Biopharmaceutical Industry Capability Building in India: Report from a Symposium

Uppal, Annu; Chakrabarti, Ranjan; Chirmule, Narendra; Rathore, Anurag S.; Atouf, Fouad

doi:10.1007/s12247-021-09596-9

Cited by 6 publications

(8 citation statements)

References 15 publications

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“…Through electro-hydrodynamic printing techniques, new 3D bioprinters help deliver higher cell survival rates and tissues with micro and nano-scale features ( 12 , 51–56 ). Thus, through pharmaceutical innovation, the BRICS countries have asserted their autonomy, boosting the quest for self-sufficiency ( 55 ).…”

Section: Discussionmentioning

confidence: 99%

On the momentum toward vaccine self-sufficiency in the BRICS: an integrative review of the role of pharmaceutical entrepreneurship and innovation

Zhang,

Li,

et al. 2023

Front. Public Health

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BackgroundWith the perspicuous effect of COVID-19 on vaccine demand, academic and business interest in vaccine production in the BRICS nations (Brazil, the Russian Federation, India, China, and South Africa) has reached a crescendo. Aware of a “dark” past when the BRICS depended heavily on vaccines and pharmaceuticals from other parts of the world, academic curiosity on how the BRICS countries have leveraged vaccine self-sufficiency and become the hub of global vaccine production and supply is justifiable, especially in times of ineffable pandemics.MethodsThe articles were searched from November 2020 to December 2022. Within this period, an electronic search of 13 reputable healthcare and public databases was conducted. The initial searches from the designated databases yielded a total of 3,928 articles. Then, duplicated studies were removed through a two-step process, articles without titles and abstracts were excluded, and the remaining 898 articles that met the qualification assessment criteria were evaluated for article quality.ResultsThe main entrepreneurial innovations that have quickened the pace of vaccine self-sufficiency in the BRICS include investment in artificial intelligence (AI), Big Data Analytics, and Blockchain technologies. These help to speed up the drug delivery process by enhancing patient identification or optimizing potential drug candidates for clinical trials and production.ConclusionOver the past 20 years, the BRICS nations have achieved major strides in vaccine development, regulation, and production. The creation of the BRICS Vaccine Research and Development (R&D) Center will have a significant impact on vaccine cost and accessibility given the anticipated development of stronger research capability, production, and distribution technology, as well as stronger standardization to improve vaccine production quality in the near future. It is anticipated that the BRICS’ contributions to vaccine development will alter the global vaccination market and hasten the availability of vaccinations in developing nations. The challenge is turning these hopes into concrete plans of action and outcomes.

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Section: Discussionmentioning

confidence: 99%

On the momentum toward vaccine self-sufficiency in the BRICS: an integrative review of the role of pharmaceutical entrepreneurship and innovation

Zhang,

Li,

et al. 2023

Front. Public Health

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“…Cultivating capability is a critical construct in the progress of biopharmaceutical establishment in that it helps keep entrepreneurs afloat, attract investors, increase a company’s market share, and ensure its competitiveness in a tightly regulated industry. To make progress, a multifaceted approach has been described in the literature to include adopting high-tech manufacturing and technology transfer, skilled human resources, increased R&D spending, tailored collaboration, favorable policy frameworks, market exclusivity rights, public funding, product inclusion in public insurance schemes, and so on ( Gu, 2021a ; Uppal et al, 2021 ; Erickson et al, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

“…China and other developing countries, especially India, lead the world in terms of the manufacturing of generic medicines, enabling cost-effective medication to be accessible in most low-income nations ( Uppal et al, 2021 ). In terms of biopharmaceuticals, biosimilars are the generic counterpart.…”

Section: Discussionmentioning

confidence: 99%

“…Obviously, it is difficult to say because, unlike generics drugs that are chemical entities, biopharmaceutical production takes more than just having the production protocols or leveraging patent expiration of originator brands. The manufacturing of biosimilars requires complex production processes, larger investment ventures, and high-quality and specific raw materials, and the approval process for biosimilars is extensive and rigorous to ensure patient safety ( Chirmule et al, 2021 ; Uppal et al, 2021 ). The current findings show a growing challenge in the development of biopharmaceutical enterprises in Shaanxi province and the constraints they endure in the sourcing of quality raw materials.…”

