Figure 3 - uploaded by Sunil Mani
Content may be subject to copyright.
Source publication
The paper undertakes a detailed mapping out of the sectoral system of innovation of India's pharmaceutical industry. The industry is one of the most innovative industries in the Indian manufacturing sector. The innovation system of the industry has three strong pillars: very pro active government policy regime especially with respect to intellectua...
Context in source publication
Similar publications
Objectives: Competitiveness is the ability of countries in increasing market share, profits, value added, and staying at the scene of fair and international competition for a long period of time. This is realized through market authority and establishing activities based on comparative and competitive advantages. On the other hand, the research-bas...
Citations
... The interventions were categorised as "direct funding [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]" or "taxation policy [5,12,16,20,22,23,26,[29][30][31][32][33][34][35][36][37]". Direct funding referred to governments or health departments directly expending funds on programs aimed at supporting or facilitating trial activity, while taxation policy referred to forgone revenue through tax credits or exemptions designed to encourage expenditure by a third party such as a pharmaceutical company or other research organisation. ...
... Interventions categorised as "taxation policy" were divided into three different categories; (1) research and development tax credits or offsets (where the research and development costs of companies were deducted from their revenue); [12,16,20,22,23,26,[29][30][31][32][33][34][35][36] (2) fees and charges exemptions (where specific fees and charges related to clinical trials were removed); [5,29,37] or (3) preferential income tax rates (where companies engaged in clinical trials were taxed at a lower rate than other companies) [36]. ...
Context
Governments have attempted to increase clinical trial activity in their jurisdictions using a range of methods including targeted direct funding and industry tax rebates. The effectiveness of the different approaches employed is unclear.
Objective
To systematically review the effects of direct government financing interventions by allowing companies to reduce their tax payable on clinical trial activity.
Data sources
Pub Med, Scopus, Sage, ProQuest, Google Scholar and Google were searched up to the 11 th of April 2022. In addition, the reference lists of all potentially eligible documents were hand searched to identify additional reports. Following feedback from co-authors, information on a small number of additional interventions were specifically sought out and included.
Data extraction
Summary information about potentially eligible reports were reviewed independently by two researchers, followed by extraction of data into a structured spreadsheet for eligible studies. The primary outcomes of interest were the number of clinical trials and the expenditure on clinical trials but data about other evaluations were also collected.
Results
There were 1694 potentially eligible reports that were reviewed. Full text assessments were done for 304, and 30 reports that provided data on 43 interventions were included– 29 that deployed targeted direct funding and 14 that provided tax rebates or exemptions. There were data describing effects on a primary outcome for 25/41 of the interventions. The most common types of interventions were direct funding to researchers via special granting mechanisms and tax offsets to companies and research organisations. All 25 of the studies for which data were available reported a positive impact on numbers and/or expenditure on clinical trials though the robustness of evaluations was limited for many. Estimates of the magnitude of effects of interventions were reported inconsistently, varied substantially, and could not be synthesised quantitatively, though targeted direct funding interventions appeared to be associated with more immediate impact on clinical trial activity.
Conclusion
There is a high likelihood that governments can increase clinical trial activity with either direct or indirect fiscal mechanisms. Direct funding may provide a more immediate and tangible return on investment than tax rebates.
... The governance interventions were divided into: co-ordinating centre (Thompson et al., 2009;Care ACoSaQiH, 2020;Industry CDo, 2011;Committee UHoCSaT, 2013), (a new government office was implemented to shepherd trials through the approval pathway); scope guidelines (Madhani, 2010;Mani, 2006;Sarma, Manisha (2018)), (governance bodies were encouraged to process applications in a particular way); single application (Srinivasan et al., 2009;Hudson et al., 2016;Srinivasan, 2009;Haynes et al., 2010), (using a centralised governance body for all institutions); streamlined approval (Fudge et al., 2010;Ippoliti, Falavigna (2014); Choudhury, Saberwal (2019)), (whereby applications were given some form of special treatment or consideration for rapid approval), other regulatory changes (Kong, 2007;Mossialos et al., 2016;Zhang et al., 2015;Caulfield 2001;Thompson, 2014;van Oijen et al., 2017;Reith et al., 2013;Berge et al., 2015;McGee, 2006;Warlow, 2005;Care ACoSaQiH, 2020;Chen, 1998;Ikegami, Campbell (1999); Konishi et al., 2018;Hackshaw et al., 2008;Newman et al., 2016;Kwon, Jung (2018); ATIC Australian Trade and Investment Commission (2018); Chengodu, 2013; Webster, Temple-Smith (2013)), (a range of different changes to the regulatory process) or other (non-regulatory governance interventions, including programmes focused on knowledge sharing, safety, or specific programmes for orphan drugs). While some interventions included aspects of another, they were categorised according to the primary objective of the intervention strategy. ...
