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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.

  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