1. SAURABH WANIGARWARE COLLEGEPGDPMPHARMACEUTICALINDUSTRY

2. PHARMACEUTICAL INDUSTRYPharmaceutical industry is defined as an industry which isinvolved in manufacturing of various formulations whichincludes solid and liquid dosage forms also involved in clinicaltrials of various drugs and through proper transportation makebest possible medicine available in the market which help intreatment of various disease 3. REASON FOR CHOOSINGPHARMACEUTICAL INDUSTRY Drugs and pharmaceutical industry play a vital role in economicdevelopment of nation India is one of the fastest growing pharmaceutical market in world,and its market size is doubled since 2005 Indian pharmaceutical market is expected to reach US$ 20 billionby 2015 , growing at compound annual growth rate of 11.7% India is third largest market in the world in terms of volume andfourteenth in terms of value IMS HEALTH INDIA which tracks drug sales in the country througha network of nationwide drug distributors, estimates thehealthcare market in India to reach US$ 31.59 billion by 2020 4. VARIOUS DEPARTMENTS INPHARMACEUTICAL INDUSTRY IT DEPARTMENTIT DEPARTMENT IN PHARMACEUTICAL INDUSTRY BASICALLYTAKES CARE OF VARIOUS PHARMA REPORTS AS WELL AS DATA OFRESEARCH AND TRIALS CONDUCTED FINANCE DEPARTMENTFINANCE DEPARTMENT IN PHARMACEUTICAL INDUSTRY PLANSAND DECIDES AMOUNT OF FINANCE THAT SHOULD BE USED FORTHE GROWTH OF THE COMPANY AND FOR THE ACHIVEMENT OFBUSSINESS GOALS 5. HUMAN RESOURCES DEPARTMENTTHIS DEPARTMENT BASICALLY TAKES CARE OF EMPLOYEESWORKING AT DIFFERENT POSITIONS IN PHARMACEUTICALINDUSTRY AND PROVIDES THEM RESOURCES AND ALSODECIDE WHAT COMPENSATION AND FACILITIES SHOULDBE GIVEN TO PARTICULAR EMPLOYEEPF AND GRATUITY DEPARTMENTTAKES CARE OF PROVIDENT FUND OF EMPLOYEEWHENEVER HE OR SHE LIVES THE COMPANY GRATUITY ISONE OF THE BENEFIT OFFERED BY AN COMPANY TO THEEMPLOYEE IN VIEW OF THE SERVICES PROVIDEDBY THEEMPLOYEE FOR THE COMPANY 6. SUPPLY CHAIN AND LOGISTICS DEPARTMENTIN PHARMACEUTICAL INDUSTRY SUPPLY CHAIN AND LOGISTICSDEPARTMENT IS BASICALLY CONCERNED WITH PACKAGING OFPHARMACEUTICAL PRODUCT AND SENDING IT INTO THE MARKETFOR THE USE OF CUSTOMERS CORPORATE AFFAIRS DEPARTMENTTHINK AS PER THE CHANGING TIME BY STUDYING THE FUTURETRENDS WHICH AFFECTS COMPANIES INTREST AND ADVISEHOW TO MAKE CHOICES WHICH WILL CREATE BENEFIT FOR THECOMPANY 7. MEDICAL DEPARTMENTMEDICAL DEPARTMENT PROVIDES BASIC MEDICAL AND PRODUCTTRAINING TO THE FIELD EMPLOYEES[MEDICALREPRESENTATIVES] OF PHARMACEUTICAL COMPANIES AND TRAINTHEM IN EACH AND EVERY ASPECT OF MEDICAL OF PARTICULARPRODUCT SALES DEPARTMENTSALES DEPARTMENT INVOLVES SALES TEAM WHICH WORKIN ORDER TO INCREASE THE COMPANIES SALES BYCOMPLETING TARGETS AND BY USING DIFFERENTSTRATEGIES 8. STRATEGIC AND BUSSINESS DEVLOPMENT UNITDEPENDING FROM COMPANIES TO COMPANIES LONG TERM ASWELL AS SHORT TERM STRATEGIES ARE PLANNED BY DIFFERENTPHARMACEUTICAL COMPANIES IN ORDER TO MEET THE DESIREDBUSSINESS OBJECTIVES AND FOR DEVLOPING THE BUSSINESS MARKETING DEPARTMENTTHE MAIN JOB OF MARKETING DEPARTMENT IN THEPHARMACEUTICAL INDUSTRY IS THE PROMOTION OF NEWPHARMACEUTICAL PRODUCTS IN MARKET TO PRESENT THEUPDATED INFORMATION AND TO RAISE PUBLIC AWARENESS 9. DIFFERENT KIND OF DOSSAGE FORMSSOLID DOSSAGE FORMS DOSSAGE FORMS HAVINGDIFFERENT SHAPES , SIZESAS WELL AS DIFFERENTCOLOURS ANDMANUFACTURED FOR THEADMINISTRATION OF THEACTIVE INGREDIENT INCLUDESTABLETS,GRANULES ,CAPSULES, POWDERS, ANDSUPPOSITORIESLIQUID DOSSAGE FORMS LIQUID FORM OFMEDICINES INTENDEDFOR HUMANCONSUMPTION INCLUDES OTICPREPRATIONS,SYRUPS,GARGLE,AROMATICWATER,NASAL