More new rules for trial sponsors and CROs in India
The requirement – set out in a document published this month – is designed to bring the trial application process into line with an order issued in October by the Indian Supreme Court in response to a petition filed by study ethics organisation, Swasthya Adhikar Manch.
Swasthya Adhikar Manch, which campaigns for the rights of clinical trial participants in India, has been lobbying Government officials to tighten up the rules that govern trials, which was acknowledged as a driver for the guidance by CDSCO.
Also under the guidance, trial sponsors are required to say if the drug they are assessing is an innovation and if there is an existing therapeutic option. They must also state if the medicine is for an unmet medical need in India.
The new guidance is the latest in a long list of rule revisions prompted by the Swasthya Adhikar Manch petition – which resulted in 162 studies being halted - and other ongoing Government investigations of the Indian trial sector.
In July, for example, CDSCO issued new guidelines on trial design, investigator working practices and on compensation for the families of trial participants who die or are seriously injured during drug research.
Trial approvals up on 2013
To date, efforts to impose stricter regulations on clinical research conducted in Indian do not appear to have made the country less attractive to sponsors.
According to data released by CDSCO in July, 76 clinical studies had been approved by the end of May which is nearly three times as many as were given the green light during the equivalent period in 2013.
Whether the number of clinical trials approved this year will top the record 262 studies that were cleared in 2012 remains to be seen.
