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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

  The National Pharmaceutical Pricing Authority or NPPA has capped the price for oxygen concentrators. With the help of the trade margin rationalization approach. It has been capped at the first point of sale of a product known as the price to the distributor according to the prescribed formula by invoking paragraph 19 of Drugs Prices Control Order 2013. It is because of the enhancement in demand because of the pandemic. An oxygen concentrator is a non-listed medical device and, at present, under the individual licensing framework of CDSCO. It falls under the purview of medical device regulations in India . Moreover, due to the pandemic, the government has marked it as an important commodity and fixed its price. The formula that has been prescribed for the Maximum retail price is Price to distributor + (PTD *TM) + applicable GST, TM = Trade margin that does not exceed 70%. It is also recommended that the manufacturer's cap MRP of the oxygen concentrator submit all data contai

CDSCO or Central Drugs Standard Control Organization, the authority that regulates medical devices regulation India released two draft notices  on September 3, 2020. The draft notification  includes the classification of non-notified medical devices and in-vitro diagnostic devices. As per the new draft notice, it helps in classifying the medical devices into appropriate device class and map the efficient date for required device registration. All medical devices are under the regulation of CDSCO in a phase-wise manner and they should be registered in required timelines. Under new draft classification CDSCO has classified 1866 medical devices. The devices are divided into 24 categories. The devices are well examined and then classified based on internationally accepted classification and the first schedule of medical device rules, 2017. As per the regulation, based on risk classes medical devices are divided into 4 categories. Under each category, there is a specified number of m

  Health ministry has released a draft classification for non- notified medical devices for its efficient regulation. The Drugs Controller General of India responsible for Drug product registration in India , had notified every stakeholder as well as associations for required comments as well as suggestions for classification of those non-notified medical devices by October 3, 2020, for efficient regulation as per New Medical Device Rules. As per the notice, all suggestions have been effectively sought about the previous gazette notification that was published on February 11, 2020, which stipulates that all medical devices must be regulated in a phase-wise manner. IVDs are classified into class A (low risk), class B (moderate risk), Class C (moderate-high risk) and Class D (high risk). For facilitating the whole procedure for classifying IVD medical devices, all devices are classified into 3 main categories like IVD analyzer, IVD instrument and IVD software and are scrutinized based

All the manufacturers of medical devices are required to obtain a medical equipment registration and a manufacturing license as per the Drugs and Cosmetics Act. Manufacture means a process or a part of the process for creating, changing, ornamenting, accomplishing, packing, labelling and breaking up or simply adopting a drug in view of its sale as per the clause of section 3 of Drugs and Cosmetics Act. It has been recently notified by the Directorate General of Health Services, Ministry of Health and Family Welfare and was recently brought to the notice of Central Drugs Standard Control Organization or CDSCO that the medical device manufacturers are facing some issues for establishing facilities for carrying out certain activities like coating and sterilization. The manufacturers are struggling for setting up facilities to carry our functions like assembling and coating and sterilization of devices for which CDSCO grant licenses to all those sites for carrying out such activities.

Although PCR is the standard test used for the detection of Covid-19, ICMR has broadened the range of options forCovid-19 test that includes Rapid CLIA ELISA kits. In India, this test forCOVID -19 has got approval only for surveys in the areas of high risk and some segments like the containment zones, some immune-compromised individuals along with the frontline and the health workers. The Indian Council of Medical Research (ICMR) has recently approved those ELISA test kits for Covid-19 that have been developed by two companies. These test kits were the first ELISA test kits that got approval in addition to those that have been used by ICMR’ own technology thereby adding to the bucket of choices for COVID-19 testing. ELISA kits fall under the category of medical devices and have already been granted the appropriate  medical equipment registration . The ELISA test for Covid-19 in India has got approval only for serosurveys that gives an estimation of the proportion of the