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Intellectual Property Rights Regimes: Comparison of Pharma Prices in India and Pakistan

Almost all earlier studies comparing pharmaceutical prices in Pakistan and India have attributed higher prices in Pakistan mainly to the differences in the intellectual property rights regime between the two countries. That Pakistan permits product patents while India does not is factually incorrect. This paper argues that a weak patent regime combined with policies to reduce market concentration, curb monopolies and encourage bulk drug production, initially through public sector investments, and the size of the Indian market could have led to development of indigenous process capabilities. Meanwhile, in Pakistan, the same patent policy was not combined with policies adopted in India and since the market size is much smaller, it did not have the same effect.

Intellectual Property Rights Regimes: Comparison of Pharma Prices in India and Pakistan

Almost all earlier studies comparing pharmaceutical prices in Pakistan and India have attributed higher prices in Pakistan mainly to the differences in the intellectual property rights regime between the two countries. That Pakistan permits product patents while India does not is factually incorrect. This paper argues that a weak patent regime combined with policies to reduce market concentration, curb monopolies and encourage bulk drug production, initially through public sector investments, and the size of the Indian market could have led to development of indigenous process capabilities. Meanwhile, in Pakistan, the same patent policy was not combined with policies adopted in India and since the market size is much smaller, it did not have the same effect.


fter the signing of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement of the General Agreement on Tariffs and Trade, the appropriateness of different intellectual property rights (IPRs) regimes has been a matter of debate as the World Trade Organisation (WTO) member nations, especially developing counties, make their IP policies “TRIPS compatible”. The potential rise in drug prices, being a major concern, has often been at the centre of this debate. The links between pharmaceutical prices and IP regimes have received much research attention in India and the higher pharmaceutical prices in Pakistan vis-à-vis India have usually been attributed to differences in IP regimes in the two countries.1 Limited information on the Pakistan pharmaceutical industry did not allow us to undertake any meaningful analysis of this issue. Presenting more relevant information, this paper argues that some premises of the debate can be questioned and that there is a need to enlarge the scope of the debate.

Pharmaceutical prices across countries may differ due to a variety of reasons. Among others, these include differences in (a) IPR regimes, (b) market structure and nature of competition, (c) drug price control regimes, (d) other industrial, trade, tax and investment policies, and (e) costs of production (machines, labour, fuel, etc). Essentially based on Basant (2000), the table provides a comparative assessment of India and Pakistan vis-à-vis these factors in the late 1990s before the IP regimes in these countries were modified. In what follows, we analyse each of these factors to ascertain their potential role in explaining the differences in pharmaceutical prices between India and Pakistan. This is followed by a discussion of problems associated with comparing prices across nations and some tentative conclusions.

IPR Regimes: Early Stages

The discussion of patent regimes in India and Pakistan during the 1980s and 1990s had maintained that while Pakistan had a product patent regime, India only provided patent protection to process inventions in the pharmaceutical sector. Till December 2000, when the new patent act was put in place, patents in Pakistan were registered under the Patents and Design Act of 1911 (PDA-1911). The duration of patent protection was normally 16 years (Section 14, PDA-1911).2 The PDA 1911 was amended several times (e g, 1939, 1960, etc) but the basic tenor of the law remained the same till 1997 when some significant changes were made. The PDA 1911 has been interpreted to provide patent protection to process inventions only, as a patentable invention was defined as “any manner of new manufacture”. The legal experts in Pakistan and even the negotiators at the WTO dispute panel (both from Pakistan and the US) agreed to this interpretation. While these interpretations are important and hold currency, the wordings in the Act were not entirely clear to a layperson. Section 2(8) of the Act states that,

‘invention’ means any manner of new manufacture and includes an improvement and an alleged invention.

While Section 2(10) says that

‘manufacture’ includes any art, process or manner of producing preparing or making an article, and also any article prepared or produced by manufacture.

The legal fraternity in Pakistan accepted the “manner of new manufacture” interpretation whereby patent protection for product inventions was not available in any industrial category. The interpretation that product patents were not permitted in any field of technology in Pakistan seems odd, but is correct.3 This was quite different from the case in India where product patents were not permitted in specific industries, e g, food, pharmaceutical and agricultural products. Thus, as in the case of India, a product manufactured from a process other than the patented one, would not be construed as patent infringement in Pakistan. Consequently, there was always a possibility that someone with a slightly different process could reproduce the same product and market it on an equal footing. Apparently, such cases of “copying” were common in Pakistan but not as common as in India. But the absence of the product patent regime and a “weak” process patent regime meant that very few patent infringement cases were registered. Most of the patent violations were ignored.4

Apart from the issue of product vs process patents, the representatives of the Pakistan pharmaceutical industry, especially those with the MNCs, complained about legal difficulties in getting injunction orders against the infringer and the threat of revocation of a patent through compulsory licensing. An application under Section 22 of the PDA 1911 could be filed in the high court claiming that the demand for a patented article in Pakistan is not being met to an adequate extent, and on reasonable terms and force, an issuance of a grant of compulsory licence. Similarly, under Section 23 of PDA 1911, the patent could be revoked if, even after a considerable lapse of time (four years after grant of patent) the patent was being worked outside Pakistan and not within the country. Both these clauses were similar to what the Indian patent law had till the 1990s. No estimate of the number of compulsory licences issued or patents revoked so far was available. Nonetheless, some sections of the pharmaceutical industry saw it as an important potential problem.5 Interestingly, despite the concerns raised above, about 1200 patents were granted in Pakistan every year during the 1990s, about 80 per cent of these related to pharmaceutical industry.

Trademark violations were rampant and in general, the trade mark law was used more widely than patent and designs law to take legal action against infringers. The manufacture and sale of counterfeit and spurious medicines was also a major cause of concern and many cases of imitative “packaging” have been found [Basant 2000 and Mirza 1998a for details]. It is not clear if these violations have had a dampening effect on pharmaceutical prices.

Changes in IPR Laws in Pakistan

In April 1996, the US sought consultations with Pakistan authorities through the auspices of the Dispute Settlement Mechanism of the WTO. The US claimed that,

Pakistan’s laws currently do not provide product patent protection for pharmaceutical or agricultural chemical inventions, or systems that conform to Articles 70.8 and 70.9 of the TRIPS Agreement, with regard to the filing and examination of applications and the grant of exclusive marketing rights. As a result, Pakistan’s legal regime appears to be inconsistent with Pakistan’s obligations under the TRIPS Agreement… [WTO 96-1733 WT/DS36/1 IP/D/2).

