INTRODUCTION:

“Pioneering spirit should continue, not to conquer the planet or space … but rather to improve the quality of life.” -Bertrand Piccard

India’s obligations under the TRIPS regime have at times rendered the availability, affordability and accessibility to the medicines essential for the treatment of life threatening diseases a nightmare. Strictly watching out against the ever greening of the patented medicines, Indian law also countenances grant of compulsory licences for manufacturing the patented medicines under certain circumstances. Supreme Court of India has out rightly stamped validity on the compulsory licence regime¹ and has ruled against the ever greening tactics² of the strong patent owners.

Despite these sincere endeavours, at times, it becomes difficult for the poverty ridden Indian population to afford most of the medicines meant for treating life threatening diseases like cancer, HIV/AIDS and Hepatitis B and C etc mostly due to the patents granted to these medicines. Due to the high cost of the patented medicines, the cost of the generics also tends to take an upward curve. Amidst this scenario, this research paper attempts to examine and elaborate the issues pertaining to availability, affordability and accessibility to the medicines mandatory for the treatment of life threatening diseases like cancer, HIV/AIDS and Hepatitis B and C. The focus begins with analysing the national and international perspectives of the Patent Regime in the Pharmaceutical Sector. It peeps into the nature of the Indian pharmaceutical sector; examines the life threatening diseases affecting the Indian population; sheds light on the pricing policies of the patented and the generic medicines required for the treatment of the life threatening diseases and recommends the efforts required for improvising the situation keeping in mind the health needs and pocket condition of the Indian population.

Conceptualization

Medicine refers to a substance that is used in treating disease or relieving pain and that is usually in the form of a pill or a liquid.³ Drugs means natural or synthetic substance which (when taken into a living body) affects its functioning or structure and is used in the diagnosis, mitigation, treatment or prevention of a disease or relief of discomfort.⁴ Patent refers to the exclusive right granted by a government to an inventor to manufacture, use or sell an invention for a certain number of years.⁵ Generic drug or medicine refers to the medicines that can be sold without a brand name.⁶ As defined by Section 2(1)(j), Drugs (Prices Control) Order, 2013, generic version of a medicine means a formulation sold in pharmacopeial name or the name of the active pharmaceutical ingredient contained in the formulation, without any brand name. A life-threatening disease is a very serious one that can cause death.⁷

Patent Regime in the Pharmaceutical Sector- International and National Perspectives

International Scenario: Established in 1975 in succession to General Agreement on Tariffs and Trade (GATT), World Trade Organization (WTO) aimed at conducting economic relations in a manner conducive to raising the standards of living.⁸ Establishment of World Intellectual Property Organization (WIPO) and adoption of TRIPS in the Uruguay Round was a significant milestone in the development of intellectual property. It envisages patents for products and process in all fields of technology, exclusive right of importation, 20 year patent period from the filing date (Article 33) and severe restrictions on compulsory licenses. Patentability of any product is based on the three dimensional criteria of novelty, inventive step and industrial application (Article 27.1). The patentee is empowered to exclude (Article 28) third parties from using the invention in the territory where it is protected but the invention is free for use in the countries where it is not protected. Even the generic medicines are not allowed to be marketed if a patent is in force. Inventions necessary for protection of human life may be excluded from patent protection (Article 27.2).

Novel chemical compounds having pharmaceutical utility, patentable per se in all countries signatories to TRIPS, fall into three categories viz., prodrug and active metabolites; natural product such as antibiotics, isolated hormones, cytokines; combination preparations and drug delivery system.⁹

Due to the rampant increase in the HIV/AIDS-infected persons in need of anti-retroviral drugs during 1990s, many governments tried to facilitate access to these drugs through domestic production or importation of generic anti-retroviral drugs. These measures conflicted with the exclusive rights of patentees and raised alarmed concerns in countries affected by public health calamities, depicting conflicts between public health and patent protection. Amidst this, Doha Declaration on the TRIPs Agreement and Public Health, 2001 was adopted on 14 November 2001 during the WTO’s Doha Ministerial Conference. Developing countries emphasized generous interpretation of TRIPS for protection of public health by promoting access to existing medicines and research and development into new medicines (Paragraph 17 of the main Ministerial Declaration). Paragraph 5(c) of the Doha Declaration tackled the issue of national emergency by providing that each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics can represent a national emergency or other circumstances of extreme urgency. Paragraph 5(d) permitted the Members to opt for a parallel import regime for drugs. Doha declaration favoured protection of public health and not its sacrifice for patent protection. It clarified the sovereign rights of the individual member countries to decide upon the circumstances warranting issuance of compulsory licenses.

