‘GOVERN­MENT RE­FORMS WILL HELP GROWTH OF IN­DIAN VAC­CINE SEC­TOR’

BioSpectrum (India) - - Bio Con­tents - Dr. Suresh Jad­hav Ex­ec­u­tive Di­rec­tor, Serum In­sti­tute of In­dia

As the world’s largest vac­cine man­u­fac­turer, Serum In­sti­tute of In­dia now sup­plies to 170 coun­tries hav­ing strength­ened its reach and ca­pa­bil­ity af­ter the ac­qui­si­tion of a Nether­lands firm. Con­tin­u­ing reg­u­la­tory re­forms will help pro­mote growth among vac­cine man­u­fac­tur­ers, says the com­pany’s Ex­ec­u­tive Di­rec­tor Dr. Suresh Jad­hav in an ex­clu­sive in­ter­view to Bio Spec­trum

What are the lat­est de­vel­op­ments at Serum In­sti­tute in terms of new prod­uct de­vel­op­ment and launches in the off­ing?

We will be launch­ing at least three – four prod­ucts. Just about a month back we got the mar­ket­ing au­tho­ri­sa­tion and li­cences for man­u­fac­tur­ing of Vero Cell Ra­bies Vac­cine and Ra­bies Mon­o­clonal an­ti­body. The ra­bies mon­o­clonal an­ti­body will be launched for the first time in the world. We had re­ceived this tech­nol­ogy al­most 7-8 years back from MBL- Mas­sachusetts Bi­o­log­i­cal Lab­o­ra­tory, Bos­ton. We de­vel­oped it and they have the right to sell the prod­uct in the US and we can sell it in the rest of the world. Very shortly, we ex­pect to get our li­cence. We have al­ready got the mar­ket­ing au­tho­ri­sa­tion for the ro­tavirus vac­cine. This vac­cine will be a game-changer as far as the in­tro­duc­tion in trop­ics is con­cerned. This is an ex­tremely sta­ble vac­cine and can stay at room tem­per­a­ture with­out any cold chain.

That will be a great boon es­pe­cially for coun­tries in Africa and some of the coun­tries in south­east Asia where we have power dis­rup­tions.

These are the three ma­jor launches in the off­ing. The oth­ers will fol­low but they are at var­i­ous stages of clin­i­cal tri­als. We are work­ing on pneu­mo­coc­cal vac­cine which is com­plet­ing phase two stud­ies. Once we sub­mit that data to DCGI, we will ex­pect per­mis­sion to start phase-3. We have also got per­mis­sion to start our phase-1 clin­i­cal trial for hu­man pa­pil­lo­mavirus (HPV) vacine. Re­cently we got per­mis­sion to start phase-1 stud­ies for diph­the­ria-tetanus-acel­lu­lar per­tus­sis (DTAP). Things are mov­ing.

How is Serum In­sti­tute placed to­day in terms of the global vac­cine market?

Glob­ally we are sup­ply­ing to 170 coun­tries to­day. Till last year or two years back, it was 150 coun­tries be­cause we were sup­ply­ing prod­ucts only from Serum In­sti­tute in Pune. But af­ter we took over a fa­cil­ity in Nether­lands (Bilthoven Bi­o­log­i­cals) which man­u­fac­tures only two prod­ucts - po­lio and BCG for the treat­ment of blad­der can­cer, the num­ber went up to over 170 coun­tries as they also sup­ply to about 20 coun­tries. So as the Cyrus Poon­awalla group, we sup­ply to over 170 coun­tries now. In that our ma­jor buy­ers are the UN agen­cies- UNICEF in Copenhagen and PAHO (Pan Amer­i­can Health Or­gan­i­sa­tion) in Washington. PAHO is a pur­chas­ing agency for vac­cines for South Amer­ica and South Pa­cific rim coun­tries. We are sup­ply­ing al­most 95 per cent of the re­quire­ment there for some of our vac­cines such as measles con­tain­ing vac­cine. There is no other man­u­fac­turer who is qual­i­fied so far for sup­ply­ing MMR vac­cines.

