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  Till now in India only notified medical devices are under the regulation of Drugs and Cosmetics Act 1940 and Rules in 1945 as Drugs. But CDSCO or Central Drugs Standards Control Organization has streamlined the application procedure for issuing free sale certificate, market standard certificate as well as a non-conviction certificate of the notified medical devices in India. This movement has been undertaken for guiding the Indian manufacturers or the importers of the medical devices for submission of application for obtaining those certificates. As per the notification, it is applicable only for those medical device manufacturers or the importers present in India having a valid manufacturing license or the drugs import license and wish to obtain a Market Standing Certificate or Non-Conviction Certificate of the notified medical devices in India. This notification was released on 30th September 2020. As per the notification, an online application will be sent to CDSCO for notifi

  A novel drug makes a great contribution to the welfare of human beings, as it helps in treating a disease or by enhancing the lifestyle of a patient. It also helps in prolonging the life of a person who is suffering from diseases that are not curable. But with every novel drug is associated the risk of side effects. This risk is one of the important concerns in association with proper regulation in the pharmaceutical sector. Such risk can cause detrimental effects for which was accepted as one of the important points to undertake for better regulation. A novel drug means novel molecular entities but in reality, it takes varied forms starting from reformulated generics to some fixed-dose combinations of the existing drugs. It has been provisioned now that all kinds of study that involves humans that are not drug trials will be under the regulation of national ethical guidelines for biomedical and health research. It is now compulsory that ethics committees should be registered with

Government of India has framed some new rules for blood centers and the blood components under Drug and Cosmetics rules, 2020 for better compliance as per the Drug Technical Advisory Board (DTAB) recommendations. According to the gazette notification, the government has made the rules to amend the Drugs and Cosmetic rules, 1945 which is to be known as Drugs and Cosmetics rules 2020. As per the Drugs and Cosmetics Rules , 1945, in part XB and part XII B, in the heading in place of blood banks the word blood centers shall be used. In the said rules it has been stated that: “The blood centre is one of the authorized premises present in an organization or an institution whatever may be the case, for operating all or part of the operations that includes collection, processing, strong and distribution of the blood that is drawn from any donor or obtained from a licensed blood centre for the sake of preparation, storing and circulation of the blood components.” In the stated rules 122