BioSpectrum (India) - - COVER STORY -

 Ear­lier re­quire­ment of Au­dio-Visual (AV) record­ing of In­formed Con­sent Process (ICP) of all sub­jects in all clin­i­cal tri­als have been re­vised and the Au­dio-Visual (AV) record­ing of ICP has been made manda­tory only in case of vul­ner­a­ble sub­jects in clin­i­cal tri­als of New Chem­i­cal En­tity (NCE)/New Molec­u­lar En­tity (NME) and in case of clin­i­cal trial of anti-HIV and anti-Leprosy drugs, only au­dio record­ing of the ICP is re­quired.

The Drugs and Cos­met­ics Rules have been amended on March 16, 2016 pro­vid­ing that no per­mis­sion is re­quired from DCG (I) for con­duct of clin­i­cal trial of ap­proved drug for­mu­la­tion for new in­di­ca­tion, route of ad­min­is­tra­tion etc. for Aca­demic / Re­search pur­poses sub­ject to con­di­tions that the trial has been ap­proved by the Ethics Com­mit­tee and the data gen­er­ated will not be sub­mit­ted to the reg­u­la­tory Author­ity for new drug ap­proval pur­pose and cer­tain other con­di­tions.

Ear­lier re­stric­tion that num­ber of clin­i­cal tri­als an In­ves­ti­ga­tor can un­der­take should be not be more than three has been re­moved pro­vid­ing that the num­ber of clin­i­cal tri­als should be de­cide by the re­spec­tive Ethics Com­mit­tee. Ear­lier re­quire­ment of at least 50 bed­ded hos­pi­tals for con­duct of clin­i­cal trial have been re­vised pro­vid­ing that cen­tres ir­re­spec­tive of num­ber of beds, could be al­lowed to con­duct clin­i­cal tri­als af­ter the Ethics Com­mit­tee ap­proval.

For ad­di­tion of new clin­i­cal trial site or in­ves­ti­ga­tor in clin­i­cal trial, no NOC from DCG (I), in the nor­mal course, would be nec­es­sary. The re­spec­tive Ethics Com­mit­tee af­ter due dili­gence can ap­prove such pro­pos­als for ad­di­tion of site(s) and in­ves­ti­ga­tor(s). How­ever the ap­pli­cant would in­form the DCG (I) about any such ad­di­tion/dele­tion and if, no ob­jec­tion was re­ceived from DCG (I), it would be deemed to have con­cur­rence of CDSCO.

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