Applied Drug Research, Clinical Trials and Regulatory Affairs - Current Issue

Due to its ability to track drug interactions and their physiological effects on humans, pharmacovigilance is a vital component of the healthcare system. The ability to monitor and analyze medications for quality as well as identify and halt any unfavorable drug side effects makes pharmacovigilance a crucial component of modern technology. Drug safety data collection and coding, as well as case management reporting and submission, comprise case processing, which is the first step in pharmacovigilance. The Pharmacovigilance Programme of India was established in response to these advancements. India participates in the Uppsala Monitoring Centre system but contributes very little to the database itself. The objective of this research is to conduct a comprehensive analysis of the pharmacovigilance program in India and provide a succinct, current evaluation of the organization, taking into account its background and possible issues. The development of “A Pharmacovigilance Programme of India” mobile application was emphasized by the National Coordination Centre PvPI to India as a means of enhancing public health and encouraging prompt reporting of adverse drug reactions. With more and more cutting-edge veterinary medications entering the market, India needs a veterinary pharmacovigilance system. One of the most significant current responsibilities is demonstrating to the world that thousands of years-old Ayurveda Siddha Unani systems are safe and grounded in science.

Due to its ability to track drug interactions and their physiological effects on humans, pharmacovigilance is a vital component of the healthcare system. The ability to monitor and analyze medications for quality as well as identify and halt any unfavorable drug side effects makes pharmacovigilance a crucial component of modern technology. Drug safety data collection and coding, as well as case management reporting and submission, comprise case processing, which is the first step in pharmacovigilance. The Pharmacovigilance Programme of India was established in response to these advancements. India participates in the Uppsala Monitoring Centre system but contributes very little to the database itself. The objective of this research is to conduct a comprehensive analysis of the pharmacovigilance program in India and provide a succinct, current evaluation of the organization, taking into account its background and possible issues. The development of “A Pharmacovigilance Programme of India” mobile application was emphasized by the National Coordination Centre PvPI to India as a means of enhancing public health and encouraging prompt reporting of adverse drug reactions. With more and more cutting-edge veterinary medications entering the market, India needs a veterinary pharmacovigilance system. One of the most significant current responsibilities is demonstrating to the world that thousands of years-old Ayurveda Siddha Unani systems are safe and grounded in science.

Brain-computer interface (BCI) technology has emerged as a groundbreaking innovation with transformative potential in medical devices. BCIs are analyzed for their ability to diagnose, treat, and manage neurological disorders, such as Parkinson's disease, ALS, and stroke.

The study explores the integration of BCI technology into medical devices and examines the challenges and opportunities regulatory authorities face in overseeing this rapidly evolving field.

The study employs a comprehensive literature review with the help of databases like Google Scholar, and PubMed, analyzing case studies and regulatory requirements.

BCI technology enables direct communication between the human brain and external devices, allowing for the control of computers or prosthetic limbs. Additionally, software tools facilitate the analysis of recorded brain signals, aided by advancements in Artificial Intelligence (AI), including Machine Learning (ML) and Deep Learning (DL), for automatic classification of EEG signals. However, the rapid advancement leads to high costs and complexity of BCI systems which can limit their accessibility and scalability, posing a barrier. Moreover, the development of standardized protocols and guidelines for BCI implementation is essential to maintain consistency and reliability across applications.

The ethical considerations surrounding BCI technology are vital and emphasize the need for government regulations to ensure its safe and effective integration into healthcare. BCI's potential for responsible innovation in patient-centric care is advocated, propelling medical technology into a new era of seamless integration and improved patient outcomes.

Contract Research Organizations are bodies that offer research and development services on a contract basis to the pharmaceutical, biotechnology, medical device, and other industries. These organizations offer a wide range of services to support the drug discovery, development, and commercialization process. Initially, CROs begin with clinical trial management facilities and assisting sponsors with clinical study design, whereas laboratory CROs provide drug discovery, manufacturing, and bioanalytical services, including site feasibility. Their services mainly cover pharmaceutical and biotechnology industry based work such as drug development, pharmaceutical product development, clinical and preclinical trials, analytical method developments, pharmacovigilance, medical writing, etc. India presents itself as a wonderful platform for CROs attributing to its huge population, varied disease conditions, accessible human resources, large number of hospitals and low treatment cost. In the clinical trial process, CROs are engaged by the sponsor to accomplish a number of duties, taking into account various administrative and technical responsibilities on behalf of the sponsor. The current manuscript highlights the globalization of clinical trials, the concept of CRO, roles and responsibilities, functions of CROs, regulatory infrastructure of CRO, criteria for selection of suitable CRO, Indian CRO market and impact of COVID-19 pandemic on it.

Blockchain technology is a decentralized, peer-to-peer network-based public, encrypted, and immutable digital federated ledger system with various applications in the digital economy. This paper examines how blockchain technology can strengthen intellectual property rights (IPR) in the digital age and the potential challenges and risks associated with this use. The paper analyses the advantages and disadvantages of blockchain technology for confirming and protecting IPR, such as transparency, security, efficiency, and scalability, as well as issues such as legal uncertainty, interoperability, and governance. The paper also explores the implications of blockchain technology for different types of IPR, such as patents, and copyrights, and how it can facilitate innovation, licensing, and enforcement. The paper concludes by providing recommendations for improving the legal and regulatory framework for IPR management using blockchain technology and identifying some areas for further research.