IN­DIA’S HIGH QUAL­ITY VACCINES ARE BUILD­ING ITS RO­BUST NEXUS GLOB­ALLY

BioSpectrum (India) - - Bio Contents - Nitin Konde

In­dia’s vac­cine pro­duc­tion is scal­ing new heights as the coun­try has emerged as one of the prom­i­nent play­ers in this sec­tor. The re­cent WHO re­port sug­gests that this sec­tor is likely to hit US $871 mil­lion mark by the end of 2017, which is more than dou­ble of 2011’s fig­ures (US $350 mil­lion). As per the Global Busi­ness In­tel­li­gence (GBI) Re­search, the In­dian vac­cine sec­tor will grow at a rate of 20 per cent an­nu­ally for the next four years. New re­search into cancer vaccines and fears of bioter­ror­ism and se­vere acute res­pi­ra­tory syn­drome (SARS) are spark­ing the rise in pro­duc­tion.

The cur­rent vac­cine mar­ket in In­dia is not only self-suf­fi­cient but due to its high niche vac­cine pro­duc­ing qual­ity it has out­run num­ber of prom­i­nent in­ter­na­tional play­ers glob­ally. This in­dus­try be­gan as a net­work of state owned man­u­fac­tur­ers, sup­ply­ing ba­sic child­hood vaccines to the na­tional im­mu­ni­sa­tion pro­gramme. The cur­rent sce­nario states that In­dia is emerg­ing as a life­line for var­i­ous re­gions where vaccines are not funded by the United Na­tions or char­i­ta­ble or­gan­i­sa­tions. Cur­rently, In­dian vaccines ex­ports have scaled 65 per cent as com­pared to last year.

In­dia’s vac­cine mar­ket ex­pe­ri­enced a growth spurt from 2005 to 2011 as big pharma com­pa­nies posted mas­sive prof­its. Glaxo Smith Kline ($GSK), Merck ($MRK), Sanofi ($SNY) and Pfizer ($PFE) all have skin in the game when it comes to in­vest­ing in the sec­ond most pop­u­lous coun­try in the world. But GBI ex­pects more growth op­por­tu­ni­ties for the pro­duc­tion and sale of vaccines from emerg­ing economies such as China.

Gov­ern­ment of In­dia has kept a close watch on this sec­tor over the years and this has acted like a cat­a­lyst to raise the bars among the vac­cine man­u­fac­tur­ers. From 2005-2011, gov­ern­ment put all the vac­cine man­u­fac­tur­ers un­der a strict scan­ner and their each and ev­ery move was closely mon­i­tored. As a re­sult, three vac­cine-pro­duc­ing units Cen­tral Re­search In­sti­tute, the Bacil­lus Cal­mette-Guerin Vac­cine Lab­o­ra­tory and the Pas­teur In­sti­tute of In­dia were sealed since these firms were found non-com­pli­ance with Good Man­u­fac­tur­ing Prac­tices (GMP). Apart from that, in April 2011, In­dia’s Min­istry of Health and Fam­ily Wel­fare (MOHFW) launched a Na­tional Vac­cine Pol­icy (NVP) that fo­cused on the fu­ture sig­nif­i­cance of the vac­cine in­dus­try.

“In the com­ing four years, the In­dian vac­cine mar­ket is ex­pected to grow sig­nif­i­cantly, dou­bling from ap­prox­i­mately €500 mil­lion to €1 bil­lion by 2020. Im­mu­ni­sa­tion pro­vides one of the most pow­er­ful, sim­ple, and cost ef­fec­tive health in­ter­ven­tions. Millions of lives are saved thanks to vac­ci­na­tion. The In­dian gov­ern­ment has taken tremen­dous ef­forts in the area of im­mu­ni­sa­tion in the last few years. The gov­ern­ment is com­mit­ted to con­tinue with its ef­forts with the in­tro­duc­tion of four new vaccines in the Uni­ver­sal im­mu­ni­sa­tion pro­gramme of In­dia by 2019. At the same time, the gov­ern­ment has given a boost to ‘Make in In­dia’, al­low­ing new vaccines to be de­vel­oped and pro­duced in the coun­try. Lastly, the reg­u­la­tory process, for the ap­proval of in­no­va­tive vaccines in In­dia, has im­proved and al­lows a faster reach of these in­no­va­tions to the pop­u­la­tion. These three fac­tors will gen­er­ate im­por­tant growth in the com­ing years,” quoted Pierre Baylet, Coun­try Head, Sanofi Pas­teur In­dia, Sri Lanka and Nepal.

