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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

  The union health ministry   has published a draft notification vide no. GSR 98 E dt 5.2.2021 on Medical Devices Amendment rules 2021 to involve American Standard Test Method (ASTM) in standards of product for all medical devices to increase the competency of indigenous medical devices internationally. According to the draft rule, all these rules might be called the Medical Devices (Amendment) Rules 2021 . All these rules will come into force on the date when they are finally published in the official gazette. In the medical device rules 2017, in rule 7, in sub-rule 2, after the words, letters, and bracket" the international electro technical commission ," the words, letter, and bracket or "American standard test method " will   be inserted. The following draft of specific rules for amending MDR 2017 is done while exercising the powers given by subsection 1 of section 12 and subsection 1 of section 33 of the Drugs and Cosmetics Act,1940. In consultation with

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.

  DCGI has asked the state drug controllers to direct the drug makers to obtain the manufacturing license of 471 novel fixed-dose combinations that are related to the vitamins, minerals along with the micronutrients that have been declared by Prof. Kokate committee as rational and have got approval from DCGI. This has brought great cheers to all the manufacturers of the drugs especially those who are involved in the manufacturing of vitamins, minerals as well as micronutrients. This is in continuance to the DCGI letter to all state DCs in December 2018 and January 2020 where all of the state licensing authorities were directed to ask the respective manufacturers to follow the process for getting the manufacturing licenses from SLA. After approval from the health ministry, it has been decided to follow a specific procedure for granting of product license by SLA in respect of FDC. Applicants have to deposit the required fees through Bharatkosh for every FDC to CDSCO as stated under t

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

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