Drugs Control Organisation issues Guidelines for Trial, marketing of Vaccines

The Central Drugs Standard Control Organisation (CDSCO) said the requirements & guidelines to conduct clinical trial or grant of permission for the marketing of new drugs including vaccines are prescribed under New Drugs & Clinical Trials Rules, 2019.

An official release said, the Indian Council of Medical Research (ICMR), has further informed that the stages of vaccine development include the following steps: Identification & development of an appropriate vaccine strain which may be safe & 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 & dose determination studies.

Preclinical studies in large animals (depending upon feasibility & availability) to determine safety, protective efficacy & potential dose & 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 hasn't received any report regarding such deviation from the standard procedures in research & development of a vaccine for COVID-19.

CDSCO has informed that it has granted test licence permission for the manufacture of Coronavirus vaccine for preclinical test, examination & analysis to 7 manufacturers in India. 

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