Applied Drug Research, Clinical Trials and Regulatory Affairs - Volume 8, Issue 2, 2021

The advent of big data analysis, genetic engineering and epigenetics has transformed the healthcare system by shifting the strategy for diagnosis, prevention and treatment of diseases from “one-size-fits-all” approach to “personalised” approach. Identification of biomarkers from molecular diagnosis has made tailoring of the medical treatment possible. Optimization of treatment decreases the costs related to the ineffective treatments and helps in avoiding possible side effects and adverse drug reactions. The efficient development of personalised medicine is largely dependent on the tools, sequencing techniques used and regulatory policies related to the personalised medicine products, tests and companion diagnostics. The uncertainties in the regulations governing personalised medicine should be eliminated and specific guidelines should be laid down by the respective regulatory authorities to bridge the emerging tools and technologies with the regulatory policies. Also, proper regulatory approval pathways for companion diagnostics will resolve the complications of organized development of therapeutic products and diagnostic tests.

Background: The article provides a brief discussion on the comparative regulations on orthopedic implants in India, the United States, and European Union. Orthopedic implants are type of high-risk medical devices manufactured to substitute or replace a missing or damaged joint or bone or to support a damaged bone or joint and to improve the quality of life of patients. Thus, there is a need to regulate the import, manufacture, clinical investigation, sale, and distribution of orthopedic implants to ensure that all orthopedic implants that were brought to market are safe quality and performance. The orthopedic implants industry is adversely affected by a lack of awareness of proper regulatory practices, lack of awareness of the current regulatory practices, separate consistent standards, separate lawful requirements, and proper guidance on the quality system, etc. Conclusion: The objective of this article is to harmonize the regulatory requirements at par with the internationally accepted regulations and to develop an ecosystem in the country to boost the Indian orthopedic device sector, and that will make India more productive for orthopedic device development to encourage national and multinational orthopedic implants industries to manufacture their orthopedic implants in India.

The ever-increasing use of digital technologies is rapidly changing the face of modern healthcare delivery. Healthcare systems are embracing digital health solutions to improve patient outcomes, enhance healthcare delivery, and reduce costs. Digital therapeutics (DTx) are now a popular category of digital health solutions aimed at preventing, managing, or treating medical disorders. These evidence-based technologies/products either complement a conventional therapy or are prescribed as stand-alone treatments for a range of conditions, including chronic diseases and mental health disorders. Many pharmaceutical companies and healthcare start-ups are developing DTx products for different health conditions. Despite similarities between DTx and conventional medicines, DTx products are not covered under reimbursement at present in many countries. There are no uniform regulations for DTx prescription and reimbursement. This review aims to analyse the current DTx scenario, particularly highlighting the regulatory aspect and reimbursement of DTx products globally.

Introduction: Silymarin is a mixture of 9 different active flavanolignans extracted from the seeds of the milk thistle (Silybum marianum) plant. It has been extensively used by local people and medicinal practitioners in European countries from around 2,000 years for the treatment of liver and biliary-related disorders. Aims: This review article documents and critically assesses, for the first time, up to date the regulatory status of the silymarin extract for the treatment of hepatic and other diseases. Methods: Information was collected systematically from electronic scientific databases including Google Scholar, Science Direct, PubMed, Web of Science, ACS Publications, Elsevier, SciFinder, and Wiley Online Library, as well as other literature sources (e.g., books). Additionally, various regulatory authority websites have been searched for exploring the data. Key Findings: Silymarin has been approved in different doses for the treatment or adjuvant therapy for liver disorders by the regulatory authorities of different countries. But, silymarin has still been used as a dietary supplement in the US, despite its high sales. The potential of silymarin to be approved for various other indications has been proved by assessing its efficacy in human patients. In addition to efficacy, it is found to be safe and well-tolerated. Conclusion: Phytochemical and pharmacological studies have demonstrated that silymarin is an important medicinal herb with prominent bioactivities. Thus, there is a need to conduct clinical trials in a larger number of patients to get approval for use in diseases like metabolic syndrome, diabetes mellitus, cancer, and many more.

