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A report on insulin delivery system


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INSULIN DELIVERY SYSTEM, Syringes , Insulin Pen, Insulin Pumps,

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A report on insulin delivery system

  1. 1. A REPORT ON INSULIN DELIVERY SYSTEMSyringesLatest syringes are smaller and have finer needles and special coatings thatwork to make injecting as easy and painless as possible. When insulin injectionsare done properly, most people discover they are relatively painless.Insulin PenAn insulin pen looks like a pen with a cartridge. Some pens use replaceablecartridges of insulin; other pen models are totally disposable. A fine, short needle,similar to the needle on an insulin syringe, is on the tip of the pen. Users turn adial to select the desired dose of insulin and press a plunger on the end to deliverthe insulin just under the skin.Insulin PumpsThese high technology products are miniature, computerized pumps. They areabout the size of a beeper, weigh about 3 ounces, and deliver insulin through aflexible plastic tube attached to the body. The pump mimics a healthy pancreasby offering insulin delivery in two ways. First, it provides a rhythmic, continuousdrip of insulin, which is known as the basal dose, all day long. Second, the pumpallows you to add an additional amount of insulin when you eat. This extra doseis called a bolus. You request your bolus with a simple push of button. Youusually determine the size of the bolus by estimating the amount of carbohydrateyouwillbeeating.Inhaled InsulinInhaled System of Insulin delivery is the latest Product offering severaladvantages over the other conventional SystemsBusiness Opportunity OverviewNumber of Diabetic Patients is on the increase & Insulin Market in India is placedaround INR 250 Crores with about 30 % growth rate. The Inject able InsulinMarket is comprised of products such as Insulin Syringes, insulin Pen , InsulinPumps & Jet Injectors Then there are Inhaled Insulin products, Oral InsulinMarkets, Nasal Insulin delivery technology, Transdermal Insulin Delivery, RectalInsulin Delivery, Ultrasound Insulin delivery, Iontophoresis Insulin DeliveryTechnology, Electro oration Insulin Delivery Technology and so on The productsare Highly Technology Oriented and there are very few players in the worldMarket. Indian Market is served by Imports & therefore priced high. There areattempts to start manufacturing these products in the country & therefore, theInsulin Delivery Systems market in India is considered to be very bright.
  2. 2. LIST OF PROSPECTIVE BUYERS FOR INSULIN DELIVERY SYSTEM IN INDIA INSULIN DELIVERY SYSTEM IN INDIAThere are seven brands of human insulin available in India. These include bothIndian and foreign brands. Insulin is available in vial form in different strengthsranging from 40 iu/ml to100 iu/ml. In November 2004, Biocon, a Bangalorebased Indian company, launched a new generation of bio-insulin called Insugen.In August 2005, Eli Lilly India launched its insulin analog under the brand nameof Humalog Mix 25-50. Indian companies like Wockhardt, Shantha Biotechnicsand Intas Pharmaceutical manufacture erythropoietin. Several other Indiancompanies have licensing agreements with the multi-national companies (MNCs)to market recombinant erythropoietin. Janssen Cilag CRF a division of Johnson& Johnson was amongst the first companies to successfully launch abiotechnology drug in India under the brand name Eprex. Hindustan Antibioticshas tied up with a U.S. company Elanex Pharmaceutical to market their productunder the brand name Hemax.Recombinant Brand CompanyHuman InsulinHuminsulin Eli Lily and Company IndiaInsugen BioconNovoMix39 and NovoRapid Novo NordiskReconsulin Shreyas Life SciencesWosulin WockhardtStreptokinaseIndikinase Bharat BiotechShankinase Shantha BiotechnicsSTPase Cadila PharmaceuticalsErythropoietinCeriton RanbaxyEpofit and Erykine Intas PharmaEprex J& JHemax Hindustan AntibioticsLG Espogen LG ChemicalsShanpoietin Shantha BiotechnicsVintor for Nephrology/Epofer for EmcureHaematinicsWepox WockhardtZyrop Zdyus BiogenHepatitis B VaccineBevac Biological EBiovac B WockhardtEngenix-B GlaxoSmithKline IndiaEnivac HB Panacea Biotec
