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Presentation on Pharmaceuticals sector In bangladesh

Course Title: English For PharmacyCourse No.: 115

Ciprocin®Presenters :

Syed Sakibul Islam Zannatul Ferdosi MD. Ashraful Islam Ashik Raka Tasmira Mukul ChandraSarkar Mahfuza Akter MD.Rabius Sany

Syed Sakibul IslamStudent ID:

161211003

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Background/History of Pharmacy

The history of pharmacy as an independent science dates back to the first third of the 19th century.

The evaluation of the profession of pharmacy can be divided into five historical periods:ANCIENT ERA-The beginning of time to

AD 1600EMPIRIC ERA-1600-1940INDUSTRIALIZATION ERA-1940-1970PATIENT CARE ERA-1970-presentBIOTECHNOLOGY AND GENETIC

ENGINEERING ERA-The new horizon

ANCIENT ERAFrom the beginning of time to 1600 ADUsed leaves, mud, and cool water to stop

bleeding and heal woundsDry clay was used to sprint broken bonesThey copied the animal behavior Began to practice healing on clay tablets

2600 B.C.Also kept document. Such as-“Ebers

Papyrus” written by George Ebers around 1500 B.C.

Hippocrates-The Father of Medicine

ANCIENT ERA

EMPIRIC ERA

The Pharmacopeia became a regulatory tool for pharmacists.

Benjamin Franklin started the first hospital in 1751. It had a pharmacy and the first hospital pharmacist was Jonathan Roberts.

1821 The Philadelphia College of Pharmacy was founded.

William Proctor-The father of American Pharmacy. He devoted his time and attention to the advancement of pharmacy. He owned an apothecary shop.

INDUSTRIALIZATION ERA

The development of manufacturing pharmacy began. Rapid mass production of medicines followed.

Standardization, biologically prepared products, complex chemical synthesis, and increased use of parenteral medications were all part of this period.

THE PATIENT CARE ERAThe beginning of this era concentrated

on research to develop new medicines. New drugs were developed. Pharmacists

began to take a more hands on role in dispensing medications and patient education.

BIOTECHNOLOGY AND GENETIC ENGINEERING ERADNA and Genetic Technology have been

started.Gene therapy is being conducted. Many

diseases are linked to genetic defacts. Recombinent DNA Technology:

Recombinent DNA is a form of syntetic DNA that is engineered through the combination of insertion of one or more DNA strands combining DNA sequences that would not normally occur together.

History of Pharmacy in BangladeshDepartment of Pharmacy started its journey in

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.

History of Pharmacy in BangladeshProf A. Jabbar became the chairman of the

Dept. of Pharmacy in 1966In 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 Pharm both in the thesis and non thesis groups

Present Status of Pharmacy in BangladeshLocal Market ConditionAbout 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.

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

Educational Sectors

Currently, there are 9 public universities and 23 private universities in Bangladesh offering pharmacy education.

Universities that offer pharmacy education in Bangladesh are –

Public Universities Private Universities

Public UniversitiesUniversity of DhakaUniversity of RajshahiJahangirnagar UniversityKhulna UniversityUniversity of ChittagongNoakhali Science & Technology UniversityJagannath UniversityBangabandhu Sheikh Mujibur Rahman Science

and Technology UniversityJessore University of Science & Technology

Private UniversitiesVarendra UniversityNorth South UniversityBRAC UniversityEast West UniversitySoutheast UniversityState University of BangladeshStamford University BangladeshDhaka International UniversityUniversity of Science and Technology Chittagong (USTC)The University of Asia Pacific DhanmondiGono Biswabiddyalay

Private UniversitiesSouthern University BangladeshUniversity of Development Alternative (UODA)International Islamic University Chittagong (IIUC)BGC Trust University of BangladeshBangladesh UniversityAtish Dipankar University of Science and TechnologyDaffodil International UniversityWorld University of BangladeshManarat International UniversityPrimeasia UniversityASA UniversityNorthern University

Scope of PharmacyCareer Scope for Pharmacy ProfessionalsProduction & ManufacturingResearch & DevelopmentAnalysis & TestingMarketingHospital PharmacyCommunity PharmacyOpportunitiesAcademics

Scope of Pharmacy Regulatory AffairsSelf employmentDocumentation, Library Information

Services & Pharma. JournalismConsultancy

Zannatun FerdousiStudent ID:16121100

Drug & MedicineDefinition of Drug

A drug ia any substance other than food, that when inhaled, injected, smoked, consumed, absorbed, via a patch on the skin or dissolved under the tongue causes a physiological change in the body.