DROPS ANDMOUTHWASH 10. INDIANPHARMACEUTICALINDUSTRYAPI FORMULATIONRAW MATERIALSSTAGESDRUGMECHANISMPK & PDPATENTS ANDAPPROVALFROM FDALAUNCHINGIN MARKETOVERVIEW OFMEDICINESDRUGS+INTERMEDIATES 11. WHAT IS ACTIVEPHARMACEUTICAL INGREDIENT? An active ingredient (AI) is the substance in a pharmaceutical drugthat is biologically active Active pharmaceutical ingredient is further activated in dosage formswhich is available in solid and liquid forms As far Indian pharma industry are concerned it is having Cgmpstandards with proper distribution channels to the consumers This process is considered to be intermediates of active formulationprocess of the drugs 12. STAGES OF MANUFACTURINGPROCESS Introductory stage In this stage the new molecule of thedrug is introduced by applying formulas and chemical bonding This further can be explained by giving example of product lifecycle The lifecycle concept links product and process development,qualification of the commercial manufacturing process Product lifecycle further gives guidance to the following HUMAN DRUGS BIOLOGICALS AND BIOTECHNOLOGY PRODUCTS FINISHED PRODUCTS AND ACTIVE PHARMACEUTICALINGREDIENT 13. WHAT ARE RAW MATERIALS A raw material or feedstock is the basic material from whichgoods, finished products or intermediate materials that are alsofeedstock's are manufactured or made. Recycling is a process to change materials into new products toprevent waste of potentially useful materials, reduce theconsumption of fresh raw materials, reduce energy usage, reduceair pollution and water pollution by reducing the need for"conventional" waste disposal, and lower emissions as comparedto plastic production. Recycling is a key component of modernwaste reduction and is the third component of the "Reduce, ReuseRecycle" waste hierarchy 14. STAGES OF USING RAW MATERIALIN PHARMA INDUSTRY Pharmaceutical companies often deal with a large number of rawmaterials and, without careful monitoring, confusion betweensimilar / mislabeled substances can easily occur. In addition, before they can be used in the production processincoming raw materials may also have to be tested to see thatthey meet certain specifications, such as moisture content, purityetc. Therefore the manufacture of high quality pharmaceuticalproducts requires two steps of initial quality analysis identificationof the incoming raw materials and quantitative analysis of the rawmaterials. Raw material should be in sterilized form with proper temperature 15. DECONTAMINATION PROCESS Decontamination is the physical or chemical process that rendersan inanimate object that may be contaminated with harmfulmicrobial life safe for further handling. The objective ofdecontamination is to protect the preparation and package workerswho come in contact with medical devices after thedecontamination process from contracting diseases caused bymicroorganisms on those devices. Steps in the Decontamination Process Transport - Used supplies and equipment should be collected andtaken to the Decontamination Area in the Sterile ProcessingDepartment in a way that avoids contamination of personnel orany area of the hospital. Equipment should be covered andsupplies should be moved in covered carts, closed totes orcontainers, or closed plastic bags. Sorting Removing impurity from a drug and using that drug inmanufacturing of dosage form 16. TESTING PROCESS OF NEWDRUG IN LABORATORY Clinical trials involving new drugs are commonly classified intofour phases. Each phase of the drug approval process is treatedas