  3. 3. Gene Vac-B Serum Institute of IndiaLGEuvax B Inj LG ChemicalsRevac B Bharat BiotechShanvac B Shantha BiotechnicsHuman Growth HormoneHumatrope Eli Lilly IndiaLG Eutropin Inj LG ChemicalsNorditropin, NordiLet Novo NordiskSaizen Serum Institute of IndiaG-CSFEmgrast EmcureGrastim Dr. Reddy’s LabsNeukine Intas PharmaInterferon alpha 2aLG Intermax alpha Inj LG ChemicalsInterferon alpha 2bIntron A Fulford India (Schering Plough)Markferon Glenmark LabsShanferon Shantha BiotechnicsZaveinex Zdyus BiogenInterferon beta 1aAvonex Nicholas Piramal- BiogenBlood Factor VIIIFSH Gonal-F Serum Institute of India Ltd.LG Follimon Inj LG ChemicalsTissue Plasminogen Activator German RemediesAlpha DrotrecoginXigris Eli Lily and Company (India)
  4. 4. Indian Disease Burden EstimationsThe growing population, change in disease patterns, and demand for newmedicines to combat these diseases are leading to increased demand for biodrug, vaccines and diagnostics products. The below table provides theestimated cases of diseases in 100,000. Disease/Health Condition 2000-05 2015 Communicable Diseases, Maternal & Prenatal Conditions Tuberculosis 85 NA HIV/AIDS 51 190 Diarrheal Disease episodes/yr 760 880 Malaria and other vector borne 20.37 NA conditions Leprosy 3.67 Expected to be eliminated MR/1000 births 63 53.14 Otitis Media 3.57 4.18 Maternal Mortality/100000 births 440 NA Non-Communicable Conditions Cancers 8.07 9.99 Diabetes 310 460 Mental Health 650 800 Blindness 141.07 129.96 Cardiovascular Diseases 290 640 COPD and Asthma 290 640Though non-injectable forms of insulin are more costly per dose than theirinjectable counterparts, demand is expected to soar in coming years, even inprice-sensitive countries like India. “If Pfizer was the only company, then pricewould be an issue. But with so many competitors, pharma companies cannot out-price themselves,” says Mr. Mattoo.Though non-injectable forms of insulin are more costly per dose than theirinjectable counterparts, demand is expected to soar in coming years, even inprice-sensitive countries like India. “If Pfizer was the only company, then pricewould be an issue. But with so many competitors, pharma companies cannot out-price themselves,” says Mr. Mattoo.Key SuppliersThe major suppliers of biotechnology products include U.S., European and Indiancompanies. Some of the Indian companies manufacturing healthcarebiotechnology products include Bharat Biotech International, Bharat
  5. 5. Immunological and Biological, Bharat Serum, Biocon, Dr Reddy’s, Haffkine Bio-Pharma, Indian Immunological, Krebs Biochemical, Panacea Biotec, SerumInstitute of India, Shantha Biotechnics, Wockhardt, Ranbaxy Laboratories,Organon India, Kee Pharma, Emcure Pharmaceuticals, Glenmark Labs, LupinLabs, Nicholas Piramal, Intas Pharma, Hindustan Antibiotics and Shreyas LifeSciences.Foreign companies in India include Eli Lilly, Novadisk, Johnson &Johnson, Fulford India, Wyeth Lederle, Glaxo SmithKline, Aventis Pharma, Pifzerand LG ChemicalDistributors in India for insulin injection system1. Shreya Life Sciences Pvt. Ltd. ( August, 2007 Generex entered into a Master Product Licensing & DistributionAgreement with Shreya Life Sciences, a leading Indian-based pharmaceuticalcompany. Shreya is the fourth largest distributor of insulin in the Indian marketand has interests in both pharmaceutical and biopharmaceutical products in keytherapeutic segments including cardiology, neuropathy, and diabetes.India has a significant and growing number of people with diabetes. According tothe Diabetes Atlas 2007, there are approximately 40.8 million diagnosed patientswith diabetes in India. There are also an estimated 35.9 million