Definition of Medicine

Medicine is the science and practice of the diagnosis, treatment and prevention of disease. The word medicine comes from a latin word

“medicus” means “A Physician

Difference between Drug & MedicinePoint Drug Medicine

Definition

Substances which act on the body and are used for the prevention, diagnosis and treatment

Substances that have definite form and therapeutic use for treatment.

Amount Drug doesn’t have any definite form & dose.

Medicine has a definite form & dose.

Potency Drugs are the active potent compound.

Medicines are the administrative form of drug

Compare All drugs are not medicines. All medicines are drugs.

Example Paracetamol, Renitidine. Napa (paracetamol) 500 mg tablet, Neocoptin-R (Renitidine) 150 mg

tablet.

Ciprocin®

Brand Name: Ciprocin 250 mg tablet.

Generic Name : Ciprofloxacin

4-Quinolone Antibiotics (Quinolone Antibiotics)

Indication: Urinary tract infections, lower respiratory tract infections, skin and soft tissue infections, bone and joint infections, G.I. infections, uncomplicated gonorrhoea

Ciprocin®

Preparation: Ciprocin™ 250 : Box containing 50, . Ciprocin™ 500 : Box containing 30 tablets, . Ciprocin™ 750: Box containing 20 tablets, Ciprocin™ XR 1 gm : Box containing 12 tablets, Ciprocin™ 250 Powder for suspension: Box containing two bottles, one HDPE bottle for active ingredient and another PET bottle for diluent.

Ashik

Student

ID:

1612110

Drug Discovery and Drug Development

It takes 10–15 years to develop a medicine or vaccine. The research-based pharmaceutical industry currently

spends over USD 135 billion on R&D per year.In 2011, 35 new pharmaceuticals were launched. In 2007–2011, the number of new chemical or

biological entities launched on the world market fell to 149 from 196 a decade earlier.

It costs an average of USD 1.38 billion to develop a single drug.

Key Points Regarding Drug Discovery and Development:

Key Points Regarding Drug Discovery and DevelopmentIn 2011, out of 10, 5 leading global R&D firms were

pharmaceutical companiesIt will take an average of 12-13 years to reach a

product in the market since the first synthesis.The cost of researching and developing a new

chemical or biological entity was estimated at €1,172 million ($ 1,506 million in year 2011 dollars) in 2012

On average, only one to two of every 10,000 substances synthesized in laboratories will successfully pass all stages of development required to become a marketable medicine.

Some International Drug Regulatory Authorities are: International Conference on Harmonisation

of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

European Medicines Agency (EMEA) Therapeutic Goods Administration (Australia)

(TGA) U.S. Food and Drug Administration (FDA) Medicines and Healthcare products

Regulatory Agency (MHRA)GMP(Good Manufacturing Practices)

Raka Student ID:1612110

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Designation of pharmacist with their recruit requirement CEO/MD/Derector: UG: 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.Training Executive : B Pharm & M Pharm.Lecturer : B Pharm & M Pharm.Lab Demonstrator : B Pharm.

Responsibilities of pharmacist (Worldwide)Development of Brand Plans/ Marketing

Strategy. Increase the Market share and ProfitabilityDesigning of Promotional campaign and

Development of required Promotional tools.Co-ordinating with the team of Product

Executives.New Product LaunchingConducting fresh training program for

Medical Promotion Officers.

Responsibilities of pharmacist (Worldwide)Maintain liaison 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.

Meeting the key doctors over the country and exchange ideas to obtain feedback on the movement of products.

Analyzing Internal Sales.Handling field forces queries.

Roles and Responsibility of pharmacist towards the society

The quality of medicines supplied to patients.Ensuring the supply of medicines is within the law.Ensuring the medicines prescribed to patients are

suitable.Advising patients about the side-effect of the

medicines, how to take them and answering patients' questions.

Supervise the production and preparation of medicines.

Pharmacists are responsible for:

Pharmacists also:Supervise the medicines supply chain and

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.

Pharmacy Council of Bangladesh (PCB)The Pharmacy Council of Bangladesh (PCB) is an

Autonomous Organization under the Ministry of Health and Family Welfare, Govt. of the People's Republic of Bangladesh.

