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National Regulator approves “Conditional Market Authorization” of two COVID19 Vaccines- Covaxin and Covishield

Newdelhi:27/1/22:The National Regulator, Drugs Controller General of India (DCGI), has given nod to market authorization of two COVID19 vaccines, Covaxin and Covishield subject to certain conditions, here today. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) had recommended for up-gradation of status for the vaccines from restricted use in emergency situations to grant of new drug permission with conditions in the adult population on 19th January 2022.

The market authorization of two COVID19 vaccines, Covaxin and Covishield, in the country by DCGI is subject to the following conditions:

1. Firm shall submit data of overseas ongoing clinical trials of the product with due analysis on six-monthly basis or as and when available, whichever is earlier.

2. The vaccine shall be supplied for programmatic setting and all vaccinations done within the country to be recorded on CoWIN platform and Adverse Event Following Immunization [AEFI], Adverse Event of Special Interest [AESI] shall continue to be monitored. The firm shall submit the safety data including AEFI and AESI with due analysis on a six-monthly basis or as and when available, whichever is earlier as per NDCT Rules, 2019.

The proactive and agile approach followed by Government of India has been a hallmark of its strategy of management of COVID19. The latest approval accorded by DCGI for conditional market authorization to two COVID19 vaccines in the country indicates the promptness and timeliness with which the public response strategy and decision-making apparatus of the country have responded to the emerging needs during the pandemic.

It may be noted that of the global Stringent Regulatory Authorities, only the United States Food and Drug Administration (USFDA) Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has granted “conditional market authorization” to Pfizer and AstraZeneca, respectively, for their COVID19 Vaccines.

“Conditional Market Authorization” is a new category of market authorization that has emerged during the current global pandemic of COVID19. The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines.

India’s nationwide COVID19 vaccination program was launched on 16th January 2021. As of today, more than 160 crore doses have been administered. The Union Government is committed to accelerating the pace and expanding the scope of COVID-19 vaccination throughout the country. New categories of the population have been added to the national COVID19 vaccination drive starting from 3rd January 2022.

About Editor in chief

Ashok Palit has completed his graduation from Upendranath College Soro, Balasore and post graduation from Utkal University in Odia Language and literture.. He has also carved out a niche for himself as a scribe of eminence after joining the profession in 1988. He is also an independent media production professional. He brings loads of experience to Advanced Media, Ashok Palit as a cineaste has been active in film criticism for over three decades. As a film society activist, he soared to eminence for his profound commitment to the art film appreciation and aesthetics of cinema. His mode of discourse is often erudite but always lucid and comprehensible marked by a perfect acumen so rare in the field. A film aesthete with an immense fond of critical sensibilities, he wrote about growth and development of odia cinema in New Indian Express, The Times of India, The Hindustan Times, The Asian Age and Screen. He has been working as an Editor for Cine Samaya from 2002-2004.. He had made solid contribution on cinema in many odia Dailies and weekly such as Samaj, Prajatantra, Dharatri, Samaya, Satabadi, and weekly Samaya.
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