Economic Impact Of Technology Interventions Streptokinase Economics Essay

About 14 million patients in India suffer from bosom onslaughts every twelvemonth. Of these, 2.8 million patients can profit from a coagulum fellow drug which would salvage the patient ‘s life and supply room for farther intervention such as medical stents if so needed. Coronary bosom disease claims over a million lives every twelvemonth in India. There is a demand for a safe and low-cost coagulum buster drug. At the bend of the century, coagulum buster drug preparations were either imported or based on imported bulk drug and formulated domestically. They were expensive, tantamount to 18 months ( tPA ) to two months ( Streptokinase ) of per capita income at that clip. Cost affairs more in India unlike in states with cosmopolitan wellness insurance as most Indians spend out of ain pocket for wellness disbursals. Given India ‘s art in generic drugs, the production capacity spread in an country of wellness exigency with terrible effects seems an anomalousness. The spread stems from the fact that coagulum fellow drugs are biotechnology drugs which require competences rather different from those of the usual drugs based on chemical synthesis.

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CSIR-IMTECH, Chandigarh made attempts to develop a procedure to bring forth coagulum fellow drugs. Initial attempts were unsuccessful, in portion due to the complex nature of the animate being beginnings based protein drug. Subsequent squads picked up the challenge once more, chose a simpler molecule and after some girls, could develop a procedure for natural streptokinase and so recombinant streptokinase, both harnessed from microorganism. The girls were of import stairss supplying important acquisition for the procedure development. Streptokinase engineering was transferred to industry spouses, natural Streptokinase to Cadila Pharma and recombinant Streptokinase to Shasun Pharma. Implementing the engineering on the shopfloor faced troubles. In the instance of recombinant streptokinase, regulative blessings took clip to obtain. The knowing-doing spread was bridged by shuting the competence spread through sustained battle between the CSIR-IMTECH scientists and the directors and engineering staff of the licensees. Doggedness, squad doggedness, leting errors, dynamic acquisition from disciplined failure, discussion by both the scientists ‘ squad and the industrial practicians ‘ squad, and a “ can-do, must-do, done ” mentality were the keys to success. Leadership guidance at both the Lab and the Industry with a committedness to join forces and continual collaborating was important. This led the passage from the lab graduated table to industrial graduated table. The several merchandises were launched in 2001 and 2009.

The consequences are rather encouraging. Monetary values have dropped ( by 65 per centum, to less than one month of per capita income ) , handiness has increased, entree to a life-saving medical specialty has risen, and patients have realized a worth of over Rs. 16,000 crores due to the CSIR-IMTECH/licensees Streptokinase. The economic impact, or the extra benefit that would be lost if this CSIR-IMTECH Streptokinase engineering intercession had non been at that place, is assessed based on medical impact of Streptokinase and utilizing per capita income to be Rs. 2180 crores. The Lab itself accomplished net net incomes valued at Rs.1.8 crores and the Industry spouses together realized value add-on of Rs. 17 crores.

Introducing for low-cost health care is inclusive invention. The benefits to patients overshadow the benefits to those who generated the engineering intercession. This chase of invention continues. CSIR-IMTECH has taken the scientific discipline of clot-buster drugs to a degree where improved Streptokinase ( smarter streptokinase ) molecules will hold the advantages of the far more expensive animate being cell line based tPA but will be much more low-cost. Similarly, while entree has expanded ( about 120,000 standard doses ) , there remain 1000000s of patients in demand of this life-saving drug. More demands to be done.


Heart onslaughts, shots, respiratory and cardiac failure have a common enemy in blood coagulums in the blood stream that can barricade blood supply to the bosom musculus, any portion of the encephalon or the lungs. The effect of obstruction is harm to the bosom musculus, the encephalon cells, or the lung tissue which is normally irreversible and debilitating, if non fatal. Extreme effects can originate if the intervention is non administered within a window of few hours ( 3-4.5 hours, Klabunde ( 2007 ) , Hacke et. Al. ( 2008 ) ) . Then, the bosom or encephalon tissue, as the instance may be, gets damaged which is largely irreversible. Treatments range from clot-dissolving medicine to surgical intercession such as angioplasty or interpolation of stents and unfastened thorax beltway surgery. Clot fellows, as coagulum fade outing drugs are called, attack the coagulum itself to fade out it and reconstruct blood supply. Angioplasty is an invasive and expensive process where blocked arterias are opened up utilizing medical stents therefore doing more infinite for the blood supply to be restored. Similarly, beltway surgery is invasive and really expensive ( see appendix 1 ) . Prevention in bad patients ( hardened and narrowed/blocked arterias ) is via blood dilutant drugs that cut down blood denseness leting blood to flux through the decreased infinite. Despite preventative intervention, coagulums can organize and occlusion in blood vass can happen. Then, coagulum fellow drugs are life Jesuss.

In India, more than a million patients die due to coronary bosom disease every twelvemonth ( appendix 1 ) . Until the twelvemonth 2001, no domestic production of clot-busters existed. The preparations were imported: among others, the lead preparations of Streptokinase – “ Kabinase ” by Kabi Pharmacia, Sweden and “ Streptase ” by Hoechst Marion Roussel, Germany – were priced so between Rs. 3000 to Rs. 4000 per phial ( Krishnan ( 2000 ) ) . The dominant drug in this category of drugs, Tissue Plasminogen Asctivator ( tPA ) cost more than Rs. 30,000 per phial. Therefore, coagulum fellow drugs were expensive and the supply was short of demand. In footings of per capita income at that clip, this amounted to 18 months of income for tPA and about two months of income for Streptokinase. The Streptokinase market was approximately 21 1000 phials of standard dosage of 1.5 miu[ 1 ]. Lack of affordability could hold restricted entree. Given Indian pharmaceutical industry ‘s art in generic drugs, realized through strengths in organic chemicals ‘ synthesis and procedure technology, this raises the inquiry about the obstructions. The Indian pharmaceutical industry was basically based on chemical entities whereas coagulum fellow drugs are based on biotechnology[ 2 ]which was about non-existent in India around the bend of the century. Thus, entree to affordable life-saving coagulum fellow drugs was limited domestically. To do it low-cost, it had to be produced domestically. To bring forth it domestically, a suited engineering had to be developed. The engineering had so to be transitioned from a research lab graduated table to an industrial graduated table.

