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    Home / News / India News / Foreign COVID-19 vaccines exempted from local trials, batch testing
    Foreign COVID-19 vaccines exempted from local trials, batch testing
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    India 3 min read

    Foreign COVID-19 vaccines exempted from local trials, batch testing

    By Sagar
    Jun 02, 2021
    12:42 pm
    Foreign COVID-19 vaccines exempted from local trials, batch testing
    The top drug regulator in India has done away with the requirement of local trails for foreign-made coronavirus vaccines.

    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.

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    'Decision in light of huge vaccination requirements in India'

    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.

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    Vaccines with approvals from certain regulators exempted

    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).

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    Assessment of first 100 beneficiaries will still be done

    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.

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    No need to test every batch at the CDL, Kasauli

    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.

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    Pfizer, Moderna had reportedly requested such exemptions

    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.

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    Government has 'no problem' granting indemnity to Pfizer, Moderna

    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.

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    3% Indians are fully vaccinated against COVID-19

    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.

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    The coronavirus crisis in India

    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.

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