Since the developing countries lacked manufacturing capacities for producing the required anti-retroviral drugs, the General Council of the WTO in 2003 decided to relax strict compliance with Article 31(f) and (h) of TRIPS from these countries. Clause (f) incorporates the obligation to issue compulsory licence for the supply of the domestic market of the member authorizing such use and Clause (h) deals with the obligation to remunerate the patentee. To make this Declaration permanent, the Protocol Amending the TRIPS Agreement was adopted on 6/12/2005 by the General Council.¹⁰

National Scenario: Patent Act, 1911 provided patents on both products and processes (technique of manufacture) in pharmaceuticals. Patents Enquiry Committee, 1950 and Pharmaceutical Enquiry Committee, 1954 recommended that patent law must take account of the national interest and level of development. Till 1970, foreign companies held 90% of the Indian pharmaceutical market. India increasingly depended on imports for bulk drugs and formulations resulting into high drug prices. Indian Patent Act, 1970 introduced process patent regime for pharmaceuticals (Section 5). This law did not clearly express the patentability criteria. It defined invention, inventive step and new invention and Section 3 stated what inventions are not patentable. Local firms developed their own processes and manufactured drugs by reverse-engineering products of the multinational competitors. This led to the growth of a strong and vibrant generic industry lowering prices and widening access to medicines and foreign ownership in Indian drug industry decreased to just 39% in 1993. Seven years process patent protection for drugs and pharmaceuticals, importation not being treated as working of a patent; the compulsory licensing and licence of right to ensure working and dissemination of technologies prohibited establishment of patent monopolies. Indian Patent Act, 1970 was in fact designed to encourage the development and production of low-cost generic medicines. Eventually, India emerged as a policy model by placing pharmaceutical patents on the agenda for the New International Economic Order. It became the hub of the generic manufacturers who dramatically drove down prices of medicines patented elsewhere. The cost of first-generation HIV treatment dropped from over $10,000 per patient per year in 2000 to $350 by 2001. Today, improved first-line treatment costs roughly $120 yearly¹¹

Upon India signing the Uruguay Round of Multilateral Trade Negotiations on 15 April 1994 to which the TRIPS is an annexure (Annexe 1C), India’s patent law had to be made TRIPS compliant. Article 70(8), TRIPS required the member countries, which had not provided for patent protection for pharmaceutical and agricultural chemical products, to establish a mechanism for filing applications for patents for such inventions and apply to such applications, the criteria for patentability as laid down in Article 27(1) and provide 20 years patent protection for successful applications. Article 70(9), TRIPS provided that when a product which is a subject matter of a patent application in a Member country under Article 70, then notwithstanding the provisions of Part VI of the TRIPS providing for transitional arrangements permitting time limits for member countries to amend their domestic laws to conform to the requirements of the TRIPS, that country has to grant exclusive marketing rights (EMRs) for the product for a period of 5 years after obtaining market approval in that country or until product patent is granted or rejected in that country, whichever period is shorter. For the grant of EMRs, the applicant must have already obtained patent for that product in any other member country along with market approval therein.

Being a developing country with no product patent protection, India availed ten years transition period for complete TRIPS compliance. In 1999, Indian Patent Act, 1970 was amended with effect from 1 January 1995 permitting the grant of EMRs through Chapter IVA. This provided pipeline protection to the interim applications claiming product patent for medicine or drug which were kept pending without being processed until the end of 2004. Inventions not falling within the purview of Section 3 and 4 were considered for EMRs. This was followed by the Patents (Amendment) Act, 2005 commencing product patent regime with 20 years protection from 4 April 2005, abolishing EMRs. Significantly, provision was made for compulsory licences for manufacture and import of patented pharmaceutical products to any country having insufficient or no manufacturing capacity for the concerned product (Section 92A). Amendment of Section 3(d) prevented extension of patent protection through minor product modifications unless a ‘significant enhancement of efficacy’ can be demonstrated. Getting a patent on new forms of existing medicines was made tougher. Since non-patentability for protecting human, animal or plant life or health or to avoid prejudice to the environment is valid under TRIPS, there exists scope to refuse patents to large number of inventions, having regard to Hindu religious sentiment and worshipful concern for plants, animals, ecology and environment. Indian government uniquely complied with TRIPS while protecting domestic industry, consumers and the economy at large.