As in the instance of low-cost chemical drugs, the drift of happening solutions and making domestic capacity besides came from CSIR Labs. In the instance of generic chemical drugs, the nucleus scientists came from Labs such as the NCL, Pune, IICT, Hyderabad and CDRI, Lucknow. These scientists and their industry coevalss developed and implemented safe and cost effectual engineerings in a short clip span. In the instance of biotechnology, procedures are being developed by IMTECH, Chandigarh and IICB, Kolkata among others. A plan at IMTECH tapped into happening a solution to the job of an low-cost coagulum buster drug. The plan has roots in undertakings dating back to 1989. The scientists examined the prevalent coagulum fellow drug – tissue Plasminogen Activator ( tPA ) – but so take alternatively an surrogate less complex protein Streptokinase for development.

This survey examines the benefits realized from the Streptokinase undertaking, specifically, the natural Streptokinase biotechnology drug licensed to Cadila Pharma and the recombinant Streptokinase drug engineering licensed to Shasun Pharma Limited, to quantify the value creative activity and to measure the economic impact.

The Industry

The Indian pharmaceutical industry is among the top scientific discipline based industries and focused on quality low-cost drugs. It is estimated to be USD 21 billion or about Rs. 105,000 crores with exports accounting for about 40 per centum ( USD 8.7 billion ) in 2009-10 ( DOP ( 2011, 2012 ) ) . The industry is turning at over 10 per centum per twelvemonth. It is the 6th largest industry in India ranked by part to GDP ( CSO ( 2011 ) ) . Globally, it ranks 3rd in footings of volume of production ( 10 per centum of planetary portion ) and 14th largest in footings of value ( 1.5 per centum of planetary portion ) . A ground for the low value portion is the lower cost of drugs in India — 5 to 50 per centum less than in developed states. Therefore, the Indian drugs and pharmaceutical industry is focused on low-cost drugs.

The Indian pharmaceutical industry is diverse. The figure of units is quoted at over 20,000. However, the existent figure of drug fabrication licences issued is about 5877 ( GOI ( 2003 ) )[ 3 ]. Registered mills are about 3500 ( CSO ( 2011 ) ) , the remainder being smaller unregistered units. The units are dispersed across India and supply deepness that accounts for the 10 per centum planetary volume portion. Apart from MNCs such as Glaxo Smithkline, Pfizer, Astra Zeneca, several Indian companies Ranbaxy, Dr. Reddy ‘s, Cipla, Lupin and others have planetary operations. Biotechnology based drugs have taken root and are turning. Companies such as Biocon, Serum Institute of India, Panacea Biotec, and Reliance Life Sciences have adopted biotechnology. The biotechnology industry value exceeds Rs. 20,000 crores in 2011-12 ( BioSpectrum-ABLE Biotech Survey 2012 ) .

Many Indian companies maintain the highest criterions in pureness, stableness and international safety, wellness and environmental protection in production and supply of majority drugs to purchaser companies, who in bend are capable to rigorous appraisal by regulative governments in importing states. These companies have secured regulative blessings from USFDA, MHRA-UK, TGA-Australia, MCC-South Africa for their workss. Quality with enfranchisement is besides a characteristic among many Indian pharmaceutical companies.

During the last decennary, the industry has embraced new engineerings and adapted to regulative governments more aligned to international regulative governments. New concern theoretical accounts have emerged to get by with and thrive in this environment. All of these have a bearing on the development of a domestic coagulum fellow drug, viz. , Streptokinase.

With the coming of merchandise patents in India from the 2005 amendment to the Patents Act, the focal point has shifted from procedure technology to drug find. Process technology remains of import. Several drugs will travel off patent over the following few old ages and supply of cost effectual quality generics would profit the industry and the consumers. However, drug find is the new mantra. Drug find is a extremely unsure multi-million multi-year activity. For every one new drug molecule approved, the grapevine requires about 12 molecules for clinical tests ‘ campaigning. For every molecule making clinical campaigning, the grapevine of molecules is three molecules based on current success rates at each phase. The entire costs coiling to over USD 600[ 4 ]million per new drug molecule in the USA over a span of a decennary. Patent protection allows recovery of the investing but besides makes the drug expensive. In India, the cost per new drug molecule can drop to less than USD 150 million due to take down costs ( such as those of clinical tests ) . This lower cost is promoting Indian drug endeavors to prosecute in drug find as they adapt to the merchandise government. However, even at the decreased cost in India, the drug would still be expensive and out of range of many Indians.

Drugs ‘ capacity edifice in India appears to be turn toing decrease in costs and so besides in the clip span for drug find. Specialization along the concatenation of drug find via outsourcing is one emerging concern theoretical account. Therefore, R & A ; D is being shaped by Contract Research Organizations ( CROs ) , Drug Discovery & A ; Development ( DD & A ; D ) and Clinical Tests Organizations ( CTO ) . Fabrication is by big incorporate companies as besides by Contract Manufacturers. Selling is besides by Contract Marketers and co-marketing confederations ( IBEF ( 2010 ) , KPMG ( 2006 ) ) .

While regulative alterations may be the trigger for drug find, demand for drugs for Indian diseases is besides an drift. Chief among these are drugs for morbific diseases found in India but non much in developed states such as TB, malaria, enteric fever, cholera etc. These diseases are far more prevailing in developing states such as India where affordability is a cardinal issue. Net incomes from patented multi-billion drug molecules will be tough to recognize for these diseases. Therefore, effectual new molecules for these diseases would hold to be developed within India. A major inaugural underway in this respect is the Open Source Drug Discovery ( OSDD ) undertaking of CSIR which seeks to tackle endowment across boundaries, cutting costs and hopes to cut down drug find clip. It is unfastened beginning and therefore drug molecules found will be distributed without the higher monetary value due to net incomes associated with patents. Costss will be cut down to the collaborative nature of the enterprise. Incentives to confederates are based on lending to drug find for enfeebling diseases and the acknowledgment among equals.

