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

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

Foreign COVID-19 vaccines exempted from local trials, batch testing
Written by Sagar
Jun 02, 2021, 12:42 pm 3 min read
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.

Quote
'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.

Details
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).

Information
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.

Details
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.

Requests
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.

Information
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.

Vaccination in India
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.

Information
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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Sagar
Sagar
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Sagar covers national news for NewsBytes. He has previously worked as an editorial intern at NDTV. Over the course of his near three-year career, Sagar has gained experience in news writing, copy editing, and video production. He holds a Bachelor's degree in Journalism and Mass Communication from the University of Delhi.
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