Innovative Approaches in Regulatory Affairs: Leveraging Artificial Intelligence and Machine Learning for Efficient Compliance and Decision-Making.

Artificial Intelligence (AI) and AI-driven technologies are transforming industries across the board, with the pharmaceutical sector emerging as a frontrunner beneficiary. This article explores the growing impact of AI and Machine Learning (ML) within pharmaceutical Regulatory Affairs, particularly in dossier preparation, compilation, documentation, submission, review, and regulatory compliance. By automating time-intensive tasks, these technologies streamline workflows, accelerate result generation, and shorten the product approval timeline.

Training and education in pharmacovigilance: The experience from the Pharmacovigilance Programme of India.

For a robust Pharmacovigilance system in a country, training of healthcare professionals is of utmost importance. The training is the integral part of continual improvement in any quality management system. The present article describes the different training modules and experience from the Pharmacovigilance Programme of India (PvPI) and emphasizes that if training and education elements with special reference to pharmacovigilance are implemented for all concerned stakeholders in a healthcare system, the efficiency of deliverables will be improved and objectives of the organization can easily be achieved.

Minimizing the risk of ethylene glycol and diethylene glycol poisoning in medications: A regulatory and pharmacopoeial response.

Pharmaceutical and personal care products, including syrups and toothpastes, extensively use glycerin, sorbitol, and propylene glycol. However, past incidents of ethylene glycol (EG) and diethylene glycol (DEG) contamination in these products have raised serious health concerns. Recently, several child deaths linked to contaminated cough syrup consumption have heightened concerns regarding the safety of Indian pharmaceuticals.

Deciphering the US Regulatory Framework: Comparison Between Oncology Biosimilars and Reference Biologics.

Biological oncology agents are vital in cancer care, but their exorbitant expenses present obstacles for patients, families, healthcare professionals, and insurance providers. The advent of biosimilars represents a transformative solution, offering more affordable alternatives after the expiration of biologics patents. Biosimilar agents, similar to biological agents in structure, function, safety, and immunogenicity, enhance healthcare accessibility, improve outcomes, and reduce costs.

Expedited pathway insights: Unveiling oncology and non-oncology drug approvals and withdrawals of USFDA and EMA.

Background: Prior to entering the market, health authorities conduct a rigorous evaluation of compiled information for drugs delaying its entry. To address this void expedited pathways are introduced.

Methods: In this study, both oncology and non-oncology drugs approved through various expedited pathways from the US and Europe have been scrutinized using the USFDA's Novel Drug approvals from 2020 to 2023 and EMA's Human Medicine Highlights 2020 to 2023.

Tapentadol: navigating the complexities of abuse, patient safety & regulatory measures.

Aim: To evaluate tapentadol abuse cases by analyzing real-world data and identifying under-reporting countries from Southeast Asian Region (SEAR) to enhance vigilance.

Method: A retrospective, observational study from 2013 to March 2024 using VigiBase was conducted.

Result: Tapentadol-related abuse falls within the System Organ Class (SOC) categories of psychiatric disorder, nervous system disorder and injury, poisoning, and procedural complications.

Health-care Professionals' Perception toward Medical Device Postmarket Surveillance Practices: A Cross-sectional Study in India.

A cross-sectional, web-based survey was conducted to assess the health-care professionals (HCPs)' perception toward existing medical device postmarket surveillance (PMS) practices in India. A total of 1756 responses (medical practitioners [19.8%], nurses [22.

Theranostics: aptamer-assisted carbon nanotubes as MRI contrast and photothermal agent for breast cancer therapy.

Breast cancer is one of the leading causes of death among women globally, making its diagnosis and treatment challenging. The use of nanotechnology for cancer diagnosis and treatment is an emerging area of research. To address this issue, multiwalled carbon nanotubes (MWCNTs) were ligand exchanged with butyric acid (BA) to gain hydrophilic character.

Report of a collaborative study to establish the first Indian Pharmacopoeia reference standard for teriparatide.

A collaborative study was conducted to establish the first Indian Pharmacopoeia Reference Standard (IPRS) for teriparatide to be used in quality control testing of marketed products in compliance with the Indian Pharmacopoeia (IP) monograph. The study objective was to evaluate the candidate standard in terms of the WHO International Standard (IS) to assign its content in mg per vial terms. This study involved four laboratories from India and the candidate standard was calibrated against the WHO IS by each participant laboratory using high-performance liquid chromatography (HPLC) assay method per IP monograph.

Supramolecular self-assembled peptide-engineered nanofibers: A propitious proposition for cancer therapy.

Cancer is a devastating disease that causes a substantial number of deaths worldwide. Current therapeutic interventions for cancer include chemotherapy, radiation therapy, or surgery. These conventional therapeutic approaches are associated with disadvantages such as multidrug resistance, destruction of healthy tissues, and tissue toxicity.

Stimuli-responsive polysaccharide-based smart hydrogels for diabetic wound healing: Design aspects, preparation methods and regulatory perspectives.

