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European Journal of Economics, Finance and Administrative Sciences ISSN 1450-2275 Issue 13 (2008) © EuroJournals, Inc. 2008 http://www. eurojournalsn. com A Study of the Role of Government of India in Helping Indian Pharma Industry Cope up with the Challenges of Product Patent Regime Neeraj Dixit IES Management College, Bandra(W), Mumbai, India Tel: 91-22-26551616; Fax: 91-22-26551818 E-mail: [email protected] co. in Abstract India has implemented the Product Patent regime from 1st January 2005.

Previously for the past 35 years India had Process Patent which allowed Indian Pharmaceutical Companies to ‘Copy’ molecules of Multinational Pharmaceutical companies and sell them under their brand names. The arrival of the Product patent meant that Indian Pharmaceutical Companies could no longer ‘Copy’ molecules. This has created lot of problems for the Indian Pharmaceutical companies as their own R&D for new molecules is at a very nascent stage.

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The purpose of this paper is to find out what are the expectations of the Indian Pharmaceutical companies from the Indian Government to help them cope up with the challenges of the Product Patent regime. The study finds out that although majority of Pharma companies are satisfied with the efforts of Government of India in helping them cope up with the challenges of product patent regime, still there were lot of areas where they expect help from the Government.

The study finds out that relaxation in Drug Price control order, giving incentives for R&D and taking decisions regarding Data Exclusivity, Compulsory Licensing & Incremental Innovation were the main issues in which Pharma companies expected help from the Government of India. Keywords: Research & Development (R&D), Intellectual Property Rights, Drugs. JEL Classification Codes: O30, O34, L65 1. Introduction The Indian Pharmaceutical industry has transformed itself over the past three decades in India, being almost non existing till 1970’s, to now being a prominent provider of Pharmaceutical Products.

The Indian Pharmaceutical industry meets approximately 95% of the country’s pharmaceutical needs. The present turnover of the Indian Pharma Industry is approximately $ 9. 0 billion of which the share of exports is 40%. Compared to the global picture, the Indian pharmaceutical Industry ranks 4th in terms of volume, and 13th in terms of value, which is highly significant. The Indian Government has implemented the new product patent regime in India, as India had signed the WTO agreement and since Trade Related Intellectual Property Rights (TRIPS) was a part of WTO agreement, India was bound to implement the provisions of TRIPS agreement.

This meant that India had to make significant changes in its patent law and respect the Intellectual Property Right’s(IPR’s) as done by other WTO member countries. India implemented from 1st January 2005 the 48 European Journal of Economics, Finance And Administrative Sciences – Issue 13 (2008) new product patent regime and hence recognized “product patent” rather than “process patent” which we were following previously. The new patent law has obvious implications for the entire pharma Industry although the hardest hit will be the small scale pharmaceutical manufacturers in India.

Pharma Industry experts have predicted that most of the Pharma SME Sector firms will be forced to close down. Overview of the Indian Pharmaceutical Industry The Indian Drug Manufacturers Association (IDMA) in its 44th annual Publication 2006 has given the following overview of the Indian Pharma Industry Table 1: Indian Pharma Industry: An Overview The Indian Pharmaceutical Industry has Grown to Rs. 40,000 Crores ($ 9 billion)Currently Exports Rs. 17,000 crores Compounded growth rate 13. % per annum Global ranking By volume 4th By value 13th Extremely Fragmented Industry Leading 250 companies market share 70% Registered units 11,000 Large & Medium scale units 300 Small scale Units 10,000 Number of Drugs under price control 74(Constitute about 37% of Formulations) Number of Bulk Drugs & Formulations More than 400 bulk drugs and about 60,000 formulation(60 categories) are produced in India produced in India meeting 95% of country’s requirements R&D Expenditure 4 to 6% of sales Per Capita Drug Expenditure Rs. 50 annually Public spending on Health 0. 9% of GDP, proposed to be increased to 2-3% of GDP Future Market Size Rs. 1,12,500 crores(USD 25 Billion) (Year 2010) US FDA Approved Plants Maximum US FDA approved plants(Outside USA) are in India- approx 80 Number of Drug Master Filings(DMF’s) Largest number of US DMF’s- 213 (38% of DMF’s filed in first half of 2005 are from India) Product Patent Law in India-Impact on Pharmaceutical Companies The Government of India has now implemented the WTO product patent law.