a separate clinical trial. The drug-development process willnormally proceed through all four phases over many years. Ifthe drug successfully passes through Phases 0, 1, 2, and 3, itwill usually be approved by the national regulatory authority foruse in the general population. Phase 0: Pharmacodynamics and Pharmacokinetics Phase 1: Screening for safety Phase 2: Establishing the efficacy of the drug, usually against aplacebo Phase 3: Final confirmation of safety and efficacy Phase 4: Sentry studies during sales Each phase has a different purpose and helps scientists answer adifferent question 17. Phase 0 trials are the first-in-human trials. Single sub therapeuticdoses of the study drug are given to a small number of subjects (10to 15) to gather preliminary data on the agent's pharmacodynamicsand pharmacokineticsIn Phase 1 trials, researchers test an experimental drug ortreatment in a small group of people (2080) for the first time toevaluate its safety, determine a safe dosage range, and identify sideeffects.In Phase 2 trials, the experimental treatment is given to a largergroup of people (100300) to see if it is effective and to furtherevaluate its safety. 18. In Phase 3 trials, the treatment is given to large groups of people(1,0003,000) to confirm its effectiveness, monitor side effects,compare it to commonly used treatments, and collect informationthat will allow it to be used safely.In Phase 4 trials, postmarketing studies delineate additionalinformation, including the treatment's risks, benefits, and optimaluse.Before pharmaceutical companies start clinical trials on a drug,they conduct extensive preclinical studies 19. DRUG APPROVAL PROCESS Once a company develops a drug, it undergoes around three anda half year of laboratory testing, before an application Thecompany then submits an application (usually about 100,000pages) to the FDA for approval, a process that can take up to twoand a half years. After final approval, the drug becomes available for physicians toprescribe. At this stage, the drug company will continue to reportcases of adverse reactions and other clinical data to the FDA. 20. PACKAGING INPHARMACEUTICALS Protection Physical or mechanical hazards Shockimpact Compression Vibration Puncture Climatic hazards Temperature Declared storage conditions (temperature) Moisture 21. PLANNING INPHARMACEUTICAL INDUSTRY Planning is the major process in the pharmaceutical industry inwhich there is planning between the members of the team inrelation to the objectives of pharmaceutical company how thoseobjectives should be accomplished 22. ORGANIZING INPHARMACEUTICAL INDUSTRY Organizing is relationship between a top level members andbase level members to achieve assigned objectives ofpharmaceutical industry with certain responsibility and in a wellorganized manner 23. STAFFING INPHARMACEUTICAL INDUSTRY Staffing or recruitment is very crucial step in pharmaceuticalindustry recruiting a proper individual and assigning him properand well defined responsibilities is very much important fordevelopment of pharmaceutical industry and will also help insmooth functioning of pharmaceutical industry 24. DIRECTING INPHARMACEUTICAL INDUSTRY Directing is responsibility assigned to a manager inpharmaceutical industry that he should properly direct ,guideand motivate employees working under him in proper directionwhich is be beneficial not only for employees but also for thatpharmaceutical company to reach towards the path of success 25. CONTROLLING INPHARMACEUTICAL INDUSTRY Controlling