It was established under the Pharmacy Ordinance, Ordinance No. X111 of 1976.

It provide scope for the graduate pharmacists.The council is the controlling authority of pharmacy

education and practice. Recently, 8 pharmacists are working in PCB with advanced

level of performance ensuring the highest standard of quality.

The Main objective of PCB is to regulate the practice of Pharmacy through out Bangladesh.

HISTORY

Structure of Pharmacy Council of Bangladesh (PCB)President secretary of ministry of health

and famillyPresident of councilDirector general of health serviceDirectorate of drug administrationDean faculty of pharmacy of Dhaka

UniversityProfessor of medicineProfessor of pharmacology of medicinal

instituteOne qualified pharmacist

The pharmacy council performs the following activities:Approve examinations in pharmacy for qualifying

persons for registration as pharmacists.Prescribe the subjects in which approve

examinations shall be held. Approve the course of study and practical

training in pharmacy for the purpose of admission.

Prescribe the condition and procedure for admission of candidates to and approved examination;

Prescribe the equipments and facilities to be made available to the students.

Mukul Chondro Sarkar

Student ID :16121100

The pharmacy council performs the following activities:To recognize degree or diploma in pharmacy for

the purpose of registration as pharmacist;Undertake inspections of institutions which

conduct the course of study in pharmacy.Prepare and maintain registers of pharmacists and

apprentices in pharmacy.To register pharmacists and grant certificates of

registration.Hold examinations for the purpose of registration.Lay down the standard of teaching to be

maintained by the institutions

Short notes on DA, DGDA

DA (Drug Administration)Founded: 1976Founder: MD. Mustafizur Rahman Headquarters: Motijheel Commercial Area,

Dhaka, Bangladesh.number of employee: 700website: www.dgda.gov. bd

DGDA (Directorate General of Drug Administration)

Founded: 1976Founder: MD. Mustafizur RahmanHeadquarters: Mohakhali, Dhaka-1212,

BangladeshTel : 8802 9880803, Fax : 8802 988054, Email : dgda.gov@gmail.comwebsite: www.dgda.gov.bd

Function of DGDA

Evaluate the proposals of new projects of all systems of medicines.

Issue and renew the drug manufacturing licenses.Issue and renew the retail and whole sale drug

licenses.Register and renew of drug products.Inspect the pharmaceutical establishments.Fix the price and certify the price of drug

products.

Major Function of DGDA

Continue…….Approve the indent for import of finished

drugs.Prosecute the cases of the drug courts and

other courtsIssue the export licenses of FSC (Free Sales

Certificate), GMP (Good ManufacturingPractices) Certificate & CPP ( Certificate for Pharmaceutical Products.).

Approve the block list for the import of raw- and packaging materials.

Short notes on WHO, USFDA, MHRA, TGA

WHO(World Health Organization)Founded: April 7, 1948Founders: France, Denmark,

Ecuador, Australia, Canada.Headquarters: Geneva, SwitzerlandCustomer service: +1 202-974-

3000Parent organization: United

NationsAwards: Lasker-Bloomberg Public

Service Award

USFDA (United States of Food and Drug Administration)Founded: 1906Founder: U. S. federal government. Headquarters: White Oak Campus, 10903

New Hampshire Silver Spring, Maryland 20993

Employees :14,824Annual budget: $4.36 billionWebsite: www.usfda.gov

MHRA (Medicines and Healthcare Products Regulatory Agency)Founded: 1 April 2003; 12 years agoFounder: Minister: George Freeman MP ,Headquarters: London, United Kingdomkey people: Sir Michael Rawlins, Chairman Dr Ian Hudson, Chief

ExecutiveWebsite: www.gov.uk/mhra

Mahfuza AkterStudent ID:161211001

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MHRA main activities areAssessing the safety, quality and efficacy of

medicines.Overseeing the UK Notified Bodies that audit

medical device manufacturers.Operating post-marketing surveillance,

reporting, investigating and monitoring adverse reactions of medicines.

Taking any necessary action to safe-guard public health, restricting the availability of products or improving designs.

Continue……………operating a proactive compliance programme for

medical devices.operating a quality surveillance system to sample and

test medicines and to address quality defects, monitoring the

safety and quality of imported unlicensed medicines and investigating Internet sales and potential counterfeiting of medicines.

regulating clinical trials of medicines and medical devices.

promoting good practice in the safe use of medicines and medical devices.