This simply means that the Indian pharma companies which were free to copy and sell patented molecules or drugs will not be able to do so. Therefore no patented drug launched after 1st January 2005 can be copied and sold, also there are patent applications of MNC Pharma Companies pending in the EMR mailbox which are going to be shortly opened by the patent office. If the patent office grants patents rights then Indian pharma companies selling those molecules will have to stop manufacturing and marketing of those drugs or may have to pay royalty if they continue to manufacture and market those drugs.

The new patent law grants 20 years to patent holders instead of 7 years which was given to patent holders under Patent act 1970. The government of India is also committed to cGMP(current Good Manufacturing Practices) norms as specified by WHO(World Health Organization) and has subsequently modified Schedule M of the Drugs & Cosmetics Act and now Pharma companies have to follow strict standards in manufacturing practices. All this is being done to under pressure from the WTO, MNC Pharma companies and the International community.

It is an open secret that Indian Pharma companies were initially regarded as producers of cheap & substandard drugs. However some big and medium Indian Pharma companies invested in Research & Development and also up gradation of their manufacturing plants and today the world over India’s image has changed. India has around 80 US FDA approved Drug Manufacturing plants, which is the highest outside the USA all over the world. These USFDA 49 European Journal of Economics, Finance And Administrative Sciences – Issue 13 (2008) pproved plants are owned by MNC Pharma companies and big Indian Pharma companies and almost none is in the SME Pharma sector. Thus in nutshell the future appears very bleak for the pharma sector and the imposition of Product patent will definitely lead to closure of majority of pharma small scale units over a period of time. 2. Literature Review Several research articles have over the past decade studied the impact of Trade related Intellectual Property rights (TRIPS) and WTO product patent law, on the Indian Pharmaceutical Industry.

Lesser studies are available on the impact of WTO product patent law on the strategies and marketing strategies in particular, as well as on the R&D scenario, of the Indian Pharmaceutical companies. The author could not find any Empirical research study on the role of government of India in helping the Pharmaceutical companies cope with the challenges of product patent regime. The major empirical research studies on impact of product patent on Indian Pharma companies are by Sampath(2005) and Lanjuow(19998). Lanjouw (1998) had analyzed how the introduction of product patents for pharmaceuticals may benefit or adversely affect India.

Her analysis is based on information obtained over a period of six months, from September 1996 to March 1997. The primary data was collected by taking interviews with a wide range of people in the Pharmaceutical industry. Although the paper does not arrive at a conclusive answer to whether the introduction of pharmaceutical product patents in India will bring about heartless exploitation of the poor and suffering, still it does provide some suggestions about the way events might unfold as the policy is implemented.

Sampath (2005) in her research paper analyzes her survey of 103 Indian pharmaceutical firms. The scope of her study was limited to analyzing emerging firm strategies of Indian firms as a response to a gradual transition to product patent protection. The study has categorized firms in the Indian Pharma Industry into 3 main groups based on empirical data collected and identified the main strategies and their triggers in each one of the 3 firm groups. The survey found that Indian firms are adapting a combination of cooperative and competitive strategies, n order to adapt and as well as capitalize on opportunities created by the new patent regime. The Indian domestic pharma companies have faced the international competition and although product patent has thrown up lot of opportunities, still consolidation will happen in the industry in coming years. The study also found a high correlation between export intensity and R&D investments in the Indian Pharma sector. Firms that had greater revenues from exports were able to invest a larger amount on R&D.

Some other studies have examined various aspects of the WTO product patent and its impact on the Indian Pharmaceutical industry using different methodological techniques, in order to predict the impact of product patent protection on the Indian pharmaceutical industry. These studies are by Fink (2000), Chaudhuri, Goldberg & Jia(2004), Watal (2000) Fink (2000) in his research paper has examined the impact of patent protection on the behavior of pharmaceutical TNC’s and market structure in India.