people who havepre-diabetic conditions which, if not properly treated and managed, could lead tofull-blown diabetes. Generex believes that early intervention with insulin therapycould delay the onset and progression of diabetes and its numerouscomplications. Generex Oral-lyn, as a convenient and pain-free alternative toinsulin injections, could encourage prandial insulin therapy among those patientswho presently avoid injections."We are pleased to anticipate the commercialization of our flagship product in amajor market like India and the attendant revenue," said Anna Gluskin,Generexs President & Chief Executive Officer. "We are optimistic about theestablishment of a new treatment paradigm for diabetes and pre-diabeticconditions in India and other countries where we are now pursuing approvals.We look forward to working with Shreya to expand the market in India in order tocapture a wider patient population." Generex Oral-lyn is presently in Phase IIIclinical trials at several sites around the world.About GenerexGenerex is engaged in the research, development, and commercialization ofdrug delivery systems and technologies. Generex has developed a proprietaryplatform technology for the delivery of drugs into the human body through theoral cavity (with no deposit in the lungs). The Companys proprietary liquidformulations allow drugs typically administered by injection to be absorbed intothe body by the lining of the inner mouth using the Companys proprietaryRapidMist(tm) device. The Companys flagship product, oral insulin (GenerexOral-lyn(tm)), which is available for sale in Ecuador for the treatment of patientswith Type-1 and Type-2 diabetes and which was approved for sale in India in
  6. 6. October 2007, is in various stages of clinical development around the world. Formore information, visit the Generex website at Harbor Statement: This release and oral statements made from time to timeby Generex representatives concerning the same subject matter may contain"forward-looking statements" within the meaning of the Private SecuritiesLitigation Reform Act of 1995. These statements can be identified by introductorywords such as "expects," "plans," "intends," "believes," "will," "estimates,""forecasts," "projects" or words of similar meaning, and by the fact that they donot relate strictly to historical or current facts. Forward-looking statementsfrequently are used in discussing potential product applications, potentialcollaborations, product development activities, clinical studies, regulatorysubmissions and approvals, and similar operating matters. Many factors maycause actual results to differ from forward-looking statements, includinginaccurate assumptions and a broad variety of risks and uncertainties, some ofwhich are known and others of which are not. Known risks and uncertaintiesinclude those identified from time to time in the reports filed by Generex with theSecurities and Exchange Commission, which should be considered together withany forward-looking statement. No forward-looking statement is a guarantee offuture results or events, and one should avoid placing undue reliance on suchstatements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events orotherwise. Generex cannot be sure when or if it will be permitted by regulatoryagencies to undertake additional clinical trials or to commence any particularphase of clinical trials. Because of this, statements regarding the expected timingof clinical trials cannot be regarded as actual predictions of when Generex willobtain regulatory approval for any "phase" of clinical trials. Generex claims theprotection of the safe harbor for forward-looking statements that is contained inthe Private Securities Litigation Reform Act. SHERYA LIFE SCIENCE PRIVATE LIMITED Company Profile Tablets, Capsules, Injections, Cream, Syrup, Solution, Ophthalmic Solution Relevant Chemicals, Pharmaceuticals And Medical Equipment Categories : Product Pharmaceutical Formulations Profile : Address : shreya house, 301/a, Pereira hill road,, andheri (e),, MUMBAI 400099 Telephone : Fax : 91-022-6939222
