Clinical Trial vs Biomedical Research: Do we need a sorting hat? New Drugs and Clinical Trial approval regulations 2019 have made a distinction between clinical research and biomedical research and the ethics Committees (EC) to approve the same. To approve clinical research, we need to approach an E...
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Doctors often have a misconception that a Phase IV study is a Post Marketing Surveillance (PMS)study. I remember having discussions with friends to clarify that if a phase III protocol is repeated after marketing a product, it does not become a PMS. They are different types of studies both conducted...
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I recount here my experience in a car showroom, where a new version of an already existing model was being marketed as hybrid. Here is how the conversation went I already own the earlier version, so please tell me how the engine switches from petrol to electricity Sir, let me first show you the othe...
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The Comptroller and Auditor General of India (CAG)does not seem to spare any department of the government. This time, it was turn of Food Safety & Standard Authority India (FSSAI) (under Health Ministry) to face the wrath. The Comptroller and Auditor General of India report on Performance audit No....
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Missed doses during vaccinations- Are they a concern? Most countries ensure that their population is protected by having national programs of vaccine delivery and strong recommendations. I am not of the autism school, so I support such programs. However I thought of writing this blog due to doctor’...
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‘Ever-expanding’ Immunization Program Recently it was reported that the Central Government has decided to introduce pneumococcal conjugate vaccine (PCV) under the Universal Immunization Program (UIP)1. The report mentioned that 50% of the pneumonia-related deaths in children below 5 years of age are...