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Multinationals and Monopolies

In January 2005, drug product patent protection was reintroduced in India to comply with the agreement on Trade Related Aspects of Intellectual Property Rights. How are the multinational pharmaceutical companies responding to the new policy environment? Is India likely to see monopolisation of the industry and high prices, which was the pattern before 1972 when India had product patent protection? Will the positive features of the post-1972 process patent era be diluted or negated? This study finds that the MNCS have started marketing new patented drugs in India at exorbitant prices particularly for life-threatening diseases such as cancer. The manufacturing and importing behaviour of the MNCS since the 1990s bear a close resemblance to that before the 1970s. Imports of high-priced finished formulations are expanding rapidly with manufacturing investments lagging far behind. The MNCS are also expanding vigorously in the generic segments and are trying to grow not only organically but through mergers & acquisitions and strategic alliance with Indian generic companies.

SPECIAL ARTICLE

Multinationals and Monopolies

Pharmaceutical Industry in India after TRIPS

Sudip Chaudhuri

In January 2005, drug product patent protection was reintroduced in India to comply with the agreement on Trade Related Aspects of Intellectual Property Rights. How are the multinational pharmaceutical companies responding to the new policy environment? Is India likely to see monopolisation of the industry and high prices, which was the pattern before 1972 when India had product patent protection? Will the positive features of the post-1972 process patent era be diluted or negated? This study finds that the MNCS have started marketing new patented drugs in India at exorbitant prices particularly for life-threatening diseases such as cancer. The manufacturing and importing behaviour of the MNCS since the 1990s bear a close resemblance to that before the 1970s. Imports of high-priced finished formulations are expanding rapidly with manufacturing investments lagging far behind. The MNCS are also expanding vigorously in the generic segments and are trying to grow not only organically but through mergers & acquisitions and strategic alliance with Indian generic companies.

The author thanks Sunil Sriwastava and Sushanta Roy for research assistance and Amitava Guha for discussions. The paper is a condensed version of a working paper of the Indian Institute of Management Calcutta (Chaudhuri 2011). A research grant from the institute is gratefully acknowledged.

Sudip Chaudhuri (sudip@iimcal.ac.in) teaches economics at the Indian Institute of Management Calcutta.

1 Background

U
nited States (US) Senate committee (The Kefauver Committee) found in the 1960s that India was among the highest priced nations in the world in pharmaceuticals.1 In 2007, Médecins sans Frontières, the international medical aid organisation operating in more than 70 countries described India as the “pharmacy for the developing world”.

One of the most important factors contributing to this remarkable transformation was the abolition of product patent protection for pharmaceuticals in 1972. After Independence, when India wanted to develop the pharmaceutical industry, the multinational corporations (MNCs) were invited to come to India to help in these efforts. But before 1972 while the MNCs themselves were not very keen on manufacturing in India, they used their patent rights to prevent Indian companies from manufacturing. As a result, on the one hand, the industry remained underdeveloped and, on the other, the monopolies led to high prices. The abolition of product patents eliminated the monopoly power of the MNCs. The cost-effi cient processes developed by the indigenous sector, often in collaboration with government laboratories, could be used for manufacturing the latest drugs, introducing them at a fraction of international prices and dislodging the MNCs from the position of dominance in the domestic market. India became self-reliant in drugs. It emerged as a major player in the global pharmaceutical industry receiving worldwide recognition as a lowcost producer of high quality pharmaceuticals. India supplies medicines not only to other developing countries but also to developed countries such as the US.2

But from 1 January 2005, drug product patent protection has been reintroduced in India to comply with the requirements under the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) of the General Agreement on Tariffs and Trade/World Trade Organisation (WTO). How are the MNCs responding to the new policy environment? As in the pre-1972 situation, is India likely to see monopolisation of the industry and high prices? Will the positive features of the post1972 experience be diluted or negated? This paper deals with the behaviour of the MNCs in the post-TRIPS situation.

2 Rising MNC Dominance

The Indian generic companies are no longer permitted to manufacture new patented drugs. These can now be manufactured only by the patentees and their licencees. Thus depending on the rate of introduction of the new patented drugs, the market

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share of the MNCs is expected to go up. We discuss in Section 3, the changes in the patented drug market in India.

But the MNCs are not interested only in patented markets. They are trying to grow aggressively in the generic segments as well. Traditionally, MNCs have relied for their growth on patented drugs and focused mainly on developed country markets. The high monopoly prices of patented drugs yielded high returns. But recent years have witnessed a sharp fall in the number of new drugs introduced in the market. The MNCs are finding it increasingly difficult to fill the product gap as the patents on their blockbuster drugs are expiring and they are facing constraints on further profitable growth in developed country markets. Pfizer, for example, is set to lose a $10 billion a year revenue stream as the patent on its blockbuster drug Lipitor expires. Desperate attempts by Pfizer to find a replacement have not yielded results.3 The net profi t of the top 15 MNCs declined sharply by 20.1% in 2010 with a major setback for companies such as Merck, Bristol-Myers and GlaxoSmithKline (GSK).4 On the other hand, some developing country markets are experiencing rapid growth. The seven emerging markets of China, Brazil, India, Russia, South Korea, Mexico and Turkey contributed to more than half of the growth of the pharmaceutical market of the world in 2009 compared to only 16% by the developed country markets of North America, western Europe and Japan. The figures were, respectively, 7% and 79% in 2001 (Tempest 2011). Not unexpectedly, the MNCs are targeting the generic industry in these emerging markets as well.

Involvement of the MNCs in the generic market is nothing new in India. When product patents were abolished in India in 1972, the MNCs did not stop their business in India. All the major MNCs decided to stay back. GSK (earlier known as Glaxo),

Table 1: M&As and Tie-ups in Indian Pharmaceutical Industry (2006-10)

in fact, remained the largest seller in the domestic formulations market till recently. But the MNCs in general maintained a low profile. They were hesitant to introduce their latest products. Some of them continued to compete but created new local brands rather than use their international brands. Others stopped selling products they thought were priced too low (Chaudhuri 2005: Chapter 4).

What is new in the post-TRIPS situation is the vigour with which the MNCs are trying to expand not only in the patented markets, but also in the generic markets. MNCs such as Pfi zer, GSK, Merck earlier opted not to introduce some of their blockbuster drugs in India. These are now being introduced. Examples are azithromycin and quinapril by Pfizer, simvastatin by Merck and carvedilol by GSK. In fact the MNCs are not hesitating to market even products developed by the other MNCs. Pfizer, for example, is marketing telmisartan developed by Boehringer Ingelheim (IDFC-SSKI 2010: 16).

