India’s top drug regulator exempted foreign-made COVD-19 vaccines from post-approval bridging trials in the country, if they are approved by certain health bodies.
According to the Indian Express, companies such as Pfizer and Cipla have asked for these exemptions during negotiations to supply vaccines to the country. However, there does not seem to be any update on Pfizer’s demand to grant indemnity – protecting it from any legal action if the vaccine leads to serious side effects, although an India Today report suggests that the Centre could “likely be in favour” to cede.
Pfizer had withdrawn its application in February this year, after the Drugs Controller General of India (DCGI)’s expert body, the Central Drugs Standard Control Organisation (CDSCO) had turned down the company’s request to waive bridging trials. These trials are mandated to determine if a vaccine is safe and generates an immune response.
The new notice issued by DCGI V.G. Somani says post-approval bridging clinical trials will be exempted if the vaccines have restricted use permissions from regulators like the US Food and Drugs Administration, European Medicines Agency, the UK’s Medicines and Healthcare Products Regulatory Agency, Japan’s Pharmaceutical and Medical Devices Agency or those listed by the for WHO Emergency Use.
The requirement to observe the first 100 beneficiaries for seven days to assess safety outcomes will still hold before the vaccine will be rolled out for larger immunisation, the newspaper said.
Companies also won’t need every batch of their vaccine to be tested by the Central Drugs Laboratory (CDL) in Kasauli, the new notification says, provided “the vaccine batch/lot has been certified and released by the National Control Laboratory of the country of origin”.
This 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”, Indian Express reported the notice as reading.
A Reuters report had said in February that Pfizer, which was the first drugmaker to seek emergency approval in India for its COVID-19 vaccine, withdrew its application after failing to meet the DCGI’s demand for a local safety and immunogenicity study.
News agency PTI had reported on May 25 that Pfizer asked the Centre to relax the requirement for post-approval bridging trial and testing them at CDL Kasauli.
Cipla, meanwhile, has been looking to commit $1 billion into bringing Moderna’s single-dose mRNA booster vaccine to India. It has also requested an exemption from bridging trials, PTI reported on May 31.
The DCGI had in April had already watered down the process for foreign vaccines to gain access to the Indian market. If companies had the approval of the regulatory authorities mentioned in Tuesday’s order, they were allowed to skip local clinical trials and apply directly for Emergency Use Authorisation. This decision had been taken as India’s second wave of COVID-19 spiralled out of control, generating a demand for vaccines that local manufacturers Serum Institute of India and Bharat Biotech could not meet.
