"KIHT to sup­port in­dige­nous re­search and man­u­fac­tur­ing ca­pa­bil­ity to make In­dia self-de­pen­dent"

BioSpectrum (Asia) - - FRONT PAGE - Dr Ji­ten­der Sharma, CEO of KHIT

In­dian bio­med­i­cal in­dus­try is un­der­go­ing a pos­i­tive trans­for­ma­tion over the few years. The change has been felt with Kalam In­sti­tute of Health Tech­nolo­gies’ (KIHT) tremen­dous ef­forts. In­dia, a coun­try which projects as be­ing ex­tremely im­port-de­pen­dent for med­i­cal de­vices, is no more the same. The ef­forts of KIHT has changed that par­a­digm and in just one year since its for­ma­tion, sig­nif­i­cant MoUs and agree­ments have been inked that aim at cre­at­ing a more in­dige­nous re­search and man­u­fac­tur­ing en­vi­ron­ment and ca­pa­bil­ity for In­dia. Sup­port­ing bio­med­i­cal star­tups, skilling In­dia’s young bio­med­i­cal work­force, nur­tur­ing tal­ent, in­ter­act­ing with pol­icy mak­ers and most of all be­ing the face of In­dia’s bio­med­i­cal in­dus­try is se­ri­ous busi­ness for KIHT.

Cel­e­brat­ing its first birth an­niver­sary and its re­cent agree­ment with Cuban coun­ter­parts has prompted BioSpec­trum to in­ter­act with Dr Ji­ten­dar Sharma, CEO of KIHT. Dr Sharma in an in­ter­ac­tive ses­sion re­veals the goals of KIHT and its ac­com­plish­ments done so far. Edited ex­cerpts;

With what pur­pose was KIHT formed and so far how has the in­sti­tute kept in lines with its ob­jec­tives?

KIHT was formed to fa­cil­i­tate fo­cused re­search on crit­i­cal com­po­nents per­tain­ing to med­i­cal de­vices by sup­port­ing in­sti­tu­tions in­volved with R&D, in­dus­try, pol­icy mak­ers and knowl­edge repos­i­to­ries. KIHT suc­cess­fully cre­ated the world’s first e-auc­tion plat­form for trans­fer of In­tel­lec­tual Prop­erty, ma­te­rial and pro­to­types and bring­ing strate­gic and co­her­ent syn­ergy of sci­en­tific fa­cil­i­ties and in­sti­tu­tions to com­ple­ment ef­forts on in­dus­trial pro­mo­tion in the med­i­cal de­vices seg­ment.

So far, KIHT has fa­cil­i­tated con­ver­gence of avail­able tech­nolo­gies to bring in­creased ac­cess to af­ford­able health prod­ucts to cit­i­zens and a thriv­ing med­i­cal de­vices man­u­fac­tur­ing sec­tor in In­dia. The in­sti­tu­tion has cre­ated a knowl­edge repos­i­tory for trade in­for­ma­tion, and has an­a­lysed emerg­ing trends in trade and in­vest­ments and pro­vided pol­icy en­abling in­puts to the gov­ern­ment.

KIHT has been in­stru­men­tal in launch­ing a pi­o­neer ini­tia­tive named NIPUN cer­tifi­cate, i.e. Non-reg­u­la­tory In­no­va­tion Po­ten­tial Util­ity and Novelty cer­tifi­cate, to act as a sin­gle point win­dow for all non-reg­u­la­tory re­quire­ments of the med­i­cal tech­nol­ogy sec­tor and pro­vide a sim­pli­fied ap­proach to the cur­rent process in the com­mer­cial­iza­tion of a prod­uct. It takes care of all the pro­cesses re­lat­ing to reg­u­la­tory fil­ing for a cer­ti­fied prod­uct in hand for gain­ing mar­ket ac­cess.

KIHT pro­mul­gated Health Tech­nol­ogy as one of the core com­po­nent of mar­ket ac­cess, which adds value to the prod­uct cred­i­bil­ity by giv­ing them com­par­a­tive over­view of clin­i­cal and eco­nomic ef­fec­tive­ness of the in­no­va­tion with its sys­tem­atic, trans­par­ent and ev­i­dence based de­ci­sion mak­ing process.