During the consultations, Pakistan agreed that its IPR laws were not TRIPS compatible and promised to modify its IPR legislation. In 1997, an amendment to the Patents and Design Act (Ordinance XXXVI of 1997) was made to provide a mailbox facility and to establish a system of granting exclusive marketing rights. Although the amendment to the PDA 1911 were made in 1997, even in late 1999 during a visit to Pakistan, the industry respondents alleged that there was no clear mechanism to obtain exclusive marketing rights (EMRs) for a new chemical entity under the “mailbox” provision. In fact, the concerned government departments were unaware of their obligations under the amended law. Some respondents argued that nothing had changed on the ground, and therefore, there was no adequate protection for new molecules. No estimates of the number of EMRs granted/ applied for were available.

Thus, till 1999, there does not seem to be any basic difference in the IPR regimes in India and Pakistan as far as the pharmaceutical industry was concerned. In December 2000, Pakistan promulgated the new patents ordinance, which complied with TRIPS’ requirements; product patents have been allowed in the law, and the life of the patent has been extended to 20 years. The Indian government brought in similar amendments in 2002.

Market Structure and Competition

The industry can be broadly divided into the formulations production and the manufacturing of active ingredients, i e, raw materials, basic and intermediate chemicals used for the manufacture of pharmaceutical products. In what follows, I briefly summarise the structure of the pharmaceutical industry in Pakistan and then based on the data summarised in the table, compare it with the industry in India.

The Formulations Market

According to the Pakistan Pharmaceutical Manufacturers’ Association (PPMA), a trade body representing the pharmaceutical firms in Pakistan, the total value of sales in 1999 was of the order of $ 0.8 billion (Rs 40 billion) in trade prices as compared to the Indian market size of about $ 3 billion. Imported medicines (in finished form) constituted about Rs 7-8 billion, i e, about 18-20 per cent of the market, compared to less than 3 per cent in India.6 It was alleged that the share of imports has increased in recent years; the imports of medicines were only of the order of Rs 3-4 billion in the early 1990s. Part of this increase can probably be attributed to the depreciation of the Pakistan rupee. Even during 1996-98, the rupee depreciated by more than 16 per cent. The Pharma Bureau (an informal group of 23 major MNCs operating in Pakistan) estimated the total market sales at trade prices to be around Rs 35.27 billion in 1997. About 87 per cent of these sales were directly made to retailers; institutional sales constituted less than 13 per cent of the pharmaceutical market. 7 The PPMA estimates suggest that the pharmaceutical market in Pakistan has been growing at the rate of more than 20 per cent per year. About 12-13 per cent of this market growth was due to the increase in the volume of sales, 3-4 per cent due to price increases and the balance due to new product introduction. While the size of the market increased at a rate of about 20 per cent per annum, with a relatively high level of per capita consumption of pharmaceuticals, more than 50 per cent of the population did not have access to modern medicine. About 10 per cent of the population was responsible for 80-90 per cent of the expenditure on drugs. Besides, a very small proportion of population was covered by some kind of health insurance.

Given the unequal distribution of the consumption of modern medicine and relatively small size of the market, the pharmaceutical market in Pakistan was much thinner than in India in the late 1990s. Size distribution of firms and the role of MNCs: According to the ministry of health (MoH) estimates, in 1999, there were about 309 licensed manufacturing units in Pakistan. Of the total 14,711 registered medicines for human consumption, 3,058 (20.8 per cent) were imported in finished form. Apparently, out of the 309 licensed manufacturers, only 100-120 or so could be viewed as major producers. About 30-35 of these were MNCs (including joint ventures) and the remaining local firms. The estimates of the share of MNCs in the total pharmaceutical market range from 52-70 per cent [for details, see Basant 2000, Table 1]. Their share in the value of sales is higher than in the total volume of sales. While estimates vary, most put the share of MNCs in the total value of sales to be in the vicinity of 60-62 per cent. Virtually all respondents agreed that the share of MNCs has declined in recent years. While no firm estimates are available, it is suggested that in the early 1990s, the share of MNCs was about 80 per cent.8 There was some indirect evidence to show that in the second half of 1990s many domestic firms have entered pharmaceutical segments which were hitherto being dominated by MNCs and imports [Basant op cit for details]. However, the share of MNCs in the value of sales continues to be much higher than their share in the volume of sales; their prices being lower, the domestic firms have to sell much more to equal the revenue of MNCs.

In general, the formulations market in India was more competitive than in Pakistan with a much larger number of registered manufacturers and even a larger number of active units.9 This seems to be true despite the fact that market concentration in therapeutic markets in India can be quite high (e g, a four-firm concentration ratio of 31 per cent for antibiotics and within some sub-groups of antibiotics even as high as 97 per cent) [Chaudhuri 1999]. The MNCs in Pakistan, however, claimed that the absence of patent protection for pharmaceutical molecules has led to the registration of many thousands of “me-too” brands from local firms in the country. On average, for every MNC brand, there are between 10 and 50 local copies, all generally cheaper, providing extremely powerful market forces to keep prices down. The production of pharmaceutical products was very unequally distributed across firms. Recent estimates are not available but in 1993 when the total number of registered units was 226, about 70 per cent of the total sales were accounted for by 32 firms. The remaining 194 shared the rest of the market [UNIDO 1993]. The top 15 firms, all MNCs, accounted for more than 50 per cent and top five more than 23 per cent of the market [Basant op cit: Table 4).

