Foreign-approved vaccines no longer need bridging trials in India: DCGI


If the Covid-19 vaccine has been approved by the top regulatory authorities in Japan, Europe, the United States, or England, or if registered in WHO EUL, a shot can be released from the requirements of conducting clinical trials that bridge and test each batch vaccine by CDL Kasauli, CDSCO said ,

The decision to exempt these bridging trials in certain specific situations,
The decision to exempt these bridging trials in certain specific situations, it was said, had been taken in view of the “huge vaccination requirements in India in the wake of the recent surge in Covid-19 cases”.

Drugs Controller General of India (DCGI), Dr. VG Soman announced that the vaccine against Coronavirus (Covid-19) was approved by certain countries and the World Health Organization (WHO) no longer require post-approval bridging trials and batch testing in India. If the vaccine has been certified and released by the National Control Laboratory of certain countries or if registered in the WHO (EUL) emergency use list, can be exempt from the requirements mentioned above, declaring a letter issued by the control of the Standard Medicine Organization Center (CDSCO) ,

‘Court bridging’, which is called because they “bridge” the gap between studies conducted in several regions, is a local clinical trial that produces data in the specific context of India, thus assessing the efficacy of certain vaccines in Indian participants. This is important because certain pharmaceutical products react differently from Indian genetic makeup than they have in the American or European population.

The decision, said, has been taken because of “large vaccination requirements in India after a recent surge in the Covid-19 case”. The drug regulatory body notes that despite the “domestic manufacture of Covid-19 vaccine is increasingly augmented”, the previous order is partly modified “to meet national requirements”.

The Indian National Medicinal Regulatory Agency, CDSCO, functions under the Directorate General of Health of the Government and, basically, serves the same function as the United States Food and Drug Administration (FDA), Pharmacy and Medical Devices (PMDA) of Japan, Medicine Medicine Agency Europe (EMA), or medicines and health product regulators (MHRA) in the UK.

The letter issued by DCGI on Wednesday modified his previous guidelines regarding the approval of limited emergency use in India Covid-19 vaccine that had been approved for limited use by the US FDA, UK MHRA, or PMDA, or PMDA. If the vaccine has been approved by the top regulatory authority mentioned in these foreign countries or if it has been listed on WHO EUL, vaccines can be released from the requirements of conducting post-approval briding clinical trials and testing requirements for each batch of vaccine by the Central Medicine Laboratory (CDL) In Kasauli, the letter noted.

DCGI has also made an exception of the requirements for “established vaccines from the point of view that millions of people have been vaccinated with the vaccine”.

However, supervision and additional reviews will continue, DCGI said, and further analysis of the Covid-19 vaccine will be carried out by CDL Kasauli for batch releases according to standard procedures. Before the vaccine was launched for further immunization programs, the first 100 recipients will also be assessed for seven days for safety results, along with other procedures for application submission and schedules, said.


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