Pharmaceutical Sector in India

Global pharmaceutical market is presently worth US$1140 billion.¹² The large pharmaceutical companies are reluctant to pursue a line of research unless they are guaranteed of assured returns. They have negligible commercial incentive to undertake research beneficial to the majority of the poor living in low income countries.¹³ Considering the high cost of research and development which goes in the invention of a patentable drug, the pharmaceutical sector aims at securing maximum effective patent term.¹⁴ Though operating under severe price competition, Indian pharmaceutical industry has depicted consistent growth over the past three decades and globally stands fourth in terms of sales volume and thirteenth in terms of value¹⁵ and is likely to reach $74 billion market by 2020.¹⁶ With more than 24,000 registered units, it is highly fragmented. Formulations account for 81.5% of the market and bulk drugs account for the remaining 18.5%. The leading 250 pharmaceutical companies control 70% of the market while the market leaders hold nearly 7% of the market share. Requirement for 85% of bulk drugs and almost all formulations is met domestically. There are around 465 main bulk drugs used in India and out of these, around 425 bulk drugs are totally manufactured in India, there being no import of these but around 60 are partially exported. Of the remaining 40 bulk drugs, 30 are totally imported whereas around 10 are partially imported.¹⁷

Life threatening diseases affecting the Indian population

The public health is relevantly a distinct key issue in public policy discourse in every mature society. India is a country which is quite infamous for its sanitation and cleanliness. The chaotic waste management system, faulty urban planning, rapid industrialization, disinterested attitude of the citizens and the authorities is responsible for the overflowing gutters, scattered waste, pollution and much more sickening circumstances in urban centres. Lack of clean water, hygiene, food and awareness in rural areas is also the culprit. The contaminated water and food increase the chances of getting infected through waterborne or foodborne diseases. Another major cause for common health issues in India is the pollution. Pollution of air, water and soil has worst affected the health of the most vulnerable.¹⁸

In spite of solid economic growth, India shares 21% of the global disease burden (WHO) and faces acute challenges in combating major public health issues. Type I diabetes, cancer, HIV-AIDS, Hepatitis B and C, asthama, influenza, polio are some of the life threatening diseases in India.¹⁹ India has the world’s largest tuberculosis patients and the third highest number of HIV/AIDS patients after South Africa and Nigeria. As per prediction of WHO, presently India is losing 1.5 per cent of its GDP to the effects of heart disease, stroke and diabetes.²⁰ According to the International Agency for Research on Cancer (IARC), a World Health Organization entity, India had 1.8 million people living with cancer (within five years of diagnosis) in 2012.²¹ Next to China, India has second highest Hepatitis B infected patients numbering around 40 million.²² Around 2 crore Indians suffer from Hepatitis C.²³ In this scenario, leaving the prices of lifesaving medicines to the market forces may turn suicidal. Problem is more acute with cancer medicines yearly priced at $50,000 in the West, Indians unable to pay even a fraction of it.²⁴

Pricing policies of the patented and the generic medicines

Availability status of selected generic medicines in the public hospitals is very poor in India.²⁶ The cost of even the generic medicines is so high that their availability at the government hospitals appears highly impossible and unaffordable due to poor state coffers. For treating the life threatening diseases, many generic medicines are manufactured by different pharmaceutical companies under different trade names. A bird’s eye view is presented in the tables below to shed light on the prices of few generic medicines required for the treatment of the life threatening diseases like HIV-AIDS, cancer, Hepatitis B and C.

HIV-AIDS is an epidemic disease, a potentially preventable, deadly infection for which there is no cure, no vaccine and it is not under control." -National Commission on AIDS, 1993.

