Background: A research ethics committee (REC) is a body responsible for ensuring that medical experimentation and human research are carried out in an ethical manner in accordance with national and international law. It is mandatory that all the research projects should be approved by EC before commencement. Recently Medical council of India has introduced mandatory online research methodology module consisting of assignments followed by mandatory exam.Methods: A cross-sectional study using a self-administered, validated questionnaire was administered among PG residents of a tertiary care hospital in Pune having a functional ethics committee was conducted for 3 months. Number of correct and incorrect responses were noted and calculated in percentage.Results: Total of 125 residents were enrolled and 119 subjects responded. The response rate was 95.2%. The respondents included 59.66% clinical and 40.33% nonclinical post graduate residents. 87.39% knew the role of IEC. 95.79% said informed consent should be mandatory document. 98.31% were aware about the institutional ethics committee (IEC) in the institution. 84.87% think EC and research ethics should be taught as a mandatory PG module.Conclusions: Authors conclude that among the clinical and non-clinical postgraduates participating in study, there is acceptance of IECs and training in research ethics, while there are knowledge gaps in research ethics guidelines and composition of IEC. The updated MCI curriculum imbibes research curriculum but should focus on details about ethics in biomedical research. It can be initiated by workshop/awareness programmes compulsory for UG and PG students.
Formoterol12mcg(11.5%), Tiotropium 18 mcg(11.5%), Ipratropium 20mcg/200mdi(19%)
Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses.
Hemovigilance is a series of monitoring procedures that cover the entire transfusion chain, from blood and its component collection to recipient follow-up, collecting and collecting information about unexpected or adverse effects resulting from the therapeutic use of unstable blood products. It is designed to be evaluated, and to prevent their occurrence and recurrence. The Haemovigilance program in developed countries is associated with IHN and has voluntary reporting requirements. In France, Germany and Switzerland, the hemodynamic system is regulated by supervisors. It is one of the blood manufacturers in Japan, Singapore and South Africa. In the Netherlands and the United Kingdom within the Medical Society; in Canada, regulated by health authorities. Intensive blood exercise program to ensure patient safety and promote public health begins on December 10, 2012 in Phase 1 in collaboration with National Institute of Biological Sciences under MOHFW for the first time in India it was done. HvPI is responding very well, as most medical colleges and laboratories have already registered and are beginning to provide data on side effects. The HvPI Unit produces educational materials in the form of publishing the Haemovigilance newsletter, information, education and communication (IEC) literature, and conducts an academic CME and awareness program on Haemovigilance throughout the year in India. The provocation is to understand not only the feedback of the internet, but even the sociology of human networks. Guaranteeing the reliability, responsiveness, and feedback of each alert is also important. Blood products are an important area of PvPI for reporting and recording post-transfusion ADRs of blood / blood products. To work efficiently, a lean mechanism and proper coordination with standardized tools at all levels is needed.
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