The research study simulates the effects of introducing patent protection for pharmaceutical products on market structure and static consumer welfare. The simulations reveal to what extent price increase, profits and static welfare losses depend on the values of assumed elasticities. The study reveals that if future drug discoveries are mainly new varieties of already existing therapeutic treatments, the impact is likely to be relatively small. If newly discovered drugs are medicinal breakthroughs, however, prices may be significantly above competitive levels and static welfare losses relatively large.

Chaudhuri, Goldberg and Jia (2004) use detailed product-level data sets from India to conduct a case study of Quinolones in India, to show the potential adverse welfare effects of the TRIPS Agreement on the Indian industry. They estimate that “in the absence of any price regulation or compulsory licensing, the total welfare losses to the Indian economy from the withdrawal of the four 50 European Journal of Economics, Finance And Administrative Sciences – Issue 13 (2008) domestic product groups in the fluoroquinolone sub-segment would be on the order of US$ 713 million, or about 118% of the entire systemic anti-bacterials segment in 2000” (p. ). Watal (2000) has examined the effect of the introduction of pharmaceutical patents on prices and welfare losses in India. The paper also points out that there are several measures available for reducing welfare measures available for reducing welfare losses available for reducing welfare losses permissible under TRIPS. The studies which have focused specifically on the change in strategies of Indian pharmaceutical companies are {Madanmohan, Rishikesh (2003), Chittor, Ray (2003), Sampath (2005), Sampath (2006), Singh, Surendar (2003), Singh, Surendar (2003), Agrawal, Thakkar (1997), Saranga, Phani (2003), Dey (2006) and Nair (2007)}.

Madanmohan, Rishikesh (2003) have dwelt upon the adaptive strategies in the Indian pharmaceutical industry. They have analyzed several adaptive strategies to be used by the Indian pharmaceutical companies to cope up with the WTO product patent law. They have also analyzed the factors driving the movement towards consolidation and augmentation in the sector. Chittor, Ray (2003) researched on the internationalization paths of emerging economy firms through a strategic group analysis of internationalizing firms in the Indian pharma industry.

This study analyzed proprietary data set of strategic variables from forty firms and the analysis revealed significant variation in their internationalization strategies. Sampath (2006) in her research paper talks about her survey of 103 Indian pharmaceutical firms. The scope of her study was limited to analyzing emerging firm strategies of Indian firms as a response to a gradual transition to product patent protection. The study has categorized firms in the Indian Pharma Industry into 3 main groups based on empirical data collected and identified the main strategies and their triggers in each one of the 3 firm groups.

The survey found that Indian firms are adapting a combination of cooperative and competitive strategies, in order to adapt and as well as capitalize on opportunities created by the new patent regime. The Indian domestic pharma companies have faced the international competition and although product patent has thrown up lot of opportunities, still consolidation will happen in the industry in coming years. The study also found a high correlation between export intensity and R&D investments in the Indian Pharma sector. Firms that had greater revenues from exports were able to invest a larger amount on R&D.

Singh, Surendar (2003) in their article have focused upon the strategies used by small and medium scale pharma companies to meet the challenges of the patent regime. The larger companies like Ranbaxy and Cipla etc. were preparing for the new patent regime since 1995 onwards, however the small and medium scale pharma companies did not make much of an effort and now realizing that their toplines and bottomlines are going to be impacted because of product patent they have devised few strategies: Toll Manufacturing, Bottom fishing, In-licensing, Niche plays and contract manufacturing.

The article is based on interviews with top executives of small and medium Pharma companies who have implemented with success the above mentioned strategies. Agrawal, Thakkar (1997) have examined the strategies adopted by different strategies adopted by different companies to survive the phase of patent expiration. The authors suggest that companies should not increase the prices when the patent is about to expire, rather if the marketing strategies are well planned the costs involved in product development can be recovered even after the expiry of the patent.

Companies need to have a combination of product modification, promotional and pricing strategies to save a company from losing market share on a patent expired product. Saranga, Phani (2003) have found out that there is evidence that there appears to be a direct relationship between internal efficiencies and higher growth. They have concluded that irrespective of the growth strategies adopted by the individual firms, internal efficiencies will have a higher probability of survival and growth.