Having a subsidiary was the most preferred method of MNCs to operate in Pakistan in the late 1990s.10 Mehdi and Kiani (1996) clearly bring out the dominance of MNCs in the Pakistan pharmaceutical market through an analysis of the top 100 medicines in terms of sales volume and value of sales. The top 100 drugs in terms of sales of their units are characterised as the “prime volume market” and the 100 best selling drugs (i e, the drugs that have earned the firms more rupees than the rest) as the “prime value market”. Each of these two sets of drugs constituted about 41 per cent of the Pakistan pharmaceutical market in 1995. The MNCs have a monopoly over the prime volume/value markets with a market share of over 90 per cent. The distribution of market shares even among the MNCs was much skewed.11

Unlike Pakistan, the Indian market was not dominated by the MNCs. In fact, the share of MNCs declined from about 68 per cent in 1970 to less than 33 per cent in 1999 and was less than 23 per cent in 2004 [Chaudhuri 2005: 18]. Besides, the distribution of market shares among MNCs was not skewed. Unlike in the case of Pakistan, where all the top 15 pharmaceutical firms were MNCs, only three of the top 15 firms were MNCs in India and five of the top 20 firms were MNCs in 2004 [Chaudhuri 2005: 17]. Role of the public sector: Only one public sector unit is engaged in the production of formulations. The Fauji Foundation, Lahore run by Army Welfare is engaged in bulk drug production.

Established with Chinese technological support, the firm is more or less defunct today making simple medicines like aspirin, etc. India has been quite different in this regard with the public sector, i e, production units and the public research and development (R&D) institutions playing a key role [Chaudhuri op cit, 2005]. Setting up of Indian Drugs and Pharmaceuticals (IDPL) and Hindustan Antibiotics (HAL) and subsequently, a few other public sector units by the state government has played an important role. IDPL and HAL were set up to produce antibiotics and synthetic drugs at a time when MNCs were not very enthusiastic about setting up basic manufacturing facilities, did not want to provide technology to others and the Indian private sector was not mature enough to undertake production of many of the bulk drugs. Overall, the Russian collaboration through the public sector units proved to be much more beneficial for India than the similar collaboration Pakistan had with China. There can be several reasons for the difference: better quality of Russian vis-à-vis Chinese technologies; relatively lower concentration of market power in the hands of small number of firms (especially MNCs) in India or simply the much larger size of the Indian market. Moreover, public R&D institutions also played an important role in India for deve loping drugs indigenously [Chaudhuri op cit 2005].

Market for Pharmaceutical Raw Materials

Although there is a relatively high degree of self-sufficiency in the formulation packing of finished pharmaceutical forms, the manufacture of active ingredients or basic production of pharmaceutical chemicals is negligible in Pakistan. This makes the economy virtually dependent on imports. While about 90-95 per cent of the active ingredients are imported, only about 35 pharmaceutical chemicals are produced in the country, either entirely or at a certain step of the chemical process. In 1999, 36 (24 domestic and 12 MNCs) firms were licensed to undertake “basic or semibasic manufacture”, but most of them were not very active.12 Some MNC representatives also complained about the nonviability of producing pharmaceutical chemicals in Pakistan. The reasons for non-viability essentially emanate from the small size of the Pakistan market. The industry representatives argued that economies of scale cannot be reaped by exporting the surplus raw material because the international markets are very competitive with the presence of low cost suppliers like China, India, Taiwan, Korea and eastern Europe. According to some respondents about seven basic manufacturers were active in Pakistan in the late 1990s. Since there was tariff protection for local manufacturers and since they specialised in specific active ingredients (basic chemicals) and do not compete with each other, local monopolies have developed. It was argued that since few firms will come forward to set up new units for basic chemical production, competition through imports is the only way to dislodge those monopolistic structures.

In India, about two-thirds of the domestic raw material requirement was satisfied internally (see the table). The absence of local capacities (and the associated technological capabilities) to produce raw materials for pharmaceutical products has adversely affected Pakistan in a variety of ways:

  • Rupee devaluation results in a significant increase in the costs of production;
  • Customs duties levied to protect local producers and to mobilise budgetary resources add to these costs;
  • – The potential of cost increases through the transfer pricing mechanism gets enhanced.

    Drug Price Control

    Till 1969-70, there was no statutory control over drug prices in Pakistan. A major cyclone in East Pakistan (now Bangladesh) in 1970 and the consequent pressures on the economy (including need for drugs) led to imposition of price controls on the pharmaceutical industry. These controls were eventually incorporated into the Drugs Act of 1976. During 1976-93, this act formed the basis for regulating prices by the federal health ministry (MoH), which used various cost plus formulae to arrive at the maximum retail price. These formulae were used to fix prices of all drugs till 1993, when the distinction between the controlled and decontrolled groups of drugs was made [Basant op cit for details].

    Pricing has been a major issue between the pharmaceutical industry and the MoH in Paksitan. During 1976-91, while applications for price increase were dealt with on a case-by-case basis13, the industry representatives consistently argued that the implementation of the “cost-plus” formulae by the health ministry did not recognise adequately the impact of domestic inflation and rupee devaluation on the industry’s operational profit margins. Over time, different types of indexation formulae have been used but the concern of the industry that cost escalations are not fully compensated has remained.

    We do not have space here for a detailed comparison of drug price control systems in India and Pakistan. However, a broad comparison would suggest that somewhat similar systems were in place.14 Both countries used cost plus formulae that provided incentives to enhance costs. Such a method was particularly problematic for Pakistan where most of the raw materials had to be imported and provided opportunities for transfer pricing. There is evidence to show that after price decontrol of some drugs, the prices in Pakistan rose sharply after 1993.15 As a result, the federal government had to reduce and then freeze prices of several drugs in the second half of the 1990s thereby dampening price increases in the country during the late 1990s. The MoH also issued an ordinance indicating their intention to amend the Drug Act of 1976 to allow the government to fix the prices of imported raw material to solve the perceived problem of transfer pricing by the MNCs. The issue of transfer pricing: Linked to the issue of pricing and price increases is the alleged practice of transfer pricing by MNCs. Such practices become problematic for any price control mechanism that uses cost plus formulae as was the case both in India and Pakistan. The phenomenon of transfer pricing is also used to argue against price increases because the MNCs are already earning profits by over-invoicing their imports from either the parent firms or related companies.

    The impact of transfer pricing can be quite significant in Pakistan as the imported material constitutes about 57 per cent of the total costs of locally manufactured goods sold by the 23 major MNCs operating in the country. The share of active ingredients alone was more than 46 per cent.16 Basant (2000: Appendix Table 1) provides invoice specific data on the cost of importing 69 different raw materials by various firms from different sources. Exceptions apart, prices of raw material imported by MNCs from their sister/ parent companies or from other sources in western countries were, in general, significantly higher than those paid by MNCs or domestic firms to suppliers from countries like India, China, Singapore and South Korea. Prima facie, therefore, there was circumstantial evidence to suggest that transfer pricing is taking place. However, before making any final judgment, several issues need to be considered.

