Emergency Approval Mechanisms for Human Vaccines in India.

The coronavirus disease 2019 (COVID-19) pandemic highlighted the world's level of preparedness in managing public health emergencies (PHEs). It revealed the critical need for timely medical therapeutics, especially vaccines. To expedite response, many nations, including India, adopted emergency approval mechanisms and offered new ways of review, such as the rolling review along with the accelerated review procedure. This response resulted in reallocating internal resources and adopting new policies and measures, such as integrating digital technology with regulatory submissions and flexibility in statistical approaches. The present review focuses on the utilization of the New Drugs and Clinical Trials Rules 2019 for granting emergency approval to COVID-19 vaccines by the Drug Controller General of India (DCGI) and explores the legislative basis for such authorization during the PHE. The review aims to elucidate key intricacies and challenges inherent in the existing 'emergency use' framework within the Indian regulatory landscape. It assesses three critical facets of the 'emergency use' paradigm: the definition of the term, establishment of a transparent decision-making process, and formulation of rules governing termination or expiration of the emergency status. It makes policy recommendations regarding the 'emergency use' framework to respond to new, emerging, or re-emerging public health threats of the future.

Post-trial access to investigational drugs in India: addressing challenges in the regulatory framework.

Through the New Drugs and Clinical Trials Rules, 2019 (2019 Rules), India has developed the rules governing post-trial access (PTA) to new drugs or investigational new drugs. However, inconsistencies and interpretational challenges exist in the application of the 2019 Rules and the Indian Council of Medical Research Guidelines 2017. This conflation poses a real harm to the trial participants, specifically the ones with limited access to healthcare facilities. Since drug laws in India do not expressly deal with other forms of access like the 'Compassionate Use' or 'Expanded Access' mechanism, demarcating the scope and describing the strategies for PTA are the need of the hour. We propose possible strategies to address inadequacies in the regulatory regime and establish 'win-win' situations among all stakeholders. We further argue that India is well positioned to provide leadership by developing detailed PTA provisions and may set a potential path for the other clinical trial host countries.

Evaluation of hard and soft tissue changes around implant in partially edentulous patients: a clinico-radiographic study.

INTRODUCTION: implant supported prosthesis has become a viable treatment option for missing teeth. An important tool to detect early changes around implants is the standardized assessment of peri-implant hard and soft tissue parameters. The purpose of this prospective study was to clinically and radiographically assess the soft and hard tissues around implants. METHODS: ten (10) patients with 13 implant supported prosthesis were included in the study. Clinical parameters plaque index (PI), gingival index (GI), modified sulcus bleeding index (mSBI), peri-implant Probing Depth (PD), gingival margin Level, width of keratinized mucosa (WKM) and implant mobility were measured at loading and at 3 and 6 months. The radiographic crestal bone loss and peri-apical implant radiolucencies were also evaluated at loading and at 3 and 6 months. Student paired t test and correlation and regression analysis was done to evaluate the effect of clinical variables over bone loss. RESULTS: there was decrease in the site specific PI, GI, mSBI and peri-implant PD and an increase in the gingival recession from baseline to 6 months. The WKM remained stable throughout the study. Significant crestal bone loss was observed around implants more on the distal as compared to the mesial aspect. No mobility or peri-apical implant radiolucency was observed. Regression analysis of the confounding variables with bone loss showed no significant effect. CONCLUSION: the occlusal loading of implants after 6 months showed significant bone loss (<1mm), which was within acceptable limits and the soft tissues around implants were in good health.

Improving Student Confidence With Electronic Health Record Order Entry.

INTRODUCTION: Despite near-universal utilization of electronic health records (EHRs) by physicians in practice, medical students in most ambulatory settings gain limited experience with placing EHR orders. In this study, an individual preceptor site investigated the usefulness of a targeted curriculum in improving students' EHR confidence and clinical reasoning skills. METHODS: Family medicine clerkship students assigned to one community health center were invited to participate in this prospective, survey-based study. In their first week, students observed a preceptor performing EHR tasks. For the remainder of the 4-week clerkship, students utilized decision support tools, assigned a working diagnosis, entered unsigned orders in the EHR, proposed an assessment, and discussed a plan with a preceptor. Students completed weekly questionnaires to self-report confidence across several EHR domains while preceptors synchronously evaluated students' accuracy with entering orders correctly. RESULTS: From February 2017 to March 2020, all 49 eligible students completed the study. One hundred percent of students reported that placing EHR orders was beneficial to their medical education. The difference over time in learner confidence with placing EHR orders was statistically significant across every domain (eg, writing prescriptions, ordering labs and imaging). Preceptors' evaluations of students' accuracy with placing orders also showed significant improvement between each week. CONCLUSION: Clerkship-wide EHR training may be limited by multiple sites with multiple EHR products. This pilot study suggests that committed faculty at an individual preceptor site can offer a targeted curriculum to help students develop EHR confidence. We propose other preceptors similarly offer students this opportunity to maximize clerkship education.

Electronic cigarettes and thirdhand tobacco smoke: two emerging health care challenges for the primary care provider.

PRIMARY CARE PROVIDERS SHOULD BE AWARE OF TWO NEW DEVELOPMENTS IN NICOTINE ADDICTION AND SMOKING CESSATION: 1) the emergence of a novel nicotine delivery system known as the electronic (e-) cigarette; and 2) new reports of residual environmental nicotine and other biopersistent toxicants found in cigarette smoke, recently described as "thirdhand smoke". The purpose of this article is to provide a clinician-friendly introduction to these two emerging issues so that clinicians are well prepared to counsel smokers about newly recognized health concerns relevant to tobacco use. E-cigarettes are battery powered devices that convert nicotine into a vapor that can be inhaled. The World Health Organization has termed these devices electronic nicotine delivery systems (ENDS). The vapors from ENDS are complex mixtures of chemicals, not pure nicotine. It is unknown whether inhalation of the complex mixture of chemicals found in ENDS vapors is safe. There is no evidence that e-cigarettes are effective treatment for nicotine addiction. ENDS are not approved as smoking cessation devices. Primary care givers should anticipate being questioned by patients about the advisability of using e-cigarettes as a smoking cessation device. The term thirdhand smoke first appeared in the medical literature in 2009 when investigators introduced the term to describe residual tobacco smoke contamination that remains after the cigarette is extinguished. Thirdhand smoke is a hazardous exposure resulting from cigarette smoke residue that accumulates in cars, homes, and other indoor spaces. Tobacco-derived toxicants can react to form potent cancer causing compounds. Exposure to thirdhand smoke can occur through the skin, by breathing, and by ingestion long after smoke has cleared from a room. Counseling patients about the hazards of thirdhand smoke may provide additional motivation to quit smoking.

Wound infection after metronidazole infiltration.

In state-run hospitals in India, pre-existing malnutrition and anaemia with late presentation, septicaemia and gross peritoneal contamination lead to a very high wound infection rate despite the use of systemic antibiotics. We studied the wound infection rate of subcutaneous infiltration of metronidazole (group B) versus irrigation with saline (group A) in patients undergoing exploratory laprotomy for perforation peritonitis with pyoperitoneum. The study included 30 patients in group A and 30 in group B. In group A 66.6% of the patients developed wound infection, whereas in group B 26.6% only developed wound infection. This difference is found to be statistically significant at a level of P < 0.01. There was no local complication attributable to infiltration of metronidazole in group B. Thus, we concluded that local infiltration of metronidazole at the incision is a safe and effective measure to control wound infection in cases of perforation peritonitis with pyoperitoneum.