These sup­port­ing steps by the gov­ern­ment have al­lured many pri­vate play­ers to step into this sec­tor. In­volve­ment of pri­vate play­ers in the vac­cine busi­ness has changed the en­tire land­scape of this busi­ness. Their

big­gest suc­cess fac­tor is sim­i­lar to the ap­proach that has been fol­lowed by In­dian generic phar­ma­ceu­ti­cal man­u­fac­tur­ers. This model in­volved con­certed ef­forts to de­velop vaccines for not only tropical ne­glected dis­eases, but also cheaper al­ter­na­tives of vaccines that are al­ready avail­able in the West.

Elab­o­rat­ing on In­dia’s cur­rent vac­cine mar­ket, Dr Kishore Ku­mar, Chair­man and Neona­tol­o­gist, Cloud­nine Group of Hospi­tals said, “Be­ing one the lead­ing play­ers in phar­ma­ceu­ti­cal sec­tor, In­dia’s vac­cine mar­ket is one of the most im­por­tant epit­o­mes of pub­lic health not just in In­dia but glob­ally. One of the most suc­cess­ful health in­ter­ven­tions i.e. pro­duc­tion of vaccines, In­dia has ex­pe­ri­enced im­pres­sive im­prove­ments in its eco­nomic sta­tus and pop­u­la­tion health during the past two decades.”

“In­dia un­de­ni­ably re­mains the vac­cine epi­cen­ter of the world, be­ing home to highly suc­cess­ful vac­cine gi­ants who have not only helped In­dia at­tain do­mes­tic self-suf­fi­ciency in vaccines for the pub­lic mar­ket, but also helped the coun­try emerge as a global vac­cine man­u­fac­tur­ing hub,” he added.

Ac­cord­ing to the re­cent re­port ‘Global Hu­man Vac­cine Mar­ket 2016-2020’ by Tech­navio re­search com­pany, head­quar­tered in Lon­don, the global hu­man vaccines mar­ket is ex­pected to grow at a CAGR of 11.69 per cent during 2016-2020. It is in­ter­est­ing to note that vac­cine man­u­fac­tur­ers from all over the world have been in­volved with gov­ern­ments re­gard­ing sup­ply and de­mand of vaccines in In­dia, and de­vel­op­ing na­tions are in­creas­ingly de­mand­ing vaccines and reg­u­la­tory ap­provals, Dr Ku­mar said.

Shed­ding some light on the tough com­pe­ti­tion with China, Pierre Baylet opined, “There is in­deed a threat from China to the In­dian ex­port in­dus­try. I be­lieve that In­dian pro­duc­ers still have an edge at least for the next five years or so. To con­tinue to sus­tain the po­si­tion, In­dian man­u­fac­tur­ers will need to ex­pand their port­fo­lio of vaccines, in­no­vate, bring new gen­er­a­tion of vaccines to the ta­ble, and main­tain the high­est qual­ity stan­dards.”

“I also be­lieve that the ado­les­cent and adult im­mu­ni­sa­tion in In­dia is not at the level where it should be. When talk­ing about vac­ci­na­tion in In­dia, most peo­ple think about chil­dren. There is an ur­gent need to boost adult im­mu­ni­sa­tion in In­dia. We saw the need last year during the out­break of in­fluenza. Of­ten vac­cine pre­ventable dis­eases are trans­mit­ted to chil­dren through par­ents, fam­ily or care­tak­ers. A good ex­am­ple is per­tus­sis. Get­ting the adults, closer to chil­dren, vac­ci­nated is cru­cial. The in­dus­try, the me­dia and the gov­ern­ment need to fur­ther boost their ef­forts in this di­rec­tion,” Baylet elab­o­rates

Echo­ing the same voice, Dr. Ku­mar opined, “In­dia has the po­ten­tial to make va­ri­eties of vaccines, but re­search is at its very nascent stage and the qual­ity of the vaccines we pro­duce is very good – get­ting ap­proval from Bill & Melinda Gates Foun­da­tion and var­i­ous other rep­utable or­gan­i­sa­tions. We have to ‘in­vest’ more in re­search to keep the pace go­ing. China is catch­ing up and they are pro­duc­ing vaccines sim­i­lar to the global vaccines but the world cur­rently is skep­ti­cal of Chi­nese vaccines to a cer­tain ex­tent as it is some­thing you ad­min­is­ter to your body, peo­ple are not en­tirely sat­is­fied with Chi­nese vaccines at this stage.”