Thus the internal efficiencies would help firms in the Indian Pharma Industry to overcome any new challenges arising out of the change in patent process from the year 2005. Dey (2006) has explored the strategies adopted by global pharma majors in India in view of the product patent in India. Among the various vigorously being pursued by MNC pharma companies are 51 European Journal of Economics, Finance And Administrative Sciences – Issue 13 (2008) accelerating patented product launches, Mergers & acquisitions, reducing R&D expenditure by outsourcing clinical trials, sourcing their anufacturing requirements for API from independent manufacturers in India. However MNC’s in India are faced with host of problems like price control, competition from big domestic Indian Pharma companies and data Exclusivity. The author concludes that MNC’s should go in for innovation, thereby slowly developing newer molecules and at the same time becoming price sensitive. Nair (2007) has stressed upon the fact that if visionary strategies are adopted by Indian pharma companies then the future will be bright for these companies.

Strategies such as Drug Discovery, Para IV filings, focus on production of high quantum and moderately priced generics, strengthening API/drug intermediates production, outsourcing to MNC’s upgrading manufacturing facilities to USFDA standards and investing in Pharma support services such as analytical services, diagnostic services, data management services and clinical research operations will prove worthwhile in the long run and help India to move up to the top of the global Pharma Industry. The present study is however an empirical research study.

The data used in this research paper was collected in a firm-level Survey of 62 Indian Pharmaceutical companies between June 2006 & July 2007 to find out impact of Product patent on Indian Pharmaceutical Industry and to study the change in marketing strategies of Indian Pharmaceutical companies. 3. Research Methodology The data for this research paper has been taken from primary data collected in a firm level survey of the Indian Pharmaceutical Industry between June 2006 & July 2007 for the doctoral thesis being prepared by the author, for submission to The U.

P Technical University, Lucknow, India. The Sampling frame used was the ORGIMS Company list of Pharmaceutical companies for which ORGIMS Company conducts a retail audit in India. This ORG Retail audit data is also used by the Government of India as it is the only authentic data regarding Indian Pharmaceutical Industry available in India. The ORGIMS list contains 450 Pharmaceutical companies. Sampling Method The sampling method chosen is simple random sampling which is a type of probability sampling. Sample size: To calculate the sample size following formula was used.

If the researcher plans the results in a variety of ways or if he/she has difficulty in estimating the proportion or standard deviation of the attribute of interest, the following formula may be more useful. NZ2?. 25 n= {d2 ? (N-1)} + {Z2 ? .25} Where n= Sample size required d= Accuracy precision level (i. e 0. 01, 0. 05, 0. 10 etc. ) Z= Standardization value indicating a confidence level(Z= 1. 96 at 95% confidence level and Z= 2. 56 at 99% confidence level N= Population Size(known or estimated) Here N= 450 Let us take confidence level as 90% and ± 10% precision level (d=0. 10 and Z= 1. 4), then the sample size (n): 450? (1. 64)2 ? 0. 25 n= [(0. 1)2 x 449] + [1. 64 2 X 0. 25] n= 58. 6= 59 companies. 52 European Journal of Economics, Finance And Administrative Sciences – Issue 13 (2008) Thus the calculated sample size works out to 59 companies. This represents 13% of the sampling frame. However since I was expecting that 20% of the companies will not respond to mail questionnaire thus the total sample size I have taken is 59+12(20% of 59) = 71 companies. Out of 71 companies which were sent questionnaire and extensive follow up was done, 62 companies filled up the questionnaire.

These companies were sent the Questionnaire, which was structured in nature. These companies were located all over India although concentrated mostly in Mumbai, Ahmedabad, NCR (Delhi and Adjoining areas), Hyderabad, Goa, Chennai etc. Questionnaires were sent through E-mail and follow up was done on telephone, E-mail etc. The Questionnaire was filled mostly by Top Management persons like Presidents, Directors and also by General Managers (Marketing). Questionnaire Testing & Reliability Analysis: The questionnaire was pretested on 38 companies and data was fed into SPSS software.

Using SPSS reliability analysis was conducted. The Cronbach Alpha test was used and in all the questions the Cronbach Alpha was at least . 7 and even more. The validity of the questionnaire was tested by using expert validity, which is part of expert validity. Two renowned Pharmaceutical Industry Market research experts were contacted. The Experts approved the questionnaire with small modifications. The Questionnaire was suitably modified and a couple of questions were deleted and one question was added.