As far as India is concerned, the most obvious refl ection of such changes in strategy is the takeover of Indian companies by MNCs and strategic alliances between MNCs and Indian companies (Table 1). Indian companies such as Dr Reddys, Aurobindo, Cadila Healthcare and Torrent have entered into supply agreements with MNCs such as GSK, Astrazeneca and Abbott. Dr Reddys, for example will supply about 100 branded formulation to GSK for marketing in different emerging markets across Latin America, Africa, west Asia and Asia-Pacifi c excluding India. Dr Reddys will get a predetermined share of the revenue earned by GSK for these products. In some markets where Dr Reddys has a presence, the formulations will be marketed jointly. Another example is the Aurobindo-Pfi zer deal. Aurobindo will supply more than 100 formulations to

Indian Company Foreign Company Date Type Comments

Aurobindo Astrazeneca 10 September Tie-up Licensing and supply agreements for several solid dosage and sterile products for emerging markets across anti-infectives, CVS & CNS segments

Primal Healthcare Abbott 10 May M&A Abbott acquired the domestic formulation business of Piramal for $3.7 billion.

Cadila Abbott 10 May Tie-up Abbott licences 24 Cadila products in 15 high growth emerging markets, holds option for more than 40 additional products

Orchid Chemicals Alvogen 10 May Tie-up Alvogen to have marketing rights for eight oral generic formulations for US in the area of CNS and Osteoporosis. The product to be sourced exclusively from Orchid

Indoco Aspen 10 March Tie-up Generic supply deal for ophthalmic products across 30 countries in emerging markets. Aspen will have market authorisation over these products

Torrent Astrazeneca 10 March Tie-up Generic supply deal for 18 products across nine countries. Further flexibility to add more products and new countries

Strides Pfizer 10 January Tie-up Generic supply of off-patent sterile injectable and oral products. Expects supplies of 40 off patent products in oncology therapeutics

Orchid Chemicals Hospira 9 December M&A Hospira acquired generic injectable business for $400 million.

Shantha Biotech Sanofi-Aventis 9 July M&A Sanofi-Aventis acquired Shantha for $783 million

Dr Reddy's GSK 9 June Tie-up GSK will gain exclusive access to Dr Reddy's rich and diverse portfolio and future pipeline. Dr Reddy’s to manufacture but will be licensed and supplied by GSK in Latin American markets with the exception of co-marketing in certain markets

Aurobindo Pfizer 9 May Tie-up Licensing and supply agreements for several solid dosage and sterile products for emerging markets. Offers rights to Pfizer for 55 solid and five sterile products in Latin American markets covering anti-infective CVS & CNS

Claris Lifescience Pfizer 9 May Tie-up The deal offers Pfizer with marketing right for 15 injectables product in area of anti-infective and pain mgt for regulated markets

Ranbaxy Daiichi-Sankyo 8 June M&A Daiichi-Sankyo acquired Ranbaxy for $4.6 billion

Dabur Pharma Fresenius Kabi 8 April M&A Fresenius Kabi of Singapore acquired Dabur for $219 million

Matrix Laboratories Mylan 6 August M&A The US generic company Mylan acquired Matrix for $736 million

Sources: SBICAP (2010); DIPP (2010).

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Pfizer for the regulated markets of US and the European Union (EU) and more than 50 products for about 70 non-US/EU markets. It has been reported that apart from revenue sharing, the deal involves payment of upfront licence fees by Pfi zer to Aurobindo. These deals enable the MNCs to get access to low-cost reliable products without undergoing the lengthy process of getting regulatory approvals in different markets and without incurring any capital expenditure for setting up manufacturing plants. The Indian companies gain by having access to the formidable marketing resources of the MNCs. Experience suggests that it is not easy to simultaneously enter into different markets on their own. Efforts by some Indian companies to enter and expand in foreign markets with their own marketing infrastructure have not always led to the desired results. The Indian companies hope to better realise their manufacturing capacities and capabilities through these alliances with the MNCs (IDFC-SSKI 2009, 2010).

More significant than these alliances is the take over of Indian companies by the MNCs. The share of the MNCs in the domestic formulations market has dramatically increased from less than 20% in March 2008 to 28% in December 2010, with the acquisition of Ranbaxy by Daiichi Sankyo in June 2008, Dabur Pharma by Fresenius Kabi Oncology in August 2008, Shantha Biotechs by Sanofi-Aventis in July 2009 and the domestic formulations business of Piramal Healthcare by Abbott in May 2010. In March 2008, there was only one MNC (GSK) among the top 10 companies in India. By December 2010 the number of MNCs in the top 10 went up to three (GSK, Ranbaxy and the Abbott group). The Abbott group comprising Abbott, Piramal Healthcare and Solvay Pharma is now the largest company in India with a market share of 6.2% ahead of the second largest Cipla (5.7%). Abbott was the 30th largest company in the domestic formulations market in March 2008 with a market share of only 1.1%.5

Thus, the declining trend in the aggregate market share of the MNCs which started in the 1970s has been reversed. The MNCs are recovering lost ground. The post-TRIPS environment and the strategy being adopted by the MNCs suggest that they are on the way to dominating the industry again. First, the MNCs are aggressively pursuing growth in the generic segments. Second, they will enjoy monopoly power in the patented drugs market. Third, they have the financial capacity to take over more Indian companies. If a few other major Indian companies such as Cipla (5.7% market share in 2010), Sun (4.3%), Cadila Healthcare (3.9%), Mankind (3.2%), Alkem (3%), Lupin (2.9%) are taken over, the MNC share will exceed 50% immediately.

The MNCs are not only taking over Indian companies. They are also consolidating their control over their Indian counterparts. Under the Foreign Exchange Regulation Act, 1973, (FERA), the pharmaceutical MNCs, which were manufacturing only formulations or bulk drugs not involving “high technology” were required to reduce foreign equity to 40% or below. With the abolition of FERA as a part of economic reforms of the 1990s, not surprisingly the MNCs have increased their equity stakes. Currently all the pharmaceutical MNCs listed in Indian stock exchanges have a majority foreign shareholding of more than 50%. The tendency to increase the equity stake has actually accelerated in the last few years (Table 2). Novartis has increased foreign equity from 50.93% in 2005 to 76.42% in 2010, Pfizer from 40% to 70.75%, Abbott from 61.7% to 68.94% and Aventis from 50.1% to 60.4%.

