rooms, labs andutilities. 1964 to 1966, Both the Dept of Biochemistry and the Dept of Pharmacy were virtually sharing the same class rooms and labs. Same batch of teachers use to teach the pharmacy and biochemistry under graduates.

3. History of Pharmacy in B □ a P r n of g A b l d a u d l J a e b b s a h r became th e chairma n of th e Dept. of Pharmacy in 1966 In 1969 the Dept first started its M Pharm Course for thesis students, limited to 3 to 4 students. In 1st Feb’1969 a group of young talented teachers( AKAC, SNK and BKD) joined the dept. Finally, In 1970 the B.Pharm graduates got the chance to do M. Pharm both in the thesis and non thesis groups

4. Present Status of Pharmacy in Bangladesh Local Market Condition About 30 companies export a significant quantity of medicines to 107 countries including USA, UK, Canada, France, Italy, Netherlands etc. More than 5600 Brands of medicines manufactured by these local companies. Pharmaceutical exports from Bangladesh rose 15.65% year to year. According to 2013 the local pharmaceutical market size of Bangladesh was 1.3 Billion USD and the annual growth rate was 8.12%. But in 2015 the market size is about 5.00 Billion USD.

5. A Data Chart are given bellow- Type of Drug Manufacture Number of Manufacturing Companies Current Manufacturing Status Allopathic Drug Manufacturers 199 Functional Ayurvedic Drug Manufacturers 172 Functional Herbal Drug Manufacturers 29 Functional Homeopathic & Biochemic Drug Manufacturers 28 Functional

6. Educational Sectors Currently, there are 11 public universities and 23 private universities in Bangladesh offering pharmacy education. Universities that offer pharmacy education in Bangladesh are – Public Universities Private Universities

7. Public □ U U n ni v i e v rsi t e y o r f s D h i a t k a ies University of Rajshahi Jahangirnagar University Khulna University University of Chittagong Noakhali Science & Technology University Jagannath University Bangabandhu Sheikh Mujibur Rahman Science and Technology University Jessore University of Science & Technology Pabna University of Science & Technology Comilla University

8. Private □ U N n ort h i v So u e t h r U s n i i v e t r s i i t e y s BRAC University Independent University United Internation University East West University Southeast University State University of Bangladesh Stamford University Bangladesh Dhaka International University University of Science and Technology Chittagong (USTC) The University of Asia Pacific Gono Biswabiddyalay Varendra University

9. Private □ U S n out h i e v rn e U n r iv e s r s i it y t B i a e ng l s adesh University of Development Alternative (UODA) International Islamic University Chittagong (IIUC) BGC Trust University of Bangladesh Bangladesh University Atish Dipankar University of Science and Technology Daffodil International University World University of Bangladesh Manarat International University Primeasia University ASA University Northern University Khwaja Yunus Ali University

10. Scope of P □ C h a r a ee r r S m cop e a f o c r P y harmac y Professionals Production & Manufacturing Research & Development Analysis & Testing Marketing Hospital Pharmacy Community Pharmacy Opportunities Academics

11. Scope of P □ R h e a g u r l a m tor y a A c ff a y irs Self employment Documentation , Librar y Information Service s & Pharma. Journalism Consultancy

12. Designation of pharmacist with their recruit r □ e C q E O u / M i D r / e D e m rec t e o r n : U t G : B.Sc , B.Tech/B.E . , Postgraduate, Doctorate. Associate Professor : Ph.D with minimum 5 years teaching experiance on Assistant professor. Production Executive : B. Pharm & M. Pharm. Quality Control (QC) : B. Pharm & M. Pharm. Quality Assurance (QA) : B. Pharm & M. Pharm . Product Development (PD) : B. Pharm. & M. Pharm. Training Executive : B. Pharm & M. Pharm. Lecturer : B . Pharm & M. Pharm (Thesis) Lab Demonstrator : B . Pharm.

13. Responsibilities of pharmacist (Worldwide) Development of Brand Plans/ Marketing Strategy. Increase the Market share and Profitability Designin g of Promotiona l campaig n an d Developmen t of required Promotional tools. Co-ordinating with the team of Product Executives. New Product Launching Conducting fresh training program for Medical Promotion Officers.

