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SUBMITTED BY: NIDHI CHAUHAN NATIONAL LAW SCHOOL OF INDIA UNIVERSITY BANGALORE
On the completion of this paper, I would like to place on record my sincere gratitude towards all those people who have been instrumental in its making. Firstly, I would like to thank Dr. Satya Prakash, Director (Law), under whose supervision I chose this topic to research. I would like to express my gratitude for his invaluable assistance, support and guidance throughout the project. Also, I would like to thank all the officers at CCI for their kind co-operation towards the fulfillment of my research paper. I also owe sincere gratitude to the staff at library for always helping in the process of finding material and other sources for research. And last I would like to thank my family and friends for supporting me throughout in my endeavors.
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DISCLAIMER
This study report has been prepared by the author as an intern under the Internship Programme of the Competition Commission of India for academic purposes only. The views expressed in the report are personal to the intern and do not necessarily reflect the views of the Commission or its Honble Members/Chairperson in any manner. This report is the intellectual property of the Competition Commission of India and the same or any part thereof may not be used in any manner, whatsoever, without express permission of the Competition Commission of India.
Nidhi Chauhan
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LIST OF CASES
1. Bharat Biotech International Ltd- v. A.P. Health and Medical Housing and Infrastructure Development Cooperation [2003(1) ALD 463] [AIR 1963 SC 665] (DECIDED ON 7TH December 2001) [AIR 1987 SC 990]
2. Chimanlal Jagjivindas Sheth v. State of Maharashtra 3. Sagar Medical Hall v. State of Bihar 4. Vincent Panikurlangara v. UOI
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LIST OF ABBREBRIATIONS
AIOCD - All India Organization of Chemists and Druggists BICP - Bureau of Industrial Costs and Prices CAF - Competition Assessment Framework CAGR Compound Annual Growth Rate
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The Indian pharmaceutical sector has come a long way, from being a small player in 1970, to becoming a prominent provider of healthcare products, meeting almost 95 per cent of the countrys pharmaceutical needs today. As per an estimate by Mckinsey & Co, t he pharmaceutical industry in India has a unique and exciting opportunity to grow about from US $5.5 bn in 2000 to US $ 25 bn in 2020. However, there are some doubts in some quarters if further growth and internationalization of the industry, in the changed scenario of a new patent regime and a deregulated environment, will benefit the common people by providing better access to affordable medicines. Since, 1970, the prices of essential drugs have been regulated by the Drug Prices Control Order (DPCO), with the National Pharmaceutical Pricing Authority (NPPA) fixing the prices of a range of drugs, since its establishment in 1997. Even though, over the last few years, a substantial decontrol of prices has taken place.1The Drug Policy,1994 needs to be revised to meet the challenges brought about the competitive international pharmaceutical industry in a globalised economic environment, as much as meeting the countrys requirements for safe and quality medicines at reasonable prices. Therefore, the government enunciates the National pharmaceuticals Pricing Policy, 2011. India accounts for 8 % of global pharmaceutical production. It is the third largest in terms of volume and fourteenth in terms of value. Indian firms produce about 60000 generic brands across 60 therapeutic categories and 500 active pharmaceutical ingredients (APIs) approximately. India boasts an export of generic drugs worth US $11 billion and the generic drug market is predicted to grow at a CAGR of 17 per cent between 2010-11 and 2012-13.2 Pharmaceutical policy in India is perceived as industrial policy rather than health policy. The formulation of pharmaceutical policy, therefore, has traditionally been the responsibility of the
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Pradeep S. Mehta, Towards a Functional Competition Policy for India: An Overview, Academic Foundation, New Delhi in association with CUTS International, Jaipur, 2005, p. 171. 2 CCI Survey Report, A Brief Report Pharmaceutical Industryr in India, January 2011. Available at http://www.cci.in/pdf/surveys_reports/indian-pharmaceuticals-industry.pdf
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http://apps.who.int/medicinedocs/en/m/abstract/Js17520en/
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Source: India Pharma 2020, McKinsey &Company4 Nature of the pharmaceuticals market5
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http://www.slideshare.net/aceglobal1/indian-pharmaceutical-sector-2011 McKinsey and Company Report, India Pharma 2020: Propelling access and acceptance, realizing true potential,2010.
