The Central Drugs Standard Control Organisation said while the rights, safety, and well-being of trial subjects were of paramount importance, protocol amendment, deviation or modification might be necessary in some cases owing to unavoidable circumstances.
The government is considering temporarily relaxing clinical trial norms as a few pharmaceutical companies are looking to develop a vaccine for the novel coronavirus (Covid-19), which has killed about 40,000 and infected more than 800,000 people around the world. Sources said no fresh approvals would be given for clinical trials, except for those related to Covid-19.
The Central Drugs Standard Control Organisation (CDSCO) said in a notification on Monday that various challenges might arise during the conduct of clinical trials in the wake of the outbreak of Covid-19, which could “lead to difficulties in complete adherence to the approved protocol and regulatory provisions”.
The regulatory authority said while the rights, safety, and wellbeing of trial subjects were of paramount importance, protocol amendment, deviation or modification might be necessary in some cases owing to unavoidable circumstances.
The industry feels such relaxations are required for the ongoing clinical trial programmes on Covid-19, as well as the fresh ones.
Currently, Cadila Healthcare and Serum Institute of India are working on a vaccine for Covid-19. These projects are in the pre-clinical stage, but human trials will start eventually.
The World Health Organization (WHO) released a list of 44 vaccine candidates in clinical evaluation globally as of March 20. Of this, only two vaccine candidates are in Phase 1 of trials, while others are in pre-clinical stages.
With the viral outbreak reaching Stage 3 of the pandemic (which implies transmission within the community where the source of the infection cannot be easily traced) in most countries, it is imperative to fast-track research on the same. Global research bodies have already indicated that in 2020, there would be several human clinical trials across the globe.
On Monday, US-based drug major Johnson & Johnson said it had selected the lead Covid-19 vaccine candidate from the constructs it had been working on since January. Zydus Cadila, which felt that developing the vaccine was in the interests of national security, said it would start animal testing now.
While most experts feel that commercialising any Covid-19 vaccine is unlikely before FY22, Zydus is working round the clock to develop a vaccine at the earliest. In an earlier interaction with Business Standard, Pankaj Patel, chairman of Zydus Cadila, had said they were working to get the vaccine candidate ready in eight to 10 months.
Zydus has taken a two-pronged approach to developing the Covid-19 vaccine -- a DNA vaccine (will work against the viral membrane protein responsible for the cell entry of the virus), and second approach involving a live weakened (attenuated) recombinant measles vaccine. The recombinant measles vaccine will induce long-term neutralising antibodies that will protect against infection.
As such India has a stringent regulatory environment for clinical trials. As a result, only 1.2 per cent of the global clinical trials take place in India.