Seeing the enormous growth of the industry we have a challenge to maintain the quality of the clinical trials happening in India .This is a very fragile industry and the succes depends deeply on the way we position us on the global platform as we have major pharma giants looking at us for a credible research data.Since it is a budding industry so the standards if placed in very start of the the industry shall reap the benefits in the later stage.Growth and global reputation of the IT industry in India a good example of this strategy .
DCGI (Drugs Controller General of India) can take a lead in this case and start issuing licences based on an activity based testing modules and experience of the monitors .The vast expanse of our country make it difficult to manage the affairs, specially when the functioning of DCGI's office is quite opaque.
This will further need specific clinical trials based on the complexity of the trials to be monitored by the licenced CRAs (Clincial Research Associate).
This wil also help establish carreer as a CRA and also encourage the free lancing career CRA's.Licencing will also give a a legal teeth to the Monitor to mange and monitor the reasearch on non compliant clinical research sites in India and contain the attitute of the rouge PI's (Principal Investigators).Once India develop this abilty it can also guide the other Asian nations in developing similar frameworks .
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