New Drugs and Clinical Trial Rules 2019, What is New? Our Views from Ethical Perspective.

A good quality research requires the incorporation of good ethical practices throughout the conduct of the study. An efficient Ethics Committee will facilitate such a research at the site, and can achieve the major objective of ICH-GCP (International Conference on Harmonisation -Good Clinical Practice) guidelines. Awareness of the changing rules among the stakeholders of clinical studies will ensure good clinical practice by safeguarding and protecting the rights, safety and well-being of the research participants. The draft of the New Drugs and Clinical Trials Rules was published in the Gazette of India by central government on March 19, 2019. Keeping abreast of the latest rules are essential for the uninterrupted conduct of clinical studies. We sought to give a summary of important changes in the new rules and to assess those rules from ethical perspective.

Can Metabotropic Glutamate Receptor 7 (mGluR 7) be a Novel Target for Analgesia?

INTRODUCTION: The present study was carried out to study the role of metabotropic glutamate receptor 7 (mGluR7) using its agonist, N,N'-bis(diphenylmethyl)-1,-ethanediamine (AMN082) for nociceptive stimuli, in animal models. By conducting this research, we aim to introduce a novel target for acute pain management. OBJECTIVE: To study the role of metabotropic glutamate receptor 7 (mGluR7), in analgesia, using mGluR7 agonist AMN082 in animal models. MATERIALS AND METHODS: Swiss albino mice of either sex, weighing 20-30gm were used for the study. The animals were divided into 3 groups with 6 mice in each group: Control or Normal group received 0.5% methylcellulose in normal saline; Standard group received the drug tramadol HCl at 40mg/kg; and test group received drug AMN 082 at 5mg/kg. All the drugs were administered by intraperitoneal route. Hot plate test and Tail flick test were done to evaluate the analgesic effect of the drug. Reaction time for the end points in both the models were noted before drug administration at 0 min and after drug administration at 15, 30,60,90 and 120 min. Statistical analysis was done using One-Way-ANOVA followed by Tukeys post hoc test. p-value was considered significant at ≤ 0.05. RESULTS: The group that received AMN082 showed significantly lesser reaction time compared to normal and standard groups in both the analgesia models. CONCLUSION: The mGluR 7 stimulation by an agonist AMN082, did not show analgesic effect but induced hyperalgesia in response to thermal nociceptive stimuli.

Acanthosis Nigricansin PCOS Patients and Its Relation with Type 2 Diabetes Mellitus and Body Mass at a Tertiary Care Hospital in Southern India.

BACKGROUND: Acanthosis nigricansis was viewed recently as a possible marker of an increased risk for diabetes. Acanthosis Nigricans (AN) can help in identifying the patients with an increased risk for Type 2 Diabetes Mellitus (T2DM) among Polycystic Ovary Syndrome (PCOS) cases. Hence, this study was carried to know the prevalence of AN in PCOS and its correlation with diabetes mellitus and the body mass. METHODS: A prospective, longitudinal study in the patients with PCOS, who attended the Department of Medicine, Kasturba Medical College [KMC] Hospital, Attavar, Mangalore, Karnatka, India between December 2008 to April 2010, was carried out. A total of 119 patients with PCOS were included in the study. A complete history, along with the demographic data of the patients who were aged between 15-35 years, were considered for the analysis. RESULTS: AN was observed in 56% of the PCOS patients. The Body Mass Index (BMI) and the waist circumference were significantly higher in the PCOS patients with AN, as compared to those without AN. Among the 119 PCOS patients,77% were found to have BMI values which were above the normal. Among the obese PCOS patients, 58% had BMI values of more than 30kg/m(2) as compared to 19% of the patients who did not have AN. Type 2 DM was observed in 77% of the PCOS patients with AN, while none of the PCOS patients were found to be diabetic among those without AN. A family history of DM in the first degree relatives was present in all the patients with AN. The results were analyzed by the Mann Whitney U test for the continuous data and by the Chi square test for the categorical data. CONCLUSION: The PCOS patients who had a family history of diabetes and obesity with a body mass index of more than 30 kg/m(2) and a waist circumference of ≥ 90 cm were more likely to develop AN, which is a marker of hyperinsulinaemia and insulin resistance. Identifying such PCOS patients will stimulate the discussions of the lifestyle modifications in the primary care setting.