The Schedule Y1 Draft Rules, which are under scrutiny by the Clinical Research Organizations (CROs) in the country, have been broadly welcomed by most of them. Key provisions of the Rules namely 122DA, 122DAA and 122 DAB are expected to check the fly-by-night operators who are rampant in the sector.

The proposed draft, approved by Drug Technical Advisory Board (DTAB), has provided 45 days window period (issued June 30, 2009) for suggestions to the Central Drug Standard Control Organization which should end by mid August.

While Schedule Y1 is a 5 year operating license for CROs, the Clinical Trial Registry India (CTRI), mandated from June 15, maintains details of human studies. Together these provide accountability, transparency and regulate the sector, said Shekhar Gupta, chief operating officer, D2L Pharma Research Solutions.

The regulation and the Registry are expected to check unscrupulous practices of the small CROs. But the challenge in a trial is to track the volunteers who participate in several studies at the same time for different companies as their traceability is difficult, said M Prashanth Babu, principal consultant – Audits, Vaatsalya Clinical.

Source : Pharmabiz

(more…)