Road Ahead for In­dian Bio­pharma Sec­tor

BioSpectrum (India) - - FRONT PAGE - Dr Renu Swarup, Sec­re­tary, DBT.

To­wards strength­en­ing the emerg­ing biotech­nol­ogy en­ter­prise in In­dia, De­part­ment of Biotech­nol­ogy (DBT), Min­istry of Sci­ence & Tech­nol­ogy has ini­ti­ated the Mis­sion pro­gramme en­ti­tled: In­dus­try-Academia Col­lab­o­ra­tive Mis­sion for Ac­cel­er­at­ing Dis­cov­ery Re­search to Early De­vel­op­ment for Bio­phar­ma­ceu­ti­cals – “In­no­vate in In­dia (i3) Em­pow­er­ing biotech en­trepreneurs & ac­cel­er­at­ing in­clu­sive in­no­va­tion”. The Na­tional Bio­pharma Mis­sion ap­proved by the Cab­i­net in May 2017 at a to­tal cost of $250 mil­lion for five years with 50 per cent fund­ing through World Bank loan is be­ing im­ple­mented by Biotech­nol­ogy In­dus­try Re­search As­sis­tance Coun­cil (BIRAC) - a Pub­lic

Sec­tor Un­der­tak­ing of DBT. Now with the com­ple­tion of a year, BioSpec­trum looks at the up­dates about the Mis­sion and its achieve­ments so far.

The Na­tional Bio­pharma Mis­sion was for­mally launched on June 30, 2017 and the le­gal agree­ment with World Bank for flex­i­ble fi­nanc­ing ar­range­ments for this Mis­sion of De­part­ment of Biotech­nol­ogy (DBT), was ex­e­cuted on April 24, 2018. The Mis­sion aims to make In­dia a hub for de­sign and de­vel­op­ment of novel, af­ford­able and ef­fec­tive bio­phar­ma­ceu­ti­cal prod­ucts for com­bat­ing pub­lic health con­cerns.

Ac­cord­ing to the DBT, this mis­sion would strengthen trans­la­tional ca­pa­bil­ity of aca­demic re­searchers; em­power bio-en­trepreneurs and SMEs by de­creas­ing the cost and risk dur­ing early stages of prod­uct de­vel­op­ment and also el­e­vate the in­no­va­tion quo­tient of the in­dus­try. The global ex­pe­ri­ence of World Bank would be in­stru­men­tal in build­ing sus­tained global link­ages, tech­ni­cal as­sis­tance and knowl­edge flow be­tween pub­lic and pri­vate part­ners for busi­ness pro­mo­tion in biotech sec­tor.

Cur­rent Sta­tus

To ini­ti­ate the Mis­sion ac­tiv­i­ties there have been con­sti­tu­tion of the In­ter-Min­is­te­rial Steer­ing Com­mit­tee (SC) com­pris­ing of mem­bers from var­i­ous Min­istries; and the Pro­gram Tech­ni­cal Ad­vi­sory Group (TAG) com­pris­ing of global and na­tional lead­ers from in­dus­try and academia, to pro­vide over­sight to the Na­tional Bio­pharma Mis­sion. In De­cem­ber 2017, BIRAC is­sued the first round of Re­quest for Ap­pli­ca­tions (RFAs) un­der the Mis­sion in align­ment to its ob­jec­tives so­lic­it­ing pro­pos­als from academia and in­dus­try fo­cus­ing on de­vel­op­ment of (i) Vac­cines for Pneu­mo­coc­cus, Dengue, HPV and can­di­dates for other dis­eases of high bur­den in In­dia (ii) Biosim­i­lars for can­cer, di­a­bet­ics and rheuma­toid arthri­tis and

(iii) Med­i­cal de­vices and di­ag­nos­tics (iv) Process De­vel­op­ment Lab­o­ra­tory; Chem­istry, Man­u­fac­tur­ing, Con­trol Units and cGLP val­i­da­tion fa­cil­ity for

Bio ther­a­peu­tics. Through a three tier screen­ing process po­ten­tial pro­pos­als have been short­listed for fi­nan­cial sup­port at this stage. In se­quel there will be launch of se­ries of RFAs in 2018 un­der the Mis­sion to strengthen in­fra­struc­ture, skill de­vel­op­ment and tech­nol­ogy trans­fer ca­pa­bil­i­ties. Fur­ther to train the next gen­er­a­tion of clin­i­cian-sci­en­tists and health pro­fes­sion­als in­volved in clin­i­cal re­search, Na­tional Bio­pharma Mis­sion or­ga­nized a course on the “Prin­ci­ples and Prac­tice of Clin­i­cal Re­search’, at Hyderabad in April 16-21, jointly with NIH-USA un­der the aegis of Indo-US Vac­cine Ac­tion Pro­gramme of DBT. DBT en­vis­ages that this pro­gramme will help de­liver 6-10 new prod­ucts in the next five years, cre­ate sev­eral ded­i­cated fa­cil­i­ties for next-gen­er­a­tion skills, and hun­dreds of jobs in the process.

