scholarly journals IMPACT OF ACTIVE PHARMACEUTICAL INGREDIENT (API) SCARCITY IN PHARMACEUTICAL SECTORS AMIDST COVID-19 PANDEMIC

2020 ◽  
pp. 22-25
Author(s):  
ARPAN SAHA ◽  
SANTANU MALLIK
Keyword(s):  
Pharmaceutical Industry ◽  
Generic Drugs ◽  
Low Cost ◽  
Active Pharmaceutical Ingredient ◽  
World Health ◽  
United States Food ◽  
Pharmaceutical Industries ◽  
Novel Coronavirus ◽  
Health Organization ◽  
Indian Pharmaceutical Industry

The novel coronavirus disease 2019 (COVID-19) was characterized as a global pandemic by the World Health Organization (WHO) on March 11, 2020. The present pandemic has caused an intolerable impact on the health structure as well as the pharmaceutical sector, which in ultimatum has created enormous issues in the everyday lives of the patient community. On the other hand, the situation may appear in short and long-term time-horizon and need identification along with appropriate planning to reduce their socio-economic burden. The Indian pharmaceutical industry is the world's third-largest drug producer by volume. India supplies affordable and low-cost generic drugs to millions of people around the globe and operates more than 250 United States Food and Drug Administration (USFDA) and United Kingdom Medicine and Healthcare products Regulatory Agency (UKMHRA) approved plants. Given the Indian pharmaceutical industry, the source of Active Pharmaceutical Ingredients (APIs) for multiple diseases is much crucial part of the Pharma industry’s strategic plan to combat the COVID-19 pandemic. China is the top global producer and exporter of APIs by volume and Indian pharmaceutical industries are also rely heavily on APIs from China for the production of their medicine formulations by importing around 70 percent of the total requirement. However, the present pandemic situation has exposed the world's over-reliance on China in terms of API import and bound world leaders to fig. out sustainable alternatives.

scholarly journals Review of Quality Deficiencies Found in Active Pharmaceutical Ingredient Master Files Submitted to the WHO Prequalification of Medicines Programme

2014 ◽  
Vol 17 (2) ◽  
pp. 169 ◽  
Author(s):  
Isabel Ortega Diego ◽  
Antony Fake ◽  
Matthias Stahl ◽  
Lembit Rägo
Keyword(s):  
Technical Assistance ◽  
Active Pharmaceutical Ingredient ◽  
The United States ◽  
World Health ◽  
European Medicines Agency ◽  
United States Food ◽  
Materials Used ◽  
The Stability ◽  
Health Organization ◽  
Over Time

Purpose. The aim of this work was to determine the number and type of active pharmaceutical ingredient (API) quality deficiencies in API Master Files (APIMFs) as submitted to the World Health Organization (WHO) Prequalification of Medicines Programme (PQP). Methods. We conducted a retrospective review of API quality deficiencies identified following the assessment of new APIMFs for non-sterile APIs during a 6-year period from 1 January 2007 to 31 December 2012. All deficiencies were collected, classified and quantified according to the Common Technical Document (CTD) sections and subsections and as groups of commonly raised questions. Results. There were 5446 deficiencies collected from 159 APIMF deficiency letters by CTD section, by selected CTD subsections and by selected CTD subsections and year. More than 50% of the total number of deficiencies related to the manufacturing sections of the CTD, followed by deficiencies concerning the impurities, the API specification and the stability sections of the CTD.  A pattern of API deficiencies across the different CTD subsections and over time was identified. Conclusions. The most frequent critical deficiencies were related to how the specific manufacturing process and the key materials used, in particular the API starting material, impact the API impurities content. The number and pattern of APIMF deficiencies did not change over time. The results are compared to the findings in similar studies as reported by the United States Food and Drug Administration (USFDA), the European Directorate for the Quality of Medicines (EDQM) and the European Medicines Agency (EMA) and similarities and differences are discussed. Our findings highlight the need for greater guidance and technical assistance for API manufacturers submitting APIMFs to the PQP. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

scholarly journals Barrier for Particle Dispersion Control During Mastoidectomy

2021 ◽  
Author(s):  
Camila Rêgo Muniz ◽  
Carlos Felype Oliveira Pena ◽  
Marcio Ribeiro Studart da Fonseca ◽  
Marcos Rabelo de Freitas
Keyword(s):  
Low Cost ◽  
Particle Dispersion ◽  
World Health ◽  
The Novel ◽  
Surgical Team ◽  
Global Pandemic ◽  
Surgical Field ◽  
Novel Coronavirus ◽  
Health Organization ◽  
Barrier Device