I would at­tribute this global pres­ence of Serum In­sti­tute to re­search, de­vel­op­ment, cir­cum­stances and luck. But ma­jorly be­cause of the vi­sion of Dr. Cyrus Poon­awalla.

One great thing about Serum In­sti­tute is the low price and af­ford­abil­ity of the prod­uct. This is ap­pre­ci­ated by many in the health­care sec­tor.

That is our USP. Dr Poon­awalla al­ways felt that if you have to make prod­ucts af­ford­able, you have to have cer­tain vol­umes. And only when you achieve those vol­umes can you give lower prices and main­tain them. Like for ex­am­ple, when we got li­cence for measles, we qual­i­fied, and started sup­ply­ing to UN agen­cies in 1994, I think we were sup­ply­ing to them at a price of $1.10. That means 11 cents a dose. We main­tained that price - 11 or 11.5 cents for 10 years. We did not change the price till 2004. That was pos­si­ble be­cause every year the de­mand was in­creas­ing and we could pro­duce ad­di­tional quan­ti­ties from the same fa­cil­ity which could take care of in­fla­tion. It was only in 2004 when the de­mand re­ally in­creased or we got such an in­di­ca­tion that we con­structed a new fa­cil­ity. So when a new fa­cil­ity is con­structed like the cur­rent GMP (good man­u­fac­tur­ing prac­tice), then of course that in­vest­ment has to be fac­tored in the price at which you are sell­ing. So we in­creased the price by an­other 10 per cent at that time. You don’t get ku­dos for main­tain­ing price for 10 years but you get flak for in­creas­ing it

by 10 per cent!

How does Serum In­sti­tute view its po­si­tion in the do­mes­tic market?

We are the largest sup­plier in the pri­vate market, there is no doubt about that. Ex­cept for the last two years when the pen­tava­lent vac­cine ten­der went to an­other com­pany be­cause of the Govern­ment of In­dia’s pol­icy of al­lot­ting ev­ery­thing to the low­est bid­der. It’s not like in UN agen­cies, where even if there are 3 or 4 sup­pli­ers, they give or­ders of some small quan­tity to every­body to take care of the vac­cine’s se­cu­rity. Be­cause if some­thing hap­pens to the ma­jor sup­plier, then they have to de­pend on some­body else. Here if you don’t give to an­other sup­plier, he can’t keep things ready and main­tain stocks . If the prod­uct is not used within its shelf life, it has to be de­stroyed.

What kind of govern­ment sup­port would be re­quired for In­dian man­u­fac­tur­ers to re­tain their po­si­tion in the world?

About four years ago we had a sit­u­a­tion when some PILs were launched by the anti-vac­cine lobby and the govern­ment pan­icked. There were so many con­straints. The govern­ment changed the rules and reg­u­la­tions. They added so many new li­cences, mak­ing them manda­tory. For every li­cence there used to be so many dif­fer­ent com­mit­tees. Every time the mem­bers of the com­mit­tees felt that if they don’t give you a sug­ges­tion, their mem­ber­ship on the com­mit­tee is use­less. So they gave sug­ges­tions ir­re­spec­tive of whether they were valid or in­valid. That has delayed things sub­stan­tially- spe­cially for clin­i­cal tri­als com­pa­nies were forced to go out of the coun­try, to Africa, Malaysia, and other na­tions in South­east Asia, but not in In­dia. I think the govern­ment re­alised that and they are amend­ing things slowly. Slowly, re­forms are be­ing put in place and in a short time, things will be­come bet­ter. I will not say easy be­cause they are not com­pro­mis­ing on qual­ity, the process or the reg­u­la­tory part, but some ad­di­tional strin­gent mea­sure which were un­nec­es­sar­ily de­lay­ing pro­duc­tion and re­search in the coun­try will be re­moved. I’m quite con­fi­dent. We had some dis­cus­sion with the DCGI and even the health sec­re­tary and they are quite sup­port­ive to help us on this.

