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 import
of drugs in India:
- 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.
- 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.
Comments