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Source: KPMG India Pharma Summit 20096 Despite being highly fragmented, it is concentrated as well. Around 250-300 companies control 70% of the total market share.
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Supra note 4
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It is often argued that Indias drug market is a competitive one with nearly 20,000 companies competing in various therapeutic segments. This is said to have kept the drug price at low level. However, it is a highly contestable claim while evidence seems to suggest that there is high market concentration in these markets.8 It needs no reiteration that consumer sovereignty simply does not exist in the pharmaceutical market. Since the consumers demand is essentially supplydriven (supplier-induced demand) in the pharmaceutical market, the physician or the pharmacist has no incentive to be price-sensitive9. It needs no reiteration that consumer sovereignty simply does not exist in the pharmaceutical market. The usual assumption that market mechanisms stabilize prices does not hold entirely true for the pharmaceutical industry. This is because unlike consumer goods, drugs are not purchased by the consumer on the basis of his choice or preference. They are purchased on the advice of the medical professionals. Hence there is no escape when drug companies build a market for their drugs through their extensive marketing network that target medical professionals and chemists with a variety of marketing techniques. Consumers have little or no choice in such a rigged market and buy what is prescribed by Doctors or what are sold by Chemists.10 The main anti-competitive issues in the pharmaceutical sector are centered on anti-competitive agreements and collusive practices along the supply and distribution chains. There was an international cartel of bulk vitamins present for quite some time and cost in India about US$25mn, in the 1990s, as a result of overcharging. Although no domestic cartel in pharmaceuticals have been detected so far. For example, most pharmacy owners in India are members of a trade association, All India Organization of Chemists and Druggists (AIOCD).
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Sakthivel Selvaraj, How Effective is Indias Drug Price Control Regime? Harvard School of Public Health, 2007. Also available at: http://www.hsph.harvard.edu/research/takemi/files/RP256.pdf 9 Fuchs V. R., Physician-Induced Demand: A Parable, Journal of Health Economics, Vol. 5, 1996. Available at: http://dx.doi.org/10.1016/0167-6296(86)90011-1 10 Amit Sengupta, Study of National Health System in India with regards Access to Health Care and Medicines, April 2010. Available at: http://www.haiap.org/wordpress/wp-content/uploads/2008/08/Dr.-Amits-Project_india.pdf
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Almost 64.25% of all pharmacists are members of AIOCD. The AIOCD is known to launch boycotts against drug companies in order to grab higher profit margins. In fact price decontrol has led to greater trade margins for the pharmacists in fact this actually beats the purpose of decontrol of prices i.e. to allow the manufacturers to be able to spend more on R&D. The suffering lies with the consumers ultimately. Some of these unethical practices were pertaining to irrational drug prescriptions by doctors motivated by kickbacks received from pharmaceutical companies. Another anti-competitive practice prevalent in the pharmaceutical sector is that of abuse of dominance. In 2005, India amended its Patents Act, 1970 to come into full compliance with its obligations under the TRIPS Agreement. Grave concerns were raised about access to affordable essential medicines and its heightened vulnerability to monopolistic abuse. The most common form of abuse of dominance is excessive or over-pricing. To illustrate this, we take the example of Novartis which exercised its exclusive marketing rights granted in India under the product patent regime. Novartis Glivec is used for treatment of Chronic Myeloid Leukaemia. There was an increase in the price of the drug from $90 to $2610 as a result of the exclusive marketing rights which put the drug out of reach of approximately 24000 patients in India who suffer from this disease. A big impediment to competition in the pharmaceutical sector is the high barriers to entry raised by market players abusing their monopoly for manufacturers of generic drugs.
