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biopharm_neweraindiatoday_jan08

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India Tday Biopharmaceuticals in India: A New Era India has made great strides in the development of its biopharmaceutical industry ndia’s biopharmaceutical industry, which was quite modest only a decade ago, is expected to generate almost $2 billion in sales in 2008, making it one of the largest biopharmaceutical segments in Asia.1 According to the Society for Industrial Microbiology’s newly published study, Advances in Biopharmaceutical Technology in India (BioPlan Associates, Inc., Rockvill
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  2 BioPharm International www.biopharminternational.com January 2008 I ndia’s biopharmaceutical industry, which wasquite modest only a decade ago, is expected togenerate almost $2 billion in sales in 2008,making it one of the largest biopharmaceuticalsegments in Asia. 1 According to the Society forIndustrial Microbiology’s newly published study,Advances in Biopharmaceutical Technology inIndia (BioPlan Associates, Inc., Rockville, MD),the Indian biopharmaceutical industry is growing25 to 30% per year. 1 Essentially all biopharmaceutical organizationstoday have established an India and Asia strategy,or they are rapidly recognizing the importance of the historic changes occurring and the potentialopportunities that are emerging there. This col-umn is the first in a monthly series on the growthand challenges facing this market. Futurecolumns will cover biogenerics, the current andfuture regulatorysituation, intellectual propertyprotection, how clinical trials are driving thisindustry segment, bioinformatics, distributionhurdles, government support for the industry,contract manufacturing, and other key topics.Afew of the key findings in India’sbiopharma-ceuticals industrythat are shaping internationalcollaborative and investment strategy include:ã Growth in India is primarily export-driven. Exportsales of Indian biopharmaceutical products arecurrently rising at an annual rate of 47%, while domestic sales of Indianbiopharmaceutical products haverisen only 4–5% per annum for eachof the past two years. The value of India’s biopharmaceutical exports isalready double the value of itsdomestic biopharmaceutical sales. 1 ã Vaccines arethe largest and fastest-growing sector. Indian vaccine salescurrently account for about 43% of the country’s total biopharma-ceutical sales, compared to 16% fordiagnostics and 13% for therapeutics. Most of the growth in Indian biopharmaceutical is alsoaccounted for by vaccines, sales of which roseby about 42% from 2005–2006 to 2006–2007,compared to just 23% for therapeutics, and amere 5% for diagnostics. India is one of theworld’s leading suppliers of vaccines formeasles and other childhood vaccinations [QA:Changed from “leading suppliers of measlesand other childhood vaccines.” Edit ok?] . 1 ã Industry growth is concentrated in a relativelysmall number of companies. About thirty Indiancompanies account for virtually all of thecountry’s biopharmaceutical sales. This groupis led by companies such as Biocon(Bangalore, India), Serum Institute (Pune,India), and Panacea Biotec (New Delhi,India), which are all local-grown players. Thelist also includes Indian-based subsidiaries of Novo Nordisk (Bagsvaerd, Denmark),GlaxoSmithKline (Middlesex, UK), Eli Lilly(Indianapolis, IN) and others. 1,2 ã Indian companies manufacture an increasingly widerange of biopharmaceutical products. Theseinclude recombinant insulin, erythropoietin(EPO), G-CSF, recombinant hepatitis-B vaccine,streptokinase, interferon alpha-2b, rituximab,and an anti-EGFR monoclonal antibodyproduct. 1,2 ã Indian biopharmaceutical R&D is increasing rapidly. Since 2003, the R&D budgets of the top tenIndian pharmaceutical companies have morethan doubled. Much of this increase has comein biopharmaceutical R&D, and the pipelinesof Indian biotech companies are filling withnovel large-molecule drugs for diabetes,cardiovascular disease, oncology and anti-inflammation applications, among others. 1,2,3 The speed with which the Indian biopharma-ceutical industry has developed in the pastdecade highlights the country’s reserves of well- India Tday Biopharmaceuticals in India: A New Era India has made great strides in thedevelopment of its biopharmaceutical industry Eric Langer is president of BioPlanAssociates,Rockville,MD,301.921.9074,elanger@bioplanassocicates.com.  educated, relatively inexpensiveworkforce. But it also shows thepower of cultural change. INDIA’S ATTITUDE ADJUSTMENT Aleader of the non-aligned move-ment after its independence, Indiawas, in fact, a close trading partnerof the Soviet Union from the 1960sthrough the 1980s. By the end of theCold War, however, it had begun tomore closely align itself with Europeand the US—economically as well asgeopolitically. By 1991, the US hadbecome India’s largest trading part-ner. Spurred on in part by thisimproving relationship and by therecognition of its own enormouspotential in the global marketplace,India in the 1990s began to push itshomegrown industries to becomeglobal competitors.One of the central aspects of thiseconomic revitalization process hasbeen the offering of tax incentives tokey sectors, including pharmaceuti-cals, biopharmaceuticals, and otherexport industries. R&D expendituresin these industries are often eligiblefor 150% deductions, and there areliberal incentives for export profits. 