The Drugs Controller General of India (DCGI) granted regular market approval for the COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions. The approval has been granted under the New Drugs and Clinical Trials Rules, 2019.
Earlier on January 19, 2022, the Subject Expert Committee of the Drugs Controller General of India (DCGI) had recommended the regular market approval of Bharat Biotech and Serum Institute of India for their COVID-19 vaccines COVAXIN and Covishield with conditions for the adult population in the country.
As per India’s Central Drugs Standard Control Organisation (CDSCO), SEC had recommended the upgrade of Covaxin and Covishield status from the restricted use in an emergency situation to grant new drug permission with certain conditions in the adult population. The Drugs Controller General of India was to further evaluate the recommendations and will give its decision.
#COVID19 | Drugs Controller General of India (DCGI) grants conditional market approval for Covishield and Covaxin pic.twitter.com/q5GO65usPr
— ANI (@ANI) January 27, 2022
Market approval granted to Covishield and Covaxin: What are the conditions?1. Both Covishield and Covaxin will not be available in the medical stores. The hospitals and clinics will be able to purchase them. 2. The vaccination data has to be submitted to DCGI every six months. 3. Data must be updated on CoWIN app as well. 4. The conditions also include the supply for programmatic settings including the registration on CoWIN platform. 5. Adverse events following immunization will also continue to be monitored. |
The Central Drugs Standard Control Organisation (CDSCO) has now upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions: Union Health Minister Dr Mansukh Mandaviya pic.twitter.com/3gt6OhRGXR
— ANI (@ANI) January 27, 2022
Market approval to Covishield and Covaxin: More data required
The Subject Expert Committee, in a meeting last week, had asked both the Serum Institute of India and Bharat Biotech to submit more data before granting the market approval.
SII had earlier applied for the market approval of Covishield in December 2021 and Bharat Biotech had also applied for the same.
Further, Bharat Biotech had also informed that COVAXIN is now a universal vaccine for adults and children. However, both the COVID-19 vaccines are currently authorized for emergency use only.
What does market approval to COVAXIN and Covishield means?
The market authorization granted to the COVID-19 vaccines means that the vaccines will be authorized for use without any form of reservations and conditions.
Emergency use authorization to COVAXIN and Covishield
Both the COVID-19 vaccines in India had received the emergency use authorization in January 2021, with more than a combined 1.5 billion doses having been administered in the country so far.
COVAXIN and Covishield COVID-19 vaccines have to be administered in two doses and the vaccines have to be stored at 2-8 degrees Celsius.
Subject Expert Committee of DCGI
The Subject Expert Committee of the Drugs Controller General of India consists of domain knowledge experts from the fields of immunology, pulmonology, microbiology, pharmacology, internal medicine, and paediatrics.
The committee before granting the emergency use authorization to both the vaccines had reviewed the data on the safety and immunogenicity of both the COVID-19 vaccines.
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