Government Approves US FDA Approved Covid Vaccines For Emergency Use

 

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 all mandatory documents as well as fees. Then CDSCO will do the processing of this application on high priority according to the requirements of the drug license registration process. The decision will be taken within three working days.

In addition, the applicant can apply for a registration certificate for importing products along with an import license for getting permission to use in case of emergency for a reliable completion of the process.

CDSCO will carry out import registration certificate and import license processing within three working days after approval of restricted use in emergency cases. After obtaining the approval for the registration certificate along with the import license, the applicants should get a batch release certificate for all batches from Central Drug Laboratory, Kasauli, before it can be used any further.

After this, the vaccines must be tested on 100 people. CDSCO checks the safety data, and then it offers authorization to the vaccine when data is found satisfactory. CDSCO with an initial consultation with the subject expert committee can approve the bridging trial protocol seven days after its proposal. After getting these approvals, the applicant must conduct the trials within the given period and submit data to CDSCO.

When DCGI receives the bridging trials data, it will assess the permission that has been granted for the vaccines for restricted use. Then the proposed place for fill finishing within India is not the same as the manufacturing site will get approval from CDSCO depending on the inspection and CDL releases.

The vaccine manufactured in India right from the initial stage of Drug substance to the fill-finish stage gets permission based on the inspection, CDL release, and stockpiling data.

Furthermore, the ready-to-use vaccines will be permitted for full utilization from May 1, 2021, according to the guidelines based on the Liberalized pricing and Accelerated National Covid 19 vaccination strategy published by the Ministry of health and family welfare.

Now, the question comes how any private sector or any government sector can import the covid 19 vaccines? A private or a government entity who wants to import covid 19 vaccines for vaccination requirements have to follow the below-given steps related to the importof drugs in India:

1. For those vaccines that have not got approval or license in India, the agent of the manufacturer or the importer must take permission or licenses as mentioned in table 1 from CDSCO.
2. Once the license is obtained, the respective agent can import the vaccine, and the private sector can receive this vaccine according to the national guidelines. The vaccine that has already been approved for getting imported by CDSCO, any of the entities can acquire the vaccine from the importer for using it according to the National Grid.