... There were 39/45 interventions for which there was a positive, null or adverse effect identified. The other 6 studies reported on the intervention form only (2 ethics (Care ACoSaQiH, 2020; Thompson, 2014) and 4 governance (Thompson, 2014;Madhani, 2010;Mani, 2006;Care ACoSaQiH, 2020), with no data on impact provided. Among the 39 interventions for which an outcome was recorded there was reporting on numbers of clinical trials for 38 (11 for ethics and 27 for governance) and expenditure on clinical trials for 5 (0 for ethics and 5 for governance). ...
Governments have attempted to increase clinical trial activity in their jurisdictions using a range of methods including simplifying the ethics review and governance process of clinical trials. This study’s objective was to systematically review the effects of government actions targeting ethics reviews or governance processes on clinical trial activity. The data sources of Pub Med, Scopus, Sage, ProQuest, Google, Google Scholar and reference lists were all searched between 9/8/20 and 6/9/20. From these sources, 1455 potentially eligible reports were reviewed and full text assessments were done for 295. Thirty-eight reports provided data on 45 interventions—13 targeting ethics review and 32 targeting governance processes—were included. There were data describing effects on a primary or secondary outcome (the number of clinical trials or expenditure on clinical trials) for 39/45 of the interventions. 23/39 (59%) reported positive effects, meaning a greater number of trials and/or expenditure on clinical trials (6/11 ethics, 17/28 governance), 7/39 (18%) reported null effects (4/11 ethics, 3/28 governance) and 9/39 (23%) reported adverse effects (1/13 ethics, 8/28 governance). Positive effects were attributable to interventions that better defined the scope of review, placed clear expectations on timelines or sought to achieve mutual acceptance of ethics review outcomes. Adverse effects were mostly caused by governance interventions that unintentionally added an extra layer of bureaucracy or were developed without full consideration of the broader clinical trial approval system. Governments have an opportunity to enhance clinical trial activity with interventions targeting ethics reviews and governance processes but must be aware that some interventions can have an adverse impact.
... Their results show that in this interval multinationals gained market, productive capacity in India, and national industries did not develop. An unsupportive political environment and weak legal certainty affected the local industry at that time.Throughout early 2000s, according toMani (2006) three pillars were crucial for the change of direction of the Indian national industry: proactive policies for the intellectual property protection (patents), strengthening of research institutes with government funding and entry of private capital in the sector in search of innovation. ...
The development of a local pharmaceutical research and development industry is essential to meet the demands of a large country with a large population such as Brazil. This work aims to explore the existing data on the ecosystem of the pharmaceutical industry in this group of countries, and through parameters based on the precursor literature, to identify the innovation factors and the position of Brazil in relation to the other representatives of the BRICS (the leading developing countries in the world). Since the mid-1940s, Brazil has received pharmaceutical multinationals and through government initiatives it has locally reproduced medicines developed abroad when the patents have ended. The BRICS represent the group of emerging countries considered “the big five”, with population capacity and economic growth that tend to boost the global economy in the coming years. The comparative analysis showed that Brazil has a certain lag in fundamental parameters for the existence of a national pharmaceutical R&D industry, having placed behind Russia, India and China, even symbolically by not producing a national vaccine in response to COVID-19.