    The MNCs argued that they do not use a supply source, which does not meet their internal quality specifications that are very strict. The domestic firms use lower quality raw material the prices of which are low. Quality differences can be significant across suppliers and this certainly explains part of the price differential between MNC suppliers and others. However, there are cases where MNCs have bought raw material from other sources at a much cheaper rate.17 Apart from quality, another reason why MNCs may pay higher prices for raw material can be that the chemical is still under patent. Typically, MNCs do not violate patent laws and in countries honouring these patents, prices are likely to be higher. In countries like India and China, where the IPR regime is weak, the same raw material could have been available at a cheaper rate. We do not have patent related information for the 69 raw materials covered in Basant (2000). However, insofar as some MNCs are able to acquire the raw material at a cheaper rate from western countries than other MNCs, the

    Table: Some Factors Affecting Pharmaceutical Prices in India and Pakistan

    Factors India Pakistan
    Market Structure
    Size of the market (Rs billion)1 130.0 ($3bn) 40.0 ($0.8bn)
    Share of top 4 firms2 18.2 (16.6) 19.8
    Share of top 8 firms2 27.5 (32.0) 33.4
    Share of MNCs (per cent)3 35.0 65.0
    Total number of registered
    manufacturers 2400 309
    Total number of active units3 9,000 (>20,000) 110-120
    Percentage of domestic requirements
    of formulations of produced locally 97.0 75
    Percentage of domestic requirements
    of raw material produced locally 66.8 6.0
    Local availability of pharmaceutical
    machinery Good Absent
    Role of public sector Important Nominal
    Customs duty on imported QRs 10, 25, 35
    raw material (per cent) (No QRs)
    Customs duty on imported > 100 per cent 10.0
    formulations (per cent) in early 1990s
    Custom duty on imported packaging
    (per cent) NA 10.0
    Customs duty on imported
    pharmaceutical/chemical machinery Medium-High (?) Zero
    FDI policies Restrictive Liberal
    Restrictions on licensing for MNCs High technology None
    only for FERA firms
    Restrictions on foreign equity Yes
    (more restrictive) No
    Potential for transfer pricing Low Relatively high (?)
    Intellectual Property Rights Only process Only process
    patents patents
    Drug price control Yes Yes
    (more restrictive?) (less restrictive?)
    Utility, fuel and labour charges Lower Higher

    Notes: (1) $ = Rs 43.4 (Indian) and Rs 57.39 (Pakistani).

  • (2) Estimates for India relate to 1997 and to 1998 (in parentheses) while for Pakistan to 1993.
  • (3) The estimates relate to 1999. The estimate in parentheses is for 1998 but from a different source.
  • (4) QRs – Quantitative Restrictions. Source: Basant (2000); Mishra (2005); Chaudhuri (2005).

    patent related justification may not be valid. And this seems to be the case.18 Thus, while both quality and intellectual property rights related explanations for MNCs paying higher prices for their raw materials seem acceptable up to an extent, the fact that transfer pricing does take place cannot be denied.

    There is evidence to suggest that MNCs in India also used transfer pricing mechanisms. Chaudhuri (2005) provides some evidence of the same in the late 1970s for which detailed data was available and for the late 1990s for which some preliminary evidence is available. It is difficult to asses if the MNCs in Pakistan used this practice more intensively than the MNCs in India but it is likely that such practices would have a larger impact on prices in Pakistan than in India because the former has higher MNC domination and imports a much larger proportion of its raw material requirements.

    Overall, both countries had drug price control in place from the early 1970s onwards. However, the larger role of MNCs in this industry in Pakistan may have made the implementation of price control somewhat more complex than in India. The impression one gets is that while the Indian price control mechanism was more stringent till 1993, the Pakistan authorities have been more pro-active and rigid during the post-1993 period although this was the period when selective decontrol of drug prices was being experimented with. On the other hand, price controls were reduced in India during the 1990s with more and more drugs put outside the drug price control net. As a result prices rose continuously in this period [Chaudhuri 2005].

    Government Policies Relating to Pharmaceutical Production

    The government policies in Pakistan have sought to promote local production of pharmaceuticals both for formulations and packaging of finished forms and the manufacture of active ingredients. As we have seen earlier, such efforts at self-reliance or self-sufficiency have not fructified in the case of active ingredients. India, post-1970s has also focused on indigenous capability building in the pharmaceutical industry and has succeeded to a major extent. Despite this broad commonality, there were significant differences in some of the policies adopted by the two nations. We discuss them briefly here.

    Tariffs and Taxes

    Till recently, Pakistan custom’s tariff rates were very favourable for local pharmaceutical production. In 1985, through a government order all raw materials and packaging materials used for the manufacture of pharmaceutical products were exempted form duties and taxes. This exemption was extended in 1989 to all plant and machinery and equipment imported for the manufacture of pharmaceutical products. The tariff policies under went some changes in the 1990s leading to protests from the industry. Since petroleum-based industry does not exist in Pakistan, tariff policies were changed in 1997 to create incentives to set up raw material production facilities in the country. A customs duty of 25 per cent was instituted on the imports of semi-basic chemicals, while a duty of 35 per cent was imposed on the imports of basic chemicals. In 1995-96 sales tax at 10 per cent was imposed not only on raw material and packaging material, but also at the rate of 5 per cent on the sale of finished products that was supposed to be absorbed by the manufacturers. However, this sales tax on finished products was withdrawn in October 1996, but in 1997 a 10 per cent customs duty was imposed on the imported raw materials and finished medicines. All this added to the costs of production in Pakistan. Besides, the high financing costs of importing pharmaceutical machinery in Pakistan, despite the fact that there were no customs duties on such imports, added to the cost disadvantages emanating from the absence of domestic raw material manufacturing capabilities. High customs duties and quantitative restrictions were prevalent in India till the late 1980s. But unlike in Pakistan, 1990s was the period when quantitative restrictions were removed, tariff rates declined continuously19 and towards the end interest rates had also started to decline reducing the financing costs and the overall costs of production.

