Indian Pharma Within Global Reach?

The Indian pharmaceutical industry is presently going through a phase of transition and potential consolidation, owing to India's new TRIPS-compliant intellectual property regime and other rules aimed at enhancing the industry's credibility nationally and internationally. Appropriate policy interventions can play a large role in cushioning the transition (and gradual consolidation) of the industry post-2005. Using firm level data collected in 2004-2005, this paper seeks to make two major contributions in this regard. The research findings show that the Indian pharmaceutical sector is a heterogeneous mix of firms with vast differences in innovative capabilities. Based on these differences, the groups can be categorized into specific "innovation modes" (the innovator, the niche operator and the manufacturer), each mode being a step closer towards the innovative pharmaceutical firm. Second, the paper highlights how the emerging strategies of firms in all three groups, although different, underpin the importance of systemic coordination in the pharmaceutical sector. The analysis links both these findings to policies pursued in the pharmaceutical sector over the past four decades and highlights the role of differential innovation policy in ensuring optimal sectoral performance.Pharmaceutical industry, Innovation policy, TRIPS, Intellectual Propery, IPR, Property rights, India

India's product patent protection regime: Less or more of "pills for the poor"?

The year 2005 marks the end of transition period for many developing countries with competent pharmaceutical sectors that competed in supplying generic versions of patented drugs to LDCs before, thereby inducing price competition and enhancing access to medicines. In a post-2005 scenario, the critical issue is whether LDCs without adequate manufacturing capabilities can make use of compulsory licensing expeditiously to induce price competition and secure lower prices. This paper uses empirical evidence collected during a firm-level survey of the Indian pharmaceutical sector to generate evidence on emerging strategies of firms. It shows that the vigour of compulsory licensing as a price-leveraging instrument post-2005 is incumbent mainly on its economic feasibility. It shows that Indian firms view the market potential (in terms of market size and profits involved in such supply, especially if they have to make specific technological investments to produce the drug) of the mechanism much more severely than before, and may be less inclined to engage in such production if their commercial expectations are grossly unmet. The analysis assesses implications of emerging strategies of firms in the Indian pharmaceutical sector for access to medicines both domestically and internationally, and highlights the challenges involved.product patents, Indian pharmaceuticals, generics, access

Rough Road to Market: Institutional Barriers to Innovations in Africa

Translating R&D and inventive efforts into a market product is characterized by significant financial skills, and the ability to overcome technical and instititonal barriers. Research into and translation of new technologies such as biotechnology products to the market requires even greater resources. This paper aims to understand the key factors that foster or hinder the complex process of translating R&D efforts into innovative products. Different pathways exist in developed countries such as firm-level efforts, the use of IPs, the spin-off of new firms that develop new products, or a mixture of these. Developing countries differ substantially in the kinds of instruments they use because of their considerably weaker institutional environment and for this reason our framework takes a systemic and institutional perspective. The paper comtributes to this issue by examining systemic institutional barriers to commercializing biotechnology in a develping context within a systems of innovation framework.research and development, biotechnology, commercialization, innovation, Africa, learning, institution building

Innovation and Competitive Capacity in Bangladeshs Pharmaceutical Sector

The global pharmaceutical sector is highly patent intensive, and firms rely on product, process and formulation patents to protect their innovations. Intellectual property rights on pharmaceutical products, as contained in the Agreement on Trade Related Aspects of Intellectual Property Rights (hereafter, the TRIPS Agreement) have been defended on grounds of extensive R&D investments required to discover and develop new drugs. But at the same time, grant of uniform pharmaceutical patents in all developing and least developed countries that are members of the World Trade Organization in accordance with the TRIPS Agreement, raises a range of issues for access to medicines. These issues can be framed under three broad areas: the restriction of reverse engineering possibilities for firms in developing countries and its implications for catch-up in this sector, higher prices of drugs and access to medicines as well as access to technologies due to patents on upstream technologies. The transitional arrangements under the TRIPS Agreement specifically mandated that all developing countries that are members to the WTO enact national laws that are TRIPS-compliant by 2005. As a result, from 2005 onwards, several countries like India, which played an important role as producers and exporters of generic copies of brand name products patented outside the country, can no longer produce such drugs due to the introduction of TRIPS-compliant patent regimes in their countries. Least developed countries have an extension until 2016 to implement the pharmaceutical patent provisions of the TRIPS Agreement under the Doha Declaration on TRIPS and Public Health. However, such legal flexibility is quite meaningless for least developed countries in the absence of local technological capabilities to produce generic drugs amongst least developed countries. Bangladesh, although a least developed country, is an exception in this regard with thriving domestic processing sectors that are actively engaged in producing textiles and ready made garments (RMGs), processed food products and generic drugs. Therefore, the question that looms large in the global access to medicines debate is whether Bangladesh's pharmaceutical sector can gradually evolve to provide low-cost substitutes of important patented drugs to other developing and least developed countries? This study is an original empirical investigation into issues of innovative capacity and competitiveness of the local pharmaceutical sector in Bangladesh.Bangladesh, WTO, TRIPs, Intellectual Property Rights, Pharmaceutical Industry, Public Health