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Grabowski H, Vernon J. Brand loyalty, entry and price competition in pharmaceuticals after the 1984 Drug Act. Journal of Law and Economics, 1992. Available at: http://books.google.co.in/books/about/Brand_loyalty_entry_and_price_competitio.html?id=8lfqGwAACAAJ&redir _esc=y 12 Espicom Business Intelligence Report, 2011. Available at: http://medical-technologyblog.com/tag/espicombusiness-intelligence-2011/ 13 http://www.justice.gov/atr/public/guidelines/0558.htm
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Overview of FTC Antitrust Actions in Pharmaceutical Services and Products. Washington DC, Federal Trade Commission (FTC), Healthcare Services and Products Division, Bureau of Competition, 2006. Available at: http://www.ftc.gov/bc/healthcare/antitrust/rxupdate.pdf 15 S. Srinivasan, Medicines for All, the Pharma Industry and the Indian State, Economic and Political Wee kly, June 2011. Available at: http://www.indiaenvironmentportal.org.in/files/medicines%20for%20all.pdf
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2003 (1) ALD 463 Case decided on 7th December 2001, available at: http://www.indiankanoon.org/doc/806287/
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34th Report on the Functioning of the three Vaccine Producing PSUs, namely CRI (Kasauli), PII (Coonoor) and the BCGVL (Chennai), Department Related Parliamentary Standing Committee Report, February 2009. Available at: http://rajyasabha.nic.in/rsnew/annual_report/2009/HF.pdf
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Retail Price MC is the material cost, including cost of bulk drugs/excipients. 23 CC is the conversion cost as per the dosage form. 24 PM is the cost of packaging material. 25 PC is the packaging charge, worked out in accordance with established costing procedures. 26 MAPE is the Maximum Allowable Post-manufacturing Expenses. 27 http://pharmaceuticals.gov.in/mshT2810/FTY2.pdf
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The 7th Report of the Standing Committee on Chemicals and Fertilizers on Availability and Price Management of Drugs and Pharmaceuticals, 2005. Available at: http://164.100.24.208/ls/CommitteeR/chemicals/7rep.pdf 29 Supra note 13
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One of the main impediments to competition in the pharmaceuticals market is strategies employed by big players to delay generic entry into the market. Ever-greening has oft been used as a routine business strategy by monopolistic patentees to delay generic competition. Patents are issued on pharmacological compounds quite early in the drug development process, which sets the clock running. The EC conducted a pharmaceutical sector inquiry under the EC Competition Rules in 2008, based on information that suggested restriction of competition in these markets leading to a reduction in the number of innovative medicines reaching the market and delays in generic entry. The inquiry found that originator companies used a range of strategies to extend exclusivity and delay generic entry as long as possible such as filing up to 1300 patents for a single medicine (creating patent thickets), and engaging generic companies in costly litigation, even though the courts upheld originator patent litigation claims in only 2% of cases. It estimated that faster generic entry could reduce public expenditure on medicines by over 5%.31 Such strategies have been witnessed in India as seen in the number of litigations filed under Section 3 (d) which has been held as a pro-competitive provision to safeguard ever greening of patents. For instance, Delhi High Court rejected the petition of Bayer Healthcare (German) preventing the Drug Controller General of India giving marketing approval to Indian company Cipla for the generic version of the cancer drug Nexavar. Similarly, Cipla in another case won the right to manufacture and market the generic version of the anti-cancer drug Tarceva originally patented by the Swiss pharma company Hoffman La Roche both in Delhi High Court
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Section 3(d) of The Patents Act, 1970: The mere discovery of any new property of new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
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II.
Granting patents of questionable validity which happens when patent examiners do not carefully evaluate the patents due to the large number of applications has been seen to stifle innovation and delaying generic entry. US FTC in a 2003 highlighted that questionable patents can deter or raise the costs of innovation, defensive patenting and licensing. This may prove anticompetitive. This provision addresses many abuses of anticompetitive nature such as the problem of patent clusters i.e. filing numerous patents for the same medicine which is used as a strategy to delay/block generic entry into the market and create uncertainty as to when generic competitors can start developing a generic medicine which does not infringe the patents. Through pre-grant oppositions under Section 25(1) such wasteful litigation could be avoided at a later stage. While the pre-grant oppositions can delay the entire procedure, in the longer run it would serve better to make the market more competitive. It is important however to interpret this provision keeping in view the objectives of patent law and hence using these rights to ensure ex ante competition by allowing blocking patents to be appropriately screened. The provision has its limitations as its use depends on the ability of stakeholders to litigate in courts. Besides many may and have used it for strategic reasons rather than to ensure quality of patents and preserving competition.
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Geeta Gauri, Competition issues in the Generic Pharmaceutical Industry in India, Competition Commission of India, April 2010.Available at: http://www.cci.gv.in/images/media/presentations/ComIssGenPharmIndusIndia_2010 0401142346.pdf.
