Drafting new SAE guidance forms part of a general tightening up of Indian drug regulations and is designed to cut missing data through standardisation of reporting.
“Multiple formats and missing information, including improper referencing for submission of follow-up reports have lead to difficulties in segregation and further processing of these reports by this office”, according to Central Drugs Standard Control Organization (CDSCO) draft guidance.
In the draft guidance the CDSCO reiterates the need to report unexpected SAEs within 14 calendar days of the sponsor becoming aware of the incident. Other elements of the guidance are also in line with earlier requirements.
“The draft guidance does not appear to make any new substantial shifts in policy”, Jacquie Mardell, partner and co-founder of Anhvita BioPharma Consulting, told Outsourcing-Pharma.
“What it looks like the draft guidance is doing is standardising the reporting mechanism, providing a cover letter format, making it clear that incomplete reports are not acceptable”, said Mardell.
Initial and follow-up reports should be accompanied by a covering letter that follows the CDSCO template included in the guidance. Reports should be printed on paper featuring the letterhead of the contract research organisation (CRO) or sponsor.
Draft guidance proposed by the CDSCO differs in a couple of ways from US Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) requirements.
In particular the Indian guidelines: have a 14 day reporting timeframe, compared to 15 days in other countries; and require expedited reporting for all serious and unexpected events, regardless of whether a causal relationship with the test product is suspected, said Mardell.
Last September the FDA published draft guidance to clarify the reporting of adverse events. The FDA stressed that unnecessary reporting of perceived adverse events is a drain on resources and emphasised the need for a belief of causal relationship between SAE and test product.
Comments must be submitted to the CDSCO within 15 days. The document is dated May 11.