  7. 7. 3. MANTHAN.INCWE ARE PHARMACEUTICAL DISTRIBUTORS DEALING IN BRANDEDFORMULATIONS AS WELL AS GENERIC MEDICINES. We ARE INTRSTED INEXPORT OF Indian PHARMA PRODUCTS. We CAN PROFESSIONALLYWORK AS AN INDENTING PARTNER FROM India. We ARE AUTHORISEDAGENT / SERVICE PROVIDER FOR MEDISENSE ABBOTTS OPTIUMGLUCOMETER & STRIPS (U. S. A) AS WELL AS INSULIN RANGE OFINJECTIONS OF NOVO NORDISK IN MUMBAI, India.WE ARE CONSIGNEE AGENT OF WELL KNOWN INTERNATIONALPRODUCTS OF VENOUS SHUNT (NEUROLOGY) , PENILE PROSTHESIS ...Company ProfileBasic InformationCompany Name: MANTHAN INC.Business Type: Trading Company, Distributor/Wholesaler Medicines, Surgicals, Venous Shunt, Ortho Implants,Product/Service: Penile ProsthiasisTrade & Market HOSPITALS/GOVT.INSTITUTIONS/CORPORATEMain Customers: CO/DOCTORSTotal Annual Sales Below US$1 MillionVolume:Export Percentage: 1% - 10%Total Annual Below US$1 MillionPurchase Volume:3, POOJA SURGICALSWe introduce with our selves, i m bhupen patel, my company established in 2001.Already i export in various country " Africa, Nigeria, malawi, Zambia, angola,seira leon, angola, Congo, netherland, trinidad tobage, lebenon, South Africa,namibia, etc. . I have ISO, ce & gmp certified product. If u any confusion so u can
  8. 8. contact directly Offering to sell transfusion set, I. v set, blood transfusion set,infusion set, scalp vein set, blood administration set, urine bag, cord clamp-twotypeCompany ProfileBasic InformationCompany Name: Pooja SurgicalsBusiness Type: Manufacturer, Distributor/Wholesaler Surgical Disposable, Medical Disposable, SurgicalProduct/Service: Equipment, Surgical Dressing, Medical Equipment, Hospital ItemNumber of 51 - 100 PeopleEmployees:Trade & Market North America South America Eastern Europe Southeast AsiaMain Markets: Africa Oceania Mid East Western EuropeTotal Annual Sales Below US$1 MillionVolume:Export Percentage: 41% - 50%Total Annual US$2.5 Million - US$5 MillionPurchase Volume:Factory InformationFactory Size1,000-3,000 square meters
  9. 9. (Sq.meters):QA/QC: In HouseNumber of Production 4Lines:Number of R&D Staff: 61 - 70 PeopleNumber of QC Staff: 21 - 30 PeopleManagement ISO 9000/9001/9004/19011: 2000Certification:Contract OEM Service OfferedManufacturing:4.HI-GI LABS PVT LIMITEDOur Company Hi-Gi Labs Pvt Ltd., started with an innovative idea of taking theHealthcare products to the doorstep of the patients. It quickly grew from ahandful of customers to 10s of 1000s of patients spread in various cities. Thehigh quality and low cost products sent to the patients on subscription basis notonly provide convenience to the patients but also offer them great savings.Today, after successfully catering to the Diabetic patients withdoor-delivery of Insulin syringesCompany ProfileBasic InformationCompany Name: HI-GI Labs Pvt LtdBusiness Type: Distributor/WholesalerProduct/Service: Post mastectomy breast forms and mastectomy brasNumber of 11 - 50 PeopleEmployees:Trade & Market North AmericaMain Markets: South America
  10. 10. Western Europe Eastern Europe Eastern Asia Southeast Asia Mid East Africa OceaniaPharmaceutical Associations In IndiaPharmaceutical Associations In India EmailSNo Name Address Address/Website Indian Drug 102-B, Poonam mailto:E-Mail:idma Manufacturers Chambers, A- Association Wing, Dr. A .B.Road, Worli Mumbai-400018 Tel : 22- @giasbmol, 4974308/4944624 Fax : 22-4950723 http://
  11. 11. Organisation of Pharmaceutical Producers of India Cooks Building, 324, Dr.Dadabhay Naroji Road, Mumbai-400001 Tel : 2045509, 2044518 Fax : 022-2 2044705 Bulk Drug Manufacturers Association A-24, 2nd floor, View Towers, Lakadi Ka Pul, Hyderabad- 500004 Tel :3 3322142/3316328 . 26, Bhargav Lane, Vivil Line, Nityanand Marg, Delhi -54 Tel : 2919140, 2918567 All India Small Scale Fax : Pharmaceutical 2524302,2937857 Manufacturers4 Association .
