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Advancements in the field of biomedical and health research pose new ethical challenges warranting the need for constant updation in the existing ethics guidance. Realizing this, revision of “Ethical Guidelines for Biomedical Research on Human Participants (2006)” was initiated in the year 2015. The preparation of guidelines was a participatory process involving large number of stakeholders from various backgrounds in order to get a variety of perspectives. The initial draft went through an extensive process of consultation at both regional and national level, with experts and stakeholders from academia, govt. agencies, departments and ministries, public and private institutions, pharmaceutical industry, non-governmental organizations, patient organizations, regulators, international agencies as well as with public. The revised “National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017” were released on October 12, 2017, and address ethical concerns, in accordance to the sociocultural milieu of our country. New sections have been added on informed consent process, vulnerability, biological materials, biobanking and datasets, responsible conduct of research, sociobehavioral research, research in emergencies or disasters. The revised guidelines must be followed by all stakeholders who are engaged in biomedical and health research including sponsors, institutions, ethics committees, and researchers. It is expected that the implementation of these guidelines would help to protect the dignity, rights, safety and well-being of research participants and also to improve the quality of biomedical and health research.

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OBJECTIVES: The objective was to study the adaptogenic effect of Chlorophytum borivilianum(CB) on physical performance when exposed to accustomed activity (AA) and unaccustomed activity (UA) and the effect of CB on heart rate (HR) and blood pressure (BP) in the presence of UA and the effect on muscle strength in comparison with placebo. MATERIALS AND METHODS: A placebo-controlled, double-blind clinical study was initiated after ethics committee approval in healthy volunteers with fixed-dose regimen. Consented volunteers (n = 60) were assigned randomly into two groups of study drug (3 g/day) or placebo (3 g/day) for 2 months. They were evaluated at days 0, 30, and 60 with physical stressors (6-min walk test [6MWT] – distance, HR, and BP; 6-min exercise test [6ETC] – distance, maximum and average speed; and fixed workload test [FWT] – systolic BP, diastolic BP [DBP], and HR on cycle ergometer) and Jammar's dynamometer test for handgrip strength test on each visit. RESULTS: In 6MWT in CB group, distance on day 30 (456 ± 42.1) and day 60 (468.3 ± 0.4) was significantly increased when compared with day 30 (422.6 ± 45.7) and day 60 (419.6 ± 45.1) of the placebo group. On day 60, distance in 6ETC in CB group was 2.92 ± 0.6 which was significantly more than that of placebo group 2.4 ± 0.6. On day 60, in FWT, DBP in the CB group was 75.8 ± 4.4 which was significantly low compared to the placebo group 82.4 ± 7.4 (P < 0.05). CONCLUSION: CB increased physical performance when exposed to AA even after one month and in case of UA increase in performance was seen when CB was administered for two months thus validating its adaptogenic (anti-stress) potential.

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Plants have been used for years for various cosmetic purposes. In the Eastern Cape province of South Africa, a large proportion of the population reliant (to some extent) on botanical resources for beauty and health. Despite the use of these botanical resources for various cosmetic purposes, only a few have been fully commercialized or used as ingredients in cosmetic formulation. The present study aimed to review plant species that are fully explored commercially for cosmetic products in the Eastern Cape province. A survey of cosmetic products with plant-based ingredients was done covering the major supermarkets (SPAR, Shoprite, and Pick n Pay), cosmetic shops (Clicks), and pharmacies in the Eastern Cape province, and electronic databases including Embase, Google Scholar, Medline, PubMed, Scopus, SciFinder^®, Springer, Science Direct, and Web of Science were used as data sources for ethnobotanical information. Surprisingly, out of 150 plant species used by both Xhosa men and women for various cosmeceutical purposes, only six plant species have been used commercially with regard to cosmeceutical application. These plants species belong to five major plant families, namely Lamiaceae (two species), Asphodelaceae (one species) Cucurbitaceae (one species), Oleaceae (one species), and Verbenaceae (one species). The findings revealed that the use of Eastern Cape plants for cosmetic purposes has not been fully explored commercially. Thus, there is a need for cosmeceutical industries to explore these species commercially in order to develop new possible cosmetic products for local and international markets.