... Nos últimos 50 anos, a indústria farmacêutica indiana (IFI) evoluiu de quase inexistente para uma líder mundial na produção de medicamentos genéricos de alta qualidade e baixo custo. Atualmente, a Índia é a 3° maior fabricante de produtos farmacêuticos no mundo, em termos de volume; a maior exportadora de medicamentos genéricos, respondendo por cerca de 20% das exportações globais, em volume; fornece mais de 50% da demanda mundial de muitas vacinas e 60% dos medicamentos antirretrovirais globais (MANI, 2006;OPPI, 2018;MAKE IN INDIA, s.d). Além disso, a importância da Índia é crescente, o país é o destino preferido de terceirização 1 no setor farmacêutico devido à alta capacidade produtiva e tecnológica que as empresas farmacêuticas indianas apresentam, aos fortes investimentos governamentais em infraestrutura de P&D e nos baixos custos produtivos, o que torna o processo de desenvolvimento e produção de medicamentos no país mais barato (RUIZ; PARANHOS, 2012). ...
... A escolha deste marco temporal dá-se pelo fato do ineditismo de se analisar e discutir o período pós 2005 na IFI sob a perspectiva das políticas de inovação. Além disso, o período anterior ao TRIPS já está bastante documentado na literatura (MANI, 2006;KALE;LITTLE, 2007;RAY, 2008;TORRES;HASENCLEVER, 2017). O artigo procura demonstrar que a implementação de políticas de inovação com características sistêmicas na IFI é um fator que contribui para tornar o país um grande centro produtivo farmacêutico de referência mundial, como os dados acima apontam. ...
... Por meio do 11º e 12º planos quinquenais, planos que estabelecem as principais prioridades, objetivos e metas de crescimento a nível nacional e setorial para cada cinco anos no país, formulados desde 1951, o governo destacou a necessidade de i) implementar uma política nacional de inovação que busque fortalecer as capacidades humanas, institucionais e de infraestrutura da indústria farmacêutica nacional e ii) ampliar a participação e ação conjunta de ministérios/departamentos relevantes e stakeholders na construção e execução de estratégias e políticas mais coordenadas para o desenvolvimento do setor (ÍNDIA, 2008;2013). O Quadro 2 apresenta um resumo das diretrizes apontadas por esses planos para o desenvolvimento da IFI. ...
... Nesse sentido, percebemos como a capacidade tecnológica na Índia não é resultado do mero acaso, mas fortemente dependente de uma sucessão de políticas industriais, regulatórias e econômicas e da resposta ativa dos laboratórios públicos e privados aos estímulos institucionais.As mudanças regulatórias, como a adoção de uma política de liberalização, mudanças nas leis de patentes indianas e mudanças nas leis referentes à entrada de genéricos nos Estados Unidos, criaram três tipos de oportunidades para empresas farmacêuticas indianas nos próximos anos: i) explorar o mercado internacional de genéricos, especialmente mercados de países desenvolvidos lucrativos; ii) realizar parcerias e estabelecimento de joint ventures de fabricação e comercialização com empresas líderes mundiais em testes clínicos e outsourcing de P&D para aumentar sua capacidade tecnológica e iii) transitar para a descoberta de novos medicamentos.Durante o período de transição ao TRIPS, as duas primeiras foram as mais praticadas. Para a descoberta e lançamentos de novos medicamentos, a estratégia das empresas farmacêuticas indianas é celebrar alianças (acordos de co-marketing/licenciamento) com empresas multinacionais(MANI, 2006;TORRES, HASENCLEVER, 2017). ...