    Foreign Direct Investment Policies

    An important aspect of government policies to encourage local production has been the incentives to foreign investors. Some key dimensions of policies implemented to attract MNCs for local production in Pakistan included:

    MNCs can own 100 per cent equity; they can independently negotiate terms and conditions of foreign currency loans; capital invested, appreciation thereof and profit on it is freely repatriable; MNCs can decide the mode and level of technology transfer; no upper ceiling on payment of royalty (such a ceiling existed earlier, but has been removed); no requirement of work permit for expatriate managerial and technical staff; enlarged access to domestic borrowing;20 national treatment of MNCs in terms of taxes on income.

    The FDI related policies in Pakistan have been significantly more liberal than those in India. Prior to 1994, Indian policies were very stringent vis-à-vis foreign investment. The key policy initiative was the introduction of the 1973 Foreign Exchange Regulation Act (FERA) and the drug policies in late 1970s which changed the earlier policy environment favouring MNCs to that which worked against them. The basic effect of FERA was to make a distinction between firms of foreign equity of more than 40 per cent (FERA companies) and those with foreign equity less than equal to 40 per cent and to restrict the activities of the former to specific areas. The new drug policy (NDP) announced in 1978 imposed restrictions on the FERA companies in pharmaceuticals that were not applicable to other sectors. Chaudhuri (1999) summarises these changes succinctly:

    The Drug TNCs (Transnational Corporations) which were manufacturing formulations alone or bulk drugs not involving “higher technology” were required to reduce foreign equity to 40 per cent or below. A number of drugs were reserved for the public sector and the Indian sector (i e, those companies with foreign equity 40 per cent or below). And in the areas open for participation of all the sectors, preference was to be given to the Indian companies. The government also announced that licences to the FERA companies would henceforth be restricted to high technology bulk drugs and related formulations provided (a) 50 per cent of the bulk drugs production was supplied to non-associated formulations and

    (b) the ratio of the value of the bulk drugs consumed from own manufacture to the value of total formulation production (the ratio parameter), did not exceed 1:5. The corresponding ratio fixed for the companies with foreign equity below 40 per cent was 1:10 (provided imported bulk drugs did not constitute more than onethird of the value of total bulk drugs consumed for the purposes of formulating drugs)… The TNCs were to face all these restrictions or reduce their foreign equity to 40 per cent or below to be eligible for treatment at par with the indigenous sector and avoid these restrictions. While some relaxations – for example broad banding

    – were provided, the stricter licensing requirements for the TNCs continued in the Drug Policy of 1986. In some senses these were made even more restrictive. The ratio parameter, for example, was reduced from 1:5 to 1:4 for the FERA companies. The FERA companies were also denied access to the scheme of delicensing introduced for 94 bulk drugs [Chaudhuri 1999].

    The MNCs in Pakistan were not subject to such controls. Besides, of the many liberal FDI-related policies listed above, several were not in place in India. For example, unlike in Pakistan, the MNCs in India could not decide the mode and (to some extent) level of technology transfer, rates of royalty (due to upper ceilings) and the appointment of expatriate staff. During the second half of 1990s, the Indian licensing and FDI policies have made the policy environment similar to Pakistan. Licensing was abolished for all the bulk drugs and formulations and no drugs are now reserved for the public sector. Similarly, the conditions stipulating mandatory supply of bulk drugs produced to non-associated formulators and the ratio parameters linking bulk drugs and formulations production has also been abolished [Chaudhuri 1999; Lalitha 2002]. The MNCs could now automatically own up to 100 per cent foreign equity. It is noteworthy that complete ownership or 100 per cent equity, which has been possible in Pakistan for a long time, was permitted in India only recently.

    Comparing Prices of Pharmaceutical Products between India and Pakistan

    There are several reasons why comparing pharmaceutical prices in Pakistan and India and ascertaining factors that contribute to these price differences is likely to be a complex task. Some of these reasons have already been summarised in the table and discussed in the earlier sections. It is evident that market size (impinging among other things on opportunity to reap economies of scale), several dimensions of market structure, policy initiatives and costs are significantly different in the two countries. In what follows, we highlight some more issues that can make price comparisons difficult.

    Most Indian scholars have undertaken a selective comparison of drug prices in the two countries. Prices of a few drugs have been compared to show that the prices in Pakistan are higher than in India and this in turn has been attributed to the alleged differences in IPR regimes [see, for example, Chaudhuri 1999]. No comprehensive comparison of prices between the two countries has been undertaken. The main reason has been the nonavailability of relevant data.

    Apart from the well-known issues of quality differences, pack size etc., one should explicitly recognise that several types of comparisons can be made: (a) between price of brands of the same MNC in the two countries; (b) between prices of the leading brand in one country with that of the leading brand in another country; (c) between prices of the leading brand in one country and prices of non-leading or generic brands (or their average) in the other country; (d) between prices of the non-leading or generic brands in the two countries; (d) between average (of all brands) prices for the same drug in the two countries.

    The results of cross-country comparisons will differ depending on which type comparisons are made. Typically, the nature of price comparisons is not made explicit.

    Basant (2007: Appendix Table 1) compares prices in the year 1998 of 182 representations of various medicines from 14 MNCs operating both in India and Pakistan. Interestingly, 128 of these representations (i e, about 70 per cent) are cheaper in Pakistan than in India. Thus, prices of MNC products in Pakistan were, on average, lower than in India during the late 1990s. One would have expected the Indian prices to be lower. We might get the expected result if we compare the MNC prices in Pakistan with generic prices in India.21

    One issue, which needs some exploration relates to the differences in pack sizes in the two countries. For example, Erythrocin 250 and 500 mg tablets are sold in pack sizes of 100 only in Pakistan, while they are available in pack sizes of 10 and 6 respectively in India. If there are economies of scale in packaging, marketing and distribution, conversion of prices of smaller packs (10 and 6 tables in this case) to prices of larger packs (100 tablets) can be problematic. Indeed, the price differential for Erythrocin 100mg is much lower than for 250/500 mg tablets; the pack size is 12 for Pakistan and 10 for India.22

    As discussed above, raw material prices can contribute to price differences. While data on these prices is not available, typically raw material prices are used to explain higher prices in Pakistan and not in India. For example, it was mentioned during a discussion that prices of Ibuprofen in Pakistan is much higher than the price of the same locally sourced compound in India. This explained higher prices of Brufen in Pakistan than India [see for price estimates, Basant 2007, Appendix Table 1, item 50]. Similarly, it was argued that ICI India is able to sell Tenormin (item 48 in the same table) at a cheaper price in India because unlike in Pakistan, it manufactures its own raw material for the drug (atenolol and Inderal) in India.