Fostering Production of Pharmaceutical Products in Developing Countries

The ways in which pharmaceutical products are currently developed, manufactured, and distributed fail to meet the needs of developing countries. The recent emergence of new infectious diseases, the associated surge of healthcare nationalism, and the prevalence of substandard and falsified drugs have strengthened substantially the net benefits of augmenting the capacity of developing countries to produce such products locally. Most previous efforts to do so have foundered. The chance of success in the future would be maximized by the adoption of five strategies : (a) clarifying the zones of discretion created by the relevant treaties to ensure that local firms have the freedom to operate; (b) the use of “production triangles” (collaborations among developing-country governments, local firms, and developed-country pharmaceutical firms) to reduce regulatory impediments and to ensure that there exist adequate markets for locally produced products; (c) developing the human capital base in developing countries through initiatives such as an international apprenticeship system; (d) strengthening the legal and administrative apparatus for preventing the dissemination in developing countries of substandard and falsified drugs; and (e) reliance on regional economic communities to create economies of scale and to ensure that medicines are made available to all residents of all developing countries, while also stimulating competition among local firms. These strategies would both save many lives and strengthen the economic and social development of developing and least-developed countries

Infrastructure for Structural Transformation : A Comeback of Planning?

Abstract: This article examines how infrastructure development may best support structural transformation in developing countries. It critiques ongoing emphasis by multilateral financial institutions and other actors on infrastructure as an asset class and their focus on bankable projects. The article considers this approach too narrow for real economic transformation and argues development requires a more holistic approach, one that includes project assessment based on developmental criteria. Drawing on the pioneers of development and more recent literature on infrastructure systems, the article proposes development planning as a more promising approach and assesses how developing countries are faring regarding infrastructure planning for growth and transformation

Technological capability and development

Presented at the GLOBELICS 6th International Conference 2008 22-24 September, Mexico City, Mexico

Is there a trade off between innovation and inequality in developing countries?

Presented at the GLOBELICS 6th International Conference 2008 22-24 September, Mexico City, Mexico

The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products

Big-pharmaceuticalisation:Clinical trials and contract research organisations in India

The World Trade Organisation's Trade Related Intellectual Property Rights [TRIPS] agreement aimed to harmonise intellectual property rights and patent protection globally. In India, the signing of this agreement resulted in a sharp increase in clinical trials since 2005. The Indian government, along with larger Indian pharmaceutical companies, believed that they could change existing commercial research cultures through the promotion of basic research as well as attracting international clinical trials, and thus create an international level, innovation-based drug industry. The effects of the growth of these outsourced and off-shored clinical trials on local commercial knowledge production in India are still unclear. What has been the impact of the increasing scale and commercialisation of clinical research on corporate science in India? In this paper we describe Big-pharmaceuticalisation in India, whereby the local pharmaceutical industry is moving from generic manufacturing to innovative research. Using conceptual frameworks of pharmaceuticalisation and innovation, this paper analyses data from research conducted in 2010-2012 and describes how Contract Research Organisations (CROs) enable outsourcing of randomised control trials to India. Focussing on twenty-five semi-structured interviews CRO staff, we chart the changes in Indian pharmaceutical industry, and implications for local research cultures. We use Big-pharmaceuticalisation to extend the notion of pharmaceuticalisation to describe the spread of pharmaceutical research globally and illustrate how TRIPS has encouraged a concentration of capital in India, with large companies gaining increasing market share and using their market power to rewrite regulations and introduce new regulatory practices in their own interest. Contract Research Organisations, with relevant, new, epistemic skills and capacities, are both manifestations of the changes in commercial research cultures, as well as the vehicles to achieve them. These changes have reinvigorated public concerns that stress not only access to new medicines but also the 'price' of innovation on research participants