Table 2: Foreign Equity in Pharmaceutical MNCs in India (2001-10, %)

2001 2005 2006 2007 2008 2009 2010

Astrazeneca Pharma India 51.5 90 90 90 90 90 90

Novartis India 50.99 50.93 50.93 50.93 50.93 50.93 76.42

Pfizer 40 40 41.23 41.23 41.23 41.23 70.75

Abbott India 51 61.7 61.7 65.14 65.14 68.94 68.94

Aventis Pharma 50.1 50.1 50.1 50.12 50.12 50.12 60.4

Fulford (India) 40 40 40 50.77 53.93 53.93 53.93

Merck 51 51 51 51 51 51 51.8

Wyeth 50.37 51.12 51.12 51.12 51.12 51.12 51.12

GlaxoSmithKline 51 49.15 50.67 50.67 50.67 50.67 50.67

Source: Foreign promoters equity data from the CMIE Prowess database.

3 Rising Imports of Finished Formulations

Legitimately, the abolition of product patent protection in India has attracted more attention. But two other policies which helped the growth of the Indian pharmaceutical industry were FERA and the New Drug Policy, 1978 (revised in 1986). The drug policy imposed restrictions on the FERA companies (i e, those with more than 40% foreign equity) which were not applicable to Indian companies. One of the most important policies that was implemented was that the MNCs were not allowed to market formulations unless they themselves produced the bulk drugs in specified ratios. This compelled the MNCs to undertake manufacturing investments from basic stages. In fact, together with the Indian companies, the manufacturing activities of the MNCs too expanded after the 1970s.6

But after the mid-1990s with the withdrawal of such restrictions, the MNCs started disinvesting in manufacturing operations. They have sold a number of plants which they had set up earlier under government pressure. Thanks to the development of the bulk drugs industry in India from 1970s onwards, most of the bulk drugs are now produced by a number of Indian producers and are available at very low competitive prices. Since it was no longer mandatory for the MNCs to manufacture bulk drugs, they could afford to close down the plants previously set up and rely on cheaper supplies form Indian bulk drugs manufacturers (Chaudhuri 2005: Chapter 4).

In 1994, the investments in plant and machinery (including computers and electrical installations) of the top nine MNCs was Rs 455.51 crore, accounting for about 70% of that of the top 10 Indian companies.7 Thereafter as Figure 1 (p 49) shows, whereas plant and machinery investments by the Indian companies increased rapidly, that of the MNCs essentially stagnated. By 2010, MNC investments accounted for only 5% of the investments of Indian companies of Rs 13,765.25 crore. These data at current prices suggest that real investments by the MNCs have been falling in absolute terms. If we use the Wholesale Price Index (1993-94 series) of the broad manufacturing group of “machinery and machine tools”,8 then MNC

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Figure 1: Plant and Machinery Investments (Rs crore)

14.000

10,000

6,000

2,000

0

Top 10 Indian cos MNCs

1994 1996 1998 2000 2002 2004 2006 2008 2010 Sources and Notes: Calculated from data from the CMIE Prowess database. See Notes to Table 3 for the names of the companies covered.

investments at 1994 prices show a decline from Rs 455.51 crore in 1994 to Rs 406.56 crore in 2009.

Thus, the manufacturing activities of the MNCs after economic liberalisation are reminiscent of the 1950s and 1960s when the official policy was quite liberal but the MNCs were reluctant to undertake manufacturing. In fact, as in the previous period one finds that the propensity to import fi nished medicines for the purposes of marketing in India has gone up.

What has attracted widespread attention is India’s success as a pharmaceutical exporter. What is less noticed is that in recent years imports of formulations have been rising sharply. Figure 2 shows the impressive growth of formulations exports. The same figure also shows the sharp rise in formulations imports. Exports exceed imports, but between 1995 and 2010, imports have grown at a faster rate than exports leading to a decrease in the “trade surplus” in formulations. Imports of formulations have expanded from $69.5 million in 1995 to $1,096.1 million, i e, at a compound annual rate of growth of 20%. Exports have grown at 17% from $503.2 million in 1995.

Figure 2: India's Formulations Trade ($ million)6,000

5,000

3,000

1,000

0

Exports Imports

1995 1997 1999 2001 2003 2005 2007 2009 2010 Sources and Notes: (i) Calculated from Directorate General of Commercial Intelligence and Statistics (DGCI&S) trade data obtained from CMIE India Trades database. (ii) Trade figures reported under Chapter 30 have been treated as formulations.

Further details are not available about the composition of these formulations imports. But there are reasons to believe that much of these imports relate to high-priced products of the MNCs for which there are no generic equivalents in the country. In 2010, about 65% of these imports came from the fi ve countries – Switzerland, US, UK, Germany and France – where most of the MNCs are located. Switzerland alone accounted for a third of these imports.9 India has demonstrated its cost competitiveness in pharmaceutical manufacturing. As mentioned above, a number of MNCs are entering into alliances with Indian companies for supplying not only bulk drugs but also formulations for generic markets across the globe. Thus it is unlikely that

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anyone would be importing mature generic formulations from these countries. In patent protected monopoly markets, costs are not so important. In fact, costs can be a small fraction of the high prices that can be charged. As we will discuss below, the MNCs have started marketing high priced patented products.

The MNCs which are already operating in the country are directly involved in such imports. Figure 3 shows how the imports of finished products by seven major MNCs have grown in recent years. After increasing sharply in the late 1990s, imports stabilised a bit. It again started increasing in the mid-2000s. The Indian companies and agents are also involved in such imports of fi nished drugs. MNCs not operating in India are entering into marketing alliances to sell their products. Indian companies which act as authorised agents for imported formulations include Elder, USV, Emcure, Cadila Healthcare, Piramal, Ranbaxy.10

Figure 3: Imports of Finished Goods by MNCs ($ million) 140 120

80

40

0

1997 1998 1991 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Sources and Notes: (i) Calculated from CMIE Prowess database. (ii) The MNCs considered here are Abbott, Aventis, GSK, Pfizer, Novartis, Merck and Wyeth. (iii) Data are available for each of the years 1997 to 2010 for only these seven MNCs in the CMIE database. These seven companies account for about 83% of sales of all the 16 MNCs reported by Prowess in 2010.