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INTRODUCTION: Riboflavin- and ultraviolet (UV)-A-mediated collagen cross-linking of the cornea is a frequently used therapeutic measure for the treatment of progressive keratoconus (PK). First, riboflavin increases cross-linking and second, it serves as a protective shield to other deep ocular structures. However, pharmacogenomic variation in riboflavin efficacy is reported. As the Northeast Indian population represents a genetically diverse group of population compared to mainstream India, we have assessed the efficacy of the procedure in a northeastern population with PK. METHODS: In this study, 78 eyes with PK were included (n = 39 in the treatment arm and n = 39 in the control arm). The primary objective was to evaluate the effect of corneal collagen cross-linking using riboflavin (C3R) (epithelium off) on maximum keratometry. The secondary objectives were evaluation of change in corneal topography parameters, i.e., minimum keratometry (K_min), simulated keratometry (Sim K), subjective refraction (cylinder power, spherical power, and spherical equivalent [SE]), uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and contrast sensitivity (CS) and safety (intraocular pressure, endothelial cell density, and percentage hexagonality) at 1, 3, and 6 months following C3R procedure. RESULTS: Statistically significant improvement was noted in K_min(6 months), Sim K (3 and 6 months), cylinder power (3 and 6 months), spherical power (3 and 6 months), SE (3 and 6 months), BCVA (6 months), and UCVA (1, 6 months) in the C3R group (n = 39) when compared to the control group (n = 39). The mean CS decreased at 1 month and gradually improved to achieve statistically significant value at 6 months in the C3R group (P < 0.05). CONCLUSION: Riboflavin-assisted C3R treatment showed promising efficacy in the treatment of PK patients in our population. As the collagen turnover rate of cornea is 2–3 years and the progression of PK is highly variable, we need long-term studies to evaluate the efficacy of C3R over time, requirement of repeat therapy, and safety of repeat cross-linking.

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AIM: Caspases-3 and 8 are key mediators of intrinsic and extrinsic pathway of apoptosis, respectively. Triterpenoids of natural and synthetic origin reported as anticancer agents with apoptotic potential and hence may prove to be good candidates for in silico testing against caspases-3 and 8. MATERIALS AND METHODS: Various naturally-occurring and synthetic triterpenoids were subjected to activity prediction using PASS Online software, and among them, 67 compounds were selected for further processing. Protein structure of caspase-3 (3DEI) and caspase-8 (3KJQ) was obtained from the protein data bank and docked with selected triterpenoids using AutoDock Tools and AutoDock Vina. Toxicological profile was predicted based on clinical manifestations using PASS online software. RESULTS: The high docking score of -10.0, -9.9, -9.8, and -9.5 were shown by friedelin, tingenone, albiziasaponin A, and albiziasaponin C, respectively, for caspase-3, and -11.0, -9.6, -9.6, and -9.4 by β-boswellic acid, bryonolic acid, canophyllic acid, and CDDO, respectively, for caspase-8. Possible adverse events were predicted with varying degree of probability and major relevant effects were reported. Hydrostatic interactions along with formation of hydrogen bonds with specific amino acids in the binding pocket were identified with each triterpenoid. CONCLUSION: Lead molecules identified through this in silico study such as friedelin, tingenone, albiziasaponin, bryonolic acid, and canophyllic acid may be utilized for further in vitro/in vivo studies as apoptotic agents targeting caspases-3 and 8.

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BACKGROUND: As the list of predatory journals is burgeoning, the researchers should have knowledge of calculating the predatory rate (PR) for the journals, in which they aim to publish their work and self-guard them from publishing in bogus journals. AIM AND OBJECTIVES: Our aim is to find out the predatory rate for various Pharmacology journals. MATERIALS AND METHODS: Here, we have examined the recently updated list (in 2017) of standalone predatory journals created and maintained by Beall, pertinent to all auspices of pharmacology including pharmacy, pharmaceutical, and pharmacognosy. The PR of various journals was calculated. RESULTS: Of 131 journals, pertinent to the pharmacology field, 45.03% of them had the PR between 0.72 and 0.84. 98.5% of journals were classified as predatory, whereas only 2 (1.53%) journals were classified in the category of predatory practice. CONCLUSION: It should be an eye-opener to the researchers, and they should deliberately select the journals to get real recognition of their work.

