A green signal has been given to the foreign vaccines for the approval in India by the Drugs Controller General of India (DCGI) without specific clinical trials in the country before usage. This can be a big step for making the vaccination initiative a bigger success.

DCGI Chief, VG Somani said in a letter that it will be applicable for vaccines already approved for restricted use by the US FDA, UK MHRA, EMA, PMDA Japan or are listed for Emergency Use by the World Health Organisation (WHO). This is done in order to make vaccines available at the earliest to the Indian population and to fulfil the requirement for vaccine imports.

Somani further stated that conducting post-approval clinical trials and testing of each batch of vaccine by the Central Drugs Laboratory (CDL), Kasauli can be exempted for those vaccines that are already in use by millions of people across the world. The specific trials will be no longer required if the vaccine batch has already been certified and also released by the National Control Laboratory of the Country of Origin.

Initially, the vaccines which had completed clinical studies outside the country were supposed to carry out limited clinical trials or "bridging trials" on the Indian population to recognize how the drug is working on people of Indian origin.

Dr Somani said in the letter that the scrutiny and review of their Summary Lot Protocol and Certificate of the analysis of Batch will be undertaken by CDL, Kasauli for batch release according to the standard procedures and the requirement of evaluation of the first 100 recipients for 7 days for safety results before the vaccine is rolled out for immunization programs, along with other measures for filing of applications and timeline for giving out of the applications, etc, as mentioned in the notice dated 15.04.21 will remain the same.

Source: ET Healthworld