Basics and Essentials of Medical Devices Safety Surveillance

Medical devices are being used in healthcare facilities for diagnosis, monitoring, prevention and treatment of an array of diseases. To ensure user/patient safety associated with the medical devices being used in healthcare industry, it is of utmost importance to closely monitor the adverse events associated with the medical devices through a robust, sustainable and scaled surveillance. Materiovigilance Programme of India (MvPI) provides a reliable system to report adverse events associated with medical devices. Under MvPI, various modalities to report adverse events associated with medical devices have been developed. These modalities include an editable medical device adverse event reporting form, a toll-free helpline number and a field safety corrective action form (FSCA). FSCA form is used to notify the regulatory authority and healthcare professionals on corrective actions or recall by the manufacturer. Due to the emergence of the Coronavirus disease 2019 (COVID-19) pandemic, one-page editable form has been developed to boost the adverse event reporting of Personal Protective Equipments (PPEs). MvPI also coordinates with healthcare facilities and medical device industries across the country for reporting the medical device-related adverse events. The collected scientific data is utilized to develop regulatory policies and enhance measures to ensure the quality of medical devices. All the healthcare workers are, therefore, encouraged to report adverse events to MvPI. This chapter aims to describe the systems, procedures and modalities available for the reporting of Medical Device Adverse Events (MDAEs) in India, in order to intensify the nature of reporting and creating an environment that encourages the public to perform MDAE reporting

Physicochemical characterization and HPTLC profiling of commercially availableKabasura Kudineer Chooranam

The novel coronavirus disease-2019 (COVID-19) is an ongoing pandemic and currently, no specific vaccines or modern drugs are available to combat this contagious viral disease. Kaba sura kudineer, an official polyherbal Siddha medicine containing numerous herbal ingredients, is being practiced primarily in southern parts of India in the management of COVID-19 pandemic for boosting the respiratory system and treating fever with flu-like symptoms. The present study is carried out to scientifically validate the traditional claim and to confirm identity, quality and purity of marketed kaba sura kudineer polyherbal formulations in India. Kabasura kudineer chooranam manufactured by two different manufacturers were procured from New Delhi, India. The physicochemical characterization of the samples was carried out in accordance with the standards laid down by Indian Pharmacopoeia (IP) 2018. HPTLC profiling of key ingredients including Kalmegh (Andrographis paniculata), Guduchi (Tinospora cordifolia), Pippali (Piper longum), Vasaka (Adhatoda vasica) and Lavang (Syzygium aromaticum) were also carried out in accordance with IP 2018 monographs. The chromatographic analysis showed presence of all major ingredients in both the marketed preparations and all the physicochemical properties were also found comparable among preparations. Our findings may enhance the global acceptance of Siddha medicines practiced widely in India and also used for laying down the pharmacopoeial standards of kaba sura kudineer chooranam

Physicochemical characterization and HPTLC profiling of commercially available Kabasura Kudineer Chooranam

629-637The novel coronavirus disease-2019 (COVID-19) is an ongoing viral infection and currently, limited vaccines with no post-market safety data or repurposed drugs are available to combat this contagious viral disease. Kabasura Kudineer, an official polyherbal Siddha medicine containing numerous herbal ingredients, is being practiced primarily in southern parts of India in the management of COVID-19 pandemic for boosting the respiratory system and treating fever with flu-like symptoms. The present study is carried out to scientifically validate the traditional claim and to confirm identity, quality and purity of marketed Kabasura Kudineer polyherbal formulations in India. Kabasura Kudineer Chooranam manufactured by two different manufacturers was procured from New Delhi, India. The physicochemical characterization of the samples was carried out in accordance with the standards laid down by Indian Pharmacopoeia (IP) 2018. HPTLC profiling of key ingredients including Kalmegh (Andrographis paniculata), Guduchi (Tinospora cordifolia), Pippali (Piper longum), Vasaka (Adhatoda vasica) and Lavang (Syzygium aromaticum) were also carried out in accordance with IP 2018 monographs. The chromatographic analysis showed the presence of all major ingredients in both the marketed preparations and all the physicochemical properties were also found comparable among preparations. Our findings may enhance the global acceptance of Siddha medicines practiced widely in India and also used for laying down the pharmacopoeial standards of Kabasura Kudineer Chooranam

