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  Severe Covid-19 is theorized to be instigated by cytokine release syndrome (CRS), which is an inflammatory immune response leading to some organ failure. Severe covid-19 and CRS have been linked with rising levels of Interleukin IL- 6 that helps in the stimulation of the liver to make C-reactive protein and fibrinogen. Other than CRP and fibrinogen, lactate dehydrogenase and ferritin are linked with plasma IL-6 levels. Serum LDH correlated with the production of IL-18 because of the activated macrophages and elevated CD 8+ cytotoxic T cell activity in most severe and chronic pulmonary infections. LDH also increases because of the destruction of the lymphocyte or the damage of the direct tissue from the microorganisms, tissue ischemia, and inflammation. Multiple organs are indeed affected because of Covid 19, but the most prominent organ is the lungs. Patients can also progress to respiratory distress syndrome and then develop micro thrombi or pulmonary embolism because of hypercoagul

With an objective to efficiently regulate the medical devices under the Drugs and Cosmetics (D&C) Act in a phase-wise manner, CDSCO or the central Drugs Control Organization has advised four medical device testing laboratories to carry out the evaluation of the medical devices. Central Government entitles different labs as Central Medical Device Testing Laboratory under MDR 2017. These laboratories offer a boost to the domestic manufacturing sector by providing the required infrastructure for testing the device depending on the project proposals and the technical support provided by the National Health Systems Resource Centre, which is a technical support organization governed by the health ministry. By perusing the powers offered by sub-rule 2 of rule 19 of the Medical Device Rules 2017, has entitled some laboratories with facilities for doing test and evaluation of the medical devices. Its sole purpose is ●        Testing and evaluation ●        Functions as an appellate

To avoid pointless delay of evaluation, the drug controller general of India has ordered all the manufacturers as well as the importers of the 4th generation HIV in-vitro diagnostics kits to provide the analytical sensitivity for HIV P-24 antigen on kit insert. DCGI gave this necessary direction after the National Institute of Biologicals or NIB in Noida figured out that various manufacturers of 4th generation HIV in-vitro diagnostics kits are not mentioning the sensitivity required for HIV P-24 antigen on the product. This delays the required evaluation of the diagnostic kits. Taking this on a serious note, Dr. VG Somani, the DCGI, asked all the licensees to do upgradation of the product insert and include the analytical sensitivity for HIV  24 antigen to make sure the evaluation is done correctly. HIV is a virus that attacks the immune system of the human body. When left untreated, it leads to AIDS. When someone is exposed to HIV, the human body produces an antigen called P-24.

The Indian Council of Medical Research and Drugs Controller General of India have jointly come up with some of the guidelines for validating and batch testing of Covid-19 diagnostic kits. In a joint meeting, all the recommended guidelines were approved and this is a recommendatory and a dynamic document without any prejudice to the statutory provisions. According to guidelines, US FDA approved RT-PCR kits, RNA extraction kits, as well as the viral transport medium, ELISA, CLIA Kits along with rapid antibody test and it will not require any ICMR validation. All the manufacturers, as well as the supplier of those kits, can apply for obtaining  approval from DCGI directly. The first batch of CE-IVD that got approval and the non-US FDA got approval but the indigenous RT PCR kits will need the basic validation from 24 ICMR recognized validation centers before getting approval from DCGI. Then for post-marketing, extra two batches must be tested according to the medical device rules in a peri

  The Drugs Controller General of India has extended the deadline for submitting notarized documents online through Sugam portal for import of medical devices along with in-vitro diagnostics (IVDs). The deadline has been extended till 4 months or till normalization of COVID-19 situation. The earlier deadline was April 24, 2020. The step was taken by DGCI after receiving representations on all issues related to submitting all notarized or apostilled documents like power of attorney, free sale certificate or QMS certificate required for applications for medical device and in-vitro diagnostics kits import under medical device rules India . All such applications when received will be processed and when found satisfactory, the import license will be issued with a condition that the concerned firm will submit apostilled or the notarized documents after the COVID-19 situation becomes normal or within four months whichever comes earlier. But the concerned person or firm has to submit an un

With the recent spread of this COVID-19 pandemic, the availability and facility of testing was a dreadful question. However, in a recent series of events, the GOI approved about 98 firms to supply PCR kits for testing the coronavirus on symptomatic or asymptomatic patients.   How fast the test is done is one of the important factors in the efficient management of an outbreak. Knowing that the patient has coronavirus implies the health care workers know how to react, the type of treatment should be given, the place where the patient should be kept in the hospital specifically in those communities having dedicated COVID-19 ward. Today, the most dependable test for detection of coronavirus is testing to confirm the presence of virus RNA. This is the reason real-time reverse transcription –Polymerase Chain Reaction (RT-PCR) depending tests are mostly recommended for diagnosis of COVID-19. This test detects the presence of the virus RNA in the human samples. It is a process