Besides of import are drugs for the so called “ lifestyle diseases ” such as diabetes ( about 50 million diabetics in India as per Ramachandran et. Al. ( 2010 ) ) and high blood pressure ( 65 million high blood pressure patients in India as per Gupta ( 2004 ) ) , both high hazard factors for exigencies such as bosom onslaughts, shots and respiratory failure. India is estimated to hold approximately 14 million patients that suffer from myocardial infarction or bosom onslaughts every twelvemonth, of which 80 per centum patients may non be having proper medical attention ( Financial Express ( 2002 ) ) . About 20 per centum ( 2.8 million ) of the cardiac patients ‘ population in India could utilize a coagulum buster drug. Merely a fraction ( about 200, 000 or under 10 per centum ) of these patients undergo beltway surgeries or angioplasty. The remainder of the patients ( 2.6 million ) could be treated with coagulum fellow drugs administered within a window of 3-4.5 hours to the patient. Remember that there are over a million deceases every twelvemonth due to coronary bosom disease in India. With a turning figure of diabetes and high blood pressure patients in India, and so increasing opportunities of blood vas occlusion related deceases, holding entree to an low-cost coagulum fellow drug is traveling to be progressively more of import. An added advantage is the possibility of exports of these drugs since the diseases addressed are prevailing globally.

The Technology Gap, Development and Commercialization

A domestic coagulum fellow drug was losing, as discussed earlier. The pick among three prevalent drugs narrowed to Streptokinase. Streptokinase is a 47kD[ 5 ]protein composed of 414 aminic acids produced by several strains of beta haemolytic streptococcus. It dissolves a coagulum obstructing blood supply through a 3-step procedure. First, Streptokinase forms a complex with plasminogen ( Pg ) . This 1:1 composite ( the “ Partner Pg ” ) quickly becomes proteolytically active. Second, the Partner Pg complex Acts of the Apostless on “ substrate ” Pg molecules in circulation to change over them to plasmin ( Pn ) , the active signifier of the pro-enzyme Pg. Plasmin is a peptidase that is capable of interrupting apart cross-links between fibrin molecules, which provide the structural unity of blood coagulums. So, 3rd, the fibrinolysin quickly dissolves the pathological coagulum obstructing blood supply to the bosom musculus in instance of myocardial infarction, to encephalon tissue in instance of shot or to the lungs in instance of respiratory failure.

The Lab, Research Capacity and Technology Development

Technology development has been enabled by scientific discipline research and ongoing ( and predecessor ) undertakings at CSIR-IMTECH. The focal point is scientific discipline and engineering related to microbic merchandises. A cardinal country is recombinant cistron engineering based merchandises. One enterprise relates to developing a domestic coagulum buster drug. The initial effort in late eightiess focused on the prevailing drug – tissue Plasminogen Activator ( tPA ) which is of course found in the human organic structure in little measures. Through recombinant cistron engineering, a innovator of the field, Professor Collen and his organisation Genentech USA produced tPA from animate being cell lines in the early 1980s. Attempts to retroflex tPA production in IMTECH did non fructify partially due to the volatile external environment prevalent at that clip and so the deficiency of adequate scientists to put to death the undertaking.

During the early 1990s, later, another squad of scientists at IMTECH chose an alternate to tPA, viz. , Streptokinase for development – due to its simpler construction and higher chance of success in developing a novel procedure for domestic production. The procedure involved two cardinal competences – protein scientific discipline and cloning scientific discipline among others. Technical jobs arose once more in implementing the recombinant cistron engineering. The scientists decided to down-shift to developing a procedure for bring forthing Streptokinase from natural beginnings. It involves two chief procedures – agitation ( protein production ) and purification ( dividing the protein from the stock, purified to an extent that it is admissible to worlds ) . This attempt was successful loaning both credibleness to the procedure and hiking the morale of the scientists concerned. The first success helped to define the undertakings possible from the undertakings non possible ( appendix 2 ) . This paved the manner for bring forthing Streptokinase utilizing recombinant cistron engineering increasing output many times over. The cardinal procedure invention was the usage of 2-step chromatography for purification.


Throughout the old ages of development crossing 1989 onward, the scientists at CSIR-IMTECH were supported by the scientific discipline leading and direction consisting four different institute managers and two different director-generals[ 6 ]. Leadership and institutional continuity combined with scientific inventiveness and doggedness to bring forth first natural and so recombinant streptokinase. The docket continues and smart Streptokinase is under development which could be a life-saving and life-enhancing merchandise non merely for India and the underdeveloped states but besides for the developed states.

The Technology Transfer, Technology Embedding and Commercialization

The lab graduated table success has to be transitioned to industrial graduated table and commercial success. Subsequent to the transportation of know-how on agitation and purification procedures and the strain, execution at an industrial graduated table besides faced many hurdlings. While the scientific discipline was established at the Lab with lab graduated table production, the passage to industrial graduated table volumes threw up challenges ( see appendix 2 ) . As at the Lab degree, informed hit and test, larning from failure, defining what non to make from what to make helped to transition the engineering to industrial graduated table. Standardization of the industrial biotechnology procedure entailed initial preparation, repeated preparation and implanting the engineering in the licensee ‘s premises. IMTECH engaged with the licensees and remained engaged thereby supplying a batch of handholding in the journey from the lab to mill production. This instance is an illustration of disciplined failure where acquisition from initial failure led to a class alteration, technological success, commercial success, and so once more picking up the more hard undertaking and taking it to fruition.

CSIR-IMTECH foremost developed a engineering to bring forth natural Streptokinase from Streptococci. It was developed in 4 old ages by 1998-99, accredited and transferred in 1999-2000 and launched commercially in 2001-2002. The recombinant Streptokinase was developed in 5 old ages by the twelvemonth 2001-2002, accredited and transferred in 2002-2003 and commercially launched in 2009-10.

Natural Streptokinase know-how was licensed to Cadila Limited for fees of Rs. 20 hundred thousand and royalty based on ex-factory gross revenues for 5 old ages. This drug was launched as STPASE injection in twelvemonth 2001-02. Subsequently, recombinant cistron engineering was licensed by CSIR-IMTECH to Shasun Pharmaceuticals Limited, Chennai for a fee of Rs. 1 crore and royalty payments based on ex-factory gross revenues for 5 old ages. The drug was launched in July 2009 and marketed by Lupin Pharma as LUPIFLO.

Comparison with prevailing surrogate interventions

Prior to acceptance of Streptokinase for clot-blockade led bosom onslaughts, the interventions were generalized and included oxygenation and intensive attention ( appendix 1 ) . Subsequent to surveies of randomized controlled tests set uping efficaciousness and high quality of Streptokinase, it was adopted widely specially in Europe. Later, other coagulum breaking drugs were developed. Still subsequently, unfastened bosom beltway surgery and so angioplasty utilizing medical stents were developed. Clot fellow drugs are more low-cost than surgical interventions. Within the category of coagulum fellow drugs, Streptokinase remains the most low-cost. Its costs are lower since its production is microorganism based unlike the others derived from animate being cell lines.