The revised questionnaire was administered and data was collected from 62 pharmaceutical companies in India. Survey: A three page, two sided Questionnaire was designed keeping in mind the objectives of the study which were to find out the impact of product patent on the Indian pharmaceutical industry and to find out the change in marketing strategies of pharmaceutical industry after implementation of the product patent regime. The Literature survey and pre study consultation with industry experts were taken into account.

The questionnaire consisted of few open ended questions, some questions were either using ranking scale or Likert scale, however the questions related to this paper on role of Government of India were open ended questions. The first question asked was whether the companies were satisfied with the government of India’s role in helping Indian Pharma Industry cope with the challenges of Product patent regime, and if No then specify the reason. The Second question asked was what help do the Indian Pharma companies expect from the Government of India to meet the challenges of Product patent regime. . Data Analysis Following table shows the frequency and percentage of Pharma companies satisfied with the Government of India’s role in helping them cope with the challenges of product patent regime. To analyze this Question Frequencies Distribution in SPSS was used. Table 2: Number of Companies satisfied with the Govt. of India’s Role in helping Indian Pharma Industry cope with the challenges of product patent regime? Frequency 42 20 62 Percent 67. 7 32. 3 100. 0 Valid Percent 67. 7 32. 3 100. 0 Cumulative Percent 67. 7 100. 0 Valid Yes No Total

It is evident from above that majority of respondents(67. 7%) are satisfied with the efforts of Government of India in helping the Indian Pharma Industry cope up with the challenges of the Product patent regime. I had further asked an open ended question that if you are not satisfied, then specify the reasons. Out of 20 respondents who were not satisfied 15 gave the reasons for being not satisfied in the questionnaire. Out of the 15 respondents who gave their reasons 10 responses were from large 53 European Journal of Economics, Finance And Administrative Sciences – Issue 13 (2008) ompanies, 4 were from medium size companies and 1 was from a small company). I have categorized the responses of the companies into three groups. 1. Responses of Large Sized Pharmaceutical Companies (having a turnover of 301 crore and above). 2. Responses of Medium Sized Pharmaceutical companies (having a turnover of 101 crore to 300 crore). 3. Responses of Small Sized Pharmaceutical Companies (having a turnover of 0 to 100 crore) Responses of Large Sized Pharmaceutical Companies Too much control over the market and not giving adequate incentives for research.

The basic problem is of Drug price control order(DPCO) because of which price restraints are there, leaving companies with lesser funds for R. Implementation of the product patent regime by the Government is biased in favor of MNC players and due to this the Indian companies will suffer a lot. Rather than helping the Indian companies in raising finance for new drug discovery, the Government is bringing most of the drugs under price control which is a big disincentive for the Industry. The pharma policy is not supportive to the Industry influences and the competitive strength building.

The government appears to be indifferent to the Pharma Industry. One large MNC player said that the government has not placed a premium on firms that bolster their R capabilities. Also the stance on recognition and granting patents(patentability)(example: Novartis/GSK) and compulsory licensing is fluid currently. This may be construed as ‘protectionist’ thereby potentially diluting investments into R by both domestic and international players. These developments are not in line with the expectations from the product patent regime.

Another company reported that procedures and paperwork involved in Exports and Imports as well as tax compliance are working to their disadvantage. One large company reported that still the “Delhi Sultanate” attitude persists in the Government of India & Clarity in laws is still not there. Responses of Medium Sized Pharmaceutical Companies Not enough incentives for the companies to invest in R. The government should give some monetary benefits for R. The Government is increasing controls.

Decisions on key policy issues are not matching with industry needs and are delayed. The price control policy is too repressive and there are no healthy SOP’s for R expenditure. Responses of Small Sized Pharmaceutical Companies One small MNC player said that the Product patent is not as per WTO guidelines specifically issues relating to Data exclusivity as well as incremental innovation is not patentable. Data Analysis of second Question In this question I had asked respondents what help do the Indian Pharmaceutical Companies expected from the Govt. f India to meet the challenges of Product patent Regime. Since this was an open ended question following is the summary of the responses. This question was answered by 48 companies and 14 companies did not answer this question. Out of 48 companies which answered this question, 15 were from large sized companies, 21 were from medium sized companies and 12 were from small sized companies) I have categorized the responses of the companies into three groups. 1. Responses of Large Sized Pharmaceutical Companies (having a turnover of 301 crore and above). 2.