ensures that there is effective and efficient utilizationof resources provided by pharmaceutical industry in order toachieve planned goals Controlling measures the deviation ofactual performance from the standard performance 26. LOGISTICS AND SUPPLYCHAIN IN PHARMACEUTICALINDUSTRY Logistics is the part of supply chain process that plans,implements and controls the efficient, effective flow of storageof goods, services and related information from the point oforigin to the point of consumption in order to meet customersrequirements Supply chain encompasses of all the activities associated withthe flow and transformation of goods from the raw material stageto the end user as well as the associated information flows 27. IMMEDIATE SUPPLY CHAINFOR AN INDIVIDUAL FIRM 28. SUPPLY CHAIN INPHARMACEUTICALINDUSTRYSUPPLIERMANUFACTURINGUNITR&DLOGISTICSPHURCHASINGUNITPHARMACYSHOPSCUSTOMERS 29. PHARMACEUTICAL SUPPLYCHAIN SUPPLIER SUPPLIES RAW MATERIAL MANUFACTURING UNIT RECIVES THE SUPPLIED WHICH ISTHEN USED FOR MANUFACTURING OF PHARMACEUTICALFORMULATION NOW,MANUFACTURED PHARMACEUTICAL FORMULATION ISSEND TO RESEARCH AND DEVELOPMENT UNIT FOR TESTING THEN MANUFACTURED FORMULATION IS FORWORDED TOLOGISTICS FOR PACKAGING AND DISTRIBUTION 30. o NOW FROM LOGISTICS PHARMACEUTICAL FORMULATION ISFORWORDED TO PHURCHASING DEPARTMENT WHICHINCLUDES STOCKIST OF THAT PHARMACEUTICAL COMPANYNOTE - EVERY PHARMACEUTICAL COMPANY HAVE THEREOWN SET OF STOCKIST NUMBER MAY VARY FROM COMPANYTO COMPANYo FROM STOCKIST PHARMACEUTICAL FORMULATIONS MOVES TOTHE PHARMACY SHOPSo AND FINALLY FROM PHARMACY SHOPS THAT FORMULATIONREACHES TO THE CUSTOMER 31. WHAT IS CIPLA Incorporated 1935 Corporate office Cipla ltd,Mumbai central, Mumbai 400008 Chairman Dr Yusuf K.Hamied Executive vice chairman Mr. M.K.Hamied Listing Equity shares:BSE limited and national stock exchangeof India limited Turnover USD 1.5 billion Employees 20,000 Highlights One of the worlds largest generic companies Over 2000 products,65 therapeutic catagories,40 dosage forms 34 state of art manufacturing facilities approved byinternational regulatory agencies Continuous innovation in R&D :over 20 world first 32. VARIOUS APPROVALS RECIVEDFROM CIPLA US FDA MHRA UK- MEDICINES & HEALTHCARE PRODUCTS REGULATORYAGENCY SUKL SLOVAK REPUBLIC- STATE INSTITUTE FOR DRUG CONTROL APVMA AUSTRALIA- AUSTRALIAN PESTICIDE AND VETERINARYMEDICINE AUTHORITY MCC SOUTH AFRICA- MEDICAL CONTROL COUNCIL PIC GERMANY-PHARMACEUTICAL INSPECTION CONVENTION ANVISA BRAZIL- BRAZILLIAN HEALTH SURVEILLANCE AGENCY INVIMA COLOMBIA- NATIONAL INSTITUTE FOR CONTROLLING OFMEDICINE NDA UGANDA- NATIONAL DRUG AUTHORITY DEPARTMENT OF HEALTH - CANADA 33. INFORMATION ABOUT CIPLA Cipla began its journey in 1935 when Dr K.A.Hamied setup a vision to make India selfSufficient in healthcare over the past 77Years Cipla is one the most respectedPharmaceutical company not only in IndiaBut also worldwide Today Cipla is one of the largest genericPharmaceutical company with strongPresence in over 170 countries maintainingWorld class quality of product and services 34. CIPLAS HISTORYIn 1935 Dr. K. A. Hamied set up Cipla to make India self-reliant inhealthcare.In 1939, Mahatma Gandhi visited Cipla and inspired Dr. K. A. Hamiedto make essential medicines for the country, and strive for self-sufficiency.During World War II, when India was dependent onimported medicines and there was an alarming shortage of life-savingdrugs, we manufactured them for the country.In 1960s Cipla pioneered API manufacturing in the country andhelped lay the foundation for the bulk drug industry in India.In 1970, Cipla spearheaded the New Patent Law by which an Indianpharmaceutical company was allowed to manufacture a patentedproduct as long as the process to manufacture it was changed. Thisenabled Indian companies for the first time to manufacture anymedicines and make them available and affordable for all Indians. 