Comparison with prevailing viing engineerings – clot-busters

Clot-buster drugs in usage are tissue plasminogen activator ( tPA ) , Streptokinase, and Urokinase. Streptokinase competes with tissue plasminogen activator ( tPA ) which is the prevailing coagulum fellow drug. tPA is preferred for its mark ( blood coagulum doing encirclement ) specificity. The advantage of tPA over Streptokinase is in the extent of systemic fibrinogenolysis generated by each. The attendant side consequence of hemorrhage ( due to suppression of coagulum formation by fibrinolysin ) can be higher for Streptokinase. However, surveies have established that streptokinase is as effectual in salvaging lives in mycocardial infarction as is tPA, despite the about tenfold higher monetary value of the latter. tPA is expensive plenty to be unaccessible to most patients for this life endangering status. Recombinant tPA reduced monetary values but the cost remains many times over that of Streptokinase. Cost of intervention is of extreme importance as most Indians wellness outgo is out of ain pocket. Appendix 1 clearly indicates that while the interventions for myocardial infarction vary from Streptokinase to tPA to angioplasty and short-circuit surgery, for a huge bulk of Indians ( with one-year income about and below the current per capita one-year income of Rs. 60,000 ) , the intervention low-cost and so possible is administrating of Streptokinase. The alternate to Streptokinase would be a mix of morphia, oxygenation, intensive-care.

Comparison with prevalent makers

Manufacturers of natural Streptokinase, for several old ages, were merely MNCs such as Behring-werke ( Germany ) and Lederle ( USA ) . In India, before CSIR-IMTECH ‘s intercession, Streptokinase was imported, Streptokinase injections were sold by MNCs – “ Kabinase ” by Kabi Pharmacia, Sweden and “ Streptase ” by Hoechst Marion Roussel, Germany – and priced so between Rs. 3000 to Rs. 4000 per phial in twelvemonth 2000 ( Krishnan ( 2000 ) ) . tPA monetary values varied from Rs. 30,000 per phial in twelvemonth 2000-01 to about Rs. 19,000 per phial in 2010-11.

In India, CSIR-IMTECH licensee Cadila Pharmaceuticals Ltd. manufactured Streptokinase as “ STPASE ” at an ex-factory monetary value of Rs. 900 per phial ( standard 1.5 miu dosage ) in 2001-02. The recombinant Streptokinase which has the same biological belongingss of natural Streptokinase ( but much higher outputs ) was produced by CSIR-IMTECH licensee Shasun Chemicals and Drugs Limited, Chennai at an ex-factory monetary value of Rs. 465 per phial in twelvemonth 2009-10. This is the bulk drug monetary value. It is marketed as “ LUPIFLO ” by Lupin Pharmaceuticals Limited and as “ STUKINASE ” by Samarth Pharma among other formulators.

Non-CSIR licensee entry besides occurred after the first CSIR licensee entered. There were three entrants, two of whom have already exited. The 3rd entrant, Biocon, is successfully bring forthing recombinant Streptokinase and marketing it as “ Myokinase. ”

Data and Methodology

Lab informations are obtained from CSIR-IMTECH. Industry informations are obtained through questionnaires and interviews. Market informations such as gross revenues value and measure Numberss for Streptokinase formulations/brands along with informations on company features such as “ MNC/Indian, ” day of the month of launch, size of preparation – are from the IMS Health India database on Streptokinase. The informations are collected at the stockist degree and are representative of the Indian pharmaceuticals market with the exclusion of gross revenues straight from producers/formulators to the infirmaries.

Given the retrospective nature of this economic impact survey, and the troubles in roll uping past informations, the initial methodological analysis proposed was a contemporary difference analysis between CSIR licensees and comparable endeavors. However, Streptokinase manufacturer informations could non be collected despite mail-clad questionnaires followed up with interviews[ 7 ]. Alternatively, for the industry analysis, market gross revenues and volume informations – for a panel of 20 old ages – are used to gauge a demand map with pooled OLS arrested developments. The pooled arrested developments permit segregation of estimations for CSIR licensees from others, and, of estimations over clip[ 8 ].

Benefits of the Technology Intervention – Making Value

Benefits to the Lab

CSIR-IMTECH developed a engineering and plugged a production capacity spread for a life-saving drug. The first of the series of streptokinase molecules established the credibleness of CSIR as a solutions supplier based on their scientific discipline rooted plan for engineering. IMTECH scientists successfully integrated scientific discipline and application bring forthing more improved molecules and earned fees and royalty in the procedure. The entire value of fees and royalty received is about Rs. 2.5 crores and the investing in footings of wages and cost of patents is about Rs. 65 hundred thousand in 2011-12 monetary values. The internal rate of return on the Lab ‘s hard currency flows for Streptokinase works out to 36 per centum[ 9 ]. Therefore, the engineering plan is rather cost effectual for CSIR.

Benefits to CSIR Licensees and the Industry

The direct benefit to the licensees in footings of value add-on therefore far ( from 2001-02 to 2011-12 ) is about Rs. 17 crores in 2011-12 monetary values, the majority of it, Rs. 16.5 crores, originating from the first licensee – Cadila Pharma Limited. The 2nd CSIR licensee – Shasun Limited – has limited value added from its two old ages of Streptokinase operations. The first molecule served as a proof-of-concept for the industry and even more as a proof-of-value creative activity. It was followed by another successful molecule discrepancy and commercial success with that besides.

From no manufacturer of Streptokinase in twelvemonth 2000, there are now at least three manufacturers domestically. The 3rd manufacturer Biocon, a non-CSIR licensee, is among three entrants, the other two holding exited already. In 2001, before entry of the first domestic manufacturer, CSIR-IMTECH licensee Cadila Pharma, there were about four Streptokinase trade names and gross revenues value was about Rs. 6 crores with about 20 1000 phials of standard dosage. The value of the Streptokinase industry is over Rs. 20[ 10 ]crores in 2011 with approximately 118 1000 phials in footings of the criterion dosage of 1.5 miu and about 30 trade names ( including different vial sizes ) marketed. While many factors are responsible for this value addition, presentation of the proof- of-concept ( engineering works ) and the proof-of-value ( commercial success ) by CSIR-IMTECH scientists and licensees may hold been important. Without these, the state may still hold been importing the drug at much higher monetary values. To that extent, the state is besides salvaging foreign exchange.