    Apart from differences in raw material prices one may have to analyse differences in competitive pressures (e g, the number of alternatives available), market size and the ability to pay in the two countries. Detailed data on these variables is not available. However, in general, competitive pressures were lower in Pakistan than in India. Detailed data analysed in Basant (2000) shows that among the top 100 best selling products in Pakistan, except in the case of five formulations, domestic firms had entered in the market only after 1996 and import competition also increased in the late 1990s. Moreover, significant price increases in the late 1990s were in cases where the concerned firm had a virtual monopoly in Pakistan.23 More detailed data of this kind is not available for India and Pakistan but most respondents in Pakistan agreed that domestic companies are increasingly becoming competitive in Pakistan and may provide competition to the MNCs in the near future.

    Another interesting fact is that of the top 120 branded products sold by MNCs in Pakistan in 1996, only 44 of them were also sold by these firms in India. Pharma Bureau had compared prices of these 44 products in Pakistan and India. Prices prevailing in September-October 1996 were compared and for 19 out of the 44 products, prices were found to be lower in Pakistan. Once again, it is not clear which prices were compared in the Pharma Bureau study, but it was claimed that Indian prices do not include between 4 and 8 per cent of sales tax applied by the Indian states. Inclusion of these taxes would have made Indian prices higher.24

    Overall, the MNCs often charge higher prices for the same drugs in India than in Pakistan and many of their products are not introduced in India at all.25 Non-introduction of new drugs in India can be partly explained by higher competition from “metoo” drugs in India due to better process capabilities, availability of raw material at cheaper prices and so on. Appropriability may be higher in Pakistan due to highly concentrated market structure and limited competition from local players. Higher prices in India for those drugs which are available in both countries are somewhat intriguing and need to be explored. One possibility is that the MNCs, faced with much higher competition in India try and keep their prices higher to signal better quality.

    Finally, while there are problems with comparability of data, available estimates suggest that the tendency of MNCs to charge relatively higher prices in India (vis-à-vis Pakistan) has increased in recent years. This may be a combined result of the ongoing liberalisation process in India, mainly de-licensing and relaxing price controls over several drugs, and the inability to raise prices in Pakistan after 1996-97 due to severe price controls. Besides, this was also the time when competitive pressures from domestic Pakistani firms and imports were building up.

    Some Concluding Remarks

    Almost all earlier studies comparing prices in Pakistan and India have attributed the claimed higher prices in Pakistan mainly to the differences in the IPR regimes. They claim that Pakistan permits product patents while India does not.26 This is factually incorrect. The IPR regime vis-à-vis pharmaceuticals was almost identical in the two countries. Besides, more detailed price comparisons need to be made before the nature of price differences can be ascertained. There is no doubt that the Indian pharmaceutical firms have significantly better process capabilities than Pakistan firms but attributing this to the patent law which permitted reverse engineering is, at least, partly incorrect. One can argue that a weak patent regime combined with policies to reduce market concentration curb MNC monopolies and encourage bulk drug production (initially through public sector investments), and most importantly, the size of the Indian market could have led to development of indigenous process capabilities. Besides, the public R&D also played its role in building capabilities in India.27 In Pakistan, where the same patent policy was not combined with policies adopted in India, and where the market size is much smaller, it did not have the same effect.

    This is not to deny the links between IPR regimes and pharmaceutical prices but to only suggest that Pakistan-India price differences cannot be explained by differences in IPR regimes. A variety of other structural and policy features will have to be analysed to get a better understanding of how IPR regimes influence prices and how other factors mediate this relationship. In other words, the role of IPR policies needs to be seen in a larger context and their interface with other policies especially those relating to trade, competition and investment needs to be explicitly recognised.

    A Postscript

    Most of the data analysed in this paper relates to the late 1990s. Similar data are not readily available for recent years. The core argument is that to explain differences in pharmaceutical prices between India and Pakistan during the pre-WTO period, one needs to look beyond differences in IPR regimes in the two countries. An obvious question would be if the same argument remains valid for the more recent period. In the absence of detailed data for recent years, I have put together whatever information is available to address this issue. Price trends: Pharmaceutical prices have continued to rise rapidly in Pakistan during the period 2000-05. Interestingly, according to some estimates, the price rise has been somewhat faster for the medicines sold by domestic firms. This was essentially due to the fact that the new drug price control system allowed local firms (if they so desired) to fix prices on par with those of the MNCs [Parab 2005].28 Therefore, the price differentials between the prices of domestic and multinational firms seem to have declined. Drug price increase has been a major issue in India as well [Srinivasan 2006). According to some estimates, prices of formulations have risen while those of raw materials have remained somewhat stagnant. Within formulations, price changes have been variable but, overall, the price rise of decontrolled drugs has been sharper. Besides, significant price differentials remain between different sellers of the same product and such differentials have remained high even for those drugs whose prices have fallen in recent years [Chaudhuri 2005: 288-90]. What processes have been at work? IPR regimes: Both the countries have now explicitly provided for product patents. Given limited information on Pakistan, a detailed comparison of the IP legislations in the two countries is not possible here but indications are that the provisions are similar. New use patents are not permitted in both countries, but the patentability of new dosage forms and incremental innovations may be possible in Pakistan [Anonymous 2006], but are generally not allowed in India. If permitted, the efficacy and novelty requirements of these are likely to be very high in India. In any case, very few patented drugs could have been introduced in the market in recent years with a limited effect on the price changes of pharmaceutical products. Consequently, recent bouts of price increases in the two countries would also have to be explained by factors other than changes in the IP regimes. Market size and structure: The pharmaceutical market size in Pakistan was worth approximately $ 1.3 billion in 2005. There exist close to 400 licensed manufacturers and about one-third of the demand is met through imports. The market share of the MNCs has declined recently but it is still about 57 per cent [Ahmed 2006].29 One of the reasons for the increase in the market share of domestic firms is the increase in the prices of their products which was made possible by the changes in the drug price control policy allowing these firms to charge prices on par with MNCs. Interestingly, in 2004, domestic firms launched 569 new brands while MNCs launched only 10 (ibid). Moreover, contract manufacturing by local firms for the MNCs is on the rise [Jawaid 2005]. Despite the emergence of domestic firms as important competitors, the industry remains highly concentrated with the top 50 firms constituting more than 83 per cent of the market and top 100 firms close to the 94 per cent. The top five MNCs have a market share of about 33 per cent (Asia-Australasia Industry Forecasts, December 2005, In addition, the raw material markets are not competitive in Pakistan. In fact, between 92 and 95 per cent of the raw material is still imported that adds upward pressure on prices [Parab 2005], especially in situations when transfer pricing possibilities are high and tariff rates are increased on cheaper imports.30

