The company called for an early meeting of the CDSCO’s Theme Experts Committee and made a decision on its application, sources told PTI.
Representative image. PTI
New Delhi: Johnson & Johnson, a major multinational pharmaceutical company, has filed with Indian drug regulators for permission to conduct a single-dose Phase 3 clinical trial. COVID-19 (new coronavirus infection) Vaccines and import licenses in India, according to sources.
They said the company wanted an early meeting of the Subject Experts Committee. COVID-19 (new coronavirus infection) To make a decision on its application by the Central Drugs Standard Control Organization (CDSCO).
This is imminent just after the central government decided to urgently approve all foreign products last week. Coronavirus Jab given a similar nod by the World Health Organization or US, European, UK, or Japanese regulators.
According to the Ministry of Health, such vaccines will be granted an emergency use authorization mandating the requirements for post-approval parallel bridging clinical trials instead of conducting regional clinical trials under the provisions of the 2019 New Drugs and Clinical Trials Regulations. ..
According to sources, Johnson & Johnson applied to the Global Clinical Trials Department on April 12 through the Sugam online portal instead of applying to the Biological Department for vaccines and other biopharmacy.
“For the technology involved, Johnson & Johnson resubmitted its application on Monday,” sources said.
The J & J vaccine can be stored at a temperature of 2-8 degrees Celsius for up to 3 months.
The Johnson & Johnson vaccine is a single-dose jab, but the three vaccines approved in India so far are double-dose.
So far, two vaccines, the Oxford / AstraZeneca vaccine COVISHIELD manufactured by the Serum Institute of India and the COVAXIN independently developed by Barrat Biotech, have been administered in India, and the third vaccine Sputnik V was developed in Russia and India. It is imported and sold at. Dr Reddy’s Laboratories is also approved by Indian drug regulators.
Meanwhile, the government allowed all people over the age of 18 to be vaccinated from May 1 on Monday, allowing state governments, private hospitals, and industrial facilities to procure vaccines directly from manufacturers. By doing so, we decided to expand our vaccination drive.
Johnson & Johnson seeks permission to conduct Phase 3 trials of single-shot vaccine in India
Source link Johnson & Johnson seeks permission to conduct Phase 3 trials of single-shot vaccine in India
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