One of the ways in which patented drugs can be made more affordable is to impose price controls. This is an important policy tool which countries have – none of the WTO agreements forbid price control. Prices of selected drugs are controlled by the National Pharmaceutical Pricing Authority (NPPA) under the Drugs Price Control Order (DPCO), 1995. If the current provisions of DPCO are to be strictly followed, NPPA cannot ask for the details of the imported cost of drugs. In fact, an attempt by NPPA to do so has failed – the concerned MNC went to the court to prevent NPPA from asking for cost data.11 NPPA is required to accept whatever costs the importers declare. Thus importing high priced drugs is one way of avoiding price control. It is important to change the provisions of DPCO. The DPCO can and should be changed to find out whether the costs and prices claimed by the importers are reasonable.

That MNCs with huge technological resources can help host countries to develop industries is one of the basic expectations of the foreign direct investment policy. Technology imports, assimilation and diffusion can help build the technological base of a country. But this cannot happen unless manufacturing activities are undertaken by the MNCs in the host country. If they are more interested in selling imported drugs and/or drugs manufactured by others in India, obviously the question of benefi cial techn logical impact does not arise. In view of the progress of the Indian companies, India may not require foreign technology for matured products. But the new drugs being introduced may require new technologies. If these products are manufactured in the country, the country may gain. But if that is not happening then it is legitimate to question the role of the MNCs and ask for proper regulations to tune their activities more in line with country’s interest.

Not only with respect to manufacturing technology. On several other counts the performance of the MNCs compares unfavourably with that of the top Indian companies (Table 3). Unlike the Indian companies, the MNCs spend more in foreign exchange for imports, interest payments, royalty/technical fees, dividend remittances, etc, than they earn through exports and other means. Whereas the foreign exchange defi cit of the MNCs has gone up from $20.52 million in 1994 to $205.05 million in 2019, i e, at 15% per annum, the foreign exchange surplus of

Table 3: Relative Performance of MNCs and Top Indian Companies

1994 2004 2010 Compound Annual CARG Rate of Growth (CARG) (2004-10) (%) (1994-2010) (%)

Exports ($ million) MNCs* 38.22 56.92 82.75 5 6

Top 10 Indian cos** 167.50 1,456.64 4,006.48 22 18

Exports/sales (%) MNCs 4.73 5.02 4.41

Top 10 Indian cos 27.78 45.71 49.31

Net forex earnings

($ million)

MNCs -20.52 -79.66 -205.05 -15 -17

Top 10 Indian cos 40.07 702.20 2,392.58 29 23

Dividend remittances

($ million)

MNCs 5.18 27.43 54.67 16 12

* The MNCs considered are: GlaxoSmithKline Pharmaceuticals, Pfizer, Aventis Pharma, Abbott India, Novartis India, Wyeth, Astrazeneca Pharma India, Merck, Fulford (India). Consistent data for 1994, 2004 and 2010 are available for only these nine MNCs out of the 17 MNCs considered by the CMIE Prowess database. ** The Indian companies considered are Cipla, Dr Reddy'S Laboratories, Ranbaxy Laboratories, Lupin, Aurobindo Pharma, Matrix Laboratories, Sun Pharmaceutical Inds., Ipca Laboratories, Torrent Pharmaceuticals, Orchid Chemicals and Pharmaceuticals.These are the top 10 Indian companies (in terms of sales in 2010) for which consistent data are available for 1994, 2004 and 2010. For some of the variables, the number of companies actually considered is less depending on the data available. Source: Calculated from CMIE Prowess database.

the top Indian companies increased at 29% per annum during the same period. Between 1994 and 2010, MNC export earnings increased by only 5% per annum (compared to 22% by the Indian companies), but dividend remittances increased by 16% per annum. Export intensity, i e, exports as a percentage of sales, has remained stagnant for the MNCs at around 4% in 2010 compared to about 50% for the Indian companies.

4 Market Structure and Prices of Patented Products

Considering the role that the abolition of product patent protection played in the pharmaceutical industry in India, reintroduction of product patent protection since 2005 has crucial significance. The basic apprehension is whether India will now go back to the pre-1972 situation of an MNC monopoly and high prices. Though product patents have been introduced from 1 January 2005, earlier from 1 January 1995, a mailbox facility was put in place to receive and hold product patent applications.12 As per the TRIPS agreement, these applications are being processed since 1 January 2005 for the grant of patents. Thus, to understand the impact on the market structure and prices, we consider the period since 1995.

50

Indian generic companies are no longer permitted to manufacture and market new drugs for which patents have been granted in India. But not all new drugs are patentable in India. Under Article 70(3) of TRIPS, a WTO member country has no obligation to provide patent protection for any subject matter which has fallen into the “public domain” before the WTO came into being, i e, before 1 January 1995. Thus any drug product patented abroad before 1995 can continue to be manufactured and sold in India after 1995 even though these may be under patent protection in other countries.

Drugs patented after 1 January 1995 can be classifi ed into the following categories:

  • (1) Those involving new chemical entities (NCEs) (also known as new molecular entities (NMEs)), and new biological entities (NBEs) patented after 1995.
  • (2) Those involving NCEs/NBEs developed before 1995 but with patents after 1995 for: (a) new formulations and compositions,
  • (b) new combinations, and (c) new chemical derivatives (salts, esters, etc).
  • According to Article 27(1) of TRIPS, patents are required to be provided for inventions, which are “new, involve an inventive step and are capable of industrial application”. The agreement, however, does not define these terms. This provides some flexibility. India has taken advantage of this fl exibility by enacting Section 3(d) in the amended Patents Act and restricting product patents to some extent. Under Section 3(d), India is not obliged to provide protection to any secondary patents (of new formulations/combinations/chemical derivatives) after 1995 involving NCEs developed before 1995 “unless they differ significantly in properties with regard to effi cacy.”

    Further, in cases where Indian companies were already producing and marketing before 1 January 2005, the products for which patent applications have been made in the mailbox, they need not suspend production even if MNCs get the patents. Under Section 11A(7), they can continue to produce on payment of “reasonable royalty”.