35. In 1978, Cipla pioneered inhalation therapy in India with themanufacture of Metered-Dose Inhaler (MDI), at a time when thecountry stopped receiving imported supplies. Today, we have theworlds largest range of inhaled medication and devices.In 1994, Cipla launched Deferiprone, the worlds first oral ironchelator which revolutionized the treatment for thalassemia. Forthe first time patients with thalassemia had an option that wasaffordable, painless and convenient.In 1996,Cipla gave the world the first transparent dry powderinhaler which was so simple and easy to use, it changed the faceof inhalation therapy in India.In 2001, Cipla pioneered the access to HIV treatment by makingantiretrovirals (ARVs) available at less than a Dollar a Day'. Thecost of treatment dramatically fell from $12,000 per patient peryear to $300 per patient per year. This caused a revolution whereHIV treatment became a reality for the world and millions of livescould be saved. 36. During the 2005 Bird Flu epidemic, Cipla produced an anti-flu drugwithin a period of 2-3 months, which would have normally taken atleast 3 years to develop.In 2012, Cipla made a breakthrough in reducing the prices ofcancer drugs, thus making world-class medicines affordable andaccessible to cancer patients.Cipla is committed to addressing the unmet medical needs of theworld by venturing into newer challenges in platform technologies,biotechnology and stem cells. 37. PLANTS OF CIPLA Cipla have dedicated plants for the technologically-challengingformulations such as Oncology products, Hormones, Metered-Dose Inhalers (MDIs), Beta-Lactams, Cytotoxic, Injectables andCephalosporin's. Our manufacturing plants and processes areseen as among the most sophisticated in the world. They rollout world-class products in over 65 therapeutic categories.We use state-of-the-art technology, the most stringentoperating procedures, a highly motivated and technicallycompetent team, highest standards of safety practices andenvironmentally green and clean processes. 38. BADDI MANUFACTURINGPLANT 39. SKIKKIM MANUFACTURINGPLANT 40. KURKUMBHMANUFACTURING PLANT 41. BANGLORE MANUFACTURING PLANT 42. INDORE MANUFACTURINGPLANT 43. PATALGANGAMANUFACTURING PLANT 44. GOA UNIT 1 MANUFACTURINGPLANT 45. GOA UNIT 2 MANUFACTURINGPLANT 46. GOA UNIT 3 MANUFACTURINGPLANT 47. GOA UNIT 4 MANUFACTURINGPLANT 48. GOA UNIT 5 MANUFACTURINGPLANT 49. GOA UNIT 6 MANUFACTURINGPLANT 50. GOA UNIT 7 MANUFACTURINGPLANT 51. GOA UNIT 8 MANUFACTURINGPLANT 52. CIPLAS PRODUCTS 53. AWARDS ANDRECOGNITIONS In April 2013, former US President Bill Clintonpraised Cipla and other Indian generic drugcompanies for their contribution in the fightagainst HIV/AIDS and noted that their cheapdrugs saved millions of lives. In 2012, Cipla received the Thomson ReutersIndia Innovation Award. Cipla won Dun & Bradstreet American ExpressCorporate Awards for 2006 In 2005, Forbes included Cipla in the 200 'Bestunder a billion' list of best small Asian companies. In 1980, Cipla won Chemexcil Award forExcellence for exports. In July 1939, Mahatma Gandhi (later conferredwith the title "Father of the Nation" byGovernment of India) visited Cipla.[ 54. THANKYOU