Applied Drug Research, Clinical Trials and Regulatory Affairs - Volume 8, Issue 1, 2021

The present review lays emphasis on the history, regulations, and processes involved in the approval of In vitro Diagnostic (IVD) kits in the Indian Market. Diagnostic system or apparatus used for diagnosis are called diagnostic kits. Some important types of kits, based on their mechanism of actions, are (i) Immunoassay diagnostic kits; (ii) Polymerase chain reaction diagnostic kits; (iii) Displacement polynucleotide assay employing polyether and diagnostic kits; (iv)Diagnostic kit as well as a diagnostic method utilizing carbohydrate receptors; (v) One-step detection of matrix metalloproteinase activity using a fluorogenic peptide probe-immobilized diagnostic kits. Previously, as per the Drugs and Cosmetics Act 1940, IVD kits were classified into notified and non-notified category. Notified category IVDs includes in vitro Diagnostic Devices for HIV; in vitro Diagnostic Devices for HBV; in vitro Diagnostic Devices for HCV and in vitro Blood grouping sera. Recently, on November 1, 2017, Central Drug Standard Control Organization (CDSCO) published risk-based classification of medical devices and IVD kits on the origin of their intended use. The guideline has been implemented with effect from January 1, 2018. As per the new guidelines, the IVD kits have been categorized into four categories based on their level of risk, such as Class A (low risk); Class B (low moderate risk); Class C (moderate high risk), and Class D (high risk). Class A and B are processed and regulated through the State Licensing Authority, while C and D are processed and regulated by the Central Licensing Authority. The new guideline is not only limited to IVDs but also regulates the in-vivo diagnostics. New guidelines are very well aligned in terms of regulations of western countries and are a significant and revolutionary step in regulations of IVDs in the Indian market.

Background: Protection of Intellectual Property Rights is a clear incentive to innovations; yet, several countries have provided further incentives to patents in pharmaceuticals because the full patent term of 20 years is largely exhausted, before marketing authorization. Objective: The purpose of this article is to describe the various incentives to patents in the form of financial support, data exclusivity and most importantly, extended market exclusivities and comparison of various incentives to patents in the United States of America, European Union and India. Methods: The detail of incentives is collected from various articles, latest topics, books, and newspapers. Results: These incentives create a positive environment to encourage the drug development process, strengthen economic growth and improve a balance between new pharmaceuticals in the market and access of that medicine to the general public at a reasonable price. Conclusion: European Union and the United States of America are leading in the field of incentives to patenting in pharmaceuticals as compared to India. Indian Patent Act, 1970, needs to be relooked in terms of data exclusivity and patent term extensions.

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 the pharmaceutical industry of any 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, and 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 and 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 top 10 pharmaceutical companies in 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.

Safety, efficacy and quality of a therapeutic product are the major concerns for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in the USA Japan respectively, that ensure the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities review a pharmaceutical drug product from its discovery phase to the marketed product. Dossier plays an important role in the approval process of a drug product, as it allows both applicants and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on an in-depth review of the approval process for new and generic drugs in the USA and Japan.

Advances in medical device technology and regulatory authorization adapt to changing requirements and market conditions. The assessment of safety and performance in the real-world scenario will help us understand clinical benefits and help in the evolution of the medical device and in-vitro diagnostic devices. The paradigm shift in the evaluation of medical devices and in vitro diagnostic devices will ensure that the device delivers intended benefits. This article discusses the new approach of the post-marketing surveillance in the context of new in vitro diagnostic regulation in the European Union.

Background: Like the latest medications, the Food and Drug Administration (FDA) endorsement procedure is expected to give assurance that, when it arrives at the commercial center, a clinical device is efficacious and safe in its planned use. Objective: The objective of the particular review is to give an outline of the FDAs’ survey method for clinical vascular devices. This audit principally focuses on the high-risk based or type-III class clinical devices that are used the most for the purpose of analyses. Methods: The clinical device guideline is achieved by the CDRH. Exacting adjustment to the wanted standards is required to get promoting approval. 510 (k), PMA, and HDE are the administrative pathways for acquiring promoting approval by the FDA. The decision of the administrative pathway received by organizations relies basically on the multifaceted nature of the structure, a potential hazard to the strength of the client, and safety. Results: Clinical devices are fundamentally imperative to vascular care, and doctors who utilize clinical gadgets ought to be increasingly mindful about the administrative procedures supporting their accessibility. The FDA audits high-risk based devices for safety and adequacy. Conclusion: The rationale for this analysis is to talk about the current FDA arrangements identified with the endorsement of medical devices alongside the ramifications of these approaches for clinical consideration, especially with regards to vascular care.

Background: COVID-19 is a most life threatening condition, therefore it is declared a pandemic by WHO as it has affected the whole world. Even though there are many advanced drug discoveries, viral afflictions are a broad area for researchers. Unfortunately, to date, no drug can treat this lethal infection. COVID -19 has raised the death rate crucially; therefore, it needs the reassigning of drugs for the control of affliction. In some cases, it shows that drug reassigning may cause adverse reactions. But in some countries, these drugs manifest fruitful effects for COVID patients. This article focuses on the effective drug moieties found in in-vitro studies. These drug moieties need further clinical testing based on their in-vitro clinical data. These moieties have shown hope as promising drugs for treating the deadly infection. Objectives: The current manuscript is prepared with the main objectives of studying the various drugs and their benefits for the preparation of a vaccine for COVID-19 pandemics and studying the clinical trial status of drugs that are in the final stage of vaccine development. Discussion and Conclusion: The vaccine development process is in progress, and has almost reached the final stage. There are drug reassignments for suppressing the COVID-19 by using various drugs such as Remdesivir, Sarilumab, Favipiravir, Tocilizumab, etc.; the whole world suffered a huge loss due to this pandemic, and the wait for the vaccine will be over shortly.

Background: The COVID19 pandemic has devastated the entire globe with an astounding death toll and various forms of human suffering worldwide. In its wake, it has uncovered serious flaws and shortcomings in healthcare systems and beyond. Objective: The objective of this perspective is to highlight the lessons learned from the catastrophic pandemic and propose recommendations for optimal future preparedness. Methods: Current literature was reviewed to identify common and serious challenges faced during and in the process of instituting solutions for addressing the COVID19 pandemic. Results: The uncovered challenges appear to be similar in various countries across the globe, clearly demonstrating universal patterns in lack of preparedness. This spanned critical shortage in healthcare facilities, equipment, consumables and staffing along with technological gaps needs to keep up with the emerging needs. There are also major obstacles impeding the rapid development and implementation of diagnostics and therapeutics, and in addition, public awareness and international collaborations are immature to effectively handle the crisis. Conclusion: Fortunately many of these shortfalls lend themselves to intervention, however country- specific strategies must be preplanned with proactive readiness for rapid implementation during crisis situations. These go beyond readiness with physical space, essential equipment and consumables, and further involve proper capacity and manpower planning as well as local and global coordinated communication and cooperative collaborations. Moreover, self-sufficiency and sustainability are key to ensure the continuous provision of essential supplies and other needs. COVID19 has taught us that the world could never be too ready or prepared for such unexpected future events.