Foreign COVID-19 vaccines exempted from local trials, batch testing
The Drugs Controller General of India has scrapped the requirement of local trials for foreign-made coronavirus vaccines - a key move to upscale the dwindling COVID-19 vaccinations in the country. The DCGI has also done away with batch-wise testing of imported vaccines in India. The government is also expected to grant indemnity from liability to foreign companies like Pfizer and Moderna.
The decision was taken "in the light of the huge vaccination requirements in India in the wake of the recent surge of COVID-19 cases and the need for increased availability of imported vaccines," the DCGI's chief VG Somani said in a letter on June 1.
The drug regulator said the need for conducting bridging clinical trails in India can be exempted for COVID-19 vaccines that have obtained restricted use permissions from certain foreign authorities. They are the US FDA, the European Medicines Agency, the UK's Medicines and Healthcare Products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency, and the World Health Organization (WHO).
However, another previous requirement that a safety assessment should be conducted on the first 100 beneficiaries of a vaccine for a period of seven days, before a large-scale roll-out still holds, the DCGI added in the order.
Another major relaxation granted by the drug regulator is there will be no need to test every batch of a vaccine at the Central Drugs Laboratory in Kasauli. This condition applies if the concerned batch has already been permitted for use by the National Control Laboratory of the country of origin. However, a certificate analysis of all batches will still be done by CDL.
The order has come just days after American firm Pfizer reportedly told the Indian government it wanted exemption from local trials in order to send its vaccine doses to the country. Cipla, which is looking to bring Moderna's single-dose mRNA booster vaccine to India, has also made a similar request to the authorities here, according to a PTI report on Monday.
These two companies have also requested indemnity or financial protection from any claims linked to the use of their coronavirus vaccines. Now, sources in the Indian Health Ministry cited by NDTV say the government has "no problem" granting this request.
India is facing a serious shortage of vaccines to timely inoculate its huge population. While nearly 22 crore doses have been administered till date, just above 3% of the Indian population has been fully vaccinated. The central government has set a target of vaccinating all Indian adults by the end of this year, though experts have raised doubts about the plan's feasibility.
India faced the world's worst coronavirus outbreak over the past couple of months, reporting lakhs of cases and thousands of deaths each day. Daily cases in India had peaked at 4,14,000 early last month. The situation is finally improving and lockdown curbs are being relaxed.