The current market monetary value of STPASE is reported to be about Rs. 1000 per phial and the monetary values of Streptokinase phials from Shasun ‘s bulk drug vary from Rs.715 to Rs. 2300. Myokinase, the 3rd non-CSIR entrant Biocon ‘s merchandise, is reportedly selling at a monetary value of about Rs. 2000 per phial. The mean market monetary value is about Rs. 1700 per phial ( standard 1.5 miu dosage ) . Monetary values of streptokinase by CSIR-IMTECH licensees are among the lowest in the industry, where over 30 versions of preparations are now being marketed domestically.

Industry Competition

With increasing market competition, monetary values bead and gross revenues addition. Competition can be enhanced more by entry of manufacturers. A pioneering paper ( Bresnahan and Reiss 1991 ) developed an empirical model for mensurating the effects of entry in concentrated markets by analyzing the relationship between the figure of houses in the market, market size, and competition. Their analysis suggests that “ competitory behavior alterations rapidly as the figure of officeholders additions. In markets with five or fewer officeholders, about all fluctuation in competitory behavior occurs with the entry of the 2nd or 3rd house. Surprisingly, one time the market has between three and five houses, the following entrant has small consequence on competitory behavior. ”

In the absence of informations on price-cost borders, they develop another key metric – the ratio of break-even gross revenues Sn+1/Sn where “ n ” refers to the last incumbent manufacturer and “ n+1 ” refers to the entrant. This threshold is equal to one in absolutely competitory markets where the minimal efficient graduated table of production is rather low relation to the market size and there are no entry barriers. In concentrated markets, the threshold of break-even gross revenues ratio is higher than one due to significant fixed costs every bit good as entry barriers. A new entrant could incur higher fixed capital cost and/or higher variable costs ( such as selling costs to set up their merchandise and recognize gross revenues ) . With increasing entry, this threshold – break-even gross revenues ratio – should worsen and near the value of one as in perfect competition.

While we do non detect price-cost borders for all three domestic manufacturers of Streptokinase – Cadila ( entry in twelvemonth 2001 ) , Biocon ( entry in 2008 ) and Shasun ( entry in 2009 ) – we do hold information on gross revenues[ 11 ]and company provided break-even old ages. Using the Bresnahan and Reiss ( 1991 ) model, the computation of break-even gross revenues ( measure of phials ) ratio is found to be 2.8 for the 2nd entrant ( Biocon, relation to first manufacturer Cadila Pharma ) and 1.6 for the 3rd entrant ( Shasun Pharma, comparative to Biocon )[ 12 ]. This speedy scrutiny points to a diminishing value of the break-even gross revenues ratio and fast increasing competition with merely three entrants, much in line with the findings of the Bresnahan and Reiss paper.

Benefits to the People and the Economy

Price Reduction, Affordability and Access

From Rs. 3000 in 2000-01 per phial of Streptokinase, the monetary value dropped to Rs. 900 per phial after the entry of Cadila ‘s STPASE. After the entry of Shasun ‘s recombinant cistron engineering based Streptokinase, the monetary value dropped further. In existent footings ( values rising prices adjusted utilizing WPI for drugs and medical specialties, base-year 2004-05 ) , monetary values have reduced by more than 65 per centum. Streptokinase based intervention has become progressively low-cost. Among prevailing interventions of bosom onslaughts due to obstruct from blood coagulums, presently, affordability ranges from one month of mean income[ 13 ]for Streptokinase ( Rs. 5000 ) to eight months of mean income for tPA ( Rs. 40,000 onward ) to ten months of mean income for angioplasty ( Rs.47,000 forth ) to 14 months of mean income for beltway surgery ( Rs. 70,000 onward ) . The increasing affordability of Streptokinase meant increasing handiness to life-saving intervention in instance of bosom onslaughts due to obstruct from blood coagulums. Supply has expanded in response to the lifting demand and so entree has been realized. This entree has been enabled by affordability due to monetary value decrease get downing with the first CSIR-IMTECH licensee, Cadila Pharma.. Thus, CSIR-IMTECH ‘s streptokinase engineering intercession has led to low-cost entree to life-saving intervention for bosom onslaughts due to coagulate encirclements. This is highlighted in the graphs below.

The graphs clearly indicate that there is a significant monetary value bead and corresponding addition in measure. Using the IMS Health India database on Streptokinase and other coagulum fellow drugs ( that are used to handle bosom onslaughts ) , arrested developments are performed to analyze whether the graphical consequences are besides statistically valid. The informations are at stockist degree, so the inexplicit monetary values computed are at stockist degree and non at retail degree. However, the fluctuations in retail monetary values are likely to be at least every bit much as those at the stockist degree.

Using pooled OLS[ 14 ]arrested developments ( appendix 3: Streptokinase Market Data – Econometric Results ) , it is found ( appendix 3, table A3.2 ) that there is a important bead in monetary value from twelvemonth 2002 ( captured through a silent person variable for observations from 2002 onward ) . There is a similar addition in mean market monetary value associated with a silent person variable from 2008 onward when there were two entrants – the 3rd Streptokinase manufacturer every bit good as a seller of recombinant tPA in the Indian market. For the 3rd twelvemonth of entry – 2009 – when the 2nd CSIR-IMTECH licensee began production, though there is an associated lessening in mean market monetary value, the coefficient is non important. The important coefficients do propose that CSIR-IMTECH licensees ‘ entry is associated with a lessening in the mean market monetary value for Streptokinase in India. Or, that the CSIR-IMTECH engineering intercession is associated with increasing affordability.

Given the above decomposition of subscribers to the lessening in mean market monetary value, it is pertinent to gauge a demand map and the monetary value snap. As appendix tabular array A3.3 clearly shows, in a arrested development of monetary value on measure, the monetary value snap estimation ( coefficient of lnqty or log measure ) is negative with absolute value less than one, bespeaking a comparatively inelastic market. The income snap is positive and higher than one bespeaking that as income rises, a disproportionately higher portion of the income is assigned to this merchandise. An industry concentration variable is associated with an addition in monetary value as expected.