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OBJECTIVE: The present study aims to investigate the role of caveolin-1 in dementia of Alzheimer's type using intracerebroventricular streptozotocin (ICV-STZ)-induced neurodegeneration model in rats. MATERIALS AND METHODS: Male Wistar rats (220–260 g) were employed. STZ 3 mg/kg via ICV route was given once to cause neuronal injury. Daidzein – a caveolin inhibitor at 0.2, 0.4, and 0.6 mg/kg s.c. were given daily whereas minoxidil – a caveolin activator was given at 0.45 mg/kg, i.p. on alternate days for 28 days. STZ was also given at its submaximal dose 1.5 mg/kg to minoxidil group only. RESULTS: ICV-STZ control animals exhibited cognitive and neurological deficits on the Morris water maze, elevated plus maze, and balance beam tests (P < 0.0001). Treatment with daidzein significantly restored memory impairments and decreased oxidative damage whereas minoxidil potentiates the effect of STZ causing significant impairment in memory. Significant oxidative stress such as lipid peroxidation and glutathione (P < 0.0001) were also observed due to ICV-STZ administration resulting in neuronal damage which was significantly prevented by treatment with daidzein in brain tissues. CONCLUSION: The findings from the present investigation may conclude that the caveolin-1 from caveolae at the cell membrane induces memory deficits and oxidative stress phenotype that resemble the neurological phenotype of Alzheimer's disease. Further studies are warranted to gauge the effect of caveolin dyshomeostasis on the amyloidogenic cascade.

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BACKGROUND: There are over 12,000 chemists registered in the capital city, Delhi to support patient health needs. A study was conducted to improve the tuberculosis (TB) notification rates as conceptualized by the Revised National Tuberculosis Control Program (RNTCP). As part of the end TB mission, the feasibility of capturing data of TB patients coming to buy anti-TB drugs at the licensee level (chemists and drug shop owners) in Central Delhi area was assessed. MATERIALS AND METHODS: The prospective study was conducted from July 2017 to March 2018. TB notification through a paper-based system and self-notification through online mode were the operational modality used for engagement with chemists. A team of paramedical workers was deployed for data collection from those pharmacists who chose to notify through the paper mode. Self-notification through online mode was through the RNTCP's NIKSHAY web-based reporting platform. RESULTS: From the 330 chemists sensitized, 871 TB notifications were received during the study. Younger age groups comprised a majority of these cases with 198 (37.5%) from 21 to 30 years and 122 (23.1%) from 11 to 20 years. By the end of six visits, 28 (46%) of the 61 pharmacies that were eventually successfully sensitized had started returning the Folio cards with filled patient details. A total of 581 (66.6%) prescriptions received by the pharmacists were from government hospitals. The annual TB case notification in Central Delhi showed a significant increase from 271 TB patients/100,000 population to 871 TB patients/100,000 population during the study period when compared with expected trends in the past year (P < 0.05). CONCLUSION: Self-notification of TB engenders successful TB notifications from chemists. This progenitor approach to TB notification in the capital emphasizes the need to categorize pharmacists as an independent private care provider for improving TB notification across high-burden settings.

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BACKGROUND: The healthcare needs of the general population are on the rise and to meet these demands, the healthcare professionals, especially doctors have to acquire a large number of skills. In the Indian settings, as of now, conventional system of education is being followed in medical colleges and this is despite the fact that it has many flaws associated with it. AIMS AND OBJECTIVES: The objective of the article is to explore the utility and the need of Competency Based Medical Education (CBME) in Indian settings. MATERIALS AND METHODS: It is a brief review of pertaining to the transition of delivery of medical education in India and is well-supported by the studies from different nations. RESULTS: CBME is a thoughtful approach to develop physicians in their future practice and encourages better accountability and flexibility. However, if so many things are good with CBME, then the question arises why it has not been implemented yet across all the medical colleges in India? This is because of the various challenges which have been identified in the planning and implementation phase of the program. CONCLUSION: In conclusion, CBME remains the ultimate solution for the problems persisting in the conventional system of medical education. However, a systemic plan and better involvement of the stakeholders in the preparedness phase will significantly enhance the chances of the success of the program.

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