  12. 12. Federation ficci.bisnet House, Tansen Marg, New Delhi- 110001 Tel : 3738760-70 Federation of Fax:91-11- Indian 3320714,3721504 Chambers of Commerce and5 Industry Confederation 23, Industrial of Indian Area, Lodi Estate, Industry New Delhi - 110 003 Tel : 4621874, http://www.indian 4629994-7 Fax: 4633168, 46261496Prospective BuyersMost of the bio drugs and diagnostic products are for the government and privatesector hospitals and patients. The second group of buyers of biotechnologyproducts and bio molecules are the research institutes and pharmaceuticalcompanies. The emerging trend of corporate players establishing diagnosticcenters in small towns and rural areas will provide opportunities for the import ofautomated systems and imported reagents. Currently, there are only a few largenational players in diagnostics care segment including SRL Ranbaxy, MaxHealthcare, Dr. Lal’s Laboratory, Metropolis, Thyrocare, Fortis Healthcare andApollo Clinics. The large private hospitals are upgrading their facilities and/oradding new facilities.
  13. 13. MARKET POTENTIAL OF INSULIN DELIVERY SYSTEM IN INDIA:SummaryThe size of the Indian biotechnology industry is estimated at $1.3 billion. Thisincludes bio-healthcare, bio-agriculture, bio-industrial, bio-informatics, andcontract and clinical research markets. Of the total market, healthcarebiotechnology products account for 38 percent. The growing population, demandfor quality diagnostics products and innovative drugs to combat diseases areleading to increased demand for biotechnology drugs and products. New typesof diseases and demand for improved drugs are also leading to greater researchand development (R&D) activitiesNumber of Diabetic Patients are on the increase & Insulin Market in India isplaced around INR 250 Crores with about 30 % growth rate. The Inject ableInsulin Market is comprised of products such as Insulin Syringes, insulin Pen ,Insulin Pumps & Jet Injectors Then there are Inhaled Insulin products, OralInsulin Markets, Nasal Insulin delivery technology, Transdermal Insulin Delivery,Rectal Insulin Delivery, Ultrasound Insulin delivery, Iontophoresis Insulin DeliveryTechnology, Electro oration Insulin Delivery Technology and so on The productsare Highly Technology Oriented and there are very few players in the worldMarket. Indian Market is served by Imports & therefore priced high. There areattempts to start manufacturing these products in the country & therefore, theInsulin Delivery Systems market in India is considered to be very bright. India hasa significant and growing number of people with diabetes. According to theDiabetes Atlas 2007, there are approximately 40.8 million diagnosed patientswith diabetes in India. There are also an estimated 35.9 million people who havepre-diabetic conditions which, if not properly treated and managed, could lead tofull-blown diabetes. Generex believes that early intervention with insulin therapycould delay the onset and progression of diabetes and its numerouscomplications. Generex Oral-lyn, as a convenient and pain-free alternative toinsulin injections, could encourage prandial insulin therapy among those patientswho presently avoid injectionsMarket TrendsIn line with the global markets the Indian market for recombinant products is showingconsiderable growth. The Department of Biotechnology (DBT) has estimated the Indian marketfor recombinant therapeutics products at $90 million, which is growing at a rate of 30 percentper annum.
  14. 14. Product Market Size Growth Rate Erythropoietin $16.6 million 20 percent G-CSF $6 million 25-30 percent FSH Market $6 million 20 percent Interferon $12-13 million 30-40 percent Insulin $55 million 40 percent Hepatitis B Vaccine $22 million NA Streptokinase $17 million 25 percentIn 2030, the number of diabetics is expected to reach 80 million in IndiaAccording to WHO statistics, the number of people with diabetes in India is set torise from 40.8 million today to approx.75 million in the year 2025. In less than 20years the number of diabetics in India will be equivalent to the whole populationof Germany today. In 2005, the Indian insulin market was worth approx. CHF 88million; this figure is likely to grow toCHF 121 million by 2010.Ypsomed sees great potential for pen needles and pen systems in IndiaIn India 85% of all insulin is administered with normal syringes and just 15%using cartridges and pen systems. The currently low level of penetration ofinsulin pen systems will rise significantly in the future as sales of insulin in pensystems are now growing by some 35% annually. “The diabetes market will growstrongly in India in the coming years and holdout very great potential forYpsomed, both for pen needles and also for insulin pens and new pen systemsfor liquidPharmaceuticals,” comments CEO Richard Fritschi.Pen needles are a major source of earnings for Ypsomed with further growthpotentialThe pen needles developed and manufactured by Ypsomed with the patentedclick-on mechanism fit all pen systems available today for insulin, growthhormones or other therapies. Ypsomed’s pen needles are currently distributed inaround30 countries, either through Ypsomed’s own subsidiary companies or vialocal distributors. Ypsomed’s pen needle business has grown in recent years byan annual average of around 25% and holds out further growth potential. SeniorVice President of Marketing & Sales, Detlef Jantos: “Ypsomed’s click-on penneedles have a number of advantages overthe competition and are very popularwith pen users. To enable future demand to be met, Ypsomed will be expandingitspen needle production capacity considerably and will invest in the next twoyears a total of more than CHF 35 million at theSolothurn site.” Ypsomed hasalso developed a new safety pen needle which is due to be launched in 2009 toenable pensystems to be used in the public healthcare sector i.e. in hospitals andnursing .