Esta dissertação de Mestrado identifica e analisa, a partir da abordagem sistêmica da inovação, as políticas e instrumentos implementados pela Índia para estimular a capacidade produtiva e tecnológica da sua indústria farmacêutica a partir de 2005, após o período de harmonização ao Acordo TRIPS. O método utilizado foi pesquisa documental das políticas, identificadas pela revisão da literatura, que mais incidem sobre a capacidade produtiva e tecnológica da indústria farmacêutica indiana, a saber: as políticas industrial e de ciência tecnologia e inovação, regulatória de preço e sanitária e de propriedade intelectual. Concluiu-se que a infraestrutura e o ambiente de inovação na Índia foram construídos em fases. A revisão de literatura mostrou que as políticas pré 2005 tiveram como estratégia estabelecer as bases para a construção da capacidade produtiva e tecnológica da indústria farmacêutica indiana, a partir de incentivos financeiros, como dedução fiscal; garantias de mercado; padrões de qualidade compatíveis com os padrões internacionais; regulações de preços; e uma legislação de patentes apoiando processos de engenharia reversa, que de forma conjunta, criaram um ambiente propício para as empresas farmacêuticas indianas dominaram com excelência a produção de medicamentos genéricos. Por sua vez, a análise documental das políticas pós 2005 mostrou que as ações governamentais nesse período deram continuidade ao compromisso de estimular o crescimento da indústria farmacêutica nacional, e estabeleceu como objetivo principal tornar a Índia um dos cinco principais centros de inovação farmacêutica do mundo. Em síntese, estas políticas buscam fortalecer as capacidades tecnológicas domésticas, resguardar a produção nacional e oferecer um ambiente doméstico favorável para os atores privados investirem em inovação. Sobre o papel do governo nesse processo, constatou-se que este ator possui uma forte influência sobre a produção e inovação nessa indústria por meio da sua atuação enquanto órgão financiador, legislador, formulador de políticas e agente regulador. Com base na análise do desenho das políticas, argumenta-se que elas apresentam características de políticas de inovação tal como definidas pela abordagem sistêmica da inovação e englobam iniciativas para mitigar problemas sistêmicos do processo inovativo. Por fim, concluiu-se que a Índia possui ações continuadas de crescimento e desenvolvimento de longo prazo, articulada por meio dos planos quinquenais que existem desde a década de 1960. Além disso, a presença de políticas coordenadas e com objetivos articulados entre si – visão de que uma política reforça a outra -, constituem-se como aprendizados para outros países em desenvolvimento.
... The industry maintains remarkable growth rate and enjoys considerable share in domestic and international markets. The process patent regime has been the key factor that enabled the industry to pass through steady growth and reach its current position (Chaudhuri, 2006;Mani, 2006). Prior to 1970, the Indian pharmaceutical industry was dominated by a few foreign firms. ...
... At best they are assumed to be introducing incremental innovations defined as adaptations of known technologies to local conditions. It is very well understood that process patent regime has enabled the pharmaceutical industry to increase its domestic technological capability (Mani, 2006). ...
... The TRIPS flexibilities offer provisions such as compulsory licensing and government use, parallel trade, exemptions from patentability, price control and so on, and these flexibilities are expected to help poor countries in addressing their healthcare needs (Bond & Saggi, 2014;Chaudhuri, 2006Chaudhuri, , 2013Chaudhuri, , 2014aChaudhuri, , 2015Mani, 2014). Provision of compulsory licensing can be adopted to reduce the exorbitant prices being charged by the MNCs for some of the products. ...
The advocates of intellectual property rights project strong patent regime as an effective way to pro-mote research and development (R&D) activities leading to innovation while others argue that they may adversely affect local industries in developing countries and result in monopoly pricing that may compromise on larger interests including public healthcare. The process patent regime has enabled Indian pharmaceutical firms to strengthen their technological capability and performance in domestic and global markets. As the country reintroduced product patent protection in 2005, Indian ‘copycats’ could not follow their reverse engineering technology anymore. Being a developing country and ‘pharmacy of the Global South’, India’s experience offers global dimensions to these debates. This article makes an attempt to reflect on India’s experience with the new patent regime; it looks into the pattern of R&D, trade and trend of product patenting in the pharmaceutical sector and revisits public health concerns.
... A escolha por realizar parcerias com ETNs, principalmente nas atividades de P&D de novos produtos, tem sido a principal forma de evitar um embate com as empresas dominantes do mercado. Além disso, dada a capacidade acumulada na formulação de medicamentos, muitas empresas indianas passaram a licenciar seus produtos melhorados (e patenteados) para as ETNs, que possuem melhores condições de comercializá-los nos grandes mercados dos países desenvolvidos Paranhos, 2013;Mani, 2008). ...
