Pharmaceutical Manufacturing and Vaccine Logistics in India

The following sections are included: • Vaccination Platform for the Country • The Second and Third Waves of Covid-19 in India • Vaccine Manufacturing in India • Vaccine Service Chain Ecosystem • Institutions • Resources • Delivery Service Infrastructure • GRIP Framework • Governance • • Orchestration • • Partner Selection • • Coordination • • Execution • Risks • Innovation • Performance • India's Vaccination Ecosystem for Covid-19 • Conclusion • Acknowledgments • References. © 2023 by World Scientific Publishing Co. Pte. Ltd.

Simulating the Impact of COVID-19 Scenarios on Air Freight Logistics Supply Chain

The current business environment seeks practice-oriented logistics solutions to sustain the pandemic situation. Increased capacity in the air freight supply chain and cargo freight operations will necessitate simplified methods to improve cargo handling efficiency. We have investigated the impact of covid 19 scenarios on global airfreight handling services. The findings of a simulation study done on a case of an Indian International Airport specialized cargo division are presented in this article. We addressed the influence of the COVID19 pandemic on supply chains by providing recent instances from one of India's biggest international airports in the eastern zone. Using anyLogistix simulation software, we demonstrate how simulation modeling rapidly and accurately simulates and evaluates supply chain interruptions. The findings of this study may help decision-makers predict operational and tactical risk mitigation methods, as well as the effects of pandemic disruptions. © 2021 IEEE.

A black intruder into the Pandemic: Rhino-Orbital Mucormycosis Complicating COVID-19

There is an increased incidence of rhino orbital mucormycosis during the Coronavirus Disease-2019 (COVID-19) pandemic attributed to Diabetes Mellitus, corticosteroid usage and immunocompromise caused by COVID-19. In this series, seven biopsy-proven cases of mucormycosis (six male patients and 1 female patients) are presented from a tertiary center in eastern India from (May 2021 to June 2021). Empirical systemic liposomal amphotericin B, radical sinus surgery with orbital decompression and irrigation of sinus and orbit with amphotericin B was performed. The mean age of the patients was 42.71 +/- 7.34 years with a male preponderance (85.7%). Five patients had orbital involvement (71.42%), and two had cerebral involvement (28.6%). All of them had elevated blood glucose levels, though only three (42.85%) were known cases of type 2 diabetes. The most common manifestations were sinus tenderness (100%), paresthesia (100%), facial swelling (71.42%) and nasal discharge (28.57%). Follow-up at two months showed zero mortality. Timely diagnosis, appropriate management with intravenous amphotericin B and endoscopic radical sinus surgery, debridement of the necrotic tissue proved to be necessary for a good outcome in rhino-orbito-cerebral mucormycosis.

A new logistic growth model applied to COVID-19 fatality data.

BACKGROUND: Recent work showed that the temporal growth of the novel coronavirus disease (COVID-19) follows a sub-exponential power-law scaling whenever effective control interventions are in place. Taking this into consideration, we present a new phenomenological logistic model that is well-suited for such power-law epidemic growth. METHODS: We empirically develop the logistic growth model using simple scaling arguments, known boundary conditions and a comparison with available data from four countries, Belgium, China, Denmark and Germany, where (arguably) effective containment measures were put in place during the first wave of the pandemic. A non-linear least-squares minimization algorithm is used to map the parameter space and make optimal predictions. RESULTS: Unlike other logistic growth models, our presented model is shown to consistently make accurate predictions of peak heights, peak locations and cumulative saturation values for incomplete epidemic growth curves. We further show that the power-law growth model also works reasonably well when containment and lock down strategies are not as stringent as they were during the first wave of infections in 2020. On the basis of this agreement, the model was used to forecast COVID-19 fatalities for the third wave in South Africa, which was in progress during the time of this work. CONCLUSION: We anticipate that our presented model will be useful for a similar forecasting of COVID-19 induced infections/deaths in other regions as well as other cases of infectious disease outbreaks, particularly when power-law scaling is observed.