Dr. Ak­shay Kapoor, Con­sul­tant Pae­di­atric Gas­troen­terol­o­gist, Hepa­tol­o­gist and Liver Trans­plant Physi­cian, In­draprastha Apollo Hos­pi­tal feels that un­der­es­ti­mat­ing China can turn the ta­ble around, he said, “China has been grow­ing rapidly in the vac­cine space, es­pe­cially after get­ting WHO ap­proval for its vaccines in 2010. It is emerg­ing as a ma­jor vac­cine pow­er­house. Cou­pled

with its low cost of pro­duc­tion it is emerg­ing as a ma­jor player chal­leng­ing In­dia. China has a bet­ter pen­e­tra­tion of its na­tional vac­ci­na­tion pol­icy as com­pared to In­dia. Ma­jor­ity of the vaccines be­ing man­u­fac­tured by lo­cal play­ers means that the cost of pro­duc­tion is low. In­dia suf­fers from a poor vac­ci­na­tion cov­er­age pol­icy. More­over, In­dian man­u­fac­tur­ers can’t sell vaccines in the Chi­nese mar­ket, while the re­verse is true.”

De­spite its re­cent growth, how­ever, the In­dian vac­cine in­dus­try still has a num­ber of chal­lenges to ad­dress. The mar­ket re­mains small (cur­rently ac­counts for less than 2 per cent of the global mar­ket) and un­der­pen­e­trated com­pared to the de­vel­oped coun­tries. The coun­try also lags be­hind its global peers in terms of vac­cine cov­er­age with a sig­nif­i­cant num­ber of lives lost due to vac­cine pre­ventable deaths.

In­dia lacks a ro­bust sys­tem to track vac­cine-pre­ventable dis­eases. Vac­ci­na­tion cov­er­age varies con­sid­er­ably from state to state, with the low­est rates in In­dia’s large cen­tral states. Dif­fer­ences in up­take are ge­o­graph­i­cal, re­gional, ru­ral-ur­ban, poor-rich and gen­der-re­lated. On av­er­age, girls re­ceive fewer im­mu­ni­sa­tions than boys and higher birth or­der in­fants have lower vac­ci­na­tion cov­er­age. Huge pop­u­la­tion with rel­a­tively high growth rate, ge­o­graph­i­cal di­ver­sity and hard to reach pop­u­la­tion, lack of aware­ness re­gard­ing vac­ci­na­tion, in­ad­e­quate su­per­vi­sion and mon­i­tor­ing, lack of mi­cro-plan­ning and gen­eral lack of in­ter-sec­toral co­or­di­na­tion are largely re­spon­si­ble.

“In­dia has ex­pe­ri­enced im­pres­sive im­prove­ments in its eco­nomic sta­tus and pop­u­la­tion health during the past two decades. How­ever, it lags other coun­tries of sim­i­lar per capita gross do­mes­tic prod­uct in child sur­vival. The mor­tal­ity rate for chil­dren age five and younger cur­rently stands at sixty-six per thou­sand live births, com­pared to thirty-four per thou­sand live births in the Philip­pines, a coun­try with roughly the same per capita gross do­mes­tic prod­uct. Be­tween 1990 and 2001, the prob­a­bil­ity of dy­ing be­fore age five fell more than twice as rapidly in Bangladesh and In­done­sia as it did in In­dia.”

Although child sur­vival rates have im­proved since 2001, In­dia failed to achieve its own goal of re­duc­ing the num­ber of in­fant deaths by half be­fore 2012. And at the cur­rent rate of de­cline, it will not meet the goal that was set in the United Na­tions’ Mil­len­nium Dec­la­ra­tion of cut­ting the mor­tal­ity rate for chil­dren un­der age five by two-thirds be­tween 1990 and 2017.

As per the WHO re­port, there are twenty-seven mil­lion new births in In­dia each year, the largest birth co­hort in the world. How­ever, fewer than 44 per cent of these chil­dren re­ceive the full sched­ule of im­mu­ni­sa­tions. This level is only slightly bet­ter than it was in 1998, when the pro­por­tion was 42 per cent. In con­trast, in Bangladesh, on the north­east bor­der of In­dia, 82 per cent of chil­dren are fully im­mu­nised by age two. In ad­ja­cent Nepal, 80 per cent of chil­dren are fully im­mu­nised by age one. The 9.6 mil­lion unim­mu­nised chil­dren in In­dia to­day ac­count for more than one-third of the 27 mil­lion unim­mu­nised chil­dren around the world.

