CDSCO All Set To Approve Use Of Foreign Covid-19 Vaccines For Restricted Use

The drug regulator of India is all set to take an important decision on applications looking for approval for controlled emergency use of the foreign manufactured Covid 19 vaccines. This move has come at a time when India is struggling with a surge in Covid 19 cases. With an average of more than 1.5 lakh cases a day. The pandemic situation is getting direr every single moment.

CDSCO, under supervision of the Drug Controller of India, will do the necessary processing for registration certificate applications and drug license application process after the approval of the restriction use in case of an emergency.

CDSCO has given a detailed guideline that specifies the regulatory pathway for approving the foreign approved Covid 19 vaccines after the central government decided to fast track the emergency sanctions for all coronavirus jabs that the WHO or regulators have given the same nod in the USA, Britain, Japan, and Europe.

The foreign manufacturer should apply sanctions for controlled use in emergencies that may be submitted to the CDSCO and the application through the Indian Subsidiary or any authorized agent in India.

The permission will be given by DCGI for controlled use in an emergency under the condition that the vaccine will be used according to the guidelines as prescribed under Covid 19 vaccination program.

The first 100 beneficiaries of such vaccines will be assessed for 7 days for all types of safety outcomes before it rolls out for further vaccination programs. The applicant will initiate conductance of post-approval bridging clinical trials within 30 days of approval. Pertaining to the norms of drug product registration in India.

All the applications for controlled utilization of vaccines should be accompanied by linking a trial protocol, applying for vaccine import registration in India, and applying for import license as per the pathway issued.

As per the present protocol of CDSCO, for any batch release of Covid 19 vaccines, every batch of vaccines will be approved by the Central Drugs Laboratory, Kasauli, before its use according to the guidelines as prescribed by the National Covid 19 vaccination program.

As per the guidelines, the applicant will use the Covid 19 vaccine after receiving the CDL approval, initially on 100 beneficiaries, and then submit these safety data to CDSCO.

CDSCO will go through the safety data that the respective applicant submits. When it is found satisfactory, it will give applicants authorization to use the vaccines and approve the protocol for bridging the trial in consultation with the subject expert committee seven days after the proposal receipt.

Every applicant will do the bridging trial within a specific time in the approved protocol and submit data created in the bridging trial to CDSCO. Once the result of the bridging trial is received, DCGI reviews the approvals granted for controlled use in an emergency.

On April 13 Government approved the streamlining and speeding of the regulatory system for Covid 19 vaccines approved for controlled use by US FDA, UK MHRA, PMDA Japan and  listed in the WHO emergency use listing.

This government's move will help get quick access to all kinds of foreign vaccines by India. It would also boost imports that include a regulatory process for import and export of drugs in India, finish capacity, etc.

Use to know more information, visit - Import of drugs in india

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Created on Jun 10th 2021 08:54. Viewed 244 times.

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