Protecting health-care professionals and workers (other than COVID-19 management facilities) from contamination during COVID-19 pandemic (March 26, 2020 - India)

People should stay at home - just as our PM has appealed on TV to the nation. This saves people plus health-care professionals from getting infected. Patients with ongoing illnesses should continue with usual treatment, cancel routine medical appointments (doctor visits and investigations), and contact their respective doctors (through email or digital platforms) only in case of new significant problems. Hospitals to divide staff into teams that work in tandem on alternate days or every 3rd day (based on the number of healthy staff available, inpatient beds, and patient workload). In hospitals/clinics, all health-care professionals to wear regular surgical masks, wear gloves, follow hand hygiene, and disinfect all surfaces in between patients. Maintain social distancing at all times - with patients and with colleagues. At least 6 ft of space in waiting area between patients, in the outpatient department between patient and doctor, and other places in between staff. If someone is contaminated/positive, the hospital/facility is NOT shut down or everyone quarantined. Only those with close contact are tested and isolated (definition of close contact used in Hong Kong was at least 15 min interaction at <6 feet without surgical mask). Less significant contacts to be self-monitored for symptoms and temperature recorded twice a day. Goggles, headgear, N95 particle filter masks, and double gloves to be reserved for interaction with COVID-19 positive cases or for procedures where respiratory aerosols might be generated - like intubation. For patients with symptoms suggestive of COVID-19 (low-grade fever, dry cough, cold, body ache, fatigue, diarrhea, and breathlessness) or family contact with COVID-19 positive case need to be dealt with as per the government directive, referred to dedicated COVID-19 health-care facility and treated by their separate team of health-care professionals.

3D printing in managing supply disruptions related to COVID-19 pandemic: Food and Drug Administration's current thinking on regulation

Recent developments and collaborations of pharmaceutical manufacturers, hospitals, and government funded research bodies using 3D printing technology have been highlighted for the management of the healthcare crisis. 3D printing is a process of converting virtual 3D models developed by computer aided design into physical forms upon addition of material layer-by-layer (also known as additive manufacturing). This 3D printing is supposed to revolutionize significantly the healthcare system in the coming years. This process involves a tailored deposition of biomaterials layer by layer such as polylactic acid (PLA), polyvinyl alcohol (PVA), or other suitable pharma-grade polymers, copolymers, and their combinations to formulate three-dimensional custom designs with controlled architecture and composition. Food and Drug Administration (FDA) is currently thinking on regulation to ease the import restrictions for products intended for the detection and diagnosis of COVID-19 to ensure the timely availability of test kits.

Developmental biology of Corona vaccine: Lipid nanoparticle mRNA-encapsulation, a safe approach

The global pandemic of COVID-19 is progressing rapidly across the world and declared as health emergency. The novel Coronavirus can cause severe lower respiratory tract infections primarily in geriatric, immunocompromised persons, infants and patients with comorbidities, or genetic disorders. Few Emergency Use Authorizations (EAUs) have been granted by FDA and other regulatory bodies with an aim to repurpose the existing approved medicines to fight the disease, and till date no specific treatment methodologies or preventive measures are available. At present, numerous medications which are already approved for other therapeutic indications, as well as the new medications, are undergoing clinical trials for the evaluation of safety and efficacy against COVID-19 infection. These therapeutic ranges include antimalarial, antiviral, steroids, convalescent plasma containing antibodies, and immune modulators, etc. Nevertheless, the primary focus is on preventive care and currently more than hundred potential vaccine candidates are under development by leading biotech companies across the globe which are at different phases of clinical development. Lipid based mRNA delivery, DNA delivery and mAbs are the most advanced technologies being embraced besides whole-virion inactivated vaccine, attenuated live vaccine, non-replicating viral vector-based vaccine, protein single unit vaccine and multiunit vaccine. This review focuses on the current progress in drug delivery systems of COVID-19 vaccine across industries, academics, and government funded research institutes with a special focus on the synthetic mRNA-based lipid nanoparticle (LNP).