Table 1: Reduces viral load and may slow the progression of the disease: 2 tablets daily

Generic Name	Trade Name	Company	No. of Tablets Per Strip	Price in Rs.
Abacavir	Abamune	Cipla	30	2205
Abacavir	Virol	Ranbaxy	60	4700

Table 2: Inhibiting formation of new cells: 2 tablets daily

Generic Name	Trade Name	Company	No. of Tablets Per Strip	Price in Rs.
Atazanavir	Atazor 150 mg	Emcure Pharmaceuticals Ltd	60 Capsule	2500
Atazanavir	Virataz (300 mg)	Genx	30 Capsule	2100

Table 3: Slows down the spread of virus in the body: 2 tablets daily

Generic Name

Trade Name

Company

No. of Tablets Per Strip

Price in Rs.

Darunavir

Daruvir

(300 mg)

Cipla

60 Tablets

4750

Cancer

Breast Cancer:

Table 4: To treat early breast cancer: One tablet daily

Generic Name	Trade Name	Company	No. of Tablets Per Strip	Price in Rs.
Anastrozole	Altrol – 1mg	Taj Pharmaceuticals Ltd	14 tablets	722.82
	Armotraz	Cipla Limited	10Tablet	495
	Anabrez	Sun Pharmaceutical Industries Ltd.	5 tablets	246

Table 5: prevents the growth of breast cancer cells: daily 2500 mg

Generic Name	Trade Name	Company	No. of Tablets Per Strip	Price in Rs.
Capecitabine	Capegard -500mg	Cipla Limited	10Tablet	1200
	Capget -500 mg	GLS PHARMA LTD	10Tablet	1500
	Capiibine (500 mg)	Dr Reddy Laboratories Ltd	10Tablet	1620

Ovarian Cancer:

Table 6: stops the growth of cancer cells: 1 dosage every four weeks

Generic Name	Trade Name	Company	No. of Vial	Price in Rs.
Carboplatin	Biocarb (450 mg)	Biochem Pharmaceutical Industrial Ltd	Injection 1 Vial	1800
	Carbomax 150mg	GLS PHARMA LTD	Injection 1 Vial	880
	Carbokem (450 mg)	Alkem Laboratories Ltd (Cytomed)	Injection 1 Vial	1908

Blood Cancer:

Table 7: stops cancer cell growth: 6000 iu:1 dosage( three times a week)

Generic Name	Trade Name	Company	No. of Vial	Price in Rs.
Asparaginase	Leucoginase	VHB Life Science Inc. (Cytocare)	Injection 1 Vial	1395
Asparaginase	Leucoginase (5000 iu)	VHB Life Science Inc. (Cytocare)	Injection 1 Vial	970

Hepatitis B (HBV) is inflammation of the liver due to infection with the hepatitis B virus.

Table 8: slows the growth of HBV by blocking reverse transcriptase, an enzyme that is helpful for viral reproduction: 10 mg daily

Generic Name	Trade Name	Company	No. of Capsule Per Strip	Price in Rs.
Adefovir Dipivoxil	Adesera - 10mg	Cipla Limited	30 Capsule	699.8
Adefovir Dipivoxil	Adheb- 10mg	Rexcel (Ranbaxy Laboratories Ltd)	30Tablet	680.19

Table 9: oral antiviral Agent: 0.5 mg to 1mg once daily.

Generic Name	Trade Name	Company	No. of Tablets Per Strip	Price in Rs.
Entecavir	Baraclude -0.5mg	Bristol Myers Squibb India Pvt Ltd	10Tablet	2197
Entecavir	Baraclude (1 mg)	Bristol Myers Squibb India Pvt Ltd	10Tablet	3507

The information in the aforementioned tables substantiates the high cost of the medicines for treating the life threatening diseases. Cost of treating these diseases is beyond the pockets of the common man who normally has no insurance cover to foot the medical expenses.

