To compare the efficacy and safety of different oral and parenteral iron preparations in patients with anemia. Methods: An observational, prospective study in patients of anemia in pregnancy and chronic kidney disease (CKD) receiving iron sucrose, oral ferrous ascorbate and ferrous sulfate were included. Demographic details, clinical history, baseline hemoglobin, anemia indices data were recorded in a case record form. The patients were followed up monthly for 12 weeks and observed for clinical and haematological improvement and adverse drug reactions (ADRs). The data was analyzed using paired t-test, unpaired t-test and Fisher`s exact test. Results: Out of 232 patients, 84 received iron sucrose, 62 ferrous ascorbate and 86 ferrous sulfate. Oral and parenteral iron preparations significantly (P<0.0001) improved mean hemoglobin, anemia indices and serum ferritin at the end of study. However, mean increase in hemoglobin and anemia indices were significant (P<0.0001) with iron sucrose (4.42 ± 0.17gms/dL) as compared to ferrous ascorbate (3.45 ± 0.1) and sulfate (3.3 ± 0.4). Increase in serum ferritin was more and rapid (at 4 weeks) with iron sucrose as compared to ferrous ascorbate in CKD patients. Surprisingly, ADRs were more in patients treated with oral ferrous sulfate (86%) and ascorbate (71%) compared to iron sucrose (63%). Conclusion: Parenteral iron sucrose improves hemoglobin. anemia indices and replenish iron stores rapidly and is well tolerated than oral iron preparations.

Background: As per World Trade Organisation (WTO), from the year 2005, India granted product patent recognition to all new chemical entities (NCEs). This may affect the new drug approvals in India. The purpose of this study was to compare the new drug approvals in India with the United States (US) and the European Union (EU) regions. Methods: We obtained information about regulatory approval of new drugs in the US, EU, or India of last 5 years (from 2011 through 2015) from the publicly accessible databases of three regulatory agencies. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, review classification and approval date. Results: There were 509 new drugs approved from 2011 through 2015 by one or more of the three regulatory agencies. Total 182 new drugs were approved in US during the period of 2011 to 2015, with an average of 36.4 new drugs approved per year. For the same period a total of 257 new drugs were approved in the EU, with an average of 51.4 new drugs approved per year and in India a total of 70 new drugs were approved, with an average of 14 new drugs approved per year. There were more number of new drug approvals in antineoplastic and immunomodulating agents (L) ATC group in all the three regions (US= 66; EU= 61 and India= 17). Conclusions: For new drugs approved between 2011 and 2015, India has lagged behind the US and the EU in approval of new drugs. There was no difference in the patterns of new drug approvals with respect to the therapeutic areas.

The objective of this study was to see the trends of new drug approvals by the U.S. FDA in last 5 years and find the therapeutic areas with higher new drug approvals. METHODS We obtained information about regulatory approvals by the U.S. FDA from publicly accessible databases at Drugs@FDA. 3 The definition of "new drug" included ABSTRACT Background: The U.S Food and Drugs Administration (FDA) is the world's leading drug regulatory authority. There are reports of more product pipelines in oncology therapy area. The objective of this study was to see the overall trends of new drug approvals by the U.S. FDA in last 5 years and find the therapeutic areas with higher new drug approvals. Methods: New drug approvals data obtained from publicly available databases of the U.S. FDA from 2011 through 2015. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, single or combination products, New Drug Application (NDA) chemical types, review classification and approval date. Results: There were 182 new drugs approved from 2011 through 2015 by the U.S. FDA with a mean of 36.4 approvals per year. Out of these 182 new drug approvals, 149 (81.87%) approvals were for new molecular entity (NME) and 33 (18.13%) for biologics license application (BLA). There were more number of new drug approvals in antineoplastic and immunomodulating agents (L) ATC group (n=66; 36.26% of total new drug approvals). Conclusions: For new drugs approved between 2011 and 2015, the U.S. FDA was first to approve majority of new drugs. There was upward trend of new drug approvals in antineoplastic therapeutic area.

Background: This study was aimed to assess the knowledge regarding basic aspects of conduct of clinical trial and associated regulatory as well as ethical issues before and after and educational intervention in form of a workshop on Good Clinical Practice (GCP). Methods: One day workshop on "Good Clinical Practice" was planned which included important ethical and regulatory issues regarding clinical research. Various resource persons from industry and academia were chosen to address the workshop. Total 60 participants were enrolled for this one day workshop. Pre-workshop questionnaire of 15 questions were distributed before the actual topic started. Each participant had to fill the questionnaire form and return it within 15 minutes. Again at the end of workshop, post-workshop questionnaire containing the same questions were distributed and the participants were asked to fill the form. Sequence of questions was changed in post workshop questionnaire. Comparison between answers in pre and post workshop questionnaire was done. The primary outcome was knowledge, which was evaluated using the Wilcoxon signed rank test. Results: In Pre workshop, out of 60, total 28 (46.66%) participants had answered all 15 questions, while 30 (50%) participants had skipped to answer one question "Define GCP." 2 out of 6 (3.33%) participants had not answered 4 and 5 questions out of 15, respectively. Total 45 out of 60 (75%) participants in post workshop answered all questions. All 15 (100%) questions were answered correctly in post workshop as compared to 11 (73.3%) questions in pre workshop. So, in post-workshop, there were significant (P <0.005) gains in knowledge regarding all good clinical practice questions. Conclusions: Good clinical practice knowledge improved markedly with a targeted education intervention in form of workshop. However, changes in behaviour and attitude were not studied by this questionnaire based study.

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Objective: To compare the efficacy and safety of cilnidipine and losartan in hypertensive patients with type 2 diabetes mellitus (type 2 DM). Materials and Methods: In this observational, prospective study, hypertensive patients with type 2 DM receiving cilnidipine and losartan were included. Demographic details, clinical history, serum potassium, and urinary albumin were recorded in a case record form. Patients were followed up every monthly up to 24 weeks and observed for clinical and laboratory parameters and adverse drug reactions (ADRs). Data were analyzed using paired t-test, unpaired t-test, and Fisher's exact test. Results: Out of 114 patients, 59 received cilnidipine and 55 patients received losartan. By 24 weeks, both cilnidipine and losartan significantly (P < 0.01) improved mean blood pressure and urinary albumin. However, mean decrease in urinary albumin was significant (P < 0.005) with cilnidipine (20.6 ± 20.4 mg/day) as compared to losartan (18.3 ± 14.3 mg/day). Mean serum potassium was increased significantly (P < 0.05) in patients treated with losartan (0.9 ± 2.8) as compared to patients treated with cilnidipine. A total of 19 ADRs were observed in both groups and out of these, 36.8% ADRs were caused by cilnidipine and 63.2% ADRs by losartan. Conclusion: Cilnidipine is equally effective as losartan in reducing blood pressure in hypertensive patients with type 2 DM. However, cilnidipine is more effective in the prevention of albuminuria and better tolerated by patients as compared with losartan.