    Elsewhere we have listed all the 180 new drugs marketed in India since 1995 (and till 2010) (Chaudhuri 2011: Appendix). We consider as new drugs all NCEs and NBEs approved for marketing in the US by the United States Food and Drug Administration (USFDA). This has been obtained from the website of the USFDA. We used the website of India’s Central Drugs Standard Control Organisation to fi nd out whether and when these have been approved for marketing in India. Since it is difficult to get systematic information on pharmaceutical product patents granted by the patent office in India, we have used the website of the USFDA for this purpose as well.13

    As Table 4 (p 51) shows, the sales of the 180 new drugs being marketed in India constitute about 9.1% of the total pharmaceutical market in India in 2010. These 180 drugs are further classifi ed into:

  • (1) Sixty-two drugs for which patents have expired in the US (3.8% of the Indian market).
  • (2) Sixty-seven drugs for which patents were granted in the US before 1995 and hence not patentable in India in accordance with the TRIPS agreement (4.2%).
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    (3) Fifty-one drugs for which patents were granted in the US after 1995 and hence patentable in India subject to Section 3(d) provisions (1.2%).

    Table 4: Patent Status of New Drugs Marketed in India (1995-2010)

    No Sales 2010 Sales 2010 (%) MNC Share
    (Rs Crore) 2010
    A New drugs 180 4,726.66 9.1 10.9
    A.1 Patented post-1995 51 599.95 1.2 25.2
    A.2 Patented pre-1995 67 2,173.20 4.2 5.5
    A.3 Patent expired 62 1,953.51 3.8 12.6
    B Total pharmaceutical market 52,052.56 100.0 19.1

    Sources and Notes: (i) See text and Chaudhuri (2011: Appendix) for the methodology to find out the new drugs and the patent status. (ii) Product-wise annual sales figures have been obtained from the “Sales audit data” of AIOCD Pharmasofttech AWACS (AIOCD-AWACS). AIOCD-AWACS is a pharmaceutical market research company formed by All Indian Origin Chemists and Distributors. AIOCD in a joint venture with Trikaal Mediinfotech. It is a corporate pharma retail chain set up by 5,50,000 members of All India Organisation of Chemists and Druggists (http://www.aiocdawacs.com/).

    Thus, the market share of patentable new drugs market in India is still very small. It would however not be correct to infer from here that patented drugs are not a problem in the country. As we will see below, for life-threatening diseases such as cancer, exorbitant prices are being charged for the new patented drugs. For these patients it is a question of not getting proper treatment if they cannot afford the high cost. Moreover, it is just in a few years that product patent protection has been introduced in India. Considering the time lag between the time when an NCE/NBE is patented and when it is fi nally approved for marketing, all the post-1995 NCEs/NBEs are not yet ready for the market. Some of the MNCs, for example, GSK have revealed ambitious plans to launch a basket of patented products. They are expanding their marketing infrastructure in anticipation of the future patented market.14 Table 5: Market Structure of New Drugs (2010)

    Total No of No of No of No of
    Molecules Molecules Molecules Molecules
    with Five or with Two to with One
    More Sellers Four Sellers Seller
    1 Patented post-1995
    1.1 No of molecules (no) 51 19 6 26
    1.2 Sales 2010 (Rs crore) 599.95 462.67 15.59 121.69
    1.3 No of molecules (%) 100.0 37.3 11.8 51.0
    1.4 Sales 2010 (%) 100.0 77.1 2.6 20.3
    2 Patented pre-1995
    2.1 No of molecules (no) 67 46 11 10
    2.2 Sales 2010 (Rs crore) 2173.20 2,115.38 30.92 26.90
    2.3 No of molecules (%) 100.0 68.7 16.4 14.9
    2.4 Sales 2010 (%) 100.0 97.3 1.4 1.2
    3 Patent expired
    3.1 No of molecules (no) 62 43 11 8
    3.2 Sales 2010 (Rs crore) 1,953.51 1,912.50 25.67 15.34
    3.3 No of molecules (%) 100.0 69.4 17.7 12.9
    3.4 Sales 2010 (%) 100.0 97.9 1.3 0.8

    Source: Same as in Table 4.

    Table 5 shows the nature of competition in these three categories of new drugs. In the first two categories where patent barriers are not there in India, the markets are much more competitive than the third category. For patent expired molecules, there are five or more sellers for 43 products accounting for 97.9% of the market. For pre-1995 molecules the figures are 46 products and 97.9%, respectively. There are

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    monopolies for only 1% of the market. Thus these markets are essentially competitive.

    But for the third category of post-1995 drugs, there are monopolies in 50% of the products accounting for 20% of the market. Surprisingly even for the post-1995 products, for about three-fourths of the market the number of sellers is fi ve or more. Two TRIPS flexibilities may explain this. Under Section 11A(7), Indian generic companies which have started manufacturing before 2005 are not required to suspend production even if patents are granted (after 2005).

    More important is the Section 3(d) fl exibility. Consider, for example, the two post-1995 products, Novartis’ anti-cancer drug, imatinib mesylate, and Gilead’s anti-HIV/AIDS drug, tenofovir disoproxil fumarate. Product patents are in force in the US for these products. But for both these products the original compound – imatinib and tenofovir, respectively – were disclosed before 1995. What actually have been patented are a particular beta crystalline form (mesylate) and a particular salt (disoproxil fumarate). Hence, these are not patentable in India subject to the enhanced efficacy clause of Section 3(d). Patent Office/high courts have rejected these patent applications. The matter is currently with the Supreme Court.15 In the absence of any legal barrier to enter these markets a number of Indian generic companies are manufacturing and selling these products in the market. There are 14 companies selling imatinib mesylate and six companies selling tenofovir disoproxil fumarate. Another product where the MNC product patent has been contested relates to the anti-cancer drug, erlotinib. This is manufactured by six Indian companies.

    In a product patent regime, the main interest centres around the behaviour of the MNCs. In India, they are involved in marketing 92 out of the 180 new drugs. As Table 6 shows,

    Table 6: New Drugs Marketed by MNCs (2010)

    No of Molecules MNC Sales 2010 MNC Sales 2010 (%)
    (Rs Crore)
    Marketed by MNCs (1 to 7) 92 517.14 100.0
    1 MNC monopoly (1.1 to 1.3) 33 160.18 31.0
    1.1 Patented 25 121.40 23.5
    1.2 Patent expired 2 12.09 2.3
    1.3 Pre-1995 6 26.69 5.2
    2 MNC share: 50-100% 8 91.01 17.6
    3 MNC share: 25-50% 12 137.64 26.6
    4 MNC share: 10-25% 7 56.70 11.0
    5 MNC share: 5-10% 9 53.19 10.3
    6 MNC share: 1-5% 12 16.59 3.2
    7 MNC share: < 1% 11 1.81 0.3

    Source: Same as in Table 4.

