"We have stream­lined the whole process of re­view­ing & ap­proval

Dr Soumya Swami­nathan

BioSpectrum (India) - - FRONT PAGE -

Direc­tor Gen­eral, In­dian Coun­cil of Med­i­cal Re­search & Sec­re­tary, Depart­ment of Health Re­search

In­dian Coun­cil of Med­i­cal Re­search (ICMR) signed an agree­ment re­cently with other global agen­cies to de­velop and im­ple­ment poli­cies within the next 12 months that re­quire all tri­als they fund, co-fund, spon­sor or sup­port to be reg­is­tered in a pub­liclyavail­able registry. ICMR as a sig­na­tory to the state­ment agreed to mon­i­tor com­pli­ance with reg­is­tra­tion re­quire­ments and to en­dorse the de­vel­op­ment of sys­tems to mon­i­tor re­sults re­port­ing. Most of these tri­als and their re­sults will be ac­ces­si­ble via WHO's In­ter­na­tional Clin­i­cal Tri­als Registry Plat­form which is a unique global data­base of clin­i­cal tri­als that com­piles data from 17 reg­istries around the world.

Dr Man­beena Chawla of BioSpec­trum In­dia spoke to Dr Soumya Swami­nathan, Direc­tor Gen­eral, ICMR & Sec­re­tary, Depart­ment of Health Re­search (DHR) about the measures taken by ICMR to im­prove the CROs space in the coun­try.

Ex­cerpts of the interview

What measures ICMR has taken up to boost the clin­i­cal tri­als space in the coun­try?

We have been work­ing with the Drug Con­troller Gen­eral of In­dia (DCGI) of­fice for the last two years and look­ing at where the ob­sta­cles are, and try­ing to de­sign the en­tire path­way of clin­i­cal de­vel­op­ment. This is be­cause we had a num­ber of dif­fer­ent stake­hold­ers telling us about the is­sues they were fac­ing, not only from the com­mer­cial side but also from the aca­demic and sci­en­tific side, and also the in­dus­try. So we have stream­lined the whole process of re­view­ing and ap­proval and for mar­ket­ing au­tho­riza­tion of the drugs.

We have also looked at the rules and reg­u­la­tions in other coun­tries espe­cially in the case of stem cell, den­dritic cell based ther­a­pies where the same path­way of drug ap­proval can­not be em­ployed. So in such cases there can be con­di­tional ap­provals granted.

We are also look­ing at train­ing the ethics com­mit­tee. For this, a series of on­line pro­grammes would be con­ducted along with a few work­shops with the help of Clin­i­cal Skills De­vel­op­ment Ser­vice (CDSC).

We are also ty­ing up with Depart­ment of Biotech­nol­ogy for look­ing into hu­man chal­lenge mod­els which have not been so far ex­plored in In­dia in case of dis­eases such as ty­phoid, cholera etc. This ba­si­cally in­cludes vac­ci­nat­ing a per­son and then giv­ing him or her an oral chal­lenge of the bac­te­ria. This might be eth­i­cally chal­leng­ing but it is a well-ac­cepted model in many other coun­tries.

We have also re-con­sti­tuted our cen­tral ethics com­mit­tee on health re­search. It is chaired by Jus­tice Mad­hava Menon. This com­mit­tee will de­bate on all sorts of eth­i­cal is­sues such as uterus trans­plant or any ex­per­i­men­tal pro­ce­dure sug­gested by the doc­tors on the pa­tients.

Do you feel the clin­i­cal re­search space in In­dia will get a boost with these measures?

Yes of course. Ear­lier we had a three tier com­mit­tee for the re­view­ing and ap­proval process. It used to in­clude a sub­ject ex­pert, eth­i­cal com­mit­tee and an apex com­mit­tee. So this en­tire process used to take a lot of time. Based on this, we de­cided to cut down on the time by es­tab­lish­ing one strong com­mit­tee at the end. A lot of re­spon­si­bil­ity is now on the ethics com­mit­tee. The apex com­mit­tee now only takes care of ap­peals. So ICMR is work­ing on the guide­lines for the ethics com­mit­tee. DCGI only works with the clin­i­cal tri­als but ICMR deals with all the clin­i­cal re­search that is tak­ing place in the coun­try. ICMR is also plan­ning to de­velop a reg­u­la­tory author­ity un­der the Depart­ment of Health Re­search in order to over­see all the non-clin­i­cal re­search. Also, the stem cell re­search guide­lines have been re­vised with re­spect to the 2013 ver­sion that we had.

What kind of sup­port the in­dus­try has been look­ing at from the govern­ment?

The in­dus­try it­self has been very sup­port­ive in this whole thing. They are the ones who have iden­ti­fied all the bar­ri­ers and chal­lenges which led to new im­ple­men­ta­tions now. We have now re­vised the ICMR eth­i­cal guide­lines, which was last touched upon in 2006. So we have in­cluded a lot of new chap­ters in that, on pub­lic health re­search, use of gene ther­apy and so on. The draft guide­lines will be of­fi­cially re­leased very soon. The in­dus­try will be of course ben­e­fited by them.

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Dr Soumya Swami­nathan Direc­tor Gen­eral, ICMR & Sec­re­tary, Depart­ment of Health Re­search (DHR)

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