India's pharmaceutical industry: hype or high tech take-off?

India has built a large pharmaceutical industry through an array of measures in support of domestic firms. The absence of product patents enabled Indian companies to become world leading producers of generic versions of patented drugs. Low costs and a strong engineering tradition continue to sustain competitive strength. The implementation of the World Trade Organization patent regime in 2005 is driving a transformation of the industry. Key elements of the present shake-up include the return of 'big pharma' companies on a large scale and the emergence of several Indian firms that aim to become fullyfledged research-based multinationals. This article provides a description of the development and structure of the Indian pharmaceutical industry and explores questions and challenges arising from its integration into global markets.

Health consumer organizations and the pharmaceutical industry : is transparency the answer?

This book examines the important role of consumer activism within health policy in different national contexts. In an age of shifting boundaries between state and civil society, consumer groups are potentially drivers of democratization in the health domain. The expert contributors explore how their activities bring new dynamics to relations between service providers, the medical profession, government agencies, and other policy actors. This book is unique in comprehensively analysing the opportunities and dilemmas of this type of activism, including ambiguous partnerships between consumer groups and stakeholders such as the pharmaceutical industry. These themes are explored within an internationally comparative framework, with case studies from various countries. Students and researchers in the fields of health policy and sociology, public policy and social movements will find this relevant and path-breaking book enlightening. It will also prove invaluable for participants and activists in patient and health consumer organizations.

The politics of the pharmaceutical industry and access to medicines : world pharmacy and India

The Pharmaceutical Industry presents one of India’s most successful stories of economic expansion and improvements in public health. Indian firms have made access to quality medicines possible and affordable in many developing countries. Indian pharmaceuticals are also exported on a large scale to the United States and other highly regulated markets. A wave of mergers, acquisitions and tie-ups point to growing integration between Indian firms and global pharma multinationals.

The Politics of the Pharmaceutical Industry and Access to Medicines: World Pharmacy and India examines this important industry from different economic, social and political perspectives. Topics covered include the implications of TRIPS-compliant intellectual property rights, the role of flexibilities under TRIPS, the market regulation system, the role of Indian firms in exporting HIV/AIDS medications to Africa, the issue of free trade agreements, the power and reach of foreign pharmaceutical multinationals in India’s domestic market, and the sustainability of India as a major generics supplier.

The Pharmaceutical Industry and Access to Medicines in India

Pharmaceutical policy in India as elsewhere is shaped by conflicting economic and social interests and opposing values and priorities. Tensions can be understood as revolving around the contradiction between use value and exchange value in the production of medicinal drugs as commodities, as per Marx’s original analysis. The use value of medicines – if safe and efficacious, of good quality, and prescribed and consumed appropriately – is the prevention, cure or alleviation of ill-health and disease. Health policy is – or should be – aimed at optimising the use value of medicines. For this purpose government agencies administer regulatory oversight of the manufacturing, marketing and distribution of medicines. Drugs made available to patients are expected to meet adequate safety, quality and efficacy standards, but regulation to ensure such standards is subject to controversy in most countries. This is a domain where definition and interpretation of scientific-technological principles and criteria is infused by partiality and bias grounded in social and material interests, as evidenced by recurrent debates about industry ‘capture’ of regulatory agencies, including the world’s most regulator, the US Food and Drug Administration (Angell 2005; Law 2006). In India, a Parliamentary Committee Report in 2012 depicted the Central Drugs Standard Control Organisation (CDSCO) as dysfunctional and influenced inappropriately by the exchange value perspective of manufacturers (Parliamentary Standing Committee on Health and Welfare 2012). The clash between use and exchange value perspectives is starkly illustrated by cases of products known to cause more harm than good, particularly common in poorly regulated markets such as India’s, as shown by Srinivasan & Phadke.

The pharmaceutical industry, intellectual property rights and access to medicines in Pakistan

The pharmaceutical industry in Pakistan is worth around US$ l.18 billion, with annual growth in 2010 approaching 10 per cent (Khan, 2012). There are more than 650 registered companies, including 31 multinationals, which in 2006 had a market share in value terms of 53.3 per cent, with national firms controlling the remaining 46.7 per cent (IMS Health, 2007). In 2007 medicines worth about US$100 million were exported. Medicines are a vital component of healthcare, and Pakistan spends around three-quarters of its healthcare budget on medicines (WHO, 2004). This chapter provides an overview, from a public health perspective, of the national pharmaceutical market and the development of drug policies and regulation. Pakistan adopted a Trade Related Aspects of Intellectual Property Rights (TRIPS) compliant patent regime in 2000, and the intersection between patents and public health is a central policy challenge. This chapter highlights key issues related to intellectual property, Free Trade Agreements (FTAs), and production and access to medicines.

Pharmaceutical companies' public relations and representation by internet

This paper is part of study of how the adoption of the Internet is affecting the traditional public relations practices of Australian pharmaceutical companies. It suggests that Australian pharmaceutical companies are behind both America and Europe, not only in their adoption of the Internet, but also in their application of Internet technologies for public relations. It also suggests that direct interpersonal communication remains the preferred option for Australian pharmaceutical companies to communicate and build relationships with doctors and pharmacists. The paper is the result of interviews with pharmacists and doctors and one pharmaceutical industry representative. It also involved a survey of pharmaceutical companies’ web sites.