Entry of CSIR-IMTECH licensees and associated formulators contributed to a lessening in the value of the monetary value snap of demand, that is, an addition in the absolute value of the monetary value snap. The entry twelvemonth silent person variables for 2002, 2008 and 2009 are non important and are dropped. However, the difference in behavior of MNC pricing is seen here every bit good – before CSIR-IMTECH licensees ‘ entry, the MNC measure coefficient is positive or that it reduces the absolute value of the monetary value snap. In other words, the pricing is associated with an even more monetary value inelastic market.

So, what? If the monetary value snap increases, what difference does it do? Economic theory and empirical grounds suggests that with a monetary value snap of one or more, when manufacturers decrease monetary value, the response from consumers is to increase measure demanded such that the overall grosss addition. This is a win-win scenario for both the consumers and the manufacturers. Table A3.3 suggests that CSIR-IMTECH licensees/formulators entry helped to do the Streptokinase market in India more monetary value rubber band. Given that approximately 2.6 million patients could utilize a coagulum fellow drug, about a million dice of coronary bosom disease, any addition in monetary value snap is an inducement for manufacturer entry. Even with the expanded production of about 120,000 standard doses, there is a long manner to travel in shutting this critical spread.

Calculating Economic Loss Averted to lasting patients

To a patient, entree to a life salvaging drug is priceless, a pecuniary value to life may look unthinkable. However, values to life are computed.

To calculate the economic loss averted, here, the disablement adjusted life old ages ( DALY, See Gold et. Al. ( 2002 ) and Lopez and Mathers ( 2006 ) ) for specific diseases for specific parts generated by the World Health Organization ( WHO ( 2008 ) ) are used. The DALYs provide the old ages of possible life lost ( YLL ) due to premature mortality and the old ages of productive life lost due to disablement ( YLD ) for a specific disease. The DALY values differ by parts. The economic value of the lives saved by Streptokinase, straight through the licensees and indirectly through the other manufacturers which followed the entry of CSIR licensees, is computed utilizing the DALYs provided by the World Health Organization ( WHO ) for South-East Asia within which India falls.

There are three constituents of the calculation of the economic value of lives saved. First, the figure of lives saved is estimated. Based on the figure of phials of streptokinase produced, the dose of streptokinase, its success rate of salvaging lives ( or opposite of mortality rate ) , the figure of lives saved is obtained. For the CSIR licensees, the ex-factory gross revenues are provided by them. Using the vial-size based gross revenues provided in the market gross revenues informations from the IMS Health Database, these are converted to units of standard dose of 1.5 million units or 1.5 miu of injectable Streptokinase administered for myocardial infarction ( Journal Watch ( 1990 ) ) . To this volume of gross revenues and the tantamount volume of Streptokinase administered ( presuming no wastage ) , the success rate or survival rate of patients is applied. Harmonizing to assorted surveies on efficaciousness of streptokinase, the success rate is over 90 % . However, the success rate may be lower in India – more than 81 % ( Xavier et. Al. 2008 ) and about 80 % as per the Delfi technique based study consequences ( appendix 1 ) . Consequently, here the endurance rate for India is taken as 80 % . This is applied to the volume of standard doses of Streptokinase administered to acquire the figure of lives saved.

Second, utilizing the ratio of ( I ) the DALYs and ( two ) the deceases associated with ischemic bosom disease ( WHO ( 2008 ) ) , the figure of old ages of life lost due to ischemic bosom disease ( coagulum barricading blood supply to the bosom musculus ) per patient decease is computed. This is so besides taken as the life old ages that would be saved per patient saved by Streptokinase. The life old ages saved per patient is 10.73 for ischemic bosom disease for the twelvemonth 2004. It is assumed here that it is no worse for the subsequent old ages.

Third, a pick of the income sum saved per patient is chosen. In the absence of existent informations about the income position of the patients, another income step has to be chosen. Given informed sentiment that patients hail from all income strata, average Indian income would be appropriate. However, in the absence of a average income estimation, the much more conservative step of per capita income is used. This multiplied with the life old ages saved provides a lower edge on the economic loss averted by administrating Streptokinase.

Economic Loss Averted

The value of economic loss averted due to lives saved by streptokinase produced by the CSIR licensees is over Rs. 16,000 crores in 2011-12 monetary values[ 15 ]. The figure of phials of standard dosage of 1.5 miu sold by Cadila by 2010-11 is about 350,000 and sold by Shasun by 2010-11 is about 160,000. As described in the old subdivision, the success rate of salvaging lives ( 80 % ) and the life-years saved per patient saved ( 10.73 ) are multiplied to the gross revenues volume in footings of the criterion dosage to obtain entire life-years saved.

The entire value of economic loss averted due to lives saved by streptokinase produced domestically is over Rs. 19,000 crores. The difference owes to the gross revenues by the 3rd manufacturer, Biocon, which entered the market in 2008 after CSIR_IMTECH licensee Cadila Pharma established the cogent evidence of value or the commercial viability of bring forthing Streptokinase in India.

Entire Value Creation

The value creative activity straight is Rs. 1.85 crores to the CSIR Lab, Rs. 17 crores to the CSIR licensees, and Rs. 16,000 crores to their surviving patients. Over and above this is the engineering cogent evidence of construct and cogent evidence of commercial value effects led value of about Rs. 3,000 crores or a sum of about Rs. 20,000 crores to the people of India.

Economic Impact of CSIR-IMTECH Streptokinase Technology

Is the CSIR-IMTECH Streptokinase engineering intercession with value creative activity of about Rs. 20,000 crores worth it? The inquiry is addressed in two parts.

Is the investing in the intercession worth it, i.e. , do participants profit from this programme? In footings of value creative activity, the results from the Streptokinase engineering development, transportation and commercialisation are positive for each set of donees – the Lab, the industry and the Indian people. The benefits are clearly rather high. Further, the undertaking IRR ( rising prices adjusted ) of 29 % compares favorably, say, with regard to GDP growing Numberss of up to 9 per centum.

Is the programme a worthwhile societal investing? The CSIR-IMTECH intercession enabled and expanded entree to a life-saving drug and so is clearly worthwhile. However, what would the outcomes be if this programme had non been at that place? Compared to the option ( contrary to fact ) province, do the results from this programme outweigh the results from the option? In other words, is the difference in results between this programme ( Streptokinase engineering development and commercialisation ) and the alternate province positive? Is the direct benefit positive? Are at that place favorable indirect benefits? Could the private sector have generated these direct ( and indirect ) benefits through options without the CSIR-IMTECH intercession?

