ABSTRACT
Background: Pharmaceutical businesses had enormous difficulties in product distribution during COVID-19, and the solution to this perpetual issue is a resilient supply chain. Aim(s): The study aims to understand the vulnerabilities to which it subjected the pharmaceutical product distribution supply chains during the COVID-19 pandemic and further develop an adaptive model through which the pharmaceutical product supply chain can enhance its resilience capabilities. Material(s) and Method(s): The conceptual model is developed for the supply chain of pharmaceutical companies based on the literature survey, and then the conceptual model is explored through factor analysis. Researchers have developed a validated model after a statistical analysis using Cronbach's alpha. Subjective analysis has concluded that the pharmaceutical supply chain's resilience is driven by factors such as "trade cost," which comprises transport cost, business practices, and raw material sourcing cost;"shock propagation," which comprises country-specific shocks, production shocks, and policy changes;and "technological infrastructure bottleneck," which relates to the availability of cold chain storage warehouses and refrigerated transport vehicle facilities. Result(s): An empirical model pertaining to supply chain resilience may be further studied with different geographies, like Pune, Hyderabad, and Delhi NCR, for the purpose of generalizing the study. Conclusion(s): The identified major factors were trade cost, shock propagation, and technological infrastructure bottlenecks. The sensitivity of the issue under investigation required a personal touch to the survey, as the COVID-19 pandemic had left these respondents emotionally vulnerable. As COVID-19 is the recent catastrophe that has hit humanity, it has made the pharmaceutical product distribution channel vulnerable during the pandemic. This difficult time of pandemic has really tested the pharmaceutical products' supply chain capabilities as well.Copyright © 2023, Association of Pharmaceutical Teachers of India. All rights reserved.
ABSTRACT
Vaccine development usually takes around 7 y to come to the market after getting necessary regulatory approvals. But recent pandemics like Covid, Ebola, Swine Flu, have resulted in the collaboration of efforts between the government doing investments in vaccine development, academia, regulatory bodies, and industry. This has shortened the timelines for approval for vaccines. In 2009, HINI, Swine flu vaccines took 93 d for identifying the vaccine candidate for clinical trials. In 2014, for Ebola vaccine, it was deployed while the epidemic was still going on. Ebola vaccine was developed in 5 y. In case of Covid (SARS-CoV-2) clinical trials were approved when 2 mo of the pandemic onset. Within a time of 9 mo about 138 vaccine candidates are being reviewed for approval of EUA. This highly helps in the shortening of vaccine development and necessary approval. In this paper, we focused on the regulatory framework of vaccine development in INDIA, US and EU.Copyright © 2023 The Authors.
ABSTRACT
It has recently been shown that the titer of the SARS-CoV-2 virus decreases in a cell culture when the cell suspension is irradiated with electromagnetic waves at a frequency of 95 GHz. We assumed that a frequency range in the gigahertz and sub-terahertz ranges was one of the key aspects in the "tuning" of flickering dipoles in the dispersion interaction process of the surfaces of supramolecular structures. To verify this assumption, the intrinsic thermal radio emission in the gigahertz range of the following nanoparticles was studied: virus-like particles (VLP) of SARS-CoV-2 and rotavirus A, monoclonal antibodies to various RBD epitopes of SARS-CoV-2, interferon-α, antibodies to interferon-γ, humic-fulvic acids, and silver proteinate. At 37 °C or when activated by light with λ = 412 nm, these particles all demonstrated an increased (by two orders of magnitude compared to the background) level of electromagnetic radiation in the microwave range. The thermal radio emission flux density specifically depended on the type of nanoparticles, their concentration, and the method of their activation. The thermal radio emission flux density was capable of reaching 20 µW/(m2 sr). The thermal radio emission significantly exceeded the background only for nanoparticles with a complex surface shape (nonconvex polyhedra), while the thermal radio emission from spherical nanoparticles (latex spheres, serum albumin, and micelles) did not differ from the background. The spectral range of the emission apparently exceeded the frequencies of the Ka band (above 30 GHz). It was assumed that the complex shape of the nanoparticles contributed to the formation of temporary dipoles which, at a distance of up to 100 nm and due to the formation of an ultrahigh strength field, led to the formation of plasma-like surface regions that acted as emitters in the millimeter range. Such a mechanism makes it possible to explain many phenomena of the biological activity of nanoparticles, including the antibacterial properties of surfaces.