Diabetes adversely affects wound-healing responses, leading to the development of chronic infected wounds. Such wound microenvironment is characterized by hyperglycaemia, hyperinflammation, hypoxia, variable pH, upregulation of matrix metalloproteinases, oxidative stress, and bacterial colonization. These pathological conditions pose challenges for the effective wound healing.

Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia.

India has a sparkling pharmaceutical sector that holds a distinguished place by producing and supplying high-quality and affordable medicines across the globe. Ensuring the quality and safety of the marketed medicinal products is one of the most important components of the drug regulatory framework and assessment of the quality of medicines is usually achieved by referring to the public standards of the official Pharmacopoeia. In India, the Indian Pharmacopoeia (IP) is published at regular intervals to fulfill the requirements of the Drugs and Cosmetics Act, 1940 to ensure the quality of medicines being manufactured and/or marketed in India.

Neutrophil membrane-based nanotherapeutics: Propitious paradigm shift in the management of cancer.

Cancer is the leading cause of death across the globe, with 19.3 million new cancer cases and 10 million deaths in the year 2020. Conventional treatment modalities have numerous pitfalls, such as off-site cytotoxicity and poor bioavailability.

Multifaceted roles of pollen in the management of cancer.

Oral drug delivery of microparticles demonstrates shortcomings like aggregation, decreased loading capacity and batch-to-batch variation, which limits its scale-up. Later, porous structures gained attention because of their large surface-to-volume ratio, high loading capacity and ability to carry biomacromolecules, which undergo degradation in GIT. But there are pitfalls like non-uniform particle size distribution, the impact of porogen properties, and harsh chemicals.

How to improve regulatory practices for refurbished medical devices.

Modern health-care facilities rely on medical devices and equipment. However, keeping up with the development of new technology is unfeasible for many health facilities, especially in low-resource settings. Thus, the demand for refurbished medical devices is increasing worldwide, especially in low- and middle-income countries.

Multifaceted applications of ulvan polysaccharides: Insights on biopharmaceutical avenues.

Ulvans are water-soluble sulfated polysaccharides predominantly found in the cell wall of green algae. They hold unique characteristics that are attributed to their 3D conformation, functional groups along with the presence of saccharides and sulfate ions. Traditionally, ulvans are widely used as food supplements and probiotics owing to the high content of carbohydrates.

Emerging insights of peptide-based nanotherapeutics for effective management of rheumatoid arthritis.

Rheumatoid arthritis (RA) is a chronic, prevalent, immune-mediated, inflammatory, joint disorder affecting millions of people worldwide. Despite current treatment options, many patients remain unable to achieve remission and suffer from comorbidities. Because of several comorbidities as well as its chronic nature, it diminishes the quality of patients' life and intensifies socioeconomic cargo.

Tumor-promoting aftermath post-chemotherapy: A focus on breast cancer.

Chemotherapy is an important tool for the management of solid tumors including breast cancers (BC). Its neo-adjuvant and adjuvant use is important for shrinking tumor size and neutralizing the disseminated cancer cells. Initial chemotherapy administration often leads to a reduction in tumor size and pathological complete response.

Tuning Mesoporous Silica Nanoparticles in Novel Avenues of Cancer Therapy.

The global menace of cancer has led to an increased death toll in recent years. The constant evolution of cancer therapeutics with novel delivery systems has paved the way for translation of innovative therapeutics from bench to bedside. This review explains the significance of mesoporous silica nanoparticles (MSNs) as delivery vehicles with particular emphasis on cancer therapy, including novel opportunities for biomimetic therapeutics and vaccine delivery.

Public-private partnership (3Ps) in ensuring safe use of medicines: An Indian experience.

Adverse drug reactions (ADRs) are major concerns to the public health. To monitor ADRs and ensure patients' safety, the Pharmacovigilance Programme of India (PvPI) has been established by the Government of India in 2010. The programme is intact with the Public-Private Partnership (3Ps) in pharmacovigilance for quality services, better management of human resources and risk minimization.

Biomimetic nanotherapeutics: Employing nanoghosts to fight melanoma.

Melanoma is a cancer of melanocytes present at the basal layer of the skin. Nanomedicine has armed us with competent platform to manage such fatal neoplastic diseases. Nevertheless, it suffers from numerous pitfalls such as rapid clearance and opsonization of surface-functionalized carriers, biocompatibility and idiopathic reactions which could be difficult to predict in the patient.

Polymer nanotherapeutics: A versatile platform for effective rheumatoid arthritis therapy.

Rheumatoid arthritis is an aggressive and severely debilitating disorder that is characterized by joint pain and cartilage damage. It restricts mobility in patients, leaving them unable to carry out simple tasks. RA presents itself with severe lasting pain, swelling and stiffness in the joints and may cause permanent disability in patients.

Comprehensive Review on Different Analytical Techniques for HIV 1- Integrase Inhibitors: Raltegravir, Dolutegravir, Elvitegravir and Bictegravir.

The advent of HIV-Integrase inhibitors (IN) has marked a significant impact on the lives of HIV patients. Since the launch of the first anti retro-viral drug "Azidothymidine" to the recent advances of IN inhibitors, about 27.4 million people benefit by antiretroviral therapy (ART).