India Mulls Relaxing Clinical Trial Rules To Develop COVID-19 Vaccine

The Centre is looking at relaxing clinical trial rules in the country temporarily to let pharmaceutical companies attempt to develop a vaccine for the deadly novel coronavirus. The pathogen has killed over 42,000 people across the globe and infected more than 8,00,000 people.

A Business Standard report states the exception will be made only for clinical trials related to COVID-19 and no fresh approvals will be granted either.

A notification issued by the Central Drugs Standard Control Organisation (CDSCO) on March 30 pointed out it would be difficult to adhere to all the protocol and regulations while conducting clinical trials of COVID-19 cures. The researchers may have to make some modifications due to unavoidable circumstances. The regulatory body, however, clarified that the rights or safety of the trial subjects would not be compromised in the process.

Healthcare researchers have agreed that such relaxations may be required for the clinical trials being conducted at present as well as the new ones. Right now, Serum Institute of India and Cadila Healthcare are trying to develop a COVID-19 vaccine. Although they are in the pre-clinical stage, human trials will be conducted eventually.

The World Health Organization (WHO) has already shared a list of 44 candidates who would participate in global clinical trials. At present, only two of them are in Phase 1 of clinical trials; the rest are still in the pre-clinical stage.

Since the regulations in place for human clinical trials in India are quite stringent, just 1.2 percent of such trials take place in the country currently.-Money Control