According to the roadmap issued on Thursday, a foreign vaccine maker can submit an application to CDSCO seeking approval for ‘restricted use in emergency situation’ either through its Indian subsidiaries or authorized agents. The Drugs Controller general of India (DCGI) will consider such applications and take a decision within three working days.
In keeping with the guidelines outlined in the National Covid-19 Vaccination
Programme, the first 100 beneficiaries will be assessed for seven days before a vaccine is rolled out for others. The applicant can initiate bridging clinical studies on Indian volunteers within 30-days of approval. The CDSCO needs to approve such applications for clinical trials within seven days.
The drug regulator, however, has added some caveats.
For example, the Central Drugs Laboratory (CDL) at Kasauli will approve each batch of the vaccine that is to be released for use in the national Covid-19 vaccination
programme. The applicant will need to submit safety data on 100 beneficiaries of the vaccine to the CDSCO after it gets the CDL approval.
The DCGI will review the permission granted for restricted use in emergency situations after it receives the results of the bridging study.
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