CDSCO Moves to Speed UP Ethics and SAE Review Processes After Criticism
According to a statement issued by the Central Drugs Standard Control Organisation (CDSCO) late last month, applications it receives from would-be ethics committees will be immediately checked to ensure that they contain the right technical information and are in the correct format before any further review.
The new guidance document – which also includes a checklist of required information and advice on presentation – is one of a number issued by the CDSCO this year and the second prescreening plan set out behind one relating to the assessment and reporting of serious adverse events (SAE) during trials that is published in January.
Both documents prescreening plans emphasize the need to improve efficiency and follow sustained criticism of the regulations and agencies that oversee clinical trials in India.
In February, for example, the US-based Association of Clinical Research Organizations (ACRO) told Outsourcing-pharma.com that amendments to the rules governing trial in the country are confusing, particularly those relating to compensation in the event of SAEs.
The efficiency efforts also come hot on the heels of the CDSCO’s release of data on the number of trials approved in India in 2012, which showed a significant decline on previous years.
According to CDSCO data only 262 clinical trials were registered on the Clinical Trials Registry India Website (CTRI) – which has been mandatory for all studies since 2009 – down from the 321 projects logged in 2011.
What is of more concern for India’s trial sector is that the decline is in keeping with a longer term trend that has seen the number of registered trial fall every year since a peak of 500 in 2010.