Hepatitis C is a viral disease that affects the liver. Originally called “non-A non-B hepatitis” it is caused by the hepatitis C virus (HCV).²⁶ HCV is a disease often leading to chronic liver failure, cirrhosis and liver cancer. Till 2011 it had been very difficult to treat HCV. With the introduction of “direct acting antivirals” (DAAs) such as Sofosbuvir, treating HCV has become possible, though expensive. Approved by the US-FDA in 2013, Sofosbuvir cures up to 80% Hepatitis C patients. Being the only cure for Hepatitis C, this medicine costs $84,000-$168,000 USD [Rs. 5504520-11009040] for a six month treatment course.²⁷ Till recently, no generic medicine was available. US-based Gilead Pharmaceuticals, manufacturer of the drug is allowing generic Indian companies to manufacture and make available the generic medicine at Rs 1.2 lakh.²⁸ A generic version of Sofosbuvir manufactured by Indian company Zydus-Cadila, Natco Pharma and Zydus-Cadila is available in the market now.

Cancer Drug Nexaver manufactured by Bayer is priced at around Rs.2.80 lakhs while the Domestic generic drug maker Natco was granted a patent in 2012 to sell a generic version of Nexavar at Rs.8,800 for a month’s dose. Swiss drugmaker Novartis was denied a patent in India for its cancer drug Gleevec on the ground that there was only an incremental improvement over the existing version. The price of Gleevec for 90 tablets, 100 mg is $8961.40 [Rs.586796.5].²⁹ 30 tablets, 400 mg is priced at $10762.33 [Rs. 704722.21]. This brings forth the effect of high price of patented medicines and the resultant high cost of the generics which are ultimately beyond the reach of a common man. All these developments call for a keen eye over the drug manufacturing companies and their pricing policies.

Analysis and Ways Forward

International and National legal mechanism crudely protects right to health. Principle 2 of International Drug Policy Consortium³¹ envisages improved access to essential medicines and harm reduction, prevention, treatment and care programmes and lays great stress on public health.³⁰ Article 12, International Covenant on Economic, Social and Cultural Rights, 1966 emphasises the obligation of the States to recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. Universal Declaration of Human Rights, 1948 recognises right to health under Article 25.³²

Health care services find place in all the three lists in the Indian Constitution and this substantiates the relevance of public health within the Constitutional framework.³³ Though not directly, different provisions of the Constitution mandate protection of public health. Article 38 calls upon the State to secure a social order for the promotion of welfare of the people. Article 39(e) emphasises protection of the health of the workers. Article 41 imposes duty on the State to ensure public assistance for the sick and disabled. Article 42 makes provision for the protection of the health of infant and mother by maternity benefit. Article 47 makes it a primary duty of the State to improve public health. These constitutional provisions cast an utmost obligation on the Central and State Governments to see that the medicines are made easily available at affordable prices to the citizenry.

Further, right to health is read as an integral part of the right to life under Article 21 of the Indian Constitution and the same has been vehemently stamped by the Supreme Court of India at different times. In C.E.S.C. Ltd. Etc vs. Subhash Chandra Bose And Ors,³⁴ Supreme Court held that right to health and medical care is a fundamental right under Article 21 read with Articles 39(c), 41 and 43 of the Constitution. In Pt.Paramanand Katara vs. Union of India and Ors,³⁵ Court emphasized the need for rendering immediate medical aid to injured persons to preserve life and the obligations of the State as well as doctors in that regard. It held that no medical authority could refuse to provide immediate medical attention to a patient in need in an emergency case and directed medical establishments to provide instant medical aid to such injured people, notwithstanding the formalities to be followed under the procedural criminal law. Decisions were rendered on similar lines in Paschim Banga Khet Mazdoor Samity vs. State of West Bengal,³⁶ Kirloskar Bros Ltd vs. ESIC,³⁷ Air India Stat. Corp vs. United Labour Union. ³⁸

The Committee on Price Negotiation for Patented Drugs classifies patented medicines into 3 categories viz., a totally new class of medicines which have no therapeutic equivalence; a medicine having therapeutic equivalence but also has a therapeutic edge over the existing one and a medicine which has similar therapeutic effectiveness compared to the existing ones. These three categories have to be treated differently while fixing the price. The observation of the Committee that the prices of patented medicines are very high and are beyond the reach of the general masses of the country needs to be paid attention to. Unilateral price fixation for the open market by the Government will result into non-availability of the medicine. The Committee recommendation that the government should expand the coverage of healthcare and insurance scheme even for prescription medicines for all the citizens is worth implementing.³⁹

Committee on Price Negotiation for Patented Drugs opines that keeping in mind the per capita gross national income with purchasing power parity, drug prices are higher in India as compared to countries like France, Australia and New Zealand,⁴⁰ thereby rendering access to these medicines tough for the common man. It also opined that despite negotiation of the prices of patented medicines by the Government Committee, the medicines are unaffordable and inaccessible to the Indian masses.