Although the cur­rent im­mu­ni­sa­tion pro­gramme tar­gets twenty-seven mil­lion in­fants and preg­nant women ev­ery year and is one of the largest im­mu­ni­sa­tion pro­grammes in the world, im­mu­ni­sa­tion rates through the na­tional pro­gramme are un­even across twenty-eight states in In­dia. The pro­por­tion of chil­dren un­der age five who are vac­ci­nated ex­ceeds 70 per cent in only eleven states; it drops be­low 53 per cent in eight states that are also the most pop­u­lous.

Clear­ing the air about the mor­tal­ity rate due to lack of avail­abil­ity of vac­cine, Baylet com­mented, “There is mis­un­der­stand­ing among the peo­ple that high mor­tal­ity is due to lack of avail­abil­ity of vac­cine but be­cause of lack of ef­fec­tive im­mu­ni­sa­tion. In or­der to re­duce mor­bid­ity and mor­tal­ity, there is a need to have more vaccines that have al­ready been proven to be safe and ef­fi­ca­cious in many other coun­tries, to be ap­proved for use in In- dia. Take Sanofi Pas­teur’s dengue vac­cine for in­stance, a cul­mi­na­tion of over two decades of sci­en­tific in­no­va­tion and col­lab­o­ra­tion, as well as 25 clin­i­cal stud­ies in 15 coun­tries, in­volv­ing 40,000 vol­un­teers, around the world. The vac­cine, which is rec­om­mended by the WHO in highly dengue-en­demic coun­tries as part of com­pre­hen­sive dengue man­age­ment and pre­ven­tion ef­forts, is proven to be ef­fec­tive against all four serotypes of the dis­ease. Since its launch, based on its safety and ef­fi­cacy re­sults, the dengue vac­cine has been ap­proved for use in 13 coun­tries across the world. The need for dengue pre­ven­tion in In­dia is ur­gent, and the In­dian pop­u­la­tion at risk for this de­bil­i­tat­ing dis­ease, for which there is no cure or treat­ment, de­serves to have a choice to be pro­tected against the dis­ease with a well-tested vac­cine proven ef­fec­tive against dengue.”

She fur­ther quoted, “Thus, there is a need to sim­plify the reg­u­la­tory ap­proval process and the im­port rules. Se­condly, we need to find a sus­tain­able model so as to guar­an­tee that vaccines are ac­ces­si­ble to ev­ery­one, but at the same time we need to en­sure some re­turns for the man­u­fac­tur­ers to be able to (a) re-in­vest in R&D (b) pro­vide more vol­umes of vaccines (c) of­fer new vaccines against cur­rent or emerg­ing threats.”

In­dian Im­muno­log­i­cals Ltd. rep­re­sen­ta­tive said, “Im­mu­ni­sa­tion is one of the most cost-ef­fec­tive pub­lic health in­ter­ven­tions and largely re­spon­si­ble for re­duc­tion of un­der-5 mor­tal­ity rate. How­ever, vac­cine pre­ventable dis­eases (VPDs) are still re­spon­si­ble for over five lakh deaths an­nu­ally in In­dia. This un­der­lines the need of fur­ther im­prove­ment. To­day, In­dia is a lead­ing pro­ducer and ex­porter of vaccines, still the coun­try is home to one-third of the world’s unim­mu­nised chil­dren.”

Con­clu­sion

In­dia is emerg­ing as prom­i­nent vac­cine man­u­fac­turer glob­ally and this tar­get has been achieved be­cause of the joint ef­forts of the gov­ern­ment and the pri­vate vac­cine man­u­fac­tur­ers. In the com­ing years, In­dian vac­cine mar­ket will fur­ther spread its wings to pen­e­trate deeper into the global mar­ket. Though it is fac­ing a tough com­pe­ti­tion with China, but the ex­perts feel that still In­dia has the up­per hand. Now, the main chal­lenge for the coun­try is to fur­ther over­haul its do­mes­tic im­mu­ni­sa­tion process as there is a big scope of im­prove­ment there. If the coun­try man­ages to tighten up these loose screws then it is on the verge of be­com­ing the ‘World Vac­cine Man­u­fac­tur­ing Hub’.

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