    MNCs have monopolies in 33 products accounting for 31% of their sales of Rs 517.14 crore of these 92 products. In fact, in 53 products accounting for more than three-fourths of their sales they have a market share of 50% or more. It is interesting to note that eight out of these 33 products, for example, anidulafungin, caspofungin, micafungin and pegaptanib, are pre1995 molecules or patents have expired. This suggests that there are entry barriers other than patent barriers, for example, complex manufacturing process.16

    Table 7 gives an idea about the pricing policy adopted by the myeloid leukaemia. The price of a 70 mg dasatinib tablet is MNCs for these 33 monopoly products. A 50 ml injection of Roche’s Rs 3,905. Assuming a treatment regimen of 100 mg per day, anti-cancer drug Herceptin (generic name: trastumuzab) costs the cost of treatment per person per year exceeds Rs 20 lakh. Rs 1,35,200. Among the other high priced drugs are Merck’s The corresponding cost in the UK is £30,477 suggesting that Table 7: Prices of MNC Monopoly Drugs the company (Bristol Myers Squibb)

    Molecule Name Brand Name MNC MRP* in Rs Therapeutic Group

    Trastuzumab Herceptin injection 50 ml Roche 1,35,200 Anti-cancer

    Cetuximab Erbitux 700 mg injection 50 ml Merck 87,920 Anti-cancer

    Ixabepilone Ixempra 45 mg injection 1 Bristol-Myers Squibb 66,430 Anti-cancer

    Pegaptanib Macugen 0.3 mg injection 90 ml Pfizer 45,350 Ophthal/ otologicals

    is essentially charging the same price and not using differential pricing.17

    All the drugs listed in Table 7 are monopoly drugs in the sense there is only one seller of the molecule concerned. Effective competition in pharmaceuticals takes place within therapeutic categories, for example, cardiac, anti-diabetic, etc, where

    Daclizumab Zenapax 25 mg injection 5 ml Roche 28,875 Anti-cancer different molecules may compete

    Etanercept Enbrel 50 mg injection 1 Wyeth 15,761 Pain/analgesics

    Caspofungin Cancidas 70 mg injection 10 ml MSD 12,500 Anti-infectives

    Anidulafungin Eraxis 100 mg injection 1 Pfizer 9,107 Anti-infectives

    Sunitinib Sutent 50 mg capsule 1 Pfizer 8,715 Anti-cancer

    Micafungin Mycamine 50 mg injection 1 Vial GlaxoSmithKline 6,250 Anti-infectives

    Lenograstim Granocyte 34 injection 1 Sanofi Aventis 5,720 Anti-cancer

    Daptomycin Cubicin 350 mg injection 1 Novartis 5,051 Others

    Lapatinib Tykerb 250 mg tablet 1 GlaxoSmithKline 4,468 Anti-cancer

    Liraglutide Victoza 6 mg injection 3 ml Abbott 4,315 Anti diabetic

    Dasatinib Sprycel 70 mg tablet 1 Bristol-Myers Squibb 3,905 Anti-cancer

    Fondaparinux Arixtra 2.5 mg injection 0.5 ml GlaxoSmithKline 620 Cardiac

    against each other. It is important to note that in therapeutic categories such as cardiac and anti-diabetic, where different molecules are available in the market, the prices of the monopoly molecules in Table 7 are relatively low, for example, cerivastation, dronedarone, saxagliptin and sitagliptin. But for life-threatening diseases such as cancer, for essential

    Reviparin Clivarine PFS SC 4,200 Iu injection 0.6 ml Abbott 482 Cardiac drugs without effective substitutes,

    Rivaroxaban Xarelto 10 mg tablet 1 Bayer 480 Cardiac

    Ceftibuten Procadax 90 mg syrup 30 ml Fulford 384 Anti-infectives

    Zuclopenthixol Clopixol Depot 200 mg injection 1 ml Lundbeck 247 Neuro/CNS

    Certoparin Troparin 3,000 Iu injection 0.3 ml Novartis 235 Cardiac

    Dronedarone Multaq 400 mg tablet 1 Sanofi Aventis 84 Cardiac

    Varenicline Champix 1 mg tablet 1 Pfizer 59 Neuro/CNS

    Aliskiren Rasilez 300 mg tablet 1 Novartis 58 Cardiac

    Sitagliptin Januvia 100 mg tablet 1 MSD 43 Anti-diabetic

    Saxagliptin Onglyza 5 mg tablet 1 Bristol-Myers Squibb 38 Anti-diabetic

    Cerivastatin Lipobay 0.3 mg tablet 1 Bayer 32 Cardiac

    Piribedil Trivastal L A 50 mg tablet Serdia 20 Neuro/CNS

    prices are exorbitant as in the cases trastuzumab, cetuximab, ixabepilone, etc. Similarly, the prices of vital drugs such as Wyeth’s Enbrel (etanercept) (Rs 15,761 per injection) used for rheumatoid arthritis, which can incapacitate people, Pfi zer’s Macugen (pegaptanib) (Rs 45,350 per 90 ml injection) used for preventing loss of vision in the case of

    Mianserin Depnon 30 mg tablet 1 Organon 12 Neuro/CNS age-related masucular degenera-

    Sources and Notes: (i) Sales data (to find out the monopoly status) and price data have been obtained from the “sales audit data” of tion, Sanofi-Aventis’ Fasturtec (ras-AIOCD-AWACS. (ii) For the selected molecules, we also tried to find out the prices from two large retail outlets in Kolkata – Calcutta

    Chemist Corner and AMRI hospitals. *: MRP: maximum retail price. #: We have also included this product for which Roche accounts for 96% of the market.