The National Pharmaceutical Pricing Authority (NPPA) has been entrusted with the job of monitoring the prices of medicines. The National Pharmaceutical Pricing Policy, 2012⁴¹ regulates prices of drugs specified under National List of Essential Medicines (NLEM)-2011.⁴² It provides that all the manufacturers/ importers manufacturing/ importing the medicines as specified under NLEM-2011 shall be under the purview of price control. Such medicines shall have an MRP equal to or lower than the ceiling price (plus local taxes as applicable) as notified by the Government for respective medicines.⁴³ Presently, patented medicines are outside the ambit of the National Pharmaceutical Pricing Policy.

Department of Industrial Promotion and Policy (DIPP) calls for caution at the time of price negotiations of the patented drugs. Organization of Pharmaceutical Producers of India recommends price negotiations for patented products only for government purchases. The representatives of the Indian Drug Manufacturer Association opine that the price negotiation should be there for all patented drugs. It also emphasised that price negotiation are importance since grant of compulsory licence takes lots of time.⁴⁴

The government may negotiate prices of patented medicines before they are launched in the Indian markets. The same rule may also be extended to the patented drugs that are already being sold in the country.⁴⁵ An inter-ministerial committee, evaluating the mechanism to negotiate prices of patented medicines, has recently sought detailed information about such drugs from NPPA including data on a number of patented medicines currently available in India, their market share, prices, disease burden, date of grant of patent and its expiry.⁴⁶ The move is significant since it may bring down prices of many medicines mostly used in treatment of life threatening diseases such as cancer, HIV/AIDS and HBV and HCV.

In a country like India where private out-of-pocket expenditure dominates the cost financing health care, effects are bound to be regressive. As per the Insurance Regulatory and Development Authority (IRDA) estimate, only 21.62 crore people or 17 % of the total population were covered by health insurance at the end of March 2014.⁴⁷ Health care at its essential core is widely recognized to be a public good. Its demand and supply cannot therefore, be left to be regulated solely by the invisible hand of the market. Nor can it be established on considerations of utility maximizing conduct alone. Covering the cost of prescribed medicines within the insurance nets, reducing inequalities in access to medicines, mandatory price negotiations with the drug manufacturers before they launch drugs in Indian markets, keeping under control the prices of the medicines required to treat life threatening diseases so that they are available, affordable and accessible to the common man is quintessential for a healthy society. Lofty legal provisions speaking high about public health with poor focus on the prices of the patented and the generic medicine amounts to deceiving the public.

REFERENCES:

1. In March 2012, India’s Patent Controller issued its first compulsory licence to an Indian generic manufacturer Natco as against a German pharmaceutical company Bayer which charged an affordable US$5,500 per person per month in India for a kidney liver cancer medicine (sorafenib tosylate, marketed as Nexavar). Consequently, a generic version is now available for 97% less at $175/month.

2. Novartis AG vs. Union of India and Others, Civil Appeal Nos. 2706-2716 of 201, 1 April 2013. In this case, the Supreme Court ruled that small changes to its leukaemia drug Glivec did not deserve a new patent since it was a clear case of ever greening i.e., making minor alterations to existing drugs in order to secure a new patent and extend its monopoly.

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9. Rajiv Jain., and Rakhee Biswas., 1999. Law of Patents. Delhi: Vidhi Publishing, pp.1.29-30

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13. Ramesh Chandra., 2004. Issues of Intellectual Property Rights. Delhi: Isha Books.

14. Philip. W. Grubb., 2004. Patents for Chemicals, Pharmaceuticals and Biotechnology. New York: Oxford University Press, p.401-2

15. An ORG-IMS Report, More on your platter, Business Today, 19 Dec 2005, 102- 116.

16. Patralekha Chatterjee., India’s Patent Case Victory Rattles Big Pharma. -Retrieved from http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2960826-0/fulltext on 16 September 2013 at 12.53 p.m.

