India’s apex drug regulator Tuesday waived the requirement for foreign companies to conduct post-launch bridging trials and test the quality and stability of their Covid-19 vaccines here if they have approvals from specific countries or health bodies. The move, which would make it easier for companies to bring their vaccines to India, follows similar demands raised by, among others, Pfizer and Cipla during negotiations to supply imported vaccines to the country.
The requirement of conducting post-approval bridging clinical trials “can be exempted” for Covid-19 vaccines with restricted use permissions from regulators like the USFDA, EMA (European Medicines Agency), the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), Japan’s PMDA (Pharmaceutical and Medical Devices Agency) or those with a WHO Emergency Use Listing, a June 1 notice by Drug Controller General of India (DCGI) Dr V G Somani says.
However, it adds, a previous requirement that a safety outcomes assessment be conducted on the first 100 beneficiaries for seven days before the vaccine is rolled out for larger immunisation still holds.
Companies are also being exempted from the requirement that “every batch” of their vaccine be tested by the Central Drugs Laboratory (CDL) in Kasauli, provided “the vaccine batch/lot has been certified and released by the National Control Laboratory of the country of origin”. However, the notice says, scrutiny and review of the summary lot protocol and certificate of analysis of batches of these vaccines will still be undertaken by CDL to release them for use in the country.
“Other” procedures for filing of applications and timelines for processing them will still have to be followed, the notice says.
As per a PTI May 25 report, Pfizer has told the Centre it wants relaxation on the requirement for a post-approval bridging trial for its vaccine, developed with BioNTech, and testing of these vaccines at CDL Kasauli.
Cipla, which has been looking to commit $1 billion into bringing Moderna’s single-dose mRNA booster vaccine to India, has also requested an exemption from bridging trials, as per a PTI report on May 31.
The latest DCGI exemptions modify an earlier notice by it on April 15 that allowed foreign companies with approvals from the same regulatory authorities as mentioned in Tuesday’s order to skip the requirement for local clinical trials in their request for Emergency Use Authorization.
The latest decision was taken “as per (the) recommendation of NEGVAC (the National Expert Group on Vaccine Administration for Covid-19),” according to the notice.
The decision comes in light of the “huge” vaccination requirements in India and “the need for increased availability of imported vaccines to meet the national requirements”, it adds.
