Tuesday, May 24, 2022


DCGI approves “Conditional Market Authorization” of Covaxin and Covishield

The Drugs Controller General of India (DCGI), India’s national regulator, has approved the marketing of two COVID19 vaccines, Covaxin and Covishield, subject to specific limitations. On January 19, 2022, the Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee (SEC) proposed that the status of vaccinations be upgraded from limited use in emergency cases to the issuance of new drug permission with conditions in the adult population.

The market authorization of two COVID19 vaccines, Covaxin and Covishield has been approved under the following conditions:

  1. The firms must submit data of overseas ongoing clinical trials of the product with due analysis on a six-monthly basis or as and when available, whichever is earlier.
  2. The vaccine will have to be supplied for programmatic setting and all vaccinations done within the country have to be recorded on CoWIN platform.
  3. Adverse Event Following Immunization (AEFI), Adverse Event of Special Interest (AESI) will be monitored in continuity.
  4. The firm will have to 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 Government of India’s proactive and flexible approach has been a feature of its COVID19 management policy.

The most recent clearance by DCGI for conditional market authorisation for two COVID19 vaccines in the country demonstrates India’s public response strategy and decision-making apparatus’s promptness and timeliness in responding to developing needs during the pandemic.

Among the various Global Stringent Regulatory Authorities, so far only the United States Food and Drug Administration (USFDA), and Medicines and Healthcare products Regulatory Agency (MHRA) of the UK have granted “conditional market authorization” to Pfizer and AstraZeneca, respectively, for their COVID19 Vaccines.

What is Conditional Market Authorization?

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

India’s National COVID19 vaccination program was launched on 16th January, 2021.

Currently, the country has administered more than 164 crore doses of the COVID19 vaccine. The Government of India is committed to accelerating the pace and expanding the scope of COVID-19 vaccination across the country. Recently, India added new categories of population to the national COVID19 vaccination drive starting from 3rd January 2022, these include Children (Age group 15-18 Years) and precautionary doses to health and frontline workers, and people aged 60 and above with comorbidities.

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