Adverse Drug Reactions Associated with Anti-Tuberculosis Therapy

The pharmacovigilance has been evolved as a professional and ethical practice in ensuring the safety of medicines. The Adverse Drug Reactions (ADRs) associated with the use of medicines including Anti-Tuberculous Therapy (ATT) through a robust system of pharmacovigilance helps in promoting the safety of patients at large. The occurrence of ADRs associated with the use of ATT is expected, a large number of medicines are combined and used for prolonged duration. The suspected ADRs associated with first line ATT are well documented. However, the drugs used in second line or multidrug resistant to tuberculosis (TB), namely bedaquiline, reported to cause QT prolongation in electrocardiogram reading as one of the most common ADRs. Therefore, early identification and prevention of ADRs during ATT is essential for promoting the rational use and reduce the burden of anti-microbial resistance, besides achieving better treatment outcomes

BH3-only protein BIM: An emerging target in chemotherapy

10.1016/j.ejcb.2017.09.002EUROPEAN JOURNAL OF CELL BIOLOGY968728-73

Morusflavone, a New Therapeutic Candidate for Prostate Cancer by CYP17A1 Inhibition: Exhibited by Molecular Docking and Dynamics Simulation

Morusflavone, a flavonoid from Morus alba L., was evaluated for its interactive ability and stability with CYP17A1, in comparison with abiraterone, which is a Food and Drug Administration (FDA)-approved CYP17A1 inhibitor. CYP17A1 inhibition is an important therapeutic target for prostate cancer. The CHAMM36 force field was used to perform molecular dynamics (MD) simulations in this study. The results show that Morusflavone has significant interactive ability and stability for CYP17A1, in comparison with abiraterone. The final interaction energies for the Morusflavone–CYP17A1 and abiraterone–CYP17A1 complexes were −246.252 KJ/mol and −207.86 KJ/mol, respectively. Since there are only limited therapeutic agents available, such as abiraterone, galeterone, and seviteronel, which are being developed for prostate cancer, information on any potent natural anticancer compounds, such as vinca alkaloids, for prostate cancer treatment is limited. The results of this study show that CYP17A1 inhibition by Morusflavone could be an important therapeutic target for prostate cancer. Further preclinical and clinical evaluations of the lead compound Morusflavone are required to evaluate whether it can serve as a potential inhibitor of CYP17A1, which will be a new hope for prostate cancer treatment

Enhanced Cellular Internalization: A Bactericidal Mechanism More Relative to Biogenic Nanoparticles than Chemical Counterparts

Biogenic synthesis of silver nanoparticles for enhanced antimicrobial activity has gained a lot of momentum making it an urgent need to search for a suitable biocandidate which could be utilized for efficient capping and shaping of silver nanoparticles with enhanced bactericidal activity utilizing its secondary metabolites. Current work illustrates the enhancement of antimicrobial efficacy of silver nanoparticles by reducing and modifying their surface with antimicrobial metabolites of cell free filtrate of <i>Trichoderma viride</i> (MTCC 5661) in comparison to citrate stabilized silver nanoparticles. Nanoparticles were characterized by visual observations, UV–visible spectroscopy, zetasizer, and transmission electron microscopy (TEM). Synthesized particles were monodispersed, spherical in shape and 10–20 nm in size. Presence of metabolites on surface of biosynthesized silver nanoparticles was observed by gas chromatography–mass spectroscopy (GC-MS), energy dispersive X-ray analysis (EDAX), X-ray diffraction (XRD), and Fourier transform infrared spectroscopy (FTIR). The antimicrobial activity of both silver nanoparticles was tested against <i>Shigella sonnei</i>, <i>Pseudomonas aeruginosa</i> (Gram-negative) and <i>Staphylococcus aureus</i> (Gram-positive) by growth inhibition curve analysis and colony formation unit assay. Further, it was noted that internalization of biosynthesized nanoparticles inside the bacterial cell was much higher as compared to citrate stabilized particles which in turn lead to higher production of reactive oxygen species. Increase in oxidative stress caused severe damage to bacterial membrane enhancing further uptake of particles and revoking other pathways for bacterial disintegration resulting in complete and rapid death of pathogens as evidenced by fluorescein diacetate/propidium iodide dual staining and TEM. Thus, study reveals that biologically synthesized silver nanoarchitecture coated with antimicrobial metabolites of <i>T. viride</i> was more potent than their chemical counterpart in killing of pathogenic bacteria