Phytochemical constituents from Xanthium strumarium L. and evaluation of their in vitro antimalarial activities

Malaria is a major threat to global health and continues to claim lives of many people each year, especially in developing countries. Xanthium strumarium L., is used by traditional health practitioners in the management of malaria fever in North East India. Bioassay guided fractionation of X. strumarium L. extracts, led to the isolation of five compounds from the aerial part and fruit of Xanthium strumarium, namely, stigmasta-5,22-dien-3beta-ol (1), xanthinosin (2), stigmasterol-3-O-beta-D-glucopyranoside (3), oleic acid (4) and (E)-2, 3-dihydroxypropyl-octadec-9-enoate (5). Antimalarial potential of isolated compounds were evaluated against 3D7 strain of Plasmodium falciparum by schizont maturation inhibition assay method. The structures of isolated compounds were established by HR-MS, NMR experiments and comparison from literature data. Compounds 2 and 3 showed significant antimalarial properties against 3D7 strain of P.falciparum with IC50 value 27.25 and 7.14M respectively. The antimalarial activities of xanthinosin (2) and stigmasterol-3-O-beta-D-glucopyranoside (3) lend credence to the application of X. strumarium against malaria and thus provides new template for development of antimalarial molecules. X. strumarium has also scope for the development of antimalarial phyto-pharmaceutical with five identified compounds with P.falciparum inhibitory activity as per the drugs and cosmetics act of India (1940, amended 31st December 2016).

Repurposing drugs: Lessons from rheumatology in the COVID-19 pandemic

Humanity currently faces one of its biggest challenges, created by a tiny quasi-life form, the severe acute respiratory syndrome coronavirus 2. The rapidity of spread and the enormous burden placed on public health infrastructure by the coronavirus disease 2019 (COVID-19) pandemic has forced researchers to look for quick answers for therapy. Drug repurposing is probably the quickest way to develop an effective therapy in a very short time. With additional input from artificial intelligence (AI), drug repurposing may emerge as one of the major techniques by which humanity can overcome this as well as future challenges. The field of rheumatology has been one of the biggest benefactors of drug repurposing. This article reviews the various ways drugs used in rheumatological disorders are being repurposed for possible COVID-19 treatment. An overview of other nonantiviral drugs being repurposed is also undertaken, and the role of AI in drug repurposing is touched upon. © 2021 Wolters Kluwer Medknow Publications. All rights reserved.

Convalescent plasma therapy in severe coronavirus disease-2019: A narrative review

Passive immunotherapy using whole blood or plasma from recovered patients is a potential therapeutic strategy for infections with no known drug therapy or prophylactic vaccines. Much before, the concept of transfusing neutralizing antibodies through convalescent blood or plasma was established;this modality demonstrated its effectiveness in containing the havoc caused by diphtheria and tetanus during the early 20th century. Convalescent blood products were effective in reducing the mortality risk when administered early in the disease course during the deadliest pandemic of Spanish flu in 1918. Even in the antibiotic era, the use of passive immunization strategy continued to expand with promising results against measles, Ebola, Argentine hemorrhagic fever, and Zika viruses. It was also effective in reducing the mortality and viral load in severe acute respiratory syndrome, H5N1, H1N1, and Middle East Respiratory Syndrome. Convalescent plasma administration carries the risk of anaphylactic reactions, transfusion-related acute lung injury, and transfusion-associated circulatory overload, but these are extremely rare. The impact of the recent coronavirus disease 2019 is enormous with significant morbidity and mortality. Until, a specific antiviral therapy or an effective vaccine is made available, the consideration for use of convalescent blood products, especially plasma, is warranted. Conceptual and observational wisdom often blossoms among therapeutic penury. © 2020 Indian Journal of Rheumatology Published by Wolters Kluwer - Medknow.