“The aim of the mis­sion is to ac­cel­er­ate early leads through the prod­uct de­vel­op­ment pipe­line to en­sure they reach the mar­ket in a time-bound man­ner. This mis­sion is not for new dis­cov­ery, but for cre­at­ing in­fra­struc­ture to move im­por­tant early leads, which are in dif­fer­ent stages, through the pipe­line, and come out with prod­ucts. The mis­sion will fol­low a con­sor­tium-based ap­proach, wherein academia and in­dus­try work­ing in an iden­ti­fied area will be en­cour­aged to work to­gether. The gov­ern­ment will hand­hold them through var­i­ous reg­u­la­tory pro­cesses so that prod­uct de­vel­op­ment can be has­tened”, shares

Prof K Vi­jayRagha­van, Prin­ci­pal Sci­en­tific Ad­vi­sor to the gov­ern­ment of In­dia says, “The Na­tional Bio­pharma Mis­sion, which is a Rs 1500 crore mis­sion, is sup­posed to set up a num­ber of plat­forms such as bioin­for­mat­ics, ge­nomic se­quenc­ing, mass spec­trom­e­try, drug dis­cov­ery and so on. Cur­rently, we lack such plat­forms for the in­dus­try. Also, right now aca­demic ar­eas have in­tel­lec­tual ca­pac­ity, a cer­tain kind of tech­ni­cal re­sources but a next level of tech­ni­cal­ity is re­quired to move into the area of com­mer­cial­iza­tion. Through this mis­sion, we fore­see a sub­stan­tial in­vest­ment in this con­text so that it will al­low the pri­vate sec­tor to use ma­jor fa­cil­i­ties of a kind that is un­think­able for them to have”.

In­dus­try View

For the last one year, the thought of the Na­tional Bio­pharma Mis­sion has been cre­at­ing waves within the biotech in­dus­try as well.

“This mis­sion will in­ject a much needed boost to the Bio­phar­ma­ceu­ti­cal Sec­tor with spe­cific ref­er­ence to the tech­no­log­i­cal and prod­uct de­vel­op­ment ca­pa­bil­i­ties to a level that will be glob­ally com­pet­i­tive over the next decade, and trans­form the health stan­dards of In­dia’s pop­u­la­tion through af­ford­able prod­uct de­vel­op­ment. If the biotech­nol­ogy in­dus­try op­er­at­ing land­scape be­comes more in­no­va­tion friendly spurred by gov­ern­ment’s poli­cies and nudge with in­creased Academia – In­dus­try – Gov­ern­ment in­ter­ac­tions and fo­cused busi­ness strate­gies, then the in­dus­try could pos­si­bly grow at higher CAGR thereby in­creas­ing In­dia’s share in the global Pharma mar­ket. How­ever, the pri­mary chal­lenge for the ex­pan­sion of bio­phar­ma­ceu­ti­cal in­dus­try is the avail­abil­ity of ex­pe­ri­enced tal­ent pool. Cur­rently there is a wide gap be­tween the qual­ity of hu­man cap­i­tal avail­able and the needs of the biotech Sec­tor. With a clear 5-10 year vi­sion by the Gov­ern­ment, stu­dents will be in­spired to take up cour­ses which will fur­ther feed the ever in­creas­ing need for skilled man­power in the Sec­tor. This will equip stu­dents with both The­o­ret­i­cal and Prac­ti­cal skills. Ex­ten­sive train­ing on so­phis­ti­cated in­stru­men­ta­tion with fur­ther spe­cial­iza­tion in the ar­eas of their in­ter­est will make these stu­dents to be In­dus­try ready and will also slow down the out­flow of skilled man­power from the coun­try”,

points out Prashant Te­wari, MD, USV In­dia.

But along­side the an­nounce­ment of the Na­tional Bio­pharma Mis­sion, the in­dus­try is also con­cerned about the ad­dres­sal of the chal­lenges In­dia is cur­rently fac­ing in the bio­phar­ma­ceu­ti­cals sec­tor.

“The ma­jor chal­lenges that lie up ahead for de­vel­op­ing bio­phar­ma­ceu­ti­cals in In­dia in­clude long lead times for prod­uct de­vel­op­ment, skilled man­power, ris­ing costs and long ges­ta­tion times for set­ting up man­u­fac­tur­ing units. Also, longer re­search and clin­i­cal de­vel­op­ment time­lines re­sult in launches closer to patent ex­piries in an in­creas­ingly com­pet­i­tive mar­ket. The is­sue of reg­u­la­tory scru­tiny also comes in to play. Com­pli­ance to dif­fer­ing re­quire­ments for global mar­kets be­comes a chal­lenge for the com­pany’s go-to com­mer­cial­iza­tion strat­egy. Global MNCs hav­ing sig­nif­i­cant economies of scale for de­vel­op­ment & man­u­fac­tur­ing lead to sig­nif­i­cantly higher com­pe­ti­tion”, men­tions Dr. Mur­taza Kho­raki­wala, MD, Wock­hardt Ltd.

In the long run, it can only be hoped that this pro­gram will be able to ad­dress the ex­ist­ing chal­lenges to an ex­tent thus en­abling sus­tain­able net­works for col­lab­o­ra­tion be­tween in­dus­try and academia, and sup­port­ing en­tre­pre­neur­ial ecosys­tem amongst many oth­ers.

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