Abstract Introduction The China Health Authority alerted the World Health Organization (WHO) of several cases of pneumonia, and the WHO has declared the novel coronavirus (COVID-19) a global pandemic. Mastoidectomy is a high-risk aerosol generating procedure with the potential to expose the surgeon to infectious particles. Objective Aim to develop a low-cost prototype for a barrier device that can be used during mastoidectomy. Methods Describe the steps involved during otological emergency, requiring immediate surgical procedure, in untested patients. The Otorhinolaryngology Surgical Team of Walter Cantídio Hospital developed the barrier for particle dispersion presented here. Results During surgery, the prototype did not compromise visualization of the surgical field and instrumentation. Microscope repositioning was not compromised or limited by tent Instrumentation and instrument pouch under the Microscope-Tent (MT) performed surgery. After surgery, the plastic sheet was removed simply, without requiring strength. Bone dust and irrigation droplets were collected on the tent. Conclusion Our team developed and practiced, in an otologic emergency, a low-cost and reproducible barrier device that can be used in mastoidectomy in COVID-19 patients. Further tests on efficacy may be necessary.

scholarly journals CORONA VIRUS OUTBREAK AND IT’S IMPACT ON THE GLOBAL PHARMACEUTICAL INDUSTRIES

2020 ◽  
pp. 11-14
Author(s):  
Vikas Sharma ◽  
Chandana Majee ◽  
Rahul Kaushik ◽  
Divya Sharma ◽  
Sunita Kumari ◽  
...  
Keyword(s):  
Direct Contact ◽  
Preventive Measure ◽  
World Health ◽  
Infected Person ◽  
The World ◽  
Pharmaceutical Industries ◽  
Novel Coronavirus ◽  
Health Organization ◽  
The Impact ◽  
General Wellbeing

There is another general wellbeing emergencies undermining the world with the rise and spread of 2019 novel coronavirus (2019-nCoV) or the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection started in bats and was transmitted to people through yet obscure go-between creatures in Wuhan, Hubei territory, China in December 2019. There are more than 48,15,484 infected cases all around the globe. This can be transmitted from one to another very quickly only by coughing or sneezing or direct contact with infected person. World Health Organization also has stated that there is no future course of this virus is available till now. As a preventive measure the complete stop on outgoings i.e. lockdown is surrendered. The lockdown all over the country or all around the globe is becoming a huge crisis for the economy and of countries the life cycle of the humans. The lockdown has affected all the businesses, works, private sectors as well as government sectors. The impact of lockdown on the pharmaceutical industries can be a great boon if its taken positively. Keywords: coronavirus, SARS-CoV 2, wuhan, transmitted, crisis, lockdown, impact.

scholarly journals Optimized qRT-PCR Approach for the Detection of Intra- and Extra-Cellular SARS-CoV-2 RNAs

2020 ◽  
Vol 21 (12) ◽  
pp. 4396 ◽  
Author(s):  
Tuna Toptan ◽  
Sebastian Hoehl ◽  
Sandra Westhaus ◽  
Denisa Bojkova ◽  
Annemarie Berger ◽  
...  
Keyword(s):  
Limit Of Detection ◽  
Low Cost ◽  
World Health ◽  
Quantitative Detection ◽  
Rt Pcr ◽  
M Gene ◽  
Control And Prevention ◽  
Pcr Assays ◽  
Novel Coronavirus ◽  
Health Organization

The novel coronavirus SARS-CoV-2 is the causative agent of the acute respiratory disease COVID-19, which has become a global concern due to its rapid spread. Meanwhile, increased demand for testing has led to a shortage of reagents and supplies and compromised the performance of diagnostic laboratories in many countries. Both the World Health Organization (WHO) and the Center for Disease Control and Prevention (CDC) recommend multi-step RT-PCR assays using multiple primer and probe pairs, which might complicate the interpretation of the test results, especially for borderline cases. In this study, we describe an alternative RT-PCR approach for the detection of SARS-CoV-2 RNA that can be used for the probe-based detection of clinical isolates in diagnostics as well as in research labs using a low-cost SYBR green method. For the evaluation, we used samples from patients with confirmed SARS-CoV-2 infections and performed RT-PCR assays along with successive dilutions of RNA standards to determine the limit of detection. We identified an M-gene binding primer and probe pair highly suitable for the quantitative detection of SARS-CoV-2 RNA for diagnostic and research purposes.

