Indian Pharmaceutical Industries Current Status and Togetherness to Overcome Speed Breakers in Term of Quality Issues to Make India as a Global Pharma Destination

Author(s):  
Vikas Rathee ◽  
Kapil Pihwal ◽  
Neelam Pawar ◽  
Sheikh Aamir ◽  
Mohammad Shahbaz Alam ◽  
...  

: Regulatory is the heart of the Pharmaceutical Industries which acts as an interface between the industries and government authorities for the growth and development of pharmaceutical industry system of their respective country. In 2017, India was a pharmaceutical country valued at USD (United States Dollar) 13 billion and accounting for 20 percent of worldwide exports, making the country the main supplier of generic drugs worldwide. Ministry of Chemicals and Fertilizers, the Department of Pharmaceutical Products said that the national pharmaceutical market's gross revenue reached approximately US $ 18.12 billion in 2018 (Rs 129,015), growing 9.4% year-on-year and export retention in 2018 was US $ 17.88 billion. 19.14 billion US$ in 2019. The Union Ministry of Health and Family Welfare has increased by 13.1 percent to Rs 61,398 crore (US $ 8.98 billion) in the Union Budget 2019-20. The Indian pharmaceutical market is facing many difficulties such as central and state regulatory compliance, data integrity, ethics committee in clinical trials, governmental control over the price of medicine, lack of research and so on. We are discussing in our article that top 10 pharmaceutical companies are doing business, their turnover in 2020 and challenge in today's era. We discuss future plans and solutions to problems, so that they can be ranked first in the world.

2019 ◽  
Vol 9 (01) ◽  
pp. 27-33
Author(s):  
Naveen Kumar ◽  
Sonia Pahuja ◽  
Ranjit Sharma

Humans have taken advantage of the adaptability of polymers for centuries in the form of resins, gums tars, and oils. However, it was not until the industrial revolution that the modern polymer industry began to develop. Polymers represent an important constituent of pharmaceutical dosage forms. Polymers have played vital roles in the formulation of pharmaceutical products. Polymers have been used as a major tool to manage the drug release rate from the formulations. Synthetic and natural-based polymers have found their way into the biomedical and pharmaceutical industries. Synthetic and Natural polymers can be produced with a broad range of strength, heat resistance, density, stiffness and even price. By constant research into the science and applications of polymers, they are playing an ever-increasing role in society. Diverse applications of polymers in the present pharmaceutical field are for controlled drug release. Based on solubility pharmaceutical polymers can be classified as water-soluble and water-insoluble. In general, the desirable polymer properties in pharmaceutical applications are film forming, adhesion, gelling, thickening, pH-dependent solubility and taste masking. General pharmaceutical applications of polymers in various pharmaceutical formulations are also discussed


2021 ◽  
Vol 15 ◽  
Author(s):  
Eduardo Muniz Santana Bastos ◽  
Victor Diogenes Amaral da Silva ◽  
Silvia Lima Costa ◽  
Samira Abdallah Hanna

Background: Medicinal plants present activities against neurodegenerative diseases with potential for the pharmaceutical industries. Therefore, the objective of this study was to investigate the current panorama of patents and articles of Brazilian medicinal plants with pharmacological activities in the Central Nervous System (CNS), regarding such aspects as: the number of patents by countries, areas of knowledge and technological maturity. Method: We carry out a technological exploration on the Questel Orbit® platform with the descriptors: Agave sisalana P., Amburana cearenses A., Dimorphandra mollis B., Jatropha curcas L, Poincianella pyramidalis T. and Prosopis juliflora (Sw.) DC. with pharmacological activity, and a scientific exploration in PubMed and Science Direct associated with the CNS in the title, abstract and methodology. Results: A total of 642 patents were identified between the years 1999-2019. India, China and Brazil are highlighted, 6th place, out of a total of 48 countries. Of these, 30 patents were not in the National Institute of Industrial Property and 10% are Brazilian in biotechnology and pharmaceutical products. Eleven articles were used in PubMed and Science Direct with scientific domains (anticancer, neuroprotection and anti-inflammatory). The Federal University of Bahia is highlighted, showing Technology Readiness Levels (TRL4), basic skills of pre-clinical research. Conclusion: Brazilian public universities have a significant role in the scientific, technological and innovative development of therapeutic assets for CNS.


2021 ◽  
Author(s):  
David Wiese ◽  
Bernard Bienstock ◽  
David Bearden ◽  
Carmen Boening ◽  
Kelley Case ◽  
...  

<p>The 2017-2027 US National Academy of Sciences Decadal Survey for Earth Science and Applications from Space classified mass change as one of five designated observables having the highest priority in terms of Earth observations required to better understand the Earth system over the next decade.  In response to this designation, NASA initiated multi-center studies with an overarching goal of defining observing system architectures for each designated observable.  Here, we discuss the progress made and future plans for the Mass Change Designated Observable study. Progress includes the development of a Science and Applications Traceability Matrix (SATM), the definition of three different architectural classes that are responsive to the designated science objectives, and a framework to quantitatively link the performance of specific architectures to the SATM.  We will describe the Value Framework that has been developed to assess the value of potential architectures in terms of science return, cost, risk, and technical maturity.  Results highlight the recommendation of satellite-satellite-tracking for the MC observing system, and have identified high value variants as a single in-line pair, dual in-line pairs, and pendulum architectures, which are similar to architectures studied by potential international partners.  The current status of the study process, and future plans will be discussed.</p>


Author(s):  
N. Smith ◽  
T. Shuttleworth ◽  
M. Grimstone ◽  
L. Hutton ◽  
M. Armishaw ◽  
...  