14. Responsibilities of pharmacist (Worldwide) Maintain communication with the concern people of Drug Administration, Drug Testing Laboratories for regulatory formalities. Conduct monthly sales meeting at different regional head quarters in order to ensure understanding of marketing action plan. Meetin g th e key doctors over th e countr y an d exchange ideas to obtain feedback on the movement of products. Analyzing Internal Sales. Handling field forces queries.

15. Roles and Responsibility of pharmacist towards the society Pharmacists are responsible for: The quality of medicines supplied to patients. Ensuring the supply of medicines is within the law. Ensuring the medicines prescribed to patients are suitable. Advisin g patients abou t th e side-effec t of th e medicines, how to take them and answering patients' questions. Supervise the production and preparation of medicines.

16. Pharmacists a □ l S s u p o er v : is e th e medicine s suppl y chai n an d ensure pharmacy premises and systems are fit for purpose Advise other healthcare professionals about safe and effective medicines use, and safe and secure supply of medicines Respond to patients' symptoms and advise on medicines for sale in pharmacies Provide services to patients, such as smoking cessation, blood pressure measurement and cholesterol management etc.

17. Health policy: Health policy refers to decisions, plans and actions that are undertaken to achieve specific health care goals within a society or a country. Latest health policy of Bangladesh was published in 2011. The Health Policy (2011) has 19 goals and objectives, 10 policy principles and 32 strategies.

18. The specific aims of the Bangladesh National Health Policy 2011 are as follows: Ensure accessibility of primary health care and emergency care for all. Ensure quality health-care services for all based on equity. Extend the coverage of quality health-care services. Increase community demand for health care considering rights and dignity. The primary goals of Bangladesh National Health Policy 2011 are as follows: Establish health care as a right in all layers of society by ensuring essential elements of care, nutrition, and public health improvement. Providing quality and easily accessible care, irrespective of an urban and rural community, mainly focusing on the poor and disadvantaged population. Establish a community clinic to provide primary health care for every citizen. Every 6000 population will be under one community clinic.

19. Prioritize emergency care. Reduce maternal and child mortality rates significantly. Achieve a replacement level of fertility within 2021. Ensure the necessary steps to improve maternal and child health status and ensure safe delivery services in each village. Ensure easy accessibility and availability of family planning services, especially to poor- and low-income community people. Ensure gender equality in health-care services. Make certain effective and efficient use of information technology in the health-care management system. Ensure adequate supply of logistics and manpower in government health-care facilities to deliver quality health-care services. Ensure a mechanism to regulate the quality and price of care and educational expenses in private facilities.

20. According to the need of the country, ensure modernization and adaptation of medical education and technology. Ensure coordination between different health-care-related departments, ministry of GoB, and MOHFW, in addition to coordination between the Government of Bangladesh and NGOs. Strengthening preventive services specially expanded program on immunization activities. Access to health-related information is right. Steps will be taken to ensure the right. Ensuring the availability of essential drugs by regulating prices for essential medicines. Ensure adequate epidemiological tracking of disease patterns and impacts of climate change on health. Ensure improvement of allied health care (Unani, Ayurveda, and homeopathic) education and care delivery system.

21. Principles of our Health Policy Every citizen has the basic right to adequate health care. The State and the government are constitutionally obliged to ensure health care for its citizens. To ensure an effective health care system that responds to the need of a healthy nation health policy provides the vision and mission for development. Pursuit of such policy will fulfill the demands of the people of the country while health service providers will be encouraged and inspired.

22. Strategies of Health Care policy

23. Our Health system The health system of Bangladesh is pluralistic: Government, the private sector, NGOs and donor agencies. The Government or public sector is the first key actor 53 District Hospitals, 425 Upazila Health Complexes, 1469 Union Health and Family Welfare centers, and 13861 community clinics at ward level. For tertiary care there are medical colleges and specialized hospitals

24. Our achievements: We achieve significant progress in reduction of maternal mortality rate, child mortality rate, low birth weight baby and increase use of immunization, reduction in malaria, leprosy and HIV. Challenges:

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