Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 4, Issue 3, 2017

Background: The Government of India regulates medical devices through a specialized division called, Medical Device and Diagnostics Division, CDSCO, Min of Health and Family Welfare. Earlier, only 14 categories of Medical Devices, called Notified Devices were regulated under CLAA scheme for the purpose Manufacture, Import, Sale and Distribution. On 17th October 2016, a draft of rules, called Medical Device Rules, Read More

Background: India presents a peculiar case for Drug Eluting Stents (DES). 85% of India's stent need is met through imports which enjoy perception premium in terms of quality. Recently, drug eluting stents' prices were capped to INR 30,000 in India by National Pharmaceutical Pricing Authority (NPPA) of DES to curb soaring high prices. Indian Market offers tremendous opportunities for stent makers. The total market for stents in Read More

Background: This paper expands on our initial research published in this journal in 2014 which analyzed global trends in biopharmaceutical R clinical trials (BPCT) covering the period 2007 – 2012. In this paper, we have built on this work and used an enhanced and improved methodology (analysis of the Phase II and Phase III BPCT data from ClinicalTrials.gov clinical trial registry with the number of active, rather than just the newly Read More

Background: Over the past decade, there has been great development arising in the field of Molecular imaging and Nuclear medicine using innovative Radiopharmaceuticals. The Radiotherapy practices are also expanding due to increasing number of Cancer cases and technological advances. Indian market is also emerging as a foremost country to carry out research for a new drug. There is a need for the implemen Read More

Background: Methamphetamine (METH) dependence becomes the major public health concern for many countries. METH is an abusive stimulant with various psychophysiological effects to its abusers. METH activates the human's brain reward circuitry and addiction, by increasing dopamine (DA) and serotonin (5-HT) levels in the synaptic cleft. Objective: We investigated allelic variants of 5-HTTLPR, 5-HT1A C(-1019)G, 5-HT2A Read More