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India has not had a strict regime that protected secrecy of data submitted by pharmaceutical companies to regulatory agencies. Many MNCs hold the view that this has helped the generics industry immensely to reverse engineer and make cheaper versions of drugs. In fact it has been debated that in India, the absence of data exclusivity legislation has resulted in serious commercial clashes between researches based pharmaceutical MNCs and powerful local generic based companies.33 Data exclusivity guarantees additional market protection for originator pharmaceuticals and prevents the regulatory authorities from assessing the safety and efficacy profile of a generic application for a period of time and therefore prevents authorities from accepting applications for generic medicines during the period of exclusivity.34 It however does not legally prevent other companies from generating their own registration. But in practice the vast financial resources and extended time required for gathering and generating pharmaceutical registration data for a new drug may create a market barrier for generic based companies35
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M. Pugatch, International political economy of intellectual property rights, Edward Elgar Publishing, 2004. Available at: http://books.google.co.in/books?id=hJpI3Ki7MhUC&pg=PA286&lpg=PA286&dq=M.+Pugatch,+%E2%80%9CInt ernational+political+economy+of+intellectual+property+rights,%E2%80%9D+Edward+Elgar+Publishing,+2004.& source=bl&ots=nQBAh8jYhB&sig=9Oo5VDGOOuUXyrmITmEI6jWzN94&hl=en&sa=X&ei=jnRDTnENc7wrQeIh9DLBw&ved=0CDoQ6AEwAQ#v=onepage&q=M.%20Pugatch%2C%20%E2%80%9CInternational %20political%20economy%20of%20intellectual%20property%20rights%2C%E2%80%9D%20Edward%20Elgar% 20Publishing%2C%202004.&f=false 34 Report of the European Generic Medicines Association, 2004. Available at: http://www.egagenerics.com/doc/ega_increase-patient-access_update_072009.pdf 35 M. Pugatch, International political economy of intellectual property rights, Edward Elgar Publishing, 2004.
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Lee C. Model competition laws. In: Cook P, Fabella R, Lee C eds. , Competitive Advantage and Competition Policy in Developing Countries, Cheltenham (UK), Edward Elgar Publishing, 2007. 37 (1) No enterprise or association of enterprises or person or association of persons shall enter into any agreement in respect of production, supply, distribution, storage, acquisition or control of goods or provision of services, which causes or is likely to cause an appreciable adverse effect on competition within India. (2) Any agreement entered into in contravention of the provisions contained in subsection (1) shall be void. (3) Any agreement entered into between enterprises or associations of enterprises or persons or associations of persons or between any person and enterprise or practice carried on, or decision taken by, any association of enterprises or association of persons, including cartels, engaged in identical or similar trade of goods or provision of services, which (a) directly or indirectly determines purchase or sale prices; (b) limits or controls production, supply, markets, technical development, investment or provision of services; (c) shares the market or source of production or provision of services by way of allocation of geographical area of market, or type of goods or services, or number of customers in the market or any other similar way; (d) directly or indirectly results in bid rigging or collusive bidding, shall be presumed to have an appreciable adverse effect on competition: Provided that nothing contained in this sub-section shall apply to any agreement entered into by way of joint ventures if such agreement increases efficiency in production, supply, distribution, storage, acquisition or control of goods or provision of services. Explanation.For the purposes of this sub-section, "bid rigging" means any agreement, between enterprises or persons referred to in sub-section (3) engaged in identical or similar production or trading of goods or provision of services, which has the effect of eliminating or reducing competition for bids or adversely affecting or manipulating the process for bidding (4) Any agreement amongst enterprises or persons at different stages or levels of the production chain in different markets, in respect of production, supply, distribution, storage, sale or price of, or trade in goods or provision of services, including (a) tie-in arrangement; (b) exclusive supply agreement; (c) exclusive distribution agreement;
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Abuse of dominance
Section 439 of the Competition Act of 2002 prohibits abuse of dominance. It is to be noted here that it is not dominance per se that is prohibited but its abuse.