Any ex­pec­ta­tions as a vac­cine man­u­fac­turer from the forth­com­ing bud­get?

Cer­tainly. I must say that af­ter Prime Min­is­ter Naren­dra Modi took oath in 2014, in his very first speech from the Red Fort, he an­nounced that he wanted to in­tro­duce four vac­cines. I think that came as a shock to every­body, in­clud­ing the Health min­istry be­cause even they were not taken into con­fi­dence that he was go­ing to make such an an­nounce­ment. So that was the start­ing point. Slowly we see that they have in­tro­duced Ro­tavirus vac­cine, they have planned to in­tro­duce pneu­mo­coc­cal vac­cine pro­gramme and have al­ready taken a de­ci­sion to change over from the cur­rent measles to measles and rubella, a com­bined vac­ci­na­tion which will be in­tro­duced from the first quar­ter of 2017. We see these as ex­cel­lent steps which were not hap­pen­ing in the past.

This will help im­prove the health profile of the coun­try. In re­al­ity, In­dia rep­re­sents one-fifth of the world with a pop­u­la­tion of 1.3 bil­lion-plus out of 6.7 or 6.8 bil­lion global pop­u­la­tion. This has to be con­sid­ered in any pol­icy of the govern­ment or of UN agen­cies whether it is WHO or UNICEF; Gates Foun­da­tion, etc. They can­not ig­nore In­dia in any plan they have for the health sec­tor.

How is China placed in this sce­nario? When it comes to man­u­fac­tur­ing, there is al­ways this talk of China and the dom­i­nant po­si­tion that it has. How do you look at China in the vac­cine market and the vac­cine space?

In the past we were ex­tremely worried about China only be­cause of what they did in the bulk drug sec­tor. They have a large num­ber of small-scale and largescale in­dus­tries . They distinctly man­u­fac­ture dif­fer­ent qual­i­ties― one man­u­fac­turer com­plies with the US re­quire­ment, one com­plies for gen­eral market, one with some lit­tle sec­tor in be­tween and that’s why they could play with pric­ing. They have played havoc by sup­ply­ing glob­ally at a very low price. The in­dus­try was get­ting com­plete sup­port from their govern­ment. The govern­ment was en­cour­ag­ing the in­dus­try to ex­port and mak­ing good their losses. Such sup­port has not come from the In­dian govern­ment.

On the vac­cine front, they have two dis­tinct sec­tors― the pub­lic sec­tor and the pri­vate sec­tor. In the pub­lic sec­tor they have state units which are lo­cated in 6-7 states but now they fall un­der one govern­ment en­tity― China Na­tional Biotech Cor­po­ra­tion. China has got two dis­tinct markets- one is Cat­e­gory A type of vac­cine- the ba­sic im­mu­ni­sa­tion type of vac­cine and other vac­cines. The ba­sic im­mu­ni­sa­tion vac­cines are sup­plied by govern­ment or­gan­i­sa­tions . They buy it from the in­dus­try and give it to their pop­u­la­tion free of cost. There are 38 pri­vate vac­cine man­u­fac­tur­ers in China. There is no price re­stric­tion for all these play­ers. When I went to China and dis­cussed with their FDA, lo­cal peo­ple and com­pa­nies, what I found was that they were sell­ing their prod­ucts at a price which was if not equal, more than the price in the US. How does