  15. 15. IMPORTING THE PRODUCT AND GOVERNMENT POLICIES IN INDIA:Globally, 240 recombinant therapeutic products have been approved. The Government of India(GOI) has approved only 14 of these products for sale in India. These include human insulin,blood factor VIII, erythropoietin, granulocyte colony stimulating factor (G-CSF), alphainterferon, interferon b, GMCSF, streptokinase, basiliximab, follicle stimulating hormone(FSH), and hepatitis-B. Of these 14 GOI approved recombinant drugs, 7 are being locallymanufactured while the rest are being imported. Sun Pharmaceutical and TorrentPharmaceutical are into contract manufacturing of recombinant products for Eli Lilly and NovoNordisk. Though several Indian companies are engaged in research and development ofrecombinant products, presently only 6 Indian companies are manufacturing them while 16companies are importing and selling recombinant products in India.Biotech ClustersThe central and state governments have been taking many initiatives to supportthe biotechnology industry through development of biotechnology parks, policyinitiatives, and tax incentives. Governments are working towards developingcities for knowledge-based sectors like biotechnology, medical biosciences, andlife sciences. It is estimated that India will have at least 20 biotech parks in thenext few years. Currently four cities – Chennai, Hyderabad, Lucknow and Pune– have taken the lead in developing biotechnology-dedicated parks. Other statesthat have announced plans to develop biotechnology parks include Karnataka,Kerala, Tamil Nadu, Gujarat, Chandigarh, Haryana, Himachal Pradesh, MadhyaPradesh, Punjab, Rajasthan, Uttar Pradesh and Uttaranchal, Orissa and WestBengal.The following are the existing biotechnology parks: The Shapoorji PallonjiBiotech Park in Andhra Pradesh is a public-private partnership between the stateGovernment and Shapoorji Pallonji Incorporated. 20 companies both Indian andforeign have established their units in this Park, making an investment of $85-90million. Sigma Aldrich from U.S. and Altanta AG from Germany are planning toestablish facilities in this Park, while Randox Laboratories from U.K. isestablishing a diagnostic kits manufacturing unit in Bangalore.Another park in Andhra Pradesh is the ICICI Knowledge Park. This park isfocused onfacilitating business-driven research and development. The park is spread over200 acres and about 13-15 companies, both Indian and foreign, are currentlyoperating there.
