The Asian Age

No drug tri­als for fa­tal dis­eases

Com­mit­tee says it is de­sir­able to ex­pe­dite the de­vel­op­ment, eval­u­a­tion and mar­ket­ing of new ther­a­pies in­tended to treat per­sons, es­pe­cially where no sat­is­fac­tory al­ter­na­tive ther­apy ex­ists

- TEENA THACKER

In a sig­nif­i­cant move, the gov­ern­ment has de­cided to waive off lo­cal clin­i­cal tri­als in case of new drugs in­di­cated for se­ri­ous, life- threat­en­ing dis­eases and dis­eases of spe­cial rel­e­vance to In­dian health sce­nario like can­cer, AIDS etc., where the like­li­hood of death is high. Ob­serv­ing that in cases of life- threat­en­ing dis­eases like can­cer, AIDS etc., where the like­li­hood of death is high un­less the course of the dis­ease is in­ter­rupted and dis­eases or con­di­tions with po­ten­tially fa­tal out­comes, the tech­ni­cal com­mit­tee un­der the Direc­torate- Gen­eral of Health Ser­vices ( DGHS), in a meet­ing held re­cently, pointed that it was de­sir­able to ex­pe­dite the de­vel­op­ment, eval­u­a­tion and mar­ket­ing of new ther­a­pies in­tended to treat per­sons, es­pe­cially where no sat­is­fac­tory al­ter­na­tive ther­apy ex­ists.

“In such cases, pa­tients/ clin­i­cians are gen­er­ally will­ing to ac­cept greater risks or side ef­fects from prod­ucts that treat life- threat­en­ing/ se­ri­ous dis­eases than they would ac­cept from prod­ucts that treat less se­ri­ous ill­nesses,” it noted. The ex­perts said that in such cases, con­duct of clin­i­cal trial was also a com­plex, time con­sum­ing and costly af­fairs as such pa­tients re­quires mul­ti­ple ther­apy to man­age the dis­ease con­di­tions. The ex­perts de­cided to waive off lo­cal clin­i­cal tri­als for cases where the ex­ist­ing ther­apy is ap­proved in the well de­vel­oped reg­u­la­tory coun­tries like the US, UK, Canada, Ja­pan and Aus­tralia. The ex­erts are now short­list­ing the list of such se­ri­ous and life- threat­en­ing dis­eases and the dis­eases of spe­cial rel­e­vance, where waiver of lo­cal clin­i­cal trial for ap­proval of new drugs can be con­sid­ered.

“It is a very valid con­cern af­fect­ing the in­ter­est of pa­tients at large in the coun­try. With such a cum­ber­some process of tri­als on drugs which are al­ready in use for years in coun­tries with highly-de­vel­oped reg­u­la­tory sys­tem, we may not achieve any­thing sub­stan­tially dif­fer­ent from that al­ready achieved in those coun­tries,” it said.

Newspapers in English

Newspapers from India