1. Balaji Roy

2. Pharmaceutical Industry in India is one of the largest andmost advanced among the developing countries. Around 70% of the countrys demand for bulk drugs, drugintermediates, pharmaceuticalformulations, chemicals, tablets, capsules, orals andvaccines is met by IPI. The Indian pharmaceutical industry has come a long wayfrom waiting for imports of bulk drugs from global playersto breaking new grounds in medical research worldwide. 3. Phase VPhase IV Innovation andGrowth Phase ResearchPhase IIIDevelopment Rapid expansion of New IP lawPhase domestic market Discovery Research Phase II ProcessInternationalConvergence Government Control development marketPhase I development Indian Patent Act ProductionEarly Years1970 infrastructureResearchorientationMarket shareDrug prices capped creationdomination byLocal companies Export initiativesforeignbegin to make ancompaniesimpactRelativeabsence oforganized Indiancompanies1970 198019902000 2010 4. VALUE InnovativeProducts Specialty Generic Generic Productsexports to exports to developed under- countriesdeveloped &API developingExportscountriesTIME 5. Pharmaceutical Industry Two percent of the worlds pharmaceuticalmarket. Estimated market value of about US $12.26 billion. 3rd rank in terms of total pharmaceuticalproduction volume. 14th in terms of value. Growing at an average rate of 8-9 %. Expected to grow to US $ 20-23 billion by 2015. The pharmaceutical industry grows at about 1.5-1.6times the Gross domestic product growth. 6. INDIAN PHARMACEUTICAL MARKETDOMESTIC MARKET OVERSEAS MARKET Ethical drugsThe Export generic drugs Over the counter (OTC) and APIsdrugsContracted Research and Active pharmaceuticalManufacturing Servicesingredient (API) market(CRAMS) 7. A patent is a limited monopoly granted in respect of aninvention. A patent confers the right to exclude others frommaking, using or selling the invention. This right is granted to the inventor (or his/her successor intitle) by a national or regional authority. This right is limited in terms of territory and duration. The scope of this right is defined by the patent claims. 8. A patent does not confer the "positive" right to use theinvention. The use of an invention, whether patented or not, issubject to other national laws and regulations. 9. Territorial scope : National patents Both granting procedure and effect are national. European patents - The granting procedure is European, the effect is national International patent applications (PCT):The application and examination procedure isinternational, the granting procedure is European/national,the effect is national. Term 20 years from filing 10. Product Broadest protection. Itcovers all uses of theproduct, even those notexplicitly disclosed. MethodThe protection for amethod of manufacturealso covers the productsobtained by that method.Relatively narrow scope of Use protection - secondmedical use 11. Generic medications are: A copy of the original (bioequivalent) andinterchangeable with the innovator drug. Manufactured without a license from theinnovator company. Marketed after expiry of patent or otherexclusive rights . 12. PatentedOff PatentProduct Introductory Growth Maturity DeclineDevelopment StageStage StageStageOff PatentScenario AScenario BScenario C Time 13. MAJOR PLAYERS AS PER NET SALES IN INDIA90008000 7686.59 6977.5 IN CRORE70006686.36000 5364.375000 4284.63 4015.564000 3152.230002641.07 2560.162352.5920001000 0 COMPANY 14. CURRENT GROWTHSCENARIOFACTORS LEADING TO THE GROWTH OFPHARAMACEUTICAL INDUSTRY Economic Growth Population growth Increase in chronic diseases Healthcare infrastructure growth Growth of health insurance Low manufacturing costs 15. Anti- infective GastrointestineCardiac RespiratoryVitamin/minerals/nutrientsPain /analgesisDermatologics gynaecologyNeuro psychiatryAntidiabeticsOthologicalsothers11% 16% 4% 2% 5%11%5% 10% 11% 6%10%10% 16. 400003500034741 US $ IN MN(APR 2011- MAR 2012)300002500020000 1685715000 129318589 9151100007942 5769 5000 2702241117780COUNTRY 17. SRILANKA 6% SOUTH AFRICAUNITED10%STATES20%MEXICO8%PAKISTAN GERMANY 7%17% BRAZIL UNITED10%KINGDOMINDIA CHINA9% 8%5% 18. EFFECT OF RECESSION Recession Proof Business. Career in the pharmaceutical industryas evergreen. Fastest growing manufacturing industries. 19. Contract manufacturing for Global Supply of APIs Quality Generic Products Process Technologies Pharmaceutical Manufacturing Equipment Alternate Medicines - Ayurvedic & Herbal 20. SWOT ANALYSISSTRENGHTS WEAKNESSESCost Competitiveness Low investments in innovative R&DStrong manufacturing baseLack of resources to compete withEstablished network of laboratories and R&DMNCsinfrastructureHighly trained scientistsInadequate regulatory standardsStrong marketing and distribution networkProduction of spurious and low qualityRich biodiversity drugs spoils the image of the industry inLargest number of US FDA approved plants international arena Opportunities ThreatsProduct patent regime poses seriousSignificant export potentialchallenge unless it invests in R&DLicensing deals with MNCsDPCO puts unrealistic ceilings onMarketing alliances to sell MNC products product in Indian marketprices & profitability & prevents inContract manufacturing agreements withgenerating investible surplusesthe MNCsExport effort hampered by proceduralPotential for developing India as a centrehurdles & non tariff barriers imposedfor international clinical trialsabroadLowering of tariff protection 21. FINDINGS AND CONCLUSION Expected to grow to US $ 20-23 billion by 2015. Export market is growing much faster than the domesticmarket. Future will see strong growth in the specialty brandedgenerics and patented drug segments. Drugs for diabetes and cardiovascular diseases are expectedto see the fastest growth among all therapy areas . 22. Vast opportunity exists for the organized market.Cipla, Ranbaxy and GlaxoSmithKline are controlling the topthree positions in the Indian pharmaceutical market. Pharma industry being a growth industry unaffected by thebusiness cycle India has: Competitive strength in research services.Availability of low cost skilled doctors and scientists.Large patient population with diverse disease characteristics.VLSS agencies recommends investment in this industry tobe a wise decision. 23. RECOMMENDATIONS Selecting right product-mix. Focusing on core competencies. More of merger and acquisition. Reengineering and investing heavily in R&D. Advances in biotechnology and Informationtechnology. 24. The obligations imposed on India are going tohave a significant impact on Indias successfulbulk and formulation-oriented pharmaceuticalindustry. Indian companies could focus on producingpatented drugs under license from foreigncompanies . 25. THANK YOU