Apesar das semelhanças de Índia e Brasil no uso de instrumentos de política industrial para desenvolver a indústria farmacêutica ao longo do século XX, houve diferenças fundamentais nas estratégias públicas e privadas que resultaram em níveis divergentes de capacitação tecnológica. O estudo histórico-comparativo apresentado neste trabalho procura elucidar essas diferenças estratégicas, que são observáveis antes e depois da abertura comercial dos anos 1990. Enquanto a Índia adotou uma política nacionalista de absorção de tecnologia externa e desenvolvimento tecnológico interno, o Brasil adotou uma política de transferência de tecnologia das empresas estrangeiras, o que criou barreiras substanciais à capacitação tecnológica das empresas nacionais.
... A rich literature base has developed in international business on the growth, drivers, and motivations of the rapid increases in OFDI from emerging markets in general (see, for instance, Dunning, 1988Dunning, , 1995Dunning, , 1998Dunning et al., 2008;Rugman, 2008;Sauvant et al., 2008;Sauvant et al., 2010) and on IPTNCs in particular (see, for instance, Athreye and Godley, 2009;Bruche, 2011;Kale, 2009Kale, , 2010Manil, 2006;Panda and Sriram, 2013;Pradhan, 2003;Pradhan and Alakshendra, 2006). International business approaches have also, in varying degrees, incorporated institutional features into their analyses. ...
This article identifies the institutional foundations of the comparative advantages of the Indian pharmaceutical industry in generic bulk drugs, active pharmaceutical ingredients (APIs) and final dosages, and formulations manufacturing. Through studying six institutional areas in connection with the internationalization strategies of nine Indian pharmaceutical firms, this study illustrates how these comparative advantages have been evolving since liberalization of the Indian economy. It demonstrates how, in the post-liberalization era, both up-market outward foreign direct investment (OFDI) and the rise of contract-based partnerships are altering the way in which Indian pharmaceutical firms coordinate their action in the local sector. The shift towards more contact-based forms of coordination could support an industry-wide transition towards specialization in novel drug discovery and development. Although firms, especially larger ones, have been the main orchestrators of this shift, this study concludes that mainstreaming the necessary institutional mechanisms across the industry and employing the appropriate policy tools will be critical to supporting this transition.
... Therefore, in export markets, Bangladeshi pharmaceutical firms face strong competition from the MNCs as well as from pharmaceutical firms in China, but the main threat is from Indian firms. Table 1 provides a list of six types of vulnerability, the potential impacts of the TRIPS Agreement and the adaptive actions undertaken to minimize those impacts which have been supported by current literature on the TRIPS Agreement (Hati 2006;Mani 2006;Chaudhuri 2007;Pradhan 2007;Wendt 2007;Chittoor et al. 2008;Li 2008;;Rai 2009;Guennif & Ramani 2010;Basant 2011;Nielsen et al. 2011). A positive (+) sign after each potential impact variable (IV) indicates the expectation of a positive functional relationship with vulnerability and a negative (−) sign indicates inverse functional relationship. ...
This study measures the different types of vulnerability experienced by Bangladeshi pharmaceutical firms since 2005, consequent upon the Agreement on Trade Related Intellectual Property Rights (TRIPS) of the World Trade Organisation (WTO). We find that that R&D-related vulnerability was the highest in the pharmaceutical sector in Bangladesh. Cluster analysis supports this proposition as 79.8% of the sampled firms had below average levels of innovativeness. We argue that the TRIPS transition period (which began in 2005 and is to end in 2015) has not been used effectively used by Bangladesh, the most technologically advanced LDC to create a strong technological platform for the pharmaceutical industry. Also, the expected process of transfer of technology has not taken place. We recommend that the post-TRIPS industrial policy for the pharmaceutical industry in Bangladesh should be designed and delivered with a key focus to improve the R&D and innovation capabilities of the domestic firms. Moreover, the WTO must evaluate the current mechanisms underpinning developed countries-LDCs technology transfer. (C) 2013 The Authors. Published by Elsevier B.V.
... There are a number of studies on National Innovation Systems with a global perspective. However, studies relating to the Indian innovation system were quite scarce at the beginning of the decade (from 2000) but grew in number thereafter (Gupta and Dutta, 2005;Bound, 2007;CII, 2007;Dutz, 2007;Mitra, 2007;Mani, 2006Mani, , 2007Arora, 2007;Nassif, 2007;Krishnan, n.d.). ...