Fol­low­ing are few achieve­ments in space of Health Tech­nol­ogy As­sess­ment (HTA):

1) KIHT got col­lab­o­rated with The Joanna Briggs In­sti­tute (JBI), and In­sti­tute of the Univer­sity of Ade­laide as JBI Af­fil­i­ated group mem­ber for ap­ply­ing in­ter­na­tional stan­dard and method­ol­ogy to con­duct sys­tem­atic re­views & meta-anal­y­sis.

2) KIHT is now re­gional hub for con­duct­ing HTA for De­part­ment of Health Re­search, Min­istry of Health and Fam­ily Wel­fare.

3) KIHT has or­ga­nized two in­ter­na­tional fel­low­ship pro­gramme on HTA and has col­lab­o­rated with Tata In­sti­tute of So­cial Sci­ence (TISS), Mum­bai for tak­ing fel­low­ship pro­gramme to next level by con­vert­ing it to Ex­ec­u­tive pro­gramme on Health Tech­nol­ogy Pol­icy, as­sess­ment and out­comes re­search. This pro­gramme would give holis­tic ap­proach in un­der­stand­ing pub­lic health poli­cies and how to uti­lize ev­i­dence based re­search for de­ci­sion mak­ing.

4) As part of NIPUN cer­ti­fi­ca­tion, KIHT is well equipped to eval­u­ate tech­nolo­gies with high­est

in­ter­na­tional stan­dards and pro­vide rec­om­men­da­tion for in­no­va­tions on the ba­sis of ev­i­dences.

As part of its con­stant en­deav­our to cater to the needs of the med­i­cal de­vices in­dus­try, KIHT has come out with unique type of dossiers to dis­sem­i­nate in­for­ma­tion spe­cific to de­vices in health­care which are com­plex in tech­nol­ogy and im­port de­pen­dent. These dossiers cap­ture key fea­tures of a prod­uct like de­sign, tech­nol­ogy, mar­ket share, etc. and fa­cil­i­tates users like star­tups, re­searchers, aca­demi­cians, man­u­fac­tur­ers and other stake­hold­ers in tak­ing de­ci­sions on R&D, in­vest­ment, po­ten­tial mar­ket, in­no­va­tions etc. KIHT pe­ri­od­i­cally con­ducts train­ing ses­sions and work­shops on med­i­cal de­vices and their func­tion­al­ity with hands on ses­sion by ex­perts on the ac­tual de­vice it­self. Such level of close prox­im­ity to ac­tual op­er­at­ing med­i­cal de­vices and in depth learn­ing has been un­prece­dented.

How does the Chan­drababu Naidu-headed Andhra Pradesh Gov­ern­ment sup­port de­vel­op­ments at KIHT?

The land and in­fras­truc­tural sup­port for KIHT has been pro­vided for within the Andhra Pradesh MedTech Zone, which is an en­ter­prise of AP Gov­ern­ment. KIHT was the knowl­edge part­ner for AP Health fes­ti­val in Visakha­p­at­nam and are of­ten con­sulted for es­sen­tial de­ci­sions in the health de­part­ment.

What are the sig­nif­i­cant mile­stones ac­com­plished by the In­sti­tute so far?

KIHT has been rec­og­nized by the Prin­ci­pal Sci­en­tific Ad­vi­sor (PSA) to the Gov­ern­ment of In­dia as of­fi­cial Project Anal­y­sis Unit for all Health Tech­nol­ogy Projects in the coun­try. The PSA him­self held a con­sul­ta­tive meet­ing at the KIHT cam­pus, where a host of in­sti­tu­tions and or­ga­ni­za­tions were called in for an in depth dis­cus­sion on the sta­tus of projects that re­ceived gov­ern­ment fund­ing in the health tech­nol­ogy do­main.

