Under New Drugs and Clinical Trials Rules, 2019, The Central Drugs Standard Control Organisation (CDSCO) has notified that the conditions and regulations to administer clinical trial or grant of approval for the retailing of new drugs and vaccines are authorised.
Moreover, the Indian Council of Medical Research (ICMR), an independent body of the Department of Health Research, has notified the stages of vaccine development undergoes the following steps:
- An appropriate vaccine strain is recognised and improved, which may be secure and immunogenic.
- The vaccine strain is completely described through in-vitro experiments.
- Pre-clinical observations in small animals like mice, rats, hamsters, guinea pigs, rabbits etc. These are some protective and dose discovering studies-
- Preclinical examinations in big animals (determining upon probability and accessibility) to ascertain security, guarded productiveness and dormant dose and articulation.
- Phase I includes human clinical tests which verify the safety of the product. The chances are normally less than 100.
- Phase II includes human clinical tests to determine immunogenicity or immune strength. The chances are normally less than 100.
- Phase III human clinical tests are to discover the effectiveness of the vaccine. The numbers fluctuate in thousands. After a thriving achievement of phase III examinations, regulatory consent is admitted.
- Phase IV is about post-marketing research studies.
CDSCO has notified that it did not receive any statement concerning a digression from the basic methods in the development and study of a vaccine for coronavirus.
It has approved review license authorisation for the production of COVID-19 vaccine for a preclinical test, research and development to the following pharmaceutical manufacturers in India:
- Serum Institute of India, Pune
- Cadila Healthcare, Ahmedabad
- Bharat Biotech International, Hyderabad
- Biological E, Hyderabad
- Reliance Life Sciences, Mumba
- Aurbindo Pharma, Hyderabad
- Genova Biopharmaceuticals, Pune
The Indian Council of Medical Research (ICMR), an independent body under the Department of Health Research. It has notified that they are promoting the following research associated with COVID-19 vaccines:
(i) An inactivated whole virion candidate vaccine (BBV152) for SARS-CoV-2 has been developed by Bharat Biotech International utilising the virus isolate (NIV-2020-770) rendered by ICMR-National Institute of Virology (NIV), Pune. The vaccine candidate’s characterisation has been moved to ICMR-NIV under security and admissible investigations in small animals like rats, mice and rabbits. Clinical trials updates as follows:
- Phase I clinical tests with identical studies in hamsters and rhesus macaques were performed. The tests revealed magnificent security of the candidate vaccine. Immunogenicity examination is in process.
- Phase II clinical tests are continuing.
(ii) A DNA vaccine (ZyCov-D) has been designed by Cadila Healthcare. Preclinical toxicity studies were carried out in small animals: rabbits, mice, rats and guinea pigs. The vaccine remained to be reliable and immunogenic. Cadila has partnered with ICMR for administering identical preclinical studies in rhesus macaques. The updates from the clinical trials are as follows-
- Phase I clinical tests was performed. The tests disclosed exceptional security of the candidate vaccine. Immunogenicity experiment is in process.
- Phase II clinical examinations are continuing.
(iii) Serum Institute of India (SII) and ICMR have collaborated for clinical progress of two universal vaccine candidates:
- ChAdOx1-S, which is a non- replicating viral vector vaccine formed by University of Oxford/AstraZeneca. This vaccine is in progress under phase III clinical analysis in Brazil. Phase II/III linked investigations were initiated by ICMR at 14 clinical test places. ICMR-National Institute for Research in Tuberculosis (NIRT), Chennai is the lead institution.
- ICMR and SII have also collaborated for clinical advancement of a glycoprotein subunit nanoparticle adjuvanted vaccine formed by Novavax from the US. The test shall start in the mid of October after the vaccine is produced by SII. The trial is led by ICMR-National AIDS Research Institute (NARI), Pune.
As per specifications given by the Department of Biotechnology (DBT)/Department of Science and Technology (DST), different stages of growth have been ascertained in more than 30 vaccine candidates.