Why in News?
- A potential COVID-19 vaccine ought to confer at least 50% protection and be able to either prevent infection or disease — but not necessarily both — according to draft guidelines issued by the Central Drugs and Standards Control Organisation.
What the other Organizations say
- These guidelines are similar to standards set by the World Health Organization (WHO) as well as peer international regulatory organisations such as the United States Food and Drug Administration (USFDA).
- In animal trials, all animals are deliberately infected with the SARS-CoV-2 virus and the responses of the vaccinated and unvaccinated group are compared.
- Because such deliberate infections are not allowed in people, trial designers deploy statistical techniques to decide on whether the administration of the vaccine has a protective effect
- The WHO says for a vaccine that safety, immunogenicity and efficacy are the three criteria.
- Though the aim is 100% efficacy, it is unlikely to achieve since its respiratory infection, and so the target is 50% and above.
Central Drugs Standard Control Organization (CDSCO)
- The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
- Major Functions are – Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority
- It comes under the Ministry of Health & Family Welfare.
Drugs Controller General of India (DCGI)
- It is a department of Central Drugs Standard Control Organization
- DCGI is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.