Responses of Medium Sized Pharmaceutical companies (having a turnover of 101 crore to 300 crore). 3. Responses of Small Sized Pharmaceutical Companies (having a turnover of 0 to 100 crore) 54 European Journal of Economics, Finance And Administrative Sciences – Issue 13 (2008) Responses of Large Sized Pharmaceutical Companies Companies want the government to relax price controls or Drug Price Control Order (DPCO), give SOP’s to research activities and allow incentives for healthcare reach. Subsidies on importing sophisticated technology must be made available to Indian companies.

The government should give support in raising finance for new drug discovery. The pricing of dugs should be liberalized and more incentives for export promotion should be made Taxes and other duties should not be revised frequently which leads to a great deal of problems for the companies. One MNC player remarked that India has developed significant capacity to manufacture pharmaceuticals. The government now hopes that India can become a major participant in developing innovative pharmaceutical products, including through R activities of its own and conducting clinical trials.

Lack of clarity in the intellectual property regime as well as in drug pricing would affect development of innovation, new drug discovery as well as new investments in R. Thus it is in India’s own interest to bring its patent practices into conformity with the TRIPS agreement. The bureaucracy in The Ministry of Chemicals should become customer sensitive. There should be one window regulatory system and research grants should be given to those pharma companies doing research.

Responses of Medium Sized Pharmaceutical Companies Companies want that incentives for R should be given as well as removal of price controls should be there. Indian Companies also want help from the government to facilitate them in going in for tieups and in-licensing with MNC companies. The government should also help in development of R and try to bridge the gap between the Indian and MNC companies. Systems and procedures which are hampering exports should be made simple and exports should be made lucrative for companies.

The price controls should rather be market driven and not government induced price controls, preferably the span of controls should be reduced in a phased manner and the government should support as well as allow more margins on new products to help companies establish their products. Taxes on the drugs should be reduced so as to benefit the consumer as well as make the companies more competitive. The companies which would not be operating from Special Economic Zones (SEZ’s) should be taxed at the same levels as in SEZ’s. The Value added Tax should be reduced and should be uniform throughout the country.

One medium sized company wanted that the government should keep an eye on those small pharma companies who are always on the lookout for piracy and counterfeiting. One medium scale MNC Company wanted that the government should make the patent process more stringent and clear as well as reduce bureaucracy in the patent office. The life saving drugs should be subsidized so as to make them affordable for the masses. Responses of Small Sized Pharmaceutical Companies Companies want the Drug Price Control Order (DPCO) to be removed.

The government should make sure that it provides a reasonable markup for all products, keeping in mind the realistic cost, and this should be done periodically. Small companies are especially hopeful that the government will come to their rescue as the pharmaceutical industry is contributing a great deal to the Indian economy. The government should protect the domestic Indian companies and not allow all MNC’s to enter into India. It should also facilitate export-import and try to prevent brain drain as requirements of R scientists and technicians is increasing in India.

One small MNC company wanted that the Government should follow up after introduction of the product patent else the government after introducing the law just goes into hibernation. The R should be exempted from Taxation. 55 European Journal of Economics, Finance And Administrative Sciences – Issue 13 (2008) 5. Conclusion It is clear now that majority of the Indian Pharmaceutical companies are satisfied with the efforts of the Indian Government in helping them cope up with the challenges of the product patent regime.

However some companies are not happy with the Government that it has not done enough to help them. They want the Government to help them specifically on the issue of drug pricing. They want the removal of the dug price control order(DPCO) which regulates prices of 74 Bulk Drugs(around 25% of the total pharma market) because they are unable to price some drugs as per their wish and instead the Government fixes the prices of these drugs & pharmaceutical companies cannot enjoy better margins on these drugs.

Thus the pharma companies feel that in order to help them face a product patent regime which they perceive is biased towards the MNC pharma companies, the Government should give some concessions. They want the Government to give them incentives for R as well as subsidies in importing sophisticated technology & Machinery. They also want clarity from the Government on key issues like Data exclusivity, Compulsory Licensing & Incremental innovation.