this trans­late? With 38 man­u­fac­tur­ers, how do they man­age to sur­vive? They make just about 5 mil­lion doses in the en­tire year but even if they make just 5 mil­lion and sell it for $100 a dose, their turnover is $500 mil­lion which is al­most equiv­a­lent to Serum In­sti­tute’s turnover where we sup­ply al­most more than 1.3 bil­lion doses. There is no com­par­i­son. These man­u­fac­tur­ers have no in­cen­tive to in­crease their pro­duc­tion and come and sup­ply to UN agen­cies. UN agen­cies re­quire vac­cines at lower price. The Chi­nese man­u­fac­tur­ers are not in­ter­ested. In­stead of sup­ply­ing at that price, they pre­fer to sup­ply within China and make prof­its. But the fear from the govern­ment sec­tor still ex­ists. The Chi­nese govern­ment can take a strate­gic de­ci­sion to ask their in­dus­try to sup­ply to the UN agen­cies and then pro­vide com­pen­sa­tion. Is there an op­por­tu­nity for Serum In­sti­tute to ex­pand the market in China?

Yes and no. I will say no di­rectly be­cause it is a very dif­fi­cult route. Any man­u­fac­turer and sup­plier of vac­cines or prod­ucts, even if you have sup­plied bil­lions of doses, if you want to go to China you have to have a lo­cal part­ner. And your drug will be treated as a new drug. If you’re sell­ing the prod­uct in China, you have to start from ba­sic tox­i­c­ity stud­ies, the an­i­mal stud­ies, then phase-1, then phase-2, and then phase-3. That process in China takes al­most 7 to 8 years. Other coun­tries don’t have the same pro­ce­dure. Ide­ally if you are a UN sup­plier, they should waive these con­di­tions, but they have not. Ac­tu­ally this is an ar­ti­fi­cial bar­rier so that oth­ers don’t challenge their dom­i­nance. The In­dian govern­ment should ap­ply the same rules for Chi­nese sup­pli­ers― whether it is bulk drugs, fin­ished prod­ucts or vac­cines. If they ap­ply the same rules then that will be a re­cip­ro­ca­tion and will help the do­mes­tic man­u­fac­tur­ers.

Are you ex­pect­ing any new mea­sures from the govern­ment?

Hon­estly, when H1N1 struck glob­ally in 2010 we were also scared. There were many deaths in Pune also. Four man­u­fac­tur­ers came for­ward, in­ter­acted with WHO and made the vac­cines. Ini­tially there was a com­mit­ment­the govern­ment en­cour­aged three com­pa­nies by giv­ing a small to­ken amount of about Rs. 10 crores each for ex­pe­dit­ing the process. Then they said they will sort of make good by buy­ing the vac­cines. How­ever, the govern­ment did not buy a sin­gle dose from the In­dian market and now they are ask­ing for that money back as they did not buy. There is a le­gal dis­pute that is go­ing on and this is dis­ap­point­ing.

Ide­ally, there should be a stock­pile pol­icy for pan­demics as is the case with WHO and al­most all Euro­pean coun­tries. Every Euro­pean coun­try has en­tered into a contract with a lo­cal man­u­fac­turer to sup­ply vac­cines even when there is no pan­demic. Be­cause when a pan­demic strikes, the govern­ment should get pri­or­ity and get a cer­tain num­ber of doses quickly- say, about 50 mil­lion doses. The govern­ment pays them 50 cents per dose, which means $25 mil­lion to just keep the fa­cil­ity up and run­ning. If a pan­demic comes they are as­sured that their 50 mil­lion doses will be sup­plied. But such proac­tive mea­sures have not been taken in In­dia as yet.

What is the up­date on the dengue vac­cine?

With re­gards to dengue vac­cine, the for­mu­la­tion is go­ing on. We have still not started the hu­man tri­als. It’s un­der de­vel­op­ment. We have got the tech­nol­ogy from Mahi­dol Univer­sity, Thai­land who are the pi­o­neers and we have also got the tech­nol­ogy from NIH; so we are pur­su­ing both arms. Which­ever gives us best re­sults in the ini­tial stud­ies that will be pur­sued. It will take at least 4 to 5 years.

Dr. Suresh Jad­hav Ex­ec­u­tive Di­rec­tor, Serum In­sti­tute of In­dia

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