Continue………monitoring and ensuring compliance with

statutory obligations relating to medicines.managing the British Pharmacopoeia (BP),

offering scientific, technical and regulatory advice on medicines and medical devices.

providing the public and professions with authoritative information.

TGA(Therapeutic Goods Administration)

founded: 1989founder: Joshua Jacobsheadquarters: 136 Narrabundah Ln,

Symonston ACT 2609, Australiawebsite: www.tga.gov.au/ Activities: medicines, medical devices, gene

technology, and blood products in Australia .

Current list of top 10 world wide pharmaceuticals companyJhonson and JhonsonNovartisRochePfizerSanofiMerckGlaxosmith kineAstra ZenecaBayerGilead Sciences

2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars)

Johnson & Johnson;

74.3

Novartis; 49.6

Roche; 49.6Pfizer; 47.7

Sanofi; 42.2

Merck; 41.2gsk; 35.8

Astra Zeneca;

24.7 Bayer; 20.1

Sales

2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars)

020406080 Johnson &

Johnson; 74.3Novartis;

49.6Roche; 49.6Pfizer; 47.7Sanofi; 42.2

Merck; 41.2

gsk; 35.8Astra Zeneca;

24.7Bayer; 20.1

Sales

World wide top 5 pharmaceutical company's details:

headquarters: Johnson & Johnson Plaza in New Brunswick, New Jersey

Founded: New Brunswick, New Jersey, United States (1886; 130 years ago)

Founders: Robert Wood Johnson I James Wood Johnson Edward Mead Johnson

Area served : WorldwideKey people :Alex Gorsky (Chairman and

CEO )

Continue…………Revenue: $ 74.331 billion Operating income: $ 20.563 billion Net income: $ 16.323 billion Total assets: $ 131.119 billion Total equity: $ 69.752 billionNumber of employees: 126,500

headquarters: BaselFounded: 1996 (from merger)Headquarters: Basel , SwitzerlandKey people: Joerg Reinhardt (Chairman),

Joseph Jimenez (CEO)Products : Pharmaceuticals, generic drugs ,

over- the-counter drugs , vaccines , diagnostics , contact lenses , animal health.

Continue…………Revenue: US$ 50.359 billionOperating income: US$8.845 billionNet income: US$17.783 billionTotal assets: US$131.55 billionTotal equity: US$77.046 billionNumber of employees: 118,700

Industry: PharmaceuticalsFounded: 1896Founder: Fritz Hoffmann-La RocheHeadquarters: Basel , SwitzerlandKey people: Christoph Franz (Chairman of

the board), Severin Schwan (CEO ), Daniel O'Day ( COO, Pharmaceuticals), Roland Diggelmann (COO,Diagnostics)

Continue……..Products: Pharmaceuticals and diagnosticsRevenue :47.462 billion Swiss francs (CHF)Operating income: CHF 14.090 billion Profit CHF :9.535 billion Total assets :CHF 47.272 billionTotal equity: CHF 21.558 billionNumber of employees :88,509

Founded 1849; 167 years agoFounder: Charles Pfizer, Charles F. ErhartHeadquarters: New York City , United StatesArea served: WorldwideKey people: Ian Read (Chairman & CEO)Products: Atorvastatin, Prevnar, Norvasc,

Norvasc, Zithromax etc..

Continue……..Revenue: US$ 48.85 billionOperating income: US$11.05 billionNet income: US$7.74 billionTotal assets: US$169.3 billionTotal equity: US$71.30 billionNumber of employees: 78,300

Founder: Jean-François Dehecq (Original Founder)

Headquarters: 82, Avenue Raspail, Gentilly , France

Key people: Olivier Brandicourt (CEO, Chairman), Jean-François Dehecq (Original Founder)

Products: Prescription and over-the-counter drugs for thrombosis , cardiovascular disease, diabetes , central nervous system disorders, oncology and internal medicine , vaccines.

