Why in news ?
Union Health Minister said if everything goes well India will get a vaccine against the novel corona virus by the end of this year.
Vaccine development in India
- Bharat Biotech in collaboration with the ICMR is under Phase I the human clinical trials.
- Zydus Cadila Ltd have been completed and the trials have moved to phase II, done in larger groups of patients.
- Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the vaccine developed by the University of Oxford has been permitted to conduct its phase two and three human clinical trials in
India - ICMR, is in the process of developing an online vaccine portal which will provide information related to vaccine development in India and abroad.
Various stages of Vaccine Development
Clinical trials are stage after pre-clinical research for testing treatments are safe for and work in people.
- Phases of Clinical trial :
- Pre-clinical Trials : The scientistv or researcher take the assessment of various feature of the treatment whether it harmful to tssues
- Phase 0 : Also called as pre-clinical trials. To learn how a drug is processed in the body and effects on the body. Small dose of drugs applied to a small group of people.
- Phase 1 : Trials are to test a drug’s safety. A fixed amount of dosage is given to the participants. This dosage is compared with the effect on human body, reaction to particular food and effect over various other medicines the person taking.
- Phase 2 : Test will be conducted to a larger group of people. New combinations of drugs are tested and participants are closely watched for effect of drug. Here it is checked for both safety and effectiveness.
- Phase 3 : The test are conducted over a defined period of time may be months. Here the test is conducted for assessing how effectively the drug works ?
- Phase 4 : Effect of the drug when widely used in patients. Besides check the ling term risk and benefits of the drugs. This stage is also called post marketing trials.
- Various regulating bodies :
- Drugs and Cosmetics Act, 1940
- Medical Council of India Act, 1956
- Indian Council of Medical Research
- Central Council for Indian Medicine Act, 1970.
Source : The Hindu
Topic
Prelims : Regulating Bodies
GS III : Science and Technology- developments and their applications and effects in everyday life