Section: Discussionmentioning

confidence: 99%

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Current situation and future development of the biopharmaceutical industry in China: A mixed-method study

et al. 2022

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Introduction: The biomedical industry has grown significantly both globally and in China; however, there are still challenges. This study aimed at evaluating the biopharmaceutical sector of China, in terms of ability to innovate, current sales volume, investment, and R&D expenditure, as well as providing a case study detailing the progress and challenges of the industry in Shaanxi province.Method: A cross-sectional mixed-method study design was used to generate a comprehensive profile of the nature of biopharmaceutical innovation capacity and development in China by triangulating country-wide survey and interview data from Shaanxi province. Only biopharmaceutical companies that are currently marketing or conducting research and development were eligible for inclusion, and Shaanxi province was selected for conducting the interviews. Categorical and continuous variables were analyzed descriptively. Interviews were thematically analyzed by using NVivo version 12.Results: The analysis includes responses from 77 biopharmaceutical enterprises; the majority (36, 46.8%) are in Eastern China, followed by 26 (33.8%) in Central China. In 2018, the total sales of biological products amounted to 26.28 billion yuan, and in 2019, a slight increase was observed (30.34 billion); the amount doubled in 2020 to about 67.91 billion yuan. The top three biopharmaceutical products on sale in 2020 were Camrelizumab (5.14 billion yuan), human albumin (4.56 billion yuan), and human immunoglobulin for injection (3.78 billion yuan). Expenditure on R&D has also increased; it amounted to 1657.7 million yuan in 2018, which more than doubled in 2019 to 3572.1 million yuan and further increased to 5857.7 million yuan in 2020. Nonetheless, the progress is not uniform across all provinces, as shown from the results from Shaanxi province, because of lack of local government policies that will impact on the funding, incentives, and market share that motivate the producers.Conclusion: China’s biopharmaceutical industry has expand significantly. The increase in sales indicates that there is an increase in demand for biologicals; moreover, R&D funding is increasing. These are key indicators that influence innovation and development. However, the sector’s capacity to innovate and develop needs to be improved, particularly in the western region, where research and production are relatively weak.

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“…Although adopting ‘single use’ has gone up in Indian biopharma recently, stainless steel systems in manufacturing still dominate. Moreover, many are yet to deploy sophisticated analytical tools [ 102 ].…”

Section: What Ails Indian Biotech Going Global?mentioning

confidence: 99%

Indian Biosimilars and Vaccines at Crossroads–Replicating the Success of Pharmagenerics

et al. 2023

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Background: The global pharma sector is fast shifting from generics to biologics and biosimilars with the first approval in Europe in 2006 followed by US approval in 2015. In the form of Hepatitis B vaccine, India saw its first recombinant biologics approval in 2000. Around 20% of generic medications and 62% of vaccines are now supplied by the Indian pharmaceutical industry. It is this good position in biologics and biosimilars production that could potentially improve healthcare via decreased treatment cost. India has witnessed large investments in biosimilars over the years. Numerous India-bred new players, e.g., Enzene Biosciences Ltd., are keen on biosimilars and have joined the race alongside the emerging giants, e.g., Biocon and Dr. Reddy’s. A very positive sign was the remarkable during the COVID-19 pandemic by Bharat Biotech and the Serum Institute of India. India’s biopharmaceutical industry has been instrumental in producing and supplying preventives and therapeutics to fight COVID-19. Despite a weak supply chain and workforce pressure, the production was augmented to provide reasonably priced high-quality medications to more than 133 nations. Biosimilars could cost-effectively treat chronic diseases involving expensive conventional therapies, including diabetes, respiratory ailments, cancer, and connective tissue diseases. Biologics and biosimilars have been and are being tested to treat and manage COVID-19 symptoms characterized by inflammation and respiratory distress. Purpose of review: Although India boasts many universities, research centers, and a relatively skilled workforce, its global University–Industry collaboration ranking is 24, IPR ranking remains 47 and innovation ranking 39. This reveals a wide industry-academia gap to bridge. There are gaps in effective translational research in India that must be promptly and appropriately addressed. Innovation demands strong and effective collaborations among universities, techno-incubators, and industries. Methodology: Many successful research findings in academia do not get translation opportunities supposedly due to low industrial collaboration, low IP knowledge, and publication pressure with stringent timelines. In light of this, a detailed review of literature, including policy papers, government initiatives, and corporate reviews, was carried out, and the compilation and synthesis of the secondary data were meticulously summarized for the easy comprehension of the facts and roadmap ahead. For easy comprehension, charts, figures, and compiled tables are presented. Results: This review assesses India’s situation in the biosimilar space, the gaps and areas to improve for Indian investment strategies, development, and innovation, addressing need for a more skilled workforce, industrial collaboration, and business models. Conclusions: This review also proposes forward an approach to empowering technopreneurs to develop MSMEs for large-scale operations to support India in taking innovative thoughts to the global level to ultimately realize a self-reliant India. The limitations of the compilation are also highlighted towards the end.

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Biopharmaceutical Industry Capability Building in India: Report from a Symposium

Cited by 6 publications

References 15 publications

On the momentum toward vaccine self-sufficiency in the BRICS: an integrative review of the role of pharmaceutical entrepreneurship and innovation

On the momentum toward vaccine self-sufficiency in the BRICS: an integrative review of the role of pharmaceutical entrepreneurship and innovation

Current situation and future development of the biopharmaceutical industry in China: A mixed-method study

Indian Biosimilars and Vaccines at Crossroads–Replicating the Success of Pharmagenerics

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