1983 ◽  
Vol 62 ◽  
pp. 191-201
Author(s):  
John Davis

AbstractThe observations of α Vir with the Narrabri Stellar Intensity Interferometer demonstrated the potential of long baseline interferometry for the determination of fundamental properties of double-lined spectroscopic binary systems. Since the completion of the programme with the Narrabri instrument the Chatterton Astronomy Department has been conducting a study aimed at developing a stellar interferometer with limiting magnitude V ≳ +8 and maximum baseline ≳ 1 km (resolution at 500 nm ≲ 7 × 10−5 seconds of arc). The way in which a long baseline interferometer may be used in the study of binary stars is outlined, the requirements for this work are discussed, and the current status and future plans of the Chatterton Astronomy Department’s programme to develop a new long baseline interferometer are summarised.


2020 ◽  
Vol 54 (6) ◽  
pp. 1461-1472
Author(s):  
L. Horavova ◽  
K. Nebeska ◽  
L. Souckova ◽  
R. Demlova ◽  
P. Babula

Abstract Introduction Paediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision. In spite of the fact that current regulations and initiatives try to enhance the quantity and quality of paediatric NICTs, there are still shortcomings that need to be addressed in order to accelerate the conduct of relevant clinical trials in children. To improve the current landscape of paediatric clinical research, it is necessary to identify and analyse the main trends and shortcomings, along with their impact on national performance in paediatric NICTs and this is the aim of this work. Method A retrospective systematic search of paediatric NICTs was performed on four international clinical trials registries. Entries were filtered by date from 01/01/2004 to 31/12/2017. Each identified paediatric NICT was screened and analysed for sponsors, funders, type of intervention, therapeutic area, design characteristics and associated publications. Results The search identified 439 unique NICTs. When stratifying the trials by enrolment ages, 86 trials were found involving the paediatric population. Most trials investigated the use of medicinal products and were focused on cancer or cardiovascular diseases. The most common sources of the funding were non-profit organizations. Furthermore, from the total number of completed trials, only half of them already published their results. Conclusion The main shortcomings—specifically, ethical, methodological and, in particular, economic obstacles were identified. There is a continual need for greater support and collaboration between all major stakeholders including health policymakers, grant agencies, research institutions, pharmaceutical industries and healthcare providers at the national and international level.


Author(s):  
Deepika Purohit ◽  
Manisha Saini ◽  
Parijat Pandey ◽  
Swagat Tripathy ◽  
Harish Dureja

Background: In pharmaceutical terms, quality means a product free from any contamination and delivers the therapeutic benefit specified in the label at a reproducible rate which can be assessed by carrying out in vivo or in vitro tests for evaluation of performance. Quality by Design (QbD) is a necessary tool in pharmaceutical environment for having product/process/method impregnated with quality. QbD is a move toward drug development that ensures the preplanned product specifications by providing guidance for architecting the manufacturing processes and formulation. Methodology: It has provided the solution to support both the regulatory bodies and industry to shift towards added proactive and scientific approach. QbD is the greatest solution to construct quality in all pharmaceutical products, while at the same time, making it a part of the system is also a key challenge for the industry. By using QbD concept, regulators as well as industries are making a move in geometric progress in bringing quality products. Regulatory bodies across the world are showing significant attention to QbD. Conclusion: Therefore, an attempt has been made to highlight quality by designing generic drugs and its implications to pharmaceutical industry including clinical trials, pharmaceutical validation processes and in biologics and also to provide a brief description on the status of QbD in India and as well as in Asia.


2019 ◽  
Vol 20 (3) ◽  
pp. 185-193 ◽  
Author(s):  
Natalie Stephenson ◽  
Emily Shane ◽  
Jessica Chase ◽  
Jason Rowland ◽  
David Ries ◽  
...  

Background:Drug discovery, which is the process of discovering new candidate medications, is very important for pharmaceutical industries. At its current stage, discovering new drugs is still a very expensive and time-consuming process, requiring Phases I, II and III for clinical trials. Recently, machine learning techniques in Artificial Intelligence (AI), especially the deep learning techniques which allow a computational model to generate multiple layers, have been widely applied and achieved state-of-the-art performance in different fields, such as speech recognition, image classification, bioinformatics, etc. One very important application of these AI techniques is in the field of drug discovery.Methods:We did a large-scale literature search on existing scientific websites (e.g, ScienceDirect, Arxiv) and startup companies to understand current status of machine learning techniques in drug discovery.Results:Our experiments demonstrated that there are different patterns in machine learning fields and drug discovery fields. For example, keywords like prediction, brain, discovery, and treatment are usually in drug discovery fields. Also, the total number of papers published in drug discovery fields with machine learning techniques is increasing every year.Conclusion:The main focus of this survey is to understand the current status of machine learning techniques in the drug discovery field within both academic and industrial settings, and discuss its potential future applications. Several interesting patterns for machine learning techniques in drug discovery fields are discussed in this survey.


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