ABSTRACT
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 disposition 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.
ABSTRACT
Current evidence suggests that coronavirus disease 2019 (COVID-19) spread occurs via respiratory droplets (particles >5 µm) and possibly through aerosol. The rate of transmission remains high during airway management. This was evident during the 2003 severe acute respiratory syndrome epidemic where those who were involved in tracheal intubation had a higher risk of infection than those who were not involved (odds ratio 6.6). We describe specific airway management principles for patients with known or suspected COVID-19 disease for an array of critical care and procedural settings. We conducted a thorough search of the available literature of airway management of COVID-19 across a variety of international settings. In addition, we have analyzed various medical professional body recommendations for common procedural practices such as interventional cardiology, gastroenterology, and pulmonology. A systematic process that aims to protect the operators involved via appropriate personal protective equipment, avoidance of unnecessary patient contact and minimalization of periprocedural aerosol generation are key components to successful airway management. For operating room cases requiring general anesthesia or complex interventional procedures, tracheal intubation should be the preferred option. For interventional procedures, when tracheal intubation is not indicated, cautious conscious sedation appears to be a reasonable approach. Awake intubation should be avoided unless it is absolutely necessary. Extubation is a high-risk procedure for aerosol and droplet spread and needs thorough planning and preparation. As updates and modifications in the management of COVID-19 are still evolving, local guidelines, appraised at regular intervals, are vital in optimizing clinical management.