Drugs Control Organisation Issues Vaccines' Trial, Marketing Guidelines. (Representational)
The Central Drugs Standard Control Organisation (CDSCO) said the requirements and guidelines to conduct clinical trial or grant of permission for the marketing of new drugs including vaccines are prescribed under New Drugs and Clinical Trials Rules, 2019.
According to an official release, the Indian Council of Medical Research (ICMR), has further informed that the stages of vaccine development include the following steps: Identification and development of an appropriate vaccine strain which may be safe and immunogenic. Full characterisation of the vaccine strain by in-vitro experiments; pre-clinical studies in small animals like rats, mice, rabbits, guinea pigs, hamsters etc. These are safety and dose determination studies.
Preclinical studies in large animals (depending upon feasibility and availability) to determine safety, protective efficacy and potential dose and formulation.
Phase I human clinical trials which establish the safety of the product. The numbers are usually less than 100.
Phase II human clinical trials to determine the immunogenicity or immune protection. The numbers are usually less than 1,000.
Phase III human clinical trials to determine the efficacy. The numbers range in several thousand. After successful completion of phase III studies, regulatory approval is accorded.
Phase IV or post-marketing surveillance studies.
CDSCO has informed that it has not received any report regarding such deviation from the standard procedures in research and development of a vaccine for coronavirus.
CDSCO has informed that it has granted test licence permission for the manufacture of COVID-19 vaccine for preclinical test, examination and analysis to seven manufacturers in India.
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