scholarly journals Optimized qRT-PCR approach for the detection of intra- and extra-cellular SARS-CoV-2 RNAs

2020 ◽  
Author(s):  
Tuna Toptan ◽  
Sebastian Hoehl ◽  
Sandra Westhaus ◽  
Denisa Bojkova ◽  
Annemarie Berger ◽  
...  
Keyword(s):  
Limit Of Detection ◽  
Low Cost ◽  
World Health ◽  
Quantitative Detection ◽  
Rt Pcr ◽  
M Gene ◽  
Control And Prevention ◽  
Pcr Assays ◽  
Novel Coronavirus ◽  
Health Organization

AbstractThe novel coronavirus SARS-CoV-2 is the causative agent of the acute respiratory disease COVID-19 which has become a global concern due to its rapid spread. Meanwhile, increased demand in testing has led to shortage of reagents, supplies, and compromised the performance of diagnostic laboratories in many countries. Both the world health organization (WHO) and the Center for Disease Control and Prevention (CDC) recommend multi-step RT-PCR assays using multiple primer and probe pairs, which might complicate interpretation of the test results especially for borderline cases. In this study, we describe an alternative RT-PCR approach for the detection of SARS-CoV-2 RNA that can be used for the probe-based detection of clinical isolates in the diagnostics as well as in research labs using a low cost SYBR green method. For the evaluation, we used samples from patients with confirmed SARS-CoV-2 infection and performed RT-PCR assays along with successive dilutions of RNA standards to determine the limit of detection. We identified an M-gene binding primer and probe pair highly suitable for quantitative detection of SARS-CoV-2 RNA for diagnostic and research purposes.

Current updates on COVID-19 - A review

2020 ◽  
Vol 10 (1) ◽  
pp. 1-8
Author(s):  
Ghotekar D S ◽  
Vishal N Kushare ◽  
Sagar V Ghotekar
Keyword(s):  
World Health Organization ◽  
Common Cold ◽  
Respiratory Diseases ◽  
Gastrointestinal Diseases ◽  
Hubei Province ◽  
World Health ◽  
The World ◽  
The Common ◽  
Novel Coronavirus ◽  
Health Organization

Coronaviruses are a family of viruses that cause illness such as respiratory diseases or gastrointestinal diseases. Respiratory diseases can range from the common cold to more severe diseases. A novel coronavirus outbreak was first documented in Wuhan, Hubei Province, China in December 2019. The World Health Organization (WHO) has declared the coronavirus disease 2019 (COVID-19) a pandemic. A global coordinated effort is needed to stop the further spread of the virus. A novel coronavirus (nCoV) is a new strain that has not been identified in humans previously. Once scientists determine exactly what coronavirus it is, they give it a name (as in the case of COVID-19, the virus causing it is SARS-CoV-2).

An approach to the understanding of the clinical-etiopathological aspect of COVID-19 (SARS-CoV-2)

2020 ◽  
Vol 11 (SPL1) ◽  
pp. 862-869
Author(s):  
Meena Kumari ◽  
Monika Agrawal ◽  
Rakesh Kumar Singh ◽  
Parameswarappa S Byadgi
Keyword(s):  
World Health ◽  
Apical Surface ◽  
Therapy Assessment ◽  
Differentiated Cells ◽  
The World ◽  
Polarized Epithelia ◽  
Well Differentiated ◽  
Novel Coronavirus ◽  
Health Organization ◽  
Epidemiological Characteristics

Currently, the world is facing a health and socioeconomic crisis caused by the novel coronavirus disease COVID-19. On 11 March 2020, the World Health Organization (WHO) has declared this disease as a pandemic. The condition (COVID-19) is an infectious disorder triggered by a newly discovered severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2. Most of the COVID-19 infected patients will experience mild to moderate respiratory symptoms and recover without any unique therapy. Assessment of the clinical and epidemiological characteristics of SARS-CoV-2 cases suggests the infected patients will not be contagious until the onset of severe symptoms and affects the other organs. Well-differentiated cells of apical airway epithelia communicating with ACE2 were promptly infected to SARS-CoV-2 virus. But the expression of ACE 2 in poorly differentiated epithelia facilitated SARS spike (S) protein-pseudo typed virus entry and it is replicated in polarized epithelia and especially exited via the apical surface. Limiting the transmission of COVID-19 infection & its prevention can be regarded as a hierarchy of controls. In this article, we briefly discuss the most recent advances in respect to aetiology, pathogenesis and clinical progression of the disease COVID-19.

