Decision on emergency use of foreign COVID-19 vaccines to be taken in 3 days

Indias drug regulator will take a decision on applications seeking approval for restricted emergency use of foreign produced COVID19 vaccines within three working days from the date of submission the government said on ThursdayThe moves comes at a time when India is battling a surge in COVID19 cases with over two lakh cases reported in a single day on Thursday taking the total number of cases to 14074564The Central Drugs Standard Control Organisation CDSCO which is headed by the Drug Controller General of India DCGI will process applications for registration certificate registration of overseas manufacturing site and product in this case COVID vaccine and import license within three working days from the date of approval of restricted use in emergency situationThe CDSCO has issued detailed guidelines specifying regulatory pathway for approval of foreign approved COVID19 vaccines after the central government on Tuesday decided to fasttrack emergency approvals for all coronavirus jabs that have been given a similar nod by the WHO or regulators in the United States Europe Britain or JapanThe Union Health Ministry on Thursday issued regulatory pathways for foreign produced COVID19 vaccines according to which the CDSCO has prepared detailed guidelines specifying regulatory pathwayApplicants for grant of approval for restricted use in emergency situation may be submitted to the CDSCO and the application can be made by the foreign manufacturer through its Indian subsidiary or through its authorised agent in India in case it does not have an Indian subsidiary the ministry saidThe CDSCO will process such applications for restricted use in emergency situation and the DCGI will consider and take a decision within 3 working days from date of submission of complete application by the applicant it saidThe DCGI will issue permission for restricted use in emergency situation with the condition that the vaccine shall be used as per guidelines prescribed under the National COVID19 Vaccination ProgrammeThe first 100 beneficiaries of such vaccines shall be assessed for 7 days for safety outcomes before it is rolled out for further vaccination program and the applicant shall initiate conduct of post approval bridging clinical trials within 30 days of such approvalApplications for restricted use in emergency situation for such vaccines maybe accompanied by bridging trial protocol application for import registration certificate and application for import license according to the pathway issuedAs per the existing protocol of CDSCO for batch release of vaccines each batch of the vaccine will be released by the Central Drugs LaboratoryCDL Kasauli before it can be used as per the guidelines prescribed under the National COVID19 vaccination programmeAccording to the guidelines the applicant will use the COVID19 vaccine after receipt of CDL approval initially only on 100 beneficiaries and submit the safety data to CDSCOThe CDSCO will review the safety data submitted by the applicant and once found satisfactory will authorise the applicant to use the vaccine and will approve the protocol for the bridging trial in consultation with the Subject Expert Committee SEC within 7 days of the receipt of the proposalAn applicant will conduct the bridging trial within the time lines specified in the approved protocol and submit data generated in the bridging trial to CDSCOAfter the receipt of the bridging trial results the DCGI will review the permission granted for restricted use in emergency situation the guidelines statedThese guidelines have been prepared and posted by the CDSCO on its website The CDSCO will take steps to widely disseminate these guidelines to stakeholdersThe government on April 13 had approved streamlining and fast tracking of regulatory system for COVID19 vaccines approved for restricted use by the US FDA EMA UK MHRA PMDA Japan or which are listed in the WHO Emergency Use Listing EULThe move will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material optimal utilization of domestic fill and finish capacity etc which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country the ministry saidThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever