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  The National Expert Group on Vaccine Administration for the Covid 19, on April 15, 2021, offered authorization for emergency use of the Covid 19 vaccine, which has already been approved for restricted use by the US FDA, MHRA, or those listed for emergency use in WHO. But certain conditions are satisfying which the applicant will get permission for making use of vaccines for restricted use like The vaccine must follow all guidelines as per the National Covid 19 vaccination program. For the first seven days after administration, the first 100 persons will be closely monitored. Within 30 days of vaccine approval, the applicant should start post-approval bridging clinical trials. Steps for processing the application. All manufacturers of vaccines outside India can apply for getting approval through the Indian Subsidiary or any authorized agent in India according to the rules under the Drugs and Cosmetics Act, 1940. The applicants can apply through the SUGAM online portal with a

  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

India's Ministry of Health and Family Welfare has granted permission to manufacturers to produce and stock vaccines for Covid-19 that are under clinical trials for getting marketing authorization for sale or distribution. Thus easing the drug license registration process . This regulation will accelerate the availability of the Covid-19 vaccine in the country sooner after they get approval post trials. This is one of the welcomed and awaited movements by the Ministry during this tough pandemic time. It allows all manufacturers of vaccines to initiate the process of manufacturing synchronously with ongoing clinical trials. If the vaccine trial becomes successful, this movement by the Ministry of Health and Family will help in saving time and the public will get easy and quick access as the vaccine is available immediately after required regulatory permissions. The early launch of Covid-19 vaccine will help in rapid vaccination of Indian public. As per the notifications issued by

Indian Council of Medical Research proposal for the clinical trial of convalescent plasma in Covid-19 has been approved by the central drug regulator. The protocol to be followed is as per the one developed by ICMR. DCGI has already expressed that ICMR has selected a list of institutes who have shown interest in the trial to the Central Drugs Standard Control Organization and they can continue doing so after prior consultation with the concerned health research body. It was informed to the public that the complete proposal of ICMR for conducting the convalescent plasma trial has been reviewed by the subject expert committee in a meeting that was held on April 13 regarding the speeding up of the approval process. It is because of the prevailing covid19 situation and due to the committee recommendation. CDSCO has given it no objection for the conductance to some of the amendments present in the protocol and several other conditions under the Drugs and Clinical Trial Rules 2019. As it w