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

If the Covid-19 vaccine has been approved by top regulatory authorities in Japan, Europe, USA, or UK, or if it's listed in WHO EUL, the shot can be exempted from the requirement of conducting post-approval bridging clinical trials and testing every batch of the vaccine by CDL Kasauli, said CDSCO.

The Drugs Controller General of India (DCGI), Dr VG Soman on Wednesday announced that vaccines against the coronavirus disease (Covid-19) approved by specific countries and the World Health Organisation (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 it is listed in the WHO Emergency Use Listing (EUL), it can be exempted from the aforementioned requirement, stated a letter issued by the Central Drugs Standard Control Organisation (CDSCO).

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". (Representational Image)

'Bridging trials', so called because they "bridge" the gap between studies conducted in several regions, are localised clinical trials that generate data in an India-specific context, thereby assessing the efficacy of a certain vaccine in Indian participants. This is important since certain pharmaceutical products react differently to Indian genetic makeup than how they might in American or European populations.

The decision, it was said, had been taken because of the "huge vaccination requirements in India in the wake of the recent surge in Covid-19 cases". The drug regulatory body noted that although the "domestic manufacturing of Covid-19 vaccines is getting augmented", the earlier order was being partially modified "to meet the national requirements".

The letter issued by the DCGI to all stakeholders through the CDSCO website.

India's national drug regulatory body, the CDSCO, functions under the Directorate General of Health Services of the central government and, in essence, serves a similar function to the Food and Drug Administration (FDA) of the United States, the Pharmaceuticals and Medical Devices (PMDA) of Japan, the European Medicines Agency (EMA), or the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.

The letter issued by the DCGI on Wednesday modified its earlier guidelines regarding restricted emergency use approval in India of Covid-19 vaccines already approved for restricted use by the US FDA, the UK MHRA, the EMA, or the PMDA Japan. If the vaccine has been approved by the aforementioned top regulatory authorities in these specified foreign countries or if it has been listed in WHO EUL, the vaccine can be exempted from the requirement of conducting post-approval bridging clinical trials and the requirement of testing every batch of the vaccine by the Central Drugs Laboratory (CDL) in Kasauli, the letter noted.

The DCGI has also made an exemption from the requirements for "well-established vaccines from the standpoint that millions of individuals have already been vaccinated with the said vaccines".

However, additional scrutiny and review shall continue, the DCGI said, and further analysis of the Covid-19 vaccines shall be undertaken by CDL Kasauli for batch release as per the standard procedures. Before the vaccine is rolled out for further immunisation programmes, the first 100 beneficiaries shall also be assessed for seven days for safety outcomes, along with other procedures for the filing of applications and timelines, it was said.