(d) refusal to deal; (e) resale price maintenance, shall be an agreement in contravention of sub-section (1) if such agreement causes or is likely to cause an appreciable adverse effect on competition in India. Explanation.For the purposes of this sub-section, (a) "tie-in arrangement" includes any agreement requiring a purchaser of goods, as a condition of such purchase, to purchase some other goods; (b) "exclusive supply agreement" includes any agreement restricting in any manner the purchaser in the course of his trade from acquiring or otherwise dealing in any goods other than those of the seller or any other person; (c) "exclusive distribution agreement" includes any agreement to limit, restrict or withhold the output or supply of any goods or allocate any area or market for the disposal or sale of the goods; 38 CUTS International, Unholy alliances in healthcare sector, June 2011 39 No enterprise shall abuse its dominant position. There shall be an abuse of dominant position under sub-section (1), if an enterprise. (a) directly or indirectly, imposes unfair or discriminatory (i) condition in purchase or sale of goods or service; or (ii) price in purchase or sale (including predatory price) of goods or service, Explanation. For the purposes of this clause, the unfair or discriminatory condition in purchase or sale of goods or service referred to in sub-clause (i) and unfair or discriminatory price in purchase or sale of goods
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Sangeeta Singh and Aman Malik, Pharma deals set to face closer scrutiny. Available at: http://www.livemint.com/2011/10/10233455/Pharma-deals-set-to-face-close.html
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http://www.oecd.org/document/24/0,3746,en_2649_34753_1916760_1_1_1_1,00.html United Nations Conference on Trade And Development, Model Law on Competition, UNCTAD Series on Issues in Competition Law and Policy, Geneva, 2003. Available at: http://www.unctad.org/en/docs/tdrbpconf5d7rev1_en.pdf
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Curbing anti-competitive agreements and collusive practices in the market Following recommendations may be looked into in this regard: Generating awareness among consumers about the different types of anti-competitive agreements and collusive practices prevalent among manufacturers, retailers and healthcare providers. Enhanced role of CCI under Section 3 of the Act to curb anti-competitive agreements. Strict Penal provisions under the Medical Council of India Act and the Regulations on malpractices of health-care providers. Coordination of NPPA and CCI in monitoring price controls.
3. Adopting measures to promote competition across the pharmaceutical value chain Strengthening the implementation of the strict criteria for patentability incorporated in section 3 of the Indian Patent Act. There have been instances where patents have been
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http://pharmaceuticals.gov.in/mshT2810/FTY2.pdf
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4. Strengthening the compulsory licensing system Flexibilities under TRIPS allow for issue of compulsory licenses. DIPP and patent offices must be advised for creating an effective and deterrent compulsory licensing mechanism to make drugs accessible under the essential facilities doctrine. Indias Patents Act provides for it under Sections 84 (if initiated by a private party), 92 (notification by government that a Compulsory Licence needs to be issued for public noncommercial use, national emergency or extreme urgency), 92A (Compulsory Licence for generic exports) and 100 (for government use). However, nothing much has been done in this regard.45 5. Careful scrutiny of mergers and takeovers in the pharmaceutical industry As discussed earlier, the High Level Committee chaired by Arun Maiara has submitted recommendation for tighter rules for mergers and takeovers in the pharmaceutical sector by the CCI. This is a great step. This calls for greater role of CCI and NPPA in dealing with anticompetitive outcomes of mergers and closely monitoring the rise in prices (if needed) as a result of such a merger. 6. Transferring the Department of Pharmaceuticals under the Ministry of Health and Family Welfare The Planning Commission's high-level experts' group on universal health coverage, headed by Dr K. Srinath Reddy in its report has said that public interest would be served best by transferring the department of pharmaceuticals to the health ministry. This recommendation should not be ignored as it is only appropriate that pharmaceuticals should
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S. Srinivasan, Medicines for All, the Pharma Industry and the Indian State, Economic and Political Weekly, June 2011. Available at: http://www.indiaenvironmentportal.org.in/files/medicines%20for%20all.pdf
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BOOKS 1. M. Pugatch, International political economy of intellectual property rights, Edward Elgar Publishing, 2004. 2. Pradeep S. Mehta, Towards a Functional Competition Policy for India: An Overview, Academic Foundation, New Delhi in association with CUTS International, Jaipur, 2005 ARTICLES 1. Amit Sengupta, Study of National Health System in India with regards Access to Health Care and Medicines, April 2010 2. Dhanajay Mahapatra, Centre gets Supreme Court notice on drug prices, The Times of India, October 12 2011. 3. Fuchs V. R., Physician-Induced Demand: A Parable, Journal of Health Economics, Vol. 5, 1996 4. Geeta Gauri, Competition issues in the Generic Pharmaceutical Industry in India, Competition Commission of India, April 2010. 5. Grabowski H, Vernon J. Brand loyalty, entry and price competition in pharmaceuticals after the 1984 Drug Act. Journal of Law and Economics, 1992 6. Lee C. Model competition laws. In: Cook P, Fabella R, Lee C eds. , Competitive Advantage and Competition Policy in Developing Countries, Cheltenham (UK), 7. McKinsey and Company Report, India Pharma 2020: Propelling access and acceptance, realizing true potential,2010. 8. S. Srinivasan, Medicines for All, the Pharma Industry and the Indian State, Economic and Political Weekly, June 2011. 9. Sakthivel Selvaraj, How Effective is Indias Drug Price Control Regime?, Harvard School of Public Health, 2007. 10. Sangeeta Singh and Aman Malik, Pharma deals set to face closer scrutiny.