Apart from the NIPUN cer­ti­fi­ca­tion and HTA ini­tia­tive, KIHT takes pride in suc­cess­fully launch­ing the first ever e-auc­tion for med­i­cal tech­nolo­gies on Fe­bru­ary 15, 2018, by Ananth Ku­mar, Union Min­is­ter for Chem­i­cals & Fer­til­iz­ers on In­dia Med­i­cal De­vice 2018, the largest ex­hi­bi­tion and con­fer­ence on the In­dian Med­i­cal De­vices Sec­tor Or­ga­nized by De­part­ment of Phar­ma­ceu­ti­cals, Min­istry of Chem­i­cals and Fer­til­iz­ers, Gov­ern­ment of In­dia in part­ner­ship with Fed­er­a­tion of In­dian Cham­bers of Com­merce & In­dus­try (FICCI). The e-Auc­tion web por­tal hosts 22 tech­nolo­gies for tech­nol­ogy trans­fer as on date. KIHT has signed MoU with 12 in­sti­tutes/ com­pany for the pur­pose of tech­nol­ogy trans­fer so far and more in progress to bring more tech­nolo­gies to mar­ket.

KIHT also par­tic­i­pated in In­ter­na­tional Tech­nol­ogy Trans­fer Con­ven­tion 2017, Bei­jing, China. China’s largest tech­nol­ogy trans­fer fo­rum to stream­line the in­no­va­tive health­care tech­nolo­gies to In­dia.

NIPUN Cer­ti­fi­ca­tion came as a boon to start-ups, in­no­va­tors and MSMEs of med­i­cal de­vice in­dus­try for com­mer­cial­iz­ing their prod­ucts. Since the in­dus­try is still in its in­fancy stage, the ex­po­sure to­wards stan­dard­iza­tion is lim­ited and there­fore the in­no­va­tors are find­ing dif­fi­culty in putting their prod­uct in the mar­ket. Soon af­ter the of­fi­cial launch of NIPUN by PSA on April 30, 2018, an over­whelm­ing re­sponse from var­i­ous peo­ple have been ob­served. The ser­vices of NIPUN in­clude: con­form­ity test­ing, HTA, Mar­ket Re­search, Pa­tent­ing, Rapid Pro­to­typ­ing and other re­lated ser­vices in or­der for the prod­uct to con­form to a par­tic­u­lar stan­dard. As a part of the con­tin­u­ous growth phase, KIHT has en­tered into 22 as­so­ci­a­tions with sev­eral in­sti­tu­tions and or­ga­ni­za­tions pan In­dia and have of­fered train­ings, work­shops, con­fer­ence speech at many events in or­der to bring more open-ended dis­cus­sions in the MedTech space.

What is the USP of KIHT and how it is dif­fer­ent from other in­sti­tutes?

No other or­ga­ni­za­tion, in any realm of any dis­ci­pline of sci­ence, has ac­com­plished what KIHT has in this short span of time. KIHT has mapped the core health tech­nol­ogy space, of­fered so­lu­tions and var­i­ous as­pects of pol­icy sup­port, along with the par­ent or­ga­ni­za­tion, Andhra Pradesh MedTech Zone Ltd (AMTZ) has cre­ated a band­width of bench to bed­side tran­si­tion and has opened up med­i­cal tech­nol­ogy as a for­mi­da­ble dis­ci­pline to con­trib­ute to the In­dian dream.

The in­sti­tute has been in­stru­men­tal in shap­ing the bio­med­i­cal skill sec­tor of In­dia. How, ac­cord­ing

to you, has this been ac­com­plished?

KIHT along with AMTZ, Na­tional Ac­cred­i­ta­tion Board for Cer­ti­fi­ca­tion Bodies (NABCB), Qual­ity Coun­cil of In­dia (QCI) and As­so­ci­a­tion of In­dian Man­u­fac­tur­ers of Med­i­cal De­vices (AIMED) joined hands to form the In­dian Bio­med­i­cal Skill Con­sor­tium on Fe­bru­ary 16, 2018 with an ob­jec­tive to re­in­force bio­med­i­cal skill sec­tor in the coun­try. In­sti­tu­tional Bio Safety Com­mit­tee (IBSC) brings an equiv­a­lence sys­tem of value-based as­sess­ment cov­er­ing ed­u­ca­tional qual­i­fi­ca­tion, work ex­pe­ri­ence and com­pe­tency pos­sessed by prac­ti­tion­ers of bio­med­i­cal en­gi­neer­ing skills. To fa­cil­i­tate this, 50 as­sess­ment cen­tres with a to­tal test­ing ca­pac­ity of 14,000 to take load of cer­ti­fi­ca­tion of more than 2 lakh bio­med­i­cal en­gi­neer­ing prac­ti­tion­ers is planned across sev­eral states in In­dia.