The Comparable Alternative to Streptokinase

To get at replies to these inquiries, the results from Streptokinase commercialisation and usage have to be compared with the results from the option that would be if the CSIR-IMTECH Streptokinase intercession did n’t go on.

Medically, the options to Streptokinase were coronary beltway surgery ( from 1960 onward ) , coronary angioplasty ( from 1977 onward ) , and other thrombolytic drugs such as tPA ( from 1987 onward ) . In pattern, in India, all of these interventions have been available and over clip, the infirmaries offering these interventions have been increasing. However, the cost of intervention of the above interventions varies well. As celebrated earlier, presently, the cost of intervention scopes from one month of mean income for Streptokinase ( Rs. 5000 ) to eight months of mean income for tPA ( Rs. 40,000 onward ) to ten months of mean income for angioplasty ( Rs.47,000 forth ) to 14 months of mean income for beltway surgery ( Rs. 70,000 onward ) .

Economically, the “ market ” for intervention of bosom onslaughts originating from encirclement due to bosom onslaughts seems segmented by buying power or affordability! To prove our premise, we performed an exercising to acquire informed sentiment of heart specialists. Mini Delphi Technique was used to near some heart specialists in public and private infirmaries across India. Results presented in Appendix 1 support our premise that the option to Streptokinase based intervention would be the even cheaper ( generalized ) interventions prevailing prior to the debut of Streptokinase, viz. , usage of Morphine, Oxygenation etc. If the patients could afford tPA or coronary surgery, they would in all likeliness take that intervention. Patients who take Streptokinase do so as the other interventions are out-of-reach economically.

Economic Impact: The Difference in value creative activity due to CSIR-IMTECH Streptokinase Technology Intervention

Several surveies of randomized controlled tests ( RCT ) utilizing Streptokinase and alternate interventions have been performed ( for illustration ISIS and GUSTO surveies ) . We use the medical impact from a relevant RCT survey as the footing for the economic impact appraisal. A survey with long term endurance rates is considered to be relevant since the value creative activity computations use the long term endurance as given by WHO ‘s DALY for ischemic bosom disease for India. The heart specialists and research workers we consulted besides validated the usage of RCT surveies on Streptokinase for the Indian population. In other words, the surveies ‘ consequences are considered to be valid for India.

The ISIS-2 survey by Baigent et. Al. ( 1998 ) surveies long term endurance among patients with acute myocardial infarction or bosom onslaughts in a randomised comparing of Streptokinase, unwritten Aspirin, both, or neither. The survey was conducted in 417 infirmaries located across 16 states and analyzing over 17,000 patients. We use the consequences for Streptokinase versus none that led the survey to reason that the early endurance advantage produced by Streptokinase persists for many old ages after intervention.

Harmonizing to the RCT survey by Baigent et. Al. ( 1998 ) , the difference in survival rates in the long term is 28 per 1000 patients or a difference of 2.8 per centum. This corresponds to a direct value difference of over Rs. 580 crores in 2011-12 monetary values due to over 14,000 extra lives saved by Streptokinase produced by CSIR-IMTECH licensees. Further, adding the value from induced entry of the 3rd manufacturer in India, the entire impact is another Rs. 98 crores and extra 2,000 lives saved therefore far.

This medical and economic impact will be realized every twelvemonth. Based merely on the latest twelvemonth production[ 16 ]( and no farther addition ) , the present value of the economic derived function in the old ages to come is another Rs. 1600[ 17 ]crores. Medically, this translates to an extra 2200 lives saved every twelvemonth traveling frontward. The direct economic impact is hence a sum of Rs. 2180 crores. Adding the impact originating from induced entry, the present value of future old ages would be Rs. 500 crores at current production degrees with an extra 700 lives saved every twelvemonth. The indirect impact is valued at Rs. 600 crores. Therefore, the entire economic impact is about Rs. 2800 crores.

Therefore, if there were no Streptokinase engineering intercession by CSIR-IMTECH, over 16 thousand lives and Rs. 680 crores would hold been lost. An extra Rs.2100 crores will accrue in the old ages to come.

Science continued and Technology improved

As already noted ( see subdivision “ Comparison with Competing Technologies ” ) , Streptokinase induces rapid plasminogen activation in the blood watercourse. The fibrinolysin therefore produced could trip unwanted proteolytic debasement of coagulating factors, that is, systemic fibrinogenolysis, and so unwanted hemorrhage and other serious side effects in some patients. A coagulum buster drug with minimum side effects will hold the ability to fade out the pathological blood coagulum without plasminogen activation through the circulatory system. This extremely coveted and premium belongings in any coagulum fellow drug was developed in the 3rd coevals coagulum specific streptokinase by IMTECH scientists. The coagulum specific streptokinase circulates in an active province without significantly triping the blood plasminogen. When it encounters and binds to the pathological blood coagulum, it is activated and generates plasmin in the locality of the coagulum. The fibrinolysin cleaves the fibrin coagulums without generalised proteolysis. This reduces the hazard of unwanted shed blooding greatly.

A farther desired belongings is the bar of re-occlusion or encirclement due to regenerate curdling, a major job restricting present twenty-four hours coagulum fellows. The 4th coevals streptokinase comprises thrombolytic molecules with mark specificity and has the belongings of thrombin inactivation in situ ( that is, at the site of vascular hurt ) to queer re-occlusion. It besides has an enhanced half life so that lower doses can be given in a individual shooting bolus.

Both these 3rd coevals and 4th coevals molecules of Streptokinase are licensed to Nostrum Pharmaceuticals Inc. , USA for USD 150 million or about Rs. 750 crores on milepost linked payments. The coagulum specific streptokinase took 8 old ages to develop from 1997-2004 and was transferred in 2006-07. It is expected to be launched in 2013. The thrombotic coagulum specific streptokinase took 9 old ages to develop and was transferred in 2010-11.