    The Indian pharmaceutical market remains much larger than that of Pakistan at about $ 5 billion in 2005. The share of MNCs continues to be much lower at about 23 per cent. While domestic firms are more dominant in India than in Pakistan, levels of concentration are still high; the top 20 firms have a market share of more than 50 per cent [Chaudhuri 2005: 16-17]. The dependence of India on imported raw material is significantly lower than in Pakistan. Moreover, levels of competition in the raw material market in India are much higher than in the Indian formulations market. However, MNCs are increasingly resorting to imports rather than local manufacturing [Chaudhuri 2005: Chapter 8] which may be adding to price increases of formulations. Drug price control: The deregulation of drug price control in Pakistan was initiated in 1993 and has been gradual with the recent price rise affected significantly by price increases introduced by domestic firms [Parab 2005]. Price control mechanism in India has been liberalised in a big way after 1995 and, as mentioned, prices have been on the rise though not uniformly for all drugs. Available evidence suggests that the prices of drugs under price control have seen lower increases than those outside price control [Chaudhuri 2005: Chapter 8; Srinivasan 2006]. The removal of control on prices of a large number of drugs has, therefore, contributed to price rise with competitive pressures not always able to keep prices under check. Pharmaceutical prices became a political issue with the industry offering to reduce prices of about 886 drugs and there was a furore when this was not implemented speedily. The implications of the recent Supreme Court directive that essential drugs should not be out of price control are still being discussed [Srinivasan 2006]. Thus, drug price decontrol seems to have increased pharmaceutical prices in both countries.

    The price rise of pharmaceutical products in Pakistan and India in recent years is not due to changes in IPR regimes. Excess dependence on imported raw materials and MNC dominance in Pakistan, and reduction in price control along with significant market concentration in both countries seem to have contributed to recent price changes. There is all the more reason to look at the impact of IPR policies in the context of other policy initiatives. For example, the competition policy – price policy interface can directly mediate the impact of IPR policies on prices. On the issue of controlling pharmaceutical prices, in India the Pranob Sen Committee had suggested debranding of selected prescription drugs when there is evidence of clear market dominance and creating countervailing forces to keep prices low. As has been suggested, the public healthcare system as a “monopsonist” can potentially be an important countervailing force.31

    Finally, in order to make the story more complete, it may be useful to add another dimension to the analysis of pharmaceutical prices – income inequalities. There is evidence to show that ceteris paribus, countries with high income inequalities observe higher drug prices than countries where income is more evenly distributed. In fact, a 1 per cent rise in the measure of income inequality tends to raise average drug prices by 0.7 per cent which is quite significant [Maskus 2003]. Unfortunately this paper has not been able to address this dimension of the analysis but it is likely to be an important determinant of drug price differences in Pakistan and India.




    [This is a slightly revised and abridged version of a paper presented at the Jenny Lanjouw Memorial Conference held at the University of California, Berkeley on March 31, 2007. Comments of the conference participants are gratefully acknowledged. Several people helped me during the course of my fieldwork in Pakistan. Officials of the Ministry of Health and the two pharmaceutical industry associations, PPMA and the Pharma Bureau were extremely helpful. Kieth Watson (Ely Lilly), Zulfiqar Khan (patent attorney) and Zafar Mirza (The Network) shared data and many insights. Simi Kamal and her extended family made my stay unforgettable. I am thankful to all of them. The usual disclaimers apply.]

    1 This was a common refrain in a large body of literature on the subject. See Chaudhury (1999) for references.

    2 However, in case the patent has not been “sufficiently remunerative” during currency of the patent period, the patentee could apply to the federal government for patent extension, at least six months before the expiry of the patent period. The government could either take a decision itself or refer it to the high court. The high court or the government could grant an extension of up to five years (Section 15, PDA-1911). With an extension, therefore, patent protection was available for a maximum period of 21 years.

    3 Thanks are due to Zulfiqar Khan, a leading Karachi based patent and trademark lawyer to clarify these issues.

    4 According to estimates provided by Zulfiqar Khan, only two to three MNC patents in pharmaceutical industry were “active” in Pakistan in 1999, in the sense that the owners/licensees of these patents take action whenever infringement takes place. Moreover, only three patent infringement cases in pharmaceutical industry had been decided till that year by the high courts, and there was no case pending in the courts!

    5 These statements are based on interviews with representatives of the pharmaceutical industry in Pakistan, mainly those of MNCs.

    6 The share of imports in Pakistan might go up to about 25 per cent if one includes drugs imported in semi-finished form. But such details are not available. Some respondents argued that “packaging firms” dominate the Pakistan pharmaceutical market! This was strongly denied by the MNC representatives. Sale of imported drugs was quite significant even for the MNCs operating in the country. In 1997, the sale of imported drugs constituted about 9.3 per cent of the total sales of the Pharma Bureau members, i e, 23 major MNCs operating in Pakistan [Pharma Bureau 1998: 24].

    7 The UNIDO (1993) estimates put the share of institutional sales at 20 per cent, much higher than that estimated by Pharma Bureau, unless the purchases by government and semi-government have declined in recent years. Most respondents, however, estimated institutional (government and semi-government) sales to be between 10 and 14 per cent. The exchange rate used in UNIDO (1993) to convert estimates in Pakistan rupees to US $ is not clearly mentioned. Some estimates in the text suggest that the implicit exchange rate was US $ 1 = Rs 24.4.