Could you elab­o­rate on the re­cent col­lab­o­ra­tion with BioCubaFarma? How is this col­lab­o­ra­tion ben­e­fit­ting In­dia and its re­la­tion­ship with Cuba?

The Pres­i­dent of In­dia vis­ited Cuba from June 2123, 2018. An MoU on col­lab­o­ra­tion in the field of Biotech­nol­ogy was signed be­tween the two coun­tries on June 22, 2018. It is to be em­pha­sized that this is a great op­por­tu­nity for In­dian star­tups and in­dus­tries in the field of Biotech­nol­ogy to col­lab­o­rate with their Cuban coun­ter­parts and vice versa.

A del­e­ga­tion com­pris­ing ex­perts from the Biotech­nol­ogy In­dus­try Re­search As­sis­tance Coun­cil (BIRAC) and KIHT, par­tic­i­pated in dis­cus­sions with ‘BioCubaFarma’, the Cuban In­dus­try pro­mo­tion in­sti­tute for health sec­tor for fur­ther po­ten­tial col­lab­o­ra­tion in ar­eas of mu­tu­ally in­ter­est.

It has been ob­served that ow­ing to its lim­ited do­mes­tic pro­duc­tion, Cuba is highly de­pen­dent on med­i­cal de­vice im­ports. More than 40 per cent of med­i­cal de­vices are im­ported from Europe, pri­mar­ily Ger­many and nearly 30 per cent come from China and Ja­pan col­lec­tively. In­dian star­tups/com­pa­nies can play a ma­jor role in pro­vid­ing bet­ter and cost-ef­fec­tive so­lu­tions through mu­tual col­lab­o­ra­tions in the field of med­i­cal de­vices and other biotech­nol­ogy re­lated tech­nolo­gies/prod­ucts. In view of the above a tri­par­tite MoU be­tween KIHT, BIRAC and ‘BioCubaFarma’ was signed to fa­cil­i­tate sev­eral stake­hold­ers, in­clud­ing in­dus­try, R&D In­sti­tutes and Tech­nol­ogy Trans­fer of­fices and pave the way for tech­no­log­i­cal & in­dus­trial progress in Biotech­nol­ogy sec­tor. Some of the com­pa­nies have been iden­ti­fied to in­ter­act with Cuban tech­nol­ogy en­ter­prises for li­cens­ing, man­u­fac­tur­ing, R&D and pro­gram up­takes.

What is KIHT’s vi­sion/goal for the next five years?

KIHT has few set goals to ac­com­plish in the next five years.

a) Create a self-de­pen­dency mod­ule for Med­i­cal Tech­nolo­gies.

b) Con­sol­i­date all gov­ern­ment funded health tech­nol­ogy projects and fa­cil­i­tate their suc­cess­ful com­ple­tion.

c) En­able more and more health tech­nol­ogy in­no­va­tions to reach out to their in­dus­try part­ners.

d) Create test­ing and val­i­da­tion band­width for all in­no­va­tors so that they can take their pro­to­types to the next phase, thus en­abling start-up’s in this tech­nol­ogy driven seg­ment.

e) Make HTA a manda­tory mod­ule for pro­cure­ment for med­i­cal de­vices.

f) En­able early re­searchers’ ac­cess to med­i­cal de­vices so that fur­ther in­no­va­tions can be car­ried out.

How do you see ac­com­plish­ing those goals as a boost to In­dia’s bio­med­i­cal in­dus­try?

The In­dian bio­med­i­cal in­dus­try is ex­tremely im­port de­pen­dent. The ef­forts of KIHT can po­ten­tially mo­ti­vate more in­dige­nous re­search and man­u­fac­tur­ing ca­pa­bil­ity and in turn make the na­tion come out of this im­port de­pen­dency.

Be­sides BioCubaFarma are there any other part­ner­ships KIHT has en­tered into? If yes, how have those part­ner­ships sup­ported the growth of KIHT?

KIHT has so far part­nered with 22 in­sti­tu­tions through which in­no­va­tions can reach out to mar­ket place for pos­si­ble health and mar­ket ac­cess av­enues. The dis­ease bur­den and trade deficit amal­ga­mated model by KIHT cre­ated the Na­tional Pri­or­ity List which was the first-ofits-kind need and trade-based grant re­leased for R&D in any sec­tor of sci­ence.

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