Treatment Options in COVID-19: The Role of Bioavailable Antiviral Ribonucleoside Analog on NHC in vitro

2020 ◽  
Author(s):  
Lara Bittmann
Keyword(s):  
World Health Organization ◽  
Clinical Picture ◽  
Treatment Options ◽  
World Health ◽  
Wuhan City ◽  
The World ◽  
Novel Coronavirus ◽  
Health Organization

On December 31, 2019, WHO was informed of cases of pneumonia of unknown cause in Wuhan City, China. A novel coronavirus was identified as the cause by Chinese authorities on January 7, 2020 and was provisionally named "2019-nCoV". This new Coronavirus causes a clinical picture which has received now the name COVID-19. The virus has spread subsequently worldwide and was explained on the 11th of March, 2020 by the World Health Organization to the pandemic.

Novel Coronavirus 2019 Outbreak: A Global Epidemic

2020 ◽  
Vol 17 (12) ◽  
pp. 1458-1464
Author(s):  
Sweta Kamboj ◽  
Rohit Kamboj ◽  
Shikha Kamboj ◽  
Kumar Guarve ◽  
Rohit Dutt
Keyword(s):  
World Health ◽  
Upper Respiratory Tract ◽  
Global Epidemic ◽  
The Public ◽  
The Government ◽  
Tract Disease ◽  
The 1960S ◽  
Novel Coronavirus ◽  
Health Organization ◽  
The Impact

Background: In the 1960s, the human coronavirus was designated, which is responsible for the upper respiratory tract disease in children. Back in 2003, mainly 5 new coronaviruses were recognized. This study directly pursues to govern knowledge, attitude and practice of viral and droplet infection isolation safeguard among the researchers during the outbreak of the COVID-19. Introduction: Coronavirus is a proteinaceous and infectious pathogen. It is an etiological agent of severe acute respiratory syndrome (SARS) and the Middle East respiratory syndrome (MERS). Coronavirus, appeared in China from the seafood and poultry market last year, which has spread in various countries, and has caused several deaths. Methods: The literature data has been taken from different search platforms like PubMed, Science Direct, Embase, Web of Science, who.int portal and complied. Results: Corona virology study will be more advanced and outstanding in recent years. COVID-19 epidemic is a threatening reminder not solely for one country but all over the universe. Conclusion: In this review article, we encapsulated the pathogenesis, geographical spread of coronavirus worldwide, also discussed the perspective of diagnosis, effective treatment, and primary recommendations by the World Health Organization, and guidelines of the government to slow down the impact of the virus are also optimistic, efficacious and obliging for the public health. However, it will take a prolonged time in the future to overcome this epidemic.

An Efficient Approach for Detection and Verification of Infected Cases of Covid-19 Virus through Block Chain: A Survey

2020 ◽  
Vol 10 ◽  
Author(s):  
Kanika Gupta ◽  
Aatif Jamshed
Keyword(s):  
Data Storage ◽  
Operations Management ◽  
World Health ◽  
Chain Model ◽  
Human Beings ◽  
Healthcare Applications ◽  
Food Market ◽  
Block Chain ◽  
Novel Coronavirus ◽  
Health Organization

: Some unknown cases of pneumonia were communicated to World Health Organization (WHO) on 31 December,2019 in China’s Wuhan state. The higher authorities of China informed novel coronavirus as the root cause and labelled as “nCov-2019”. This virus is lying into the virus’s family which propagates the diseases like cold flu, lungs infection and more serious diseases. It is not detected earlier in human beings as it is considered to be a new patch on life. Many countries have increased their surveillance forces around the globe to detect any new novel coronavirus cases. An efficient and safe network for secure data storage i.e. Block chain is used in several applications such as food market, healthcare applications, finance, operations management, Internet of Things (IoT). In this paper, with the use of this emerging technology, are able to track useful information and accelerate the treatment process of patients. It also preserves the person’s identity. Correct implementation of block chain model has the chances to restrict the coronavirus transmissions and its related mortality rate where there are inadequate facilities of testing. Other infectious diseases will also be curbed by this model. The advantages of this model can reach to various stakeholders who are involved in the healthcare field which helps us to restrict the transmission of various diseases.

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