Continue………..Operating income: €6.14 billionProfit: €4.39 billionTotal assets: €96.07 billionTotal equity: €56.89 billionNumber of employees: 112,128

MD.Rabius Sany

Student

ID :

16121

1005

Top 20 Pharmaceutical Company in BangladeshSquareBeximcoINCEPTA PHARMAOPSONIN PHARMARENATAESKAYEFACMEACIARISTOPHARMASANOFI AVENTIS

DRUG INTERNATIONAL

HEALTHCARE PHARMAIBN SINANOVO NORDISKORION PHARMA LTDGLAXOSMITHKLINESANDOZGENERALNOVARTISPOPULAR PHARMA

Brief on top 5 Pharmaceutical companies of Bangladesh

Founded: 1958Founder: Samson H. ChowdhuryHeadquarters: Dhaka, set beside the

Buriganga River.Key people :Tapan Chowdhury, Samson H.

Chowdhury, Anjan ChowdhuryProducts:Sedno,Square Zinc,UritenWebsite:

http://www.squarepharma.com.bd/

Founded: 1972Founder: Sohail Rahman is the Chairman and

founder of Beximco.Headquarters: Dhaka , Bangladesh.Key people: ASF Rahman (Chairman),

Salman F Rahman (Vice Chairman)Products:Napa,Flubex,Neoceptin-

R,Nitrosol,Tycil Revenue: $2 billion (estimated)Number of employees: 48,000Website: website: www.beximcopharma .com/

Founded: 1999Founder: Abdul MuktadirHeadquarters: Shahid Tajuddin Ahmed Sarani,

Tejgaon I/A, Dhaka , BangladeshKey people :Managing Director and Chairman: Abdul MuktadirStrategy: S. RahmanProducts :Aritone-Z,Carvista,Magfin,ResetRevenue: 1.6 billionNumber of employees: AnonymousWebsite;

http://www.inceptapharma.com/index.php.

Founded: 1956Founder: Late Abdul Khaleque KhanHeadquarters: 30 New Eskaton, Dhaka,

BangladeshKey people: Moudood Choudhury Deputy

Manager.Products:Hypen

SR,Tadol,Bislol,Diclofen,UrinomRevenue: Above US$100 MillionNumber of employees: 5001-10,000Website http://www.opsonin-pharma.com

Founded: 1993Founder: Syed S Kaiser Kabir - CEOHeadquarters: Mirpur , Dhaka , BangladeshKey people: Syed S Kaiser Kabir – CEOProducts:Anorexon,Calcin,Cardipin,V-capRevenue: taka 36 billionNumber of employees: 4,334Website: www.renata-ltd.com

Local Market Share In Medicine Marketing:

Source:The Bangladesh Pharmacutical Index

18.70

9.80

8.60

5.305.00

52.60

Sales

SquareBeximcoInceptaOpsoninRenataOthers

GMP(Good Manufacturing Practices) DefinationA GMP is a system for ensuring that products

are consistently produced and controlled according to quality standards.

designed to minimize the risks involved in any pharmaceutical production.

ImportanceGMP is a critical concept in pharmaceutical industry. Many countries have legislated GMP procedures for the manufacturing units, with an aim to ensure the quality of medicines and thereby safeguard the health of patients. If the manufacturers fail to comply with the standards, their license may be cancelled or their product may be banned, and they may be charged for negligence/ non-compliance.Good Manufacturing Practices (GMPs) are systems

created and mandated by the government to regulate production, verification and validation of drugs, food and/or medical devices, ensuring that finished products are effective and safe for market distribution.

ImportanceIt’s important to have GMPs because they are guidelines which are enacted to ensure food, drugs, cosmetics, medical devices and related products have no harmful substances. These regulations, enforced by the FDA, help reduce the instances of product recalls, harmful effects and eventual lawsuits that may arise from defective products.

RequirementManufacturing facilities must maintain a clean and hygienic

manufacturing area.Controlled environmental conditions in order to prevent cross

contamination of food or drug product from adulterants that may render the product unsafe for human consumption.

Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.

Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.

Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)

Operators are trained to carry out and document procedures.Cross contamination with unlabelled major allergens is prevented.

Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations are investigated and documented.

Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.

The distribution of the food or drugs minimizes any risk to their quality.

A system is available for recalling any batch from sale or supply.Complaints about marketed products are examined, the causes of

quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.

Practices are recommended with the goal of safeguarding the health of consumers and patients as well as producing good quality food, medicine, medical devices, or active pharmaceutical products. In the United States, a food or drug may be deemed "adulterated" if it has passed all of the specifications tests, but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline. Therefore, complying with GMP is mandatory in all pharmaceutical manufacturing, and most food processing.