    Erbitux (cetuximab) (Rs 87,920), Bristol-Myers-Squibb’s Ixempra (ixabepilone) (Rs 66,430), Pfizer’s Macugen (pegaptanib) (Rs 45,350), Sanofi-Aventis’ Fasturtec (rasburicase) (Rs 45,000), Roche’s Avastin (bevicizumab) (Rs 37,180). There are six products costing between Rs 10,000 and Rs 45,000 (for example, Wyeth’s Enbrel (etanercept): Rs 15,761), eight products between Rs 1,000 and Rs 10,000 (GSK’s Tykerb (lapatinib): Rs 4,468), another six products between Rs 100 and Rs 1,000 (Bayer’s Xarelto (rivaroxaban): Rs 480) and only eight products with prices below Rs 100 (for example, MSD’s Januvia (sitagliptin): Rs 43).

    It is important to note that the prices mentioned in Table 7 are for a single injection/tablet, etc. The cost of treatment per person per year would of course be much higher. Consider, for example, dasatinib, which is used for the treatment of chronic buricase) (Rs 45,000 per injection)

    used to treat the side effects of

    chemotherapy for treating leukaemia and lymphoma are very highly priced.

    Table 7 does not cover all the patented and monopoly drugs marketed in India. We have tried to focus on products where MNCs have a monopoly. There are also products where MNCs do not have a monopoly but are charging very high prices pending the settlement of patent disputes. This paper has not systematically studied these products. But an example can be given. The price of pegalyted interferons beta (Roche’s Pegasys) costs between Rs 14,000 and Rs 18,000 per dose. It is used for Hepatitis co-infected with HIV. Roche got the product patent in India. But due to patent disputes, some Indian generic companies are also manufacturing and marketing it.18

    Table 7 lists the monopoly products directly marketed by MNCs. But, as we have mentioned above, MNCs not operating in India are using the marketing infrastructure of Indian companies

    march 24, 2012 vol xlviI no 12

    to import and sell their products. We have also not been able to find out the structure of prices of these imported products. But the example of poractant alfa shows that these prices also can be very high. The drug is imported by Piramal.19 Piramal as the sole seller charges a price of Rs 17,957.8 per 80 mg injection 3 ml vial.

    Though we have not been able to list all the products with high prices in Table 7, it is clear that the days of monopolies and high drug prices are back again in India particularly for drugs without close substitutes.

    In the product patent regime, the prices of new drugs will depend on:

  • the prices the MNCs holding the patents would charge;
  • the steps that can be taken to regulate such prices including price control or price negotiation;
  • the steps which are taken to provide competition from generic producers.
  • If MNCs charge affordable prices for patented drugs in developing countries, access may not be adversely affected. Some MNCs are selling drugs at a discount compared to the prices charged in the developed country markets. GSK is an example

    – the company has adopted the policy of selling drugs at a discount compared to the US price. But even with a discount, the cost of treatment of Tykerb is about Rs 6 lakh per person per year.20 Or if the MNCs give voluntary licences to generic companies to manufacture the patented drugs, the consequent competition can make drugs more affordable. But, voluntary licences have mainly been given for products which have very little patent life left and have rarely been given voluntarily. Usually they follow some public pressure or legal action and sometimes they have been used as a strategy to thwart oppositions by generic companies.

    Price control is not forbidden under TRIPS or any other agreement of the WTO. India’s Draft National Pharmaceuticals Policy, 2006 recommended mandatory price negotiations of patented drugs before granting marketing approval and stressed the importance of studying the experiences of Canada, Australia, France and other countries believed to have a good system (p 15). In fact a Committee on Price Negotiations on Patented Drugs has been set up in the department of pharmaceuticals. This is an important initiative and efforts should be expedited to initiate measures to control the prices of patented drugs. One important difference between direct price control measures and efforts to enhance generic competition to keep price in directly under control may be noted. The former, if properly implemented, makes drugs more affordable but does not provide any room for the generic companies. The latter not only makes the prices more affordable through competition. It also ensures some space to the generic companies, which is vital for their long term sustenance.

    The importance of generic competition is clear from cases of Section 3(d) of the Patents (Amendment) Act 2005. Like dasatinib, imatinib mesylate is indicated for chronic myeloid leukaemia. For dasatinib, there is only one seller and the price is very high (Table 7). But there are about 14 Indian generic companies manufacturing imatinib mesylate. As a result, the cost of treatment has gone down sharply compared to that of the MNC (Novartis) product. Sun, the market leader, charges a price of Rs 203 for a 400 mg tablet. Similarly there are six manufacturers of tenofovir. Cipla the market leader charges a price Rs 150 per 30 mg tablet. Again for erlotinib, compared to Roche’s Tarceva’s price of Rs 4,200 (150 mg tablet) Cipla’s Erlocip costs Rs 1,530.

    While Section 3(d) has played quite a useful role in India in recent years, the policy option which is much more potent and sustainable in the longer run in compulsory licensing. Compulsory licensing is a permission given by the government to a non-patentee to manufacture a drug without (or even against) patentee’s consent. As is widely recognised, compulsory licensing is one of the ways in which TRIPS attempts to strike a balance between promoting access to existing drugs and promoting Research and Development (R&D) into new drugs. If generic companies are given licenses to produce a patented drug on payment of royalty, then competition among manufacturers would drive down prices, but the royalty paid to the innovators would continue to provide funds and the incentive for R&D.

    The exorbitant prices being charged by the MNCs for some of the products provide a very good rationale for compulsory licensing intervention. It is really surprising that it has not yet attracted the attention it deserves among generic companies, civil society organisations and government.

    5 Conclusions

    The most important conclusion of this study is that the days of product monopolies and high prices are back in India. The MNCs have started marketing new patented drugs at exorbitant prices particularly for life-threatening diseases such as cancer.

    The manufacturing and importing behaviour since the 1990s bears a close resemblance to that before the 1970s. Imports of high priced finished formulations are expanding rapidly, with manufacturing investments lagging far behind.

    The MNCs are also expanding vigorously in the generic segments. They are trying to grow not only organically but through mergers & acquisitions and strategic alliance with Indian generic companies. The aggregate market share in the formulations market has gone up dramatically with the taking over of some Indian companies by the MNCs. The MNCs are on the way to dominating the industry again.

    Notes

    1 Cited by Kidron (1965: 251). 2 See Chaudhuri 2005: Chapter 2 for an account of the rise and growth of the Indian pharmaceutical industry.

    3 “Drug Firms Face Billions in Losses as Patents End”, New York Times article reproduced in Business Standard, 3 August 2011.

