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Panel pitches full market nod for Covaxin, Covishield
As per the process, the drugs controller general of India takes the final call on granting the approval based on the expert panel’s recommendations.
The subject expert panel (SEC) of the national drugs regulator on Wednesday recommended full market authorisation for both Covaxin and Covishield under certain conditions, according to people familiar with the developments.
These vaccines were till now approved for use under emergency circumstances – from a regulatory point of view, this referred to the pandemic – and full approvals typically take time. While the conditions laid down by the CDSCO subject expert committee were not immediately clear, full licensure often means that a product can be sold in regular market, although whether that happens during a pandemic and in the case of an essential biological remains to be seen.
“SEC of CDSCO has recommended for upgrade of covishield and covaxin status from restricted use in emergency situations to grant of new drug permission with conditions In adult population, DCGI (Drugs Controller General of India) will evaluate the recommendations and give its decision,” Central Drug Standard Control Organisation (CDSCO) tweeted from its handle.
As per the process, the drugs controller general of India takes the final call on granting the approval based on the expert panel’s recommendations.
Serum Institute of India (SII) and Bharat Biotech International Ltd, manufacturers of Covishield and Covaxin respectively, separately applied to the central drugs standard control organisation (CDSCO) to seek full market authorisation stating that more than a billion vaccine doses have been administered to beneficiaries under the national Covid-19 immunisation programme.
Experts also that the government should consider granting full licensure now.
“There is adequate data available now from the real-world also that has further established safety and efficacy; therefore, high-time that the vaccines should be given complete market authorization,” said Dileep Mavalankar, director, Indian Institute of Public Health, Gandhinagar
At least 1.37 billion doses of Covishield, and about 210 million Covaxin doses have been administered under the programme to date.
Full market authorisation is granted when there is enough data to demonstrate that the vaccine is safe and effective for most people who receive it, while an emergency approval is often based on the premise that the benefits of using a product immediately outweigh its known harms.
SII locally manufactures the Oxford-AstraZeneca Covid-19 vaccine under the brand name Covishield; and Covaxin has been developed and manufactured by Bharat Biotech International Ltd in collaboration with the Indian Institute of Medical Research (ICMR).
Both the vaccines were granted approval for restricted use in emergency situation by the drugs controller general of India, VG Somani, on January 3, last year, and both the vaccines have been the mainstay of India’s covid immunisation programme.