17. M D.Nair., An industry in transition: The Indian pharmaceutical industry, Journal of Intellectual Property Rights, 7(5), 2002, 405-415.

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19. http://listverse.com/2007/10/04/top-10-incurable-diseases/ accessed 2 November 2015 at 5.34 a.m.

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21. http://www.business-standard.com/article/current-affairs/india-has-1-8-mn-cancer-patients-but-only-one-oncologist-to-treat-every-2-000-114052401140_1.html accessed 4 November 2015 at 6.22 a.m.

22. http://articles.economictimes.indiatimes.com/2014-07-27/news/52089053_1_hepatitis-b-world-hepatitis-day-hepatitis-c accessed 4 November 2015 at 6.30 p.m.

23. http://www.dnaindia.com/mumbai/report-hepatitis-c-drug-from-rs-18-crore-to-rs-12-lakh-2073038 accessed 4 November 2015 at 6.29 p.m.

24. John LaMattina., India’s Solution to Drug Costs: Ignore Patents and Control Prices- Except for Home Grown Drugs. -Retrieved from http://www.forbes.com/sites/johnlamattina/2013/04/08/indias-solution-to-drug-costs-ignore-patents-and-control-prices-except-for-home-grown-drugs/ on 16 September 2013 at 2.24 p.m.

25. http://apps.who.int/gho/data/node.main.517?lang=en accessed 2 November 2015 at 5.57 a.m.

26. http://www.medindia.net/drugs/medical-condition/hepatitis-c.htm accessed 4 November 2015 at 12.22 p.m http://www.medindia.net/patients/patientinfo/new-treatments-for-hepatitis-c.htm accessed 4 November 2015 at 12.30 p.m.

27. Supra n.23.

28. http://www.drugs.com/price-guide/gleevec accessed 4 November 2015 at 1.11 p.m.

29. International Drug Policy Consortium is a global network of 134 NGOs that focus on issues related to drug production, trafficking and use. It is a global network promoting objective and open debate on drug policy. - http://idpc.net/about accessed 5 November 2015 at 4.43 p.m.

30. http://idpc.net/about/policy-principles/principle-2 accessed 5 November 2015 at 4.46 p.m.

31. Article 25 provides that everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.

32. Schedule 7, Article 246 classifies constitutional provisions into three lists viz., Central List, State List the Concurrent List. Public health services are placed in all the three lists. Entry 28, Central list refers to hospitals. Entry 6, State list enumerates public health, hospitals and dispensaries. Entry 19 (drugs), Concurrent List point towards health care services.

33. 1991 SCR Supl. (2) 267.

34. (1989) 4 SCC 286: AIR 1989 SC 2039.

35. (1996) 4 S.C.C. 37.

36. (1996) 2 S.C.C. 682.

37. (1997) 9 S.C.C. 377.

38. Retrieved from https://www.pharmamedtechbi.com/~/media/ Supporting%20Documents/Pharmasia%20News/2012/August/India%20Patent%20Drug%20Pricing%20Report.pdf on 4 November 2015 at 1.03 p.m.

39. Ibid.

40. This policy has been notified on 07.12.2012.

41. NLEM-2011 contains 614 formulations of specified strengths and dosage forms, spread over 27 therapeutic categories and satisfy the priority healthcare needs of majority of the population of the country. -http://pib.nic.in/newsite/backgrounders.aspx?relid=94324 accessed 4 November 2015 at 1.24 p.m.

42. http://pib.nic.in/newsite/backgrounders.aspx?relid=94324 accessed 4 November 2015 at 1.24 p.m.

43. Ibid.

44. http://timesofindia.indiatimes.com/india/Govt-may-negotiate-price-of-drugs-before-market-entry/articleshow/45986019.cms accessed 4 November 2015 at 12.53 p.m.

45. Ibid.

46. http://www.thehindu.com/news/national/only-17-have-health-insurance-cover/article6713952.ece accessed 4 November 2015 at 1.30 p.m.

Received on 09.05.2016 Accepted on 04.06.2016

Asian J. Pharm. Res. 2016; 6(3): 175-182.

DOI: 10.5958/2231-5691.2016.00021.6