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REPORTS 1. 34th Report on the Functioning of the three Vaccine Producing PSUs, namely CRI (Kasauli), PII (Coonoor) and the BCGVL (Chennai), Department Related Parliamentary Standing Committee Report, February 2009 2. CCI Survey Report, A Brief Report Pharmaceutical Industryr in India, January 2011. 3. CUTS International, Unholy alliances in healthcare sector, June 2011 4. CUTS Report, Options for Using Competition Law/Policy Tools in Dealing with Anticompetitive Practices in Pharmaceuticals and the Health Delivery System, September 2006. 5. DIPP Draft Discussion Paper on Compulsory Licensing in the Indian Pharmaceutical Sector: An Acquired Afterthought?, August 2010 6. EC Pharmaceutical Sector Inquiry Report, 2009 7. EC Pharmaceutical Sector Inquiry Report, 2009. 8. Espicom Business Intelligence Report, 2011 9. Overview of FTC Antitrust Actions in Pharmaceutical Services and Products. Washington DC, Federal Trade Commission (FTC), Healthcare Services and Products Division, Bureau of Competition, 2006 10. Report of the European Generic Medicines Association, 2004. 11. The 7th Report of the Standing Committee on Chemicals and Fertilizers on Availability and Price Management of Drugs and Pharmaceuticals, 2005 12. United Nations Conference on Trade And Development, Model Law on Competition, UNCTAD Series on Issues in Competition Law and Policy, Geneva, 2003.
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STATUTES 1. Competition Act, 2002 2. Drug and Cosmetic Rules, 1945 3. Drugs and Cosmetics Act, 1940 4. Drugs Price Control Order, 1995 5. Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 6. Indian Medical Council Act, 1956 WEBSITES
1. http://www.cci.in/pdf/surveys_reports/indian-pharmaceuticals-industry.pdf 2. http://apps.who.int/medicinedocs/en/m/abstract/Js17520en/ 3. http://www.slideshare.net/aceglobal1/indian-pharmaceutical-sector-2011 4. http://www.kpmg.de/docs/Pharma_Summit_2009.pdf 5. http://www.hsph.harvard.edu/research/takemi/files/RP256.pdf 6. http://dx.doi.org/10.1016/0167-6296(86)90011-1, 7. http://www.haiap.org/wordpress/wp-content/uploads/2008/08/Dr.-AmitsProject_india.pdf 8. http://books.google.co.in/books/about/Brand_loyalty_entry_and_price_competitio.html?i d=8lfqGwAACAAJ&redir_esc=y 9. http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_par t1.pdf 10. http://medical-technologyblog.com/tag/espicom-business-intelligence-2011/ 11. http://www.ftc.gov/bc/healthcare/antitrust/rxupdate.pdf 12. http://www.indiaenvironmentportal.org.in/files/medicines%20for%20all.pdf 13. http://rajyasabha.nic.in/rsnew/annual_report/2009/HF.pdf 14. http://164.100.24.208/ls/CommitteeR/chemicals/7rep.pdf
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