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Indigenous Covid-19 vaccine will be launched by 15 August after clinical trials are completed

Indigenous Covid-19 vaccine will be launched by 15 August after clinical trials are completed

The Indigenous COVID-19 vaccine will be launched for public use by the Indian Council of Medical Research (ICMR) by 15 August after the clinical trials are completed. Bharat Biotech International Limited and ICMR have collaborated for the development of the path-breaking vaccine.

Key Points:

  • Recently Bharat Biotech India was granted approval by the Central Drug Standard Control Organisation (CDSCO), that regulated the Indian Pharmaceuticals and medical devices at the national level for the conduction of clinical trials on humans for the Coronavirus vaccine called ‘Covaxin’.’
  • Bharat Biotech has been approached by ICMR for fast-tracking the clinical trial mechanism and initiating the subject enrolment by 7 July 2020.
  • The vaccine has been derived from a SARS-COV2 strain that was isolated by ICMR-National Institute of Virology in Pune.
  • The two organisations are working in a collaborative manner for the development of a pre-clinical and clinical version of the vaccine.

Note:

  • CDSCO is the Central Drug Authority and carries out the functions of the Government of India under the Drugs and Cosmetics Act.
  • The organisation has under its control the regulatory functions and control over the import of drugs, approval of new drugs and clinical trials, and approval of certain licenses as Central License Approving Authority along with the organisation of certain meetings of the committee.

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