  16. 16. Indian government rules and regulation for pharmaceutical firmThe drug and pharmaceutical industry in the country today faces new challengeson account of liberalization of the Indian economy, the globalization of the worldeconomy and on account of new obligations undertaken by India under the WTOAgreements. These challenges require a change in emphasis in the currentpharmaceutical policy and the need for new initiatives beyond those enumeratedin the Drug Policy 1986, as modified in 1994, so that policy inputs are directedmore towards promoting accelerated growth of the pharmaceutical industry andtowards making it more internationally competitive. The process of liberalizationset in motion in 19901, has considerably reduced the scope of industrial licensingand demolished many non-tariff barriers to imports. Some of the steps taken are:Abolition of industrial licensing for manufacture of all drugs and pharmaceuticalsexcept for bulk drugs produced by the use of recombinant DNA technology, bulkdrugs requiring in-vivo use of nucleic acids, and specific cell tissue targetedformulation. Reservation of 5 drugs for manufacture by the public sector only wasabolished in Feb.1999, thus opening them up for manufacture by the privatesector also. Foreign investment through automatic route was raised from 51% to74% in March, 2000 and the same has been raised to 100%.Drugs and pharmaceuticals manufacturing units in the public sector are beingallowed to face competition including competition from imports. Whereverpossible, these units are being privatized.Introduction of the Patents (Second Amendment) bill in the Parliament. It, inter-alia, provides for the extension in the life of a patent to 20 years.The main objectives of this policy are:- a. Ensuring abundant availability at reasonable prices within the country of good quality essential pharmaceuticals of mass consumption. b. Strengthening the indigenous capability for cost effective quality production and exports of pharmaceuticals by reducing barriers to trade in the pharmaceutical sector. c. Strengthening the system of quality control over drug and pharmaceutical production and distribution to make quality an essential attribute of the Indian pharmaceutical industry and promoting rational use of pharmaceuticals. d. Encouraging R&D in the pharmaceutical sector in a manner compatible with the countrys needs and with particular focus on diseases endemic or relevant to India by creating an environment conducive to channelising a higher level of investment into R&D in pharmaceuticals in India. e. Creating an incentive framework for the pharmaceutical industry which promotes new investment into pharmaceutical industry and encourages the introduction of new technologies and new drugs.
  17. 17. Industrial LicensingIndustrial licensing for all bulk drugs cleared by Drug Controller General (India),all their intermediates and formulations will be abolished, subject to stipulationslaid down from time to time in the Industrial Policy, except in the cases of  bulk drugs produced by the use of recombinant DNA technology,  bulk drugs requiring in-vivo use of nucleic acids as the active principles, a  specific cell/tissue targeted formulationsForeign InvestmentForeign investment unto 100% will be permitted, subject to stipulations laid downfrom time to time in the Industrial Policy, through the automatic route in the caseof all bulk drugs cleared by Drug Controller General (India), all their intermediatesand formulations, except those, referred to in Para 12.I above, kept underindustrial licensingImportsImports of drugs and pharmaceuticals will be as per EXIM policy in force. Acentralized system of registration will be introduced under the Drugs andCosmetics Act and Rules made there under. Ministry of Health and FamilyWelfare will enforce strict regulatory processes for import of bulk drugs andformulationsPricing of Formulations  For Scheduled formulations, prices shall be determined as per the present practice. The time frame for granting price approvals will be two months from the date of the receipt of the complete prescribed information.  The present stipulation that a manufacturer, distributor or wholesaler shall sell a formulation to a retailer, unless otherwise permitted under the provisions of Drugs (Prices Control) Order or any other order made there under, at a price equal to the retail price, as specified by an order or notified by the Government, (excluding excise duty, if any) minus sixteen percent thereof in case of Scheduled drugs, will continue.  The present provision of limiting profitability of pharmaceutical companies, as per the Third Schedule of the present Drugs (Prices Control) Order, 1995, would be done away with. However, if necessary so to do in public interest, price of any formulation including a non-Scheduled formulation would be fixed or revised by the Government
  18. 18. Promotional strategy to be followed 1) Targeting the various hospitals within the country which includes: Apollo group. Wockhart., Escort hospital etc 2) Going for the TV commercial and also showing various close associations by showing the approval of drug my the health ministry of India& various other medical associations 3) Running various diabetics awareness by tying up with various news channels and local NGO like rotary club which show we care our customer as well as to gain top of the mind awareness slot in the mind of customers. 4) Going for a celebrity, who might be suffering from diabetes, show how our product had help him/her to control the disease and same thing can work for you to. 5) Going for various print media. Like newspaper again we help in the awareness about the product. 6) Tying up with various distributors like Sherya science private limited so as to make the availability as well as the reach of the product to be as far as possible within the country. 7) High ring various medical representatives (MR) and send them to various doctors at different places within the country so as to again make product getting familiar with the doctor, hence also can be recommended to the various patient arriving for the treatment. 8) Running promotional activities two to three times a year within the country.