Intellectual Property Rights (IPR) are intellectual privileges that allow authors and inventors to defend their original inventions from misuse or theft. With the assistance of algorithms, clinical science has taken on a different level in recent years. Various advanced tools can be used to investigate pharmacokinetics profiling, in silico experiments, receptor simulations, drug synergistic effects, and so on. Computational scientists are making continuous efforts to figure out how to connect business models in pharmacology. However, software theft and security rights remain major concerns for all. In order to avoid such violations, IPR compliance for R as well as promoting machine applications is critical. This compilation will illustrate diverse software concepts, the latest patent data structures, copyright management laws for software, trade secrets, compliance rights, software patenting and contracts, artificial technology priorities and problems, licenses, and case studies relating to IPR violations in pharmaceutical and other fields.

Artificial intelligence and robotics are two of the hottest and most recent technologies to emerge from the world of science. There is tremendous potential for these technologies to solve a wide range of pharmaceutical problems, including the reduction of the enormous amounts of money and time invested in the drug discovery and development process, technical solutions related to the quality of drug products, and an increase in the demand for pharmaceuticals. Nanorobotics is a new subfield that has emerged from the field of robotics itself. This technique makes use of robots that are as small as nano- or micron-sized to diagnose diseases and deliver drugs to the targeted organ, tissue, or cell. These techniques, as well as their various applications in the pharmacy sector, are extensively discussed throughout this article. Internationally renowned pharmaceutical companies are collaborating with Artificial Intelligence behemoths in order to revolutionise the discovery and development process of potential drug molecules and to ensure the highest possible quality in their products.

Background: Improper drug usages expose patients to drug-related problems (DRPs) and can be the cause of patient morbidity and even mortality, especially frequent in hospitalized patients and pediatric groups. Objective: The objective of the present study was to identify and assess the drug-related problems in the pediatric department of tertiary care hospitals. Methods: The cross-sectional, observational study was carried out for six months included pediatric in-patients of age ≤15 years of either gender in pediatric units of tertiary care hospitals of India. The enrolled pediatric patients were observed for any drug-related problem that were further recorded and classified using the DRP registration format taken from Cipolle et al. The assessment of therapy was done by using positional statements from standard organizations and guidelines. Main outcome measure: Incidences of drug-related problems and their assessment and root cause analysis. Results: A total of 970 DRPs were identified in 296 patients, with an overall incidence of 49.3%. The incidence of DRPs was maximum in the age group of 2-12 years of children (51.2%). Patients who took six or more drugs were around eight (OR:8.41, 95% CI: 5.22 to 13.55) times more likely to have DRPs compared to those patients who took less than six drugs. The incidences of DRPs were more in patients who were hospitalized for ≥ 7 days. Conclusion: The present study revealed significantly higher incidences of DRPs in hospitalized pediatric patients necessitating the involvement of clinical pharmacists in the pediatric department of tertiary care hospitals.

Background: Despite the availability of many topical formulations for scar treatment, an objective evaluation of their effectiveness is lacking. Objective: To assess the physiological, structural, and mechanical parameters of scar healing by a scar ointment (MEBO-Scar). Methods: 45 patients from the Department of Obstetrics at Al Ain Hospital, UAE, with recently acquired Pfannenstiel scars were recruited into this prospective, open-label, controlled study. Scar ointment was applied to a lateral third of the scar; positive control (silicone gel based topical) to the other lateral third; the middle third was left untreated (negative control). The scars were evaluated at 4 time points up to 12 weeks using non-invasive devices and a scar questionnaire. Results: In comparison with silicone gel, there was a significant reduction in trans epithelial water loss at weeks 2, 4, 8, and 12 (p<0.001) and scar area at weeks 4, 8 and 12 (p<0.001) with scar ointment. The skin elasticity at week 4 was significantly increased by scar ointment (p=0.007). By week 12, gross colour mismatch of the scar was described by 9% patients with scar ointment (24% with silicone gel, 42% with no treatment; p<0.001). There was a significant improvement in scar texture with scar ointment by week 12 (p<0.001). Conclusion: Scar ointment has beneficial effects on objective and subjective patient-reported parameters of Pfannenstiel scars.