1,2 The Department of Biotechnology(DBT), set up under the Ministryof Science and Technology in 1986, hasbeen another big factor in the eco-nomic revitalization. The DBTbecame more active in the 1990s inits funding of vaccine and otherbiotech research at Indian institutesand universities. The DBT now alsoprovides grants and loans to Indiancompanies to cover internationalpatent and other R&D costs, and hasset up biotech industrial parks withspecial economic zone privileges.Another sign of India’seconomicadjustment has been its 1995 agree-ment to the World TradeOrganization’s TRIPS (trade relatedaspects of intellectual propertyrights) regime, committing thecountryto a reform of its patent law.At the time, the law protected onlyprocess patents. Under this lawIndian pharmaceutical companieshad effectively been encouraged toreverse-engineer western drugs,devise and patent new productionprocesses, and sell the drugs cheaplywherever they could. Despite a cer-tain amount of delay, India didadhere to TRIPS, and in 2005, itspatent law was extended to coverproduct patents, including those fornew drug molecules. 4 One major effect of the newpatent law has been to shift thefocus of India’s pharmaceuticalcompanies away from generics andprocess optimization and towardsinnovative drug research, includingR&D on biopharmaceuticals.The new patent law, combinedwith India’s friendlier tax regime, itsincreasingly skilled and inexpensivelabor force, and its evident serious-ness about building a biotech indus-try, has also helped to bring about aflow of western investment toIndian biopharmaceutical compa-nies. Many Indian companies nowconduct contract research and man-ufacturing for major multinationalsand use the earnings to fund theirbiopharmaceutical R&D efforts.The improving business climate inIndia also has encouraged westernMNCs [QA: multinational corpora-tions?] to increase their presence inthe countrymore directly. A signifi-cant part of the Indian biopharma-ceutical industryis accounted for byIndian-based subsidiaries of westernMPCs [QA: please define MPC] . ROOM FOR IMPROVEMENT India remains weak in a number of crucial areas. To begin with, there isstill only a limited system for attract-ing and nurturing postdoctoral stu-dents, who comprise a key researchworkforce in the west. The strengthof the west’s postdoctoral system isone of the reasons for India’sshort-coming in this area. Today, mostIndian postdoctoral students goabroad and rarely return. In India,the academic research that normallyleads to the development of bio-pharmaceuticals is still largely car-ried out by young students workingtowards their PhDs.Partly for this reason, and alsobecause the biopharmaceuticalindustry in India is still so young,the country’s expertise in standardbiopharmaceutical R&D techniquesremains weak by western stan-dards. Cell culture development,biochemistry, toxicological assaysand animal tests—all are areaswhere Indian laboratories tradition-ally have had less capability. That islikely to change in the comingyears, but at present, India’sphar-maceutical R&D strengths lie onthe chemistry side of the industry.Another drag on India’s ability toinnovate is its intellectual propertyenvironment, which shows signifi-cant room for improvement despitethe 2005 patent law reform legisla-tion. There remains a taint of theold attitudes in India’s business andregulatory culture, and westerncompanies who do business therestill complain of intellectual prop-erty rights (IPR) abuses. Referring to“unfair commercial use of undis-closed test and other data submit-ted by pharmaceutical companiesseeking marketing approval fortheir products,” and citing “proce-dural barriers and delay,” the Officeof the US Trade Representative keptIndia on its IPR watch list in 2006and put the country on its prioritywatch list in early 2007. 4 LOOKING FORWARD On November 13, 2007, India’sDepartment of Biotechnologyannounced the approval of itsNational Biotechnology Develop-ment Strategy, 5 which increases theDBT’s budget to more than $300million annually, and includes pro-motions in the following areas:ãThe establishment of moreuniversity-linked biotechnologyresearch centers, withinternational-quality facilities BioPharm International www.biopharminternational.com January 2008 3 India Today  and teaching standards.ãThe rapid expansion of biotech-related PhD and postdoctoralprograms, including commercial-oriented courses.ãIncentives for the repatriation of Indian-born scientists currentlyworking abroad.ãSupport for partnerships betweenacademic laboratories and privatebiotech firms.The world market for biophar-maceutical drugs is currentlyapproaching $100 billion, andmany first-generation blockbusterproducts have lost or will soon losetheir patent protection. Indiaclearly intends to take advantage of the opportunity. It aims at nothingless than a world-class, end-to-endbiopharmaceutical capability in thenext decade or so. N REFERENCES 1.Kulkarni N. A window into India’sbiopharma sector. In: Langer E,editor.Advances in BiopharmaceuticalTechnology in India. Gaithersburg:Bioplan; 2008.2.Kumar A. Biogeneric Manufacturing inIndia. In: Langer E,editor. Advances inBiopharmaceutical Technology in India.Gaithersburg: Bioplan; 2008.3.Biocon Ltd. [homepage on the Internet].Bangalore,India:c2007 [accessed 16Nov 2007]. Available from:http://www.biocon.com/biocon_products_bio_biological.asp?subLink=bio.4.Schnabel J. Outsourcing BiopharmaR&D to India. In: Langer E,editor.Advances in BiopharmaceuticalTechnology in India. Gaithersburg:Bioplan; 2008.5.Dept of Biotechnology [homepage onthe Internet]. India:c2006 [accessed16 Nov 2007]. Available from:http://dbtindia.nic.in/biotechstrategy/National%20Biotechnology%20Development%20Strategy.pdf. 4 BioPharm International www.biopharminternational.com January 2008 India Today
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