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Government has extended the validity of the import license along with the registration certificate by six months. This step has been taken to make sure the medicines are available in the country. On July 27 2020, the Ministry of Health and Family Welfare gave a notification affirming that drug supply should not be affected and it should remain accessible to the public. So, due to the ongoing pandemic, COVID-19 pharmaceutical companies have wished for extending the validity of the registration certificates for about six months. Thus, exercising the powers deliberated by section 26B under Drugs and Cosmetics Act, 1940, the central government directed a notice, without withstanding anything in the rule 28A of the Drugs and Cosmetics Rules, 1945 for drugs import for the sole purpose of sale or distribution. That if an existing registration certificate holder as per given rules applies for a fresh registration certificate before expiry of the present, the present certificate will remain v

  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