Context:
COVAXIN is India’s indigenous COVID-19 vaccine. Human clinic trail of this vaccine have been approved recently.
- The vaccine was developed and manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility.
- The vaccine was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
- The vaccine received CDSCO approval for Phase I & II Human Clinical Trials and the trials will commence across India.
Four phases of clinical trials
- Phase I: It studies test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
- Phase II: It studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.
- Phase III: Its studies are conducted on larger populations and in different regions and countries and are often the step right before a new treatment is approved.
- Phase IV: Its studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.
| Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. |
Central Drugs Standard Control Organisation (CDSCO)
- Under Directorate General of Health Services, Ministry of Health & Family Welfare, CDSCO is the National Regulatory Authority (NRA) of India.
- The Drugs & Cosmetics Act, 1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.
- CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera
| ICMR The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. NATIONAL INSTITUTE OF VIROLOGY The National Institute of Virology, Pune is an Indian virology research institute, and one of the translational science cells part of Indian Council of Medical Research (ICMR). It was previously known as ‘Virus Research Center’ and was founded in collaboration with the Rockefeller Foundation. It has been designated as a WHO H5 reference laboratory for SE Asia region. BHARAT BIOTECH Limited or Bharat Biotech International Limited is a Pharmaceuticals company headquartered in Hyderabad, India engaged in manufacturing vaccines, bio-therapeutics and health care products. |