Diffusing knowledge-based core competencies for leveraging innovation strategies: modelling outsourcing to knowledge process organizations (KPOs) in pharmaceutical networks

As pharmaceutical firms try to market their products and reduce costs, vertically integrated structureshamper innovation processes. Yet, pharmaceutical firms must innovate to compete. Outsourcing knowledgeintensive activities to knowledge process organizations (KPOs) serves to reduce innovation process obstacles.Grounded in diffusion theory and strategic management literature, this conceptual paper explores fourinterrelated strategic concepts: core competencies, economies of scale and scope, knowledge sharing,and learning. This paper claims that (a) accumulated core competencies of multinational pharmaceuticalcompanies (MPCs) erode over time and these companies become dependent on KPOs (b) MPCs mustunderstand how KPOs manage core competencies (c) economies of scope benefit KPOs enabling them tosustain competitive advantages for their MPC partners, meanwhile the benefits from economies of both scaleand scope shift from MPCs to KPOs (d) KPOs need to monitor their rate of learning to remain competitive.The paper identifies implications for industrial managers and directions for future research.

Pharmaceuticals in Australia: developments in regulation and governance

The pharmaceutical domain represents a type of internationalised policy network theorised in recent writings on neo-liberalism, neo-corporatism and governance. This article presents an analysis of developments in prescription drug regulation in Australia. A relatively stable, state-managed pattern of interaction has been superseded by less closed exchange, and the government itself has fragmented into agencies pursuing different objectives. Developments in the three core regulatory areas are described: safety and efficacy controls, social policy (access and equity), and state support for industry (economic) development. Consensus-building occurs within the context of the National Medicines Policy. The pharmaceutical industry, represented by Medicines Australia, has a stake in all aspects of pharmaceutical policy and regulation, and draws upon unique resources (expertise and lobbying capacity). The context for the developments described is Australia's abandonment of a protectionist version of the Keynesian welfare national state in favour of the model of the competition state, which is oriented towards support for the growth of high technology industries such as pharmaceuticals, premised on partnerships with business.

Improvements to separation and detection for forensic analysis of illicit substances

This article gives an overview of our recent research into separation and detection of analytes of forensic interest. This work has been carried out in collaboration with local forensic service providers and is based on our previous studies of chemiluminescence detection, flow analysis and capillary electrophoresis as applied to process analytical chemistry for the pharmaceutical industry. Chemiluminescence has the potential to provide low limits of detection in combination with high selectivity, while capillary electrophoresis allows for rapid, highly efficient separations. Examples of recent forensic applications are presented and future directions are discussed.

Novel routes to new chiral rings and cages

The successful synthesis and characterisation of a series of new chiral cages was achieved through the use of a BINOL backbone linked to a variety of organotin carboxylates. These novel chiral cages may ultimately find use as catalysts in reaction syntheses for the pharmaceutical industry.

Molecular characterization and enzymatic hydrolysis of flavanoid extracted from citrus waste

The citrus fruit processing industry generates substantial quantities of waste rich in phenolic substances, which is a valuable natural source of polyphenols (flavonoids) such as naringin and its disposal is becoming a major problem. In the US alone, the juice processing of oranges and grapefruit generates over 5 Mt of citrus waste every year. In the case of India, about 2.15 Mt of citrus peel out of 6.28 Mt of citrus fruits are produced yearly from citrus juice processing. In case of Australia, about 15-40% of citrus peel waste is generated by processing of citrus fruit (0.85 Mt). Thus Isolation of functional compounds (mostly flavanoids) and their further processing can be of interest to the food and pharmaceutical industry. This peel is rich in naringin and may be used for rhamnose production by utilizing α-L-rhamnosidase (EC 3.2.1.40), an enzyme that catalyzes the cleavage of terminal rhamnosyl groups from naringin to yield prunin and rhamnose. We recently purified recombinant α-L-rhamnosidase from E. coli cells using immobilized metal-chelate affinity chromatography (IMAC) and used it for naringin hydrolysis. The purified enzyme established hydrolysis of naringin extracted from citrus peel and thus endorses its industrial applicability for producing rhamnose. Infrared (IR) spectroscopy confirmed molecular characteristics of naringin extracted from citrus peel waste.

Democratizing health : consumer groups in the policy process

This timely book examines the role of consumer organisations in the health policy process. In an age of shifting boundaries between state and civil society, consumer groups are potentially drivers of democratisation in the health domain. Their activities bring new dynamics to relations between service providers, the medical profession, government agencies, and other policy actors. This book is unique in comprehensively exploring the opportunities and dilemmas of this type of activism, including sometimes ambiguous partnerships between consumer groups and stakeholders such as the pharmaceutical industry. These themes are explored within an internationally comparative frameThis book examines the important role of consumer activism within health policy in different national contexts. In an age of shifting boundaries between state and civil society, consumer groups are potentially drivers of democratization in the health domain. The expert contributors explore how their activities bring new dynamics to relations between service providers, the medical profession, government agencies, and other policy actors. This book is unique in comprehensively analysing the opportunities and dilemmas of this type of activism, including ambiguous partnerships between consumer groups and stakeholders such as the pharmaceutical industry. These themes are explored within an internationally comparative framework, with case studies from various countries. work, with case studies from many countries.