Background: India as an important clinical trial hub in the world. In clinical trials, many of the drug issues related to the safety are inadequately studied in highly selected and limited number of patients. Due to introduction of many new drugs in the country, it has become essential to have an effective Pharmacovigilance system nationwide. Under reporting of ADRs is widespread and a daunting challenge in Pharmacovigilance programme of India (PvPI).Methods: A cross sectional study was conducted for two months with the objective to study the pattern of ADRs reporting in two teaching hospitals of Tripura. The data were collected in “Suspected ADR reporting forms” of Indian Pharmacopoeia Commission (IPC). Suspected ADRs were assessed for causality using Naranjo ADR probability scale.Results: 44 ADR reporting forms were received with 58 ADRS. Among them, Gastrointestinal System ADRs were the highest (25.86%). More ADRs were seen in males than females (52.27% vs 47.72%). 68.18% cases had the medication through oral route. Out of all ADRs, 67.24% were Type A reactions. Most of the reactions reported, were mild (90.9%) based on modified Hartwig severity scale. Most of the ADRs reported were of probable causality (score 5-9) measured by Naranjo’s Algorithm.Conclusions: This study would definitely give an insight into the pattern of ADRs in tertiary health care centers and may help to increase awareness of health care provider for further Pharmacovigilance studies.

Background: Jaundice in pregnancy complicates 3-5% of cases and carries a grave prognosis. The purpose of the study was to assess the epidemiology, magnitude, causes and the maternal and fetal outcome of pregnancies complicated by jaundice.Methods: The maternal and fetal outcomes of 101 cases of jaundice in pregnancy were reviewed retrospectively from July 2013-June 2016.Results: The incidence of jaundice in pregnancy was 2.32%. Primigravidas constituted 46.53%. Women aged 20-30 years constituted 86.13%. Unbooked cases included 60.39%. Serum bilirubin was >10 mg/dl at admission in 1.98%. Out of the 101 women, 4 remained undelivered. Labor was spontaneous in 53.52%, vaginal delivery in 55.67%. However, 38.63% newborns required NICU care.  Perinatal mortality was 8.91% (3.96% stillbirths and 4.95% early neonatal deaths. The causes for jaundice were viral hepatitis (30.69%), HELLP syndrome (30.69%), intrahepatic cholestasis (15.84%), acute fatty liver of pregnancy (13.86%) and the rest in combination constituted 8.91%. Maternal mortality was 3 in 101. The various maternal complications were DIC (44.55%), septicemia (10.89%), ARDS (7.92%), acute renal failure (8.91%) and MODS (3.96%). ICU was needed in 14.85% of mothers and blood component therapy in 70.29% cases. All deaths were within 3 weeks of admission.Conclusions: This study emphasizes the need for essential antenatal care at domiciliary and peripheral levels. Early detection and treatment can prevent most of the complications.