Reasoning Remarks

This survey highlights the good function played by CSIR-IMTECH Streptokinase engineering intercession in enabling low-cost entree to a life-saving drug. The Lab ‘s net net incomes are Rs. 1.85 crores with the undertaking IRR being 36 per centum. The licensees are bring forthing value every twelvemonth with Rs. 17 crores realized. The patients have realized huge value of over Rs. 16,000 crores. Therefore, based on ( public and private ) benefits realized on initial public investing, this can said to be a profitable and valuable public-private partnership ( PPP ) exercising. Including the indirect induced entry related benefits takes the sum to about Rs. 20,000 crores. As a societal plan besides, the economic impact generated therefore far is Rs. 680 crores with accrual of an extra Rs. 2100 crores.

Among the cardinal issues highlighted, one pertains to pull offing the passage from the lab graduated table to industrial graduated table. This up-scaling was managed by prolonging battle with the licensees by the cardinal scientists and preparation and retraining the proficient forces on the shopfloor. Beyond development and transportation of engineering, handholding by the Lab during commercialisation was fruitful in shuting the “ knowing-doing spread. ”

While much advancement has been achieved, there are still over 2.4 million patients ( 2.6 million patients less latest production of streptokinase ) who could profit from entree to a safe and low-cost coagulum buster drug. CSIR-IMTECH scientists are difficult at work to better Streptokinase as a drug, with belongingss equivalent to tPA. Attempts are besides required to intensify the public-private partnership theoretical account here ( Public Lab-Private Licensee ) and possibly experiment with other theoretical accounts as good.


On the methodological analysis, there is entry of new manufacturers. There is besides exit and re-entry, or variable engagement, in the Streptokinase market. The issue and re-entry of manufacturers does non look to be random. Therefore, the informations seem disposed for choice based econometric analysis. However, the non-participation old ages have no information available on the producers/formulators other than fixed features such as MNC/Indian. Similarly, upward prejudice can be expected on the monetary value snap estimations. Instrumentation utilizing GMM techniques is hard owing to the short length of the panel. Using an instrument variable from the supply side such as works degree TFP ( Foster et. Al. 2008 ) is besides non executable given deficiency of informations on the manufacturers. Attempts are required to roll up appropriate informations for economic impact appraisal.


We would wish to thank Dr. TS Balganesh, CSIR for important treatments on the methodological analysis to measure impact on patients and on the economic sciences of drug find and development. We besides thank Dr. Sudeep Kumar, CSIR for priceless support in placing beginnings of information and obtaining the same. We thank the CSIR Licensees – Cadila Pharma and Shasun Pharma – for sharing informations and information with us. We would wish to thank Dr. Kiram Mazumdar, Dr. Sriram Akundi, Dr. Sandeep Kamath and Rajesh Venugopalan of Biocon for valuable inputs. . We besides thank Anjan Das, Mallikarjun Javali and Mayank Tiwari of Technology Unit, CII, New Delhi for set uping interviews with several Streptokinase producers/formulators. We besides thank Dr. Rajendra Soni, IMTECH, CSIR for supplying engineering related informations and assisting to obtain market informations. We besides acknowledge team-IPU, CSIR for supplying informations on patents. The writers besides thank Team-DGTC ( Gauri Deshpande, Zahoor Ahmad Wani, Nitin Gupta, Govind Kumar, Tarak Dey ) CSIR for their hardworking administrative and logistics support.

Writer Contributions

Wrote the study: Manisha G. Singh ; Appendix 1: Nisha Chandran ; Appendix 2: Samir Brahmchari, Girish Sahni, Manisha Singh ; Technology description and inside informations: Girish Sahni ; Project Conceptualization: Samir K. Brahmchari ; Project Design: Manisha Singh ; Project Management: Dipankar Basu, Zakir Thomas, Manisha Singh.


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Appendix 1: Streptokinase and other Clot-buster Drugs

Affordability and Drug Market Segmentation


Cardiovascular diseases have become the taking cause of deceases worldwide[ 18 ]. The cognition about these diseases is abundant as are the spectrum of interventions available for it. The survey below looks at the important factors involved in make up one’s minding which of the available life salvaging interventions for Ischemic Heart Diseases would be finally administered. Based on the Lancet- 2008 CREATE survey[ 19 ], it was shown that 64.5 % patients of the higher income group received Streptokinase while merely 52.3 % of the lower income group received Streptokinase. As of 2012 about 90 % public infirmaries administer Streptokinase. Costss of intervention with Streptokinase, tPA and with surgical interventions indicate market cleavage. The cardinal driver seems to be affordability, go forthing Streptokinase in its ain section.


It is known that the earliest intervention for Myocardial Infarctions ( MIs ) included Morphine, Oxygenation and in the 1950s came Aspirin[ 20 ]. These nevertheless have non been seen as interventions instead as therapies. It was non until 1977[ 21 ], about 35 old ages after its find, that Streptokinase found acknowledgment as an effectual “ remedy ” as a clot-buster. Assorted Streptococci species are known to release a protein called as Streptokinase, which is capable of adhering to human plasminogen thereby leting the transition of Plasminogen to Plasmin[ 22 ]. This find has found possible usage as a thrombolytic in instances of Myocardial Infarctions ( MIs ) , pneumonic intercalations and strokes.Tissue Plasminogen Activator ( t-PA ) and Recombinant t-PA interventions were besides discovered and used as coagulum fellows in the intervention of Acute Ischemic Stroke. Figure1 shows a clip development of clot busters used for MIs.

Degree centigrades: Usersvikramjit.mandalPicturesPicture167.png

Fig 1: Milestones in the development of MI interventions


Thrombolytic Agent


Mechanism of Action


( 30 twenty-four hours mortality )

Side Effectss


Produce through recombinant DNA engineering

t-PA is responsible for the transition of inactive plasminogen to active preotease fibrinolysin

Mortality at three months was 17 per centum in the t-PA group and 21 per centum in the placebo group[ 24 ]


Shed blooding

Plasminogen activator

Produced by the kidney

Direct moving plasminogen activator

Easy bruising

Shed blooding




Group C I? hemolytic streptococcus

Performs fibrinolysis by change overing plasminogen to plasmin

Vascular Mortality at 5 hebdomads was 9.2 % in Streptokinase group and 12 % for those treated with placebo[ 25 ].

Cerebral Bleeding

Low blood force per unit area

Allergic Chemical reactions



As of 2010, in India Coronary Heart Diseases has become the taking cause of decease, followed by Lung diseases and Diarrhoeal disease, killing about 1.5 million people per twelvemonth thereby accounting for about 14 per centum of the causes for decease


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