    8 This is based on the interviews of the secretary and director general MoH and the PPMA chairman published in the April 12, 1996 issue of the newspaper, The News on Friday.

    9 According to some estimates, the number of active units is more than 20,000 [Lalitha 2002].

    10 Earlier there were some tax advantages for firms listed in the local stock exchange and local listing was based on the number of local shareholders. Such a tax advantage encouraged firms to enter into JV arrangements earlier but now since these advantages have been withdrawn, a subsidiary has become the most preferred organisational form for the MNCs.

    11 In fact, six MNCs Glaxo-Wellcome, Parke Davis, Beecham, Abbott, Rhone Poulanc Rover and Sandoz had about 53 per cent share of the prime volume market. The share of Glaxo-Wellcome in this market was as high as 23.9 per cent; Parke Davis with a share of 6.6 per cent was a distant second. Similarly, seven firms, Glaxo-Wellcome, Beecham, Hoechst, Squibb, Abbott, Pfizer and Merck Sharp and Dohme had more than 50 per cent of the prime value market in 1995. These seven top MNCs achieved this market share by selling 43 medicines of which 23 were antibiotics. About two-thirds of their prime market turnover was contributed by these antibiotics. The total share of all the local firms was less than the shares of Glaxo-Wellcome (11.5 per cent) and Beecham (10 per cent).

    12 In 1993, only two major units in the private sector (Glaxo-Wellcome and Hoechst) and two in the public sector (Antibiotics and Kurrum) were active in this field. Kurrum was subsequently sold to Upjohn. Antibiotics also has been divested but the details of this privatisation were not available. Glaxo-Wellcome shut down its basic manufacturing plant in 1998-1999 and Hoechst is on the verge of closure. Apparently, Antibiotics, even after privatisation, is also not a fully functioning plant, but this could not be confirmed. The situation was similar in 1993 when 31 firms had the licence.

    13 According to some, these selective price increases made possible, to some extent, cross-subsidisation across drugs of the same firm.

    14 See discussions in Basant (2000) and Chaudhuri (2005: Chapter 8).

    15 See Basant (2000) for different estimates of price increases during this period.

    16 Computed from the estimates provided in Pharma Bureau (1998: 24). The share imported excipients in the total costs of drugs locally manufactured by MNCs was about 8 per cent and that of imported packaging material was about 5 per cent.

    17 For example, while Bayer, Karachi bought cyprofloxacin from Bayer, Germany at the rate of $ 197/kg, Novaritis, Karachi got at $48/kg from Euland Labs India and Ciba, Karachi bought at $ 53/kg from Biochem, Austria. The facts are similar in other cases. In some cases, like that of Metocloframide the same MNC (SK and B) has paid significantly higher rates when the raw material was bought from UK than from India.

    18 Apart from the examples quoted above, while Searle/ICI, Karachi paid $196/kg for proronol to Zeneca, UK, Knoll acquired the same raw material at the rate of $ 34.7 per kg.

    19 Import tariff rates have come down from the peak tariff rate of 150 per cent in 1991 to 20 per cent in 2004 [Chaudhuri 2005: 138].

    20 A foreign controlled firm, exporting 50 per cent or more of its production can borrow working capital from the domestic capital market and the firms which do not export but fulfil the demand of the domestic market can borrow rupee loans equal to their equity.

    21 The detailed data shows that within Pakistan, prices of brands manufactured by MNCs are usually the highest, followed by the prices of the imported drugs and the brands of local companies.

    22 Besides, some calculations in Basant 2007, Appendix Table 1 seem to be incorrect. For example, Pakistan equivalent of Indian prices for Ovral tablets and Primarin seem to be wrongly calculated. It is difficult to check the estimates as the relevant information on pack sizes seems to be incorrect.

    23 For example, the prices of one mg vials increased by more than 54 per cent during 1993-97. Ely Lilly was the only producer of these vials. Similarly, the prices of Ciproxin infusions increased by more than 147 per cent during 1995-98 and Bayer was the sole manufacturer. In the same vein, due to its monopoly Hoechst was able to increase the price of Tarivid injections by about 160 per cent during 1995-97.

    24 See Basant 2000 for more details on these data.

    25 Some MNC representatives in Pakistan also claimed that the age profile of the drugs marketed by MNCs in Pakistan was different from that of India. The Pakistan portfolio had a higher number of relatively new drugs, although this portfolio was also ageing.

    26 See, for example, Chaudhuri (1999) and the references therein.

    27 The Drugs Act 1976 of Pakistan requires the pharmaceutical manufacturers to contribute 1 per cent of their gross profit towards a Drug Research Fund which is supposed to be spent for conducting research on the development of new pharmaceutical formulations. Firms having their own R&D facility need not pay this cess. The MoH officials claimed that these funds were used to conduct research in some university and public sector labs. And industry was also involved in some of this research. No details were, however, available. The manufacturers claim that this research fund has remained unutilised.

    28 A more recent news item also highlights this phenomenon. See, ‘Pak Pharma in Transition’,, January 12, 2006.

    29 The estimates of the number of active MNCs vary between 30 and 35 and their market shares between 40 and 60 per cent. For more details see, ‘Industry Forecasts – Asia and Australasia’, December 2005 at (pp 71-76) and 6439575_63872702_7685613000.html.

    30 No new evidence is available of transfer pricing in Pakistan but duties on imported raw material add upward pressure on prices. For example, raw material imports from India have been on the rise in recent years but the import duty was increased from 10 to 35 per cent increasing the costs of production (, March 16, 2005).

    31 See editorial comments on these lines in two issues of the Economic and Political Weekly (December 2, 2006, pp 4927-28 and October 8, 2005, pp 4391-92).


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    Anonymous (2006): ‘Pak Law Includes New and Useful Improvements as Well’,, January 12.

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  • (2007): ‘Intellectual Property Rights Regimes and Pharmaceutical Prices in India and Pakistan: Some Issues’, paper presented at the Jenny Lanjouw Memorial Conference held at the University of California, Berkeley on March 31.
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