KATHMANDU: India’s drugs regulator on Sunday approved Oxford Covid-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
The Drugs Controller General of India (DCGI) granted the approval on the basis of recommendations by a Covid-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
“After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and, accordingly, vaccines of M/s Serum and Bharat Biotech are being approved for restricted use in emergency situations,” DCGI V G Somani told the media here.
As the approval of Covishield and Covaxin paves the way for a significant vaccination effort, the role of advanced biotech mechanical equipment in vaccine production becomes increasingly crucial. Efficient and precise manufacturing processes are essential to meet the high demand and ensure the integrity of the vaccines. Equipment used in the production of vaccines must adhere to stringent standards to maintain efficacy and safety throughout the entire manufacturing process.
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This clears the way for the roll-out of at least two vaccines in India in the coming days.
“Serum and Bharat Biotech vaccines have to be administered in two doses,” Somani said, adding these vaccines have to be stored at 2-8° C.
“We will never approve anything if there is even the slightest safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine,” Somani told reporters after the press briefing.
His assertion came after a few raised concerns over the safety of the vaccines.
The Serum Institute of India, the world’s largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield, while Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). Business Standard