    Economic & Political Weekly march 24, 2012

    EPW
    4 Sanjay Pingle, “Leading 15 Global Pharma Majors identified by us as MNCs out of the 671 compa-
    Suffer Setback in 2010, Net Falls by Over 20%”, nies reported by AIOCD-AWACS based on mis
    www.pharmabiz.com, 6 June 2011. cellaneous sources including, the list of top 50
    5 As mentioned in Table 4, sales data have been MNCs in the world in Pharmaceutical Executive,
    obtained from AIOCD-AWACS. The MNC sec- May 2010 (www.pharmexec.com); CMIE Prowess
    tor comprises the following two groups. The database; the list of MNCs from market survey
    first group of 35 companies (see Table 2, reports of ORG-IMS as used in Chaudhuri (2005),
    Chaudhuri 2011) are those which have been Table 2.2 and relevant company websites. The
    vol xlviI no 12 53

    second group of four companies are the Indian companies which have been taken over by MNCs in recent years and are now part of the MNC sector. Another Indian company, Matrix taken over by Mylan in August 2006, not being a domestic formulations player is not considered above.

    6 MNCs invested more in India during 1972-94 than they did in the earlier period see the interview with N H Israni, in IDMA Bulletin, XXXIII (42), 14 November 2002.

    7 CMIE Prowess database. Consistent data for 1994 to 2010 are available for only these nine MNCs out of the 17 MNCs considered by the CMIE Prowess database. For the names of these MNCs and the top 10 companies, see Table 3.

    8 Accessed on 1 March 2012 from the website of the Office of the Economic Adviser, Ministry of Commerce and Industry (www.eaindustry.nic.in). 9 Calculated from CMIE India Trades database.

    10 See, for example, “List of Finished formulation registered from 2003 to 2009” accessed from the website of Central Drugs Standard Control Organisation (www.cdsco.nic.in).

    11 “Eli Lilly Insulin Brand Paves Way for Hike in Imported Rug Prices”, Economic Times, 11 June 2011.

    12 Under Articles 65.2 and 64.4 of TRIPS, India had time till 1 January 2005 to introduce product patent protection in pharmaceuticals. But Articles 70.8 and 70.9 put a limitation on the transition period allowed under Article 65 – India was required to introduce “mail box” and “exclusive marketing rights” from 1 January 1995.

    13 See the notes to the Appendix of Chaudhuri (2011) for further elaboration of the methodology and also of the limitations.

    14 Business Monitor, “India: Pharmaceuticals and Healthcare Report”, June 2011.

    15 For the background, see Park (2010).

    16 Another possibility is that the use of USFDA Orange Book did not correctly reveal the patent status. As explained in the notes to the Appendix of Chaudhuri 2011, we have considered the patent with the earliest expiry date as the NME patent. The earliest patents for these four products, for example, expires during 2011 to 2013 and hence these have been treated as pre-1995 molecules. But there are also other patents listed expiring after 2014 and if any of these are the relevant product patents, then these are actually post-1995 products.

    17 “Leukaemia (chronic myeloid) – dasatinib, high dose imatinib and nilotinib (review): appraisal consultation document” in the website of the National Institute for Health and Clinical Excellence, http://guidance.nice.org.uk/TA/ WaveR/99/Consultation/DraftGuidance. Foreign exchange rates fluctuate. Assuming a rate of Rs 70 per GBP, the cost of treatment is same.

    18 “Hepatitis C Virus – Prevention and Treatment”, Press statement issued by International Treatment Preparedness Coalition – India (ITPC- India), 21 October 2011.

    19 See, for example, “List of Finished Formulation Registered from 2003 to 2009”, accessed from the website of Central Drugs Standard Control Organisation (www.cdsco.nic.in).

    20 “GlaxoSmithKline Launches Two Cancer Drugs at Reduced Prices” in The Hindu Business Line, 22 July 2011, http://www.thehindubusinessline.com/companies/article2285697.ece.

    References

    Chaudhuri, Sudip (2005): The WTO and India’s Pharmaceuticals Industry: Patent Protection TRIPS and Developing Countries (New Delhi: Oxford University Press).

  • (2010): “The Industry Response” in Chaudhuri, Park and Gopakumar.
  • (2011): “Multinationals and Monopolies: Pharmaceutical Industry in India after TRIPS”, Working Paper Series Number 685, Indian Institute of Management Calcutta, November (http://facultylive.iimcal.ac.in/sites/facultylive. iimcal.ac.in/fi les/WPS%20685_0.pdf).
  • Chaudhuri, Sudip, Chan Park and K M Gopakumar (2010): Five Years into the Product Patent Regime: India’s Response (New York: United Nations Development Programme) (http://content.undp.org/go/cms-service/download/publ ication/?version=live&id=3089934).

    DIPP (2010): “Discussion Paper: Compulsory Licensing” (New Delhi: Department of Industrial Promotion and Policy, Government of India).

    Gopakumar, K M (2010): “Landscape of Pharmaceutical Patent Applications in India: Implications for Access to Medicines” in Chaudhuri, Park and Gopakumar.

    IDFC-SSKI (2009): “Recent MMNC Alliances: Signalling Paradigm Shift?”, IDFC-SSKI Securities Ltd, June.

    – (2010): “MNC Pharma: New Avatar?”, IDFC-SSKI Securities Ltd, March. Kidron, Michael (1965): Foreign Investments in India ( London: Oxford University Press).

    Ministry of Commerce and Industry (2008): “Strategy of Increasing Exports of Pharmaceutical products – Report of a Task Force” (New Delhi: Ministry of Commerce and Industry).

    Park, Chan (2010): “Implementation of India’s Patent Law: A Review of Patents Granted by the Indian Patent Office” in Chaudhuri, Park and Gopakumar.

    Sengupta, Amit, Reji K Joseph, Shilpa Modi and Nirmalya Syam (nd): Economic Constraints to Access to Essential Medicines in India (New Delhi: Centre for Technology and Development Studies, Society for Economic and Social Studies).

    SBICAP (2010): “India Equity: Pharma”, SBICAP Securities Ltd.

    Tempest, Brian (2011): “The Structural Changes in the Global Pharmaceutical Marketplace and Their Possible Implications for Intellectual Property”, UNCTAD-ICTSD Project on IPRs and Sustainable Development, Policy Brief Number 10, July (http://ictsd.org/i/publications/111430/).

    REVIEW OF RURAL AFFAIRS

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