The Government of India should solve the problems of the pharma companies because the introduction of the product patent has already hit the pharma companies hard. The Indian pharma companies entrepreneurs are already becoming disinterested (example: Ranbaxy which is India’s largest pharma company has sold out to Daiichi Sankyo of Japan) and if slowly MNC pharma companies take over the Indian pharma industry then MNC companies will price medicines higher and the common man of India will be a sufferer. References [1] [2] [3] Speech of the President OPPI, Mr.

Ranjit Shahani, 39th annual General Meeting Sep24, 2005. Competitiveness of the Indian Pharma industry in the New product Patent Regime March 2005, FICCI Report for National Manufacturing Competitiveness Council(NMCC) [3] Background Paper by Cygnus Business Consultancy & research for India-Africa-Asean & GCC Pharma & Health Conference Dec1&2, 2005, http://www. cygnusindia. com/white_papers. asp. White paper on Indian Pharma Industry-Quest for Global Leadership,2006, http://www. cygnusindia. com/Articles/Indian_Pharma_Industry_Quest_for_Global_Leadership09. 11. df Jean O. Lanjouw, The Introduction of Pharmaceutical product patents in India: “Heartless exploitation of the poor and suffering”? , National Bureau of Economic Research, Working paper 6366, www. nber. org/papers/w6366. Padmashree Gehl Sampath, India’s product patent protection regime: less or more of “ Pills for the Poor”? , United Nations University working paper series, 2006-019, www. merit. unu. edu. T. R. Madanmohan, Rishikesha T. Krishnan, Adaptive strategies in the Indian pharmaceutical industry, International journal of Technology & Management, 2003, Vol. 5, Issue 3/4. Raveendra Chittor, Sougata Ray, Internationalization paths of Indian pharmaceutical firms-A strategic group analysis, World patent information, Vol. 25, Issue 2. Padmashree Gehl Sampath, Economic Aspects of Access to medicines after 2005: Product patent protection and emerging firm strategies in the Indian pharmaceutical Industry, Study commissioned by CIPIH, WHO, http://www. who. int/intellectualproperty/studies/PadmashreeSampathFinal. pdf Gina Singh, T. Surendar, Pharma SME’s plans for 2005 and beyond, Business World, 20 October 2003.

Madhu Agrawal, Nimish Thakkar, Surviving patent expiration strategies for marketing pharmaceutical products, Journal of Product & Brand Management, 1997, Vol. 6, No. 5. Haritha saranga, BV Phani, The Indian Pharmaceutical Industry-An overview of cost efficiency using DEA, www. iitk. ac. in. Sushmi Dey, Being Indian, Express Pharma, 16-31 Oct 2006, www. expresspharmaonline. com. [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] 56 [14] [15] European Journal of Economics, Finance And Administrative Sciences – Issue 13 (2008) Dr. Gopakumar G.

Nair, Indian Pharma Industry: The Road Ahead, Feb-Mar 2007, Modern Pharmaceuticals, www. gnaipr. com/newsroom. Sudip Chaudhuri, The WTO and India’s Pharmaceuticals Industry, Oxford University Press, 2005. Annexure Table 3: S. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. List of Pharmaceutical companies filled up Questionnaire S. No. Name of the Company 19. DWD Pharma 20. Galpha labs. 21. Zydus Pharma 22. Paras Pharma 23. Indswift Labs. 24. Kee pharma 25. Bal pharma 26. Mercury Labs 27. IndChemie Ltd. 28.

Geno pharma 29. Sun pharma 30. Rexcel Labs. 31. Unichem 32. Zandu 33. Elder 34. Ajanta Labs. 35. FDC Ltd. S. No. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. 50. 51. 52. 53. Name of the Com. IPCA Wallace E Merck Alembic Indoco Novartis Lupin Pfizer Natco Biologic Dr. Reddy Labs. Emcure Reliance Allergan Dabur Amrutanjan Martin & Harris S. No. 55.. 56. 57. 58. 59. 60. 61. 62. Name of the Company Orchid Heinz Baidyanath USV Charak Hetero Eisai CFL Labs. Name of the Company Nicholas Piramal Centaur Pharma Franco India Alkem Labs.

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