IN­DIAN PHARMA SPEND­ING Rs 200 Bn on R&D

BioSpectrum (India) - - BIO CONTENT -

In­dian pharma com­pa­nies are gear­ing up to take on their global peers in terms of ex­pen­di­ture on re­search and de­vel­op­ment (R&D), which has shown a steady in­crease in the last few years. Be­sides build­ing on the tra­di­tional generic prod­uct pipe­line, pharma com­pa­nies are now in­vest­ing in re­search on com­plex gener­ics, spe­cialty and dif­fer­en­ti­ated prod­ucts, and biosim­i­lars. For the FY2018, the R&D ex­penses have con­sti­tuted 9.1 per cent of the cu­mu­la­tive rev­enues of the com­pa­nies. The cu­mu­la­tive R&D spend for the top 10 pharma com­pa­nies has been around Rs 95 bil­lion or Rs 9500 crores this fis­cal. This fig­ure even­tu­ally reaches a score of Rs 20,000 crores after con­sid­er­ing the cu­mu­la­tive ex­pen­di­ture by other small and medium play­ers of the In­dian pharma in­dus­try work­ing equally hard in the field of R&D.

In­dian pharma com­pa­nies are gear­ing up to take on their global peers in terms of ex­pen­di­ture on re­search and de­vel­op­ment (R&D), which has shown a steady in­crease in the last few years. Over the years In­dian pharma in­dus­try has been of­ten pulled up for spend­ing too lit­tle on R&D.

But the lat­est trend shows that In­dia’s big­gest phar­ma­ceu­ti­cal com­pa­nies are now in­vest­ing more in this di­rec­tion. Be­sides build­ing on the tra­di­tional generic prod­uct pipe­line, pharma com­pa­nies are now in­vest­ing in re­search on com­plex gener­ics, spe­cialty and dif­fer­en­ti­ated prod­ucts, and biosim­i­lars. For the FY2018, the R&D ex­penses have con­sti­tuted 9.1 per cent of the cu­mu­la­tive rev­enues of the com­pa­nies. The cu­mu­la­tive R&D spend for the top 10 pharma com­pa­nies has been around Rs 95 bil­lion or Rs 9500 crores this fis­cal. This fig­ure even­tu­ally reaches a score of Rs 20,000 crores after con­sid­er­ing the cu­mu­la­tive ex­pen­di­ture by other small and medium play­ers of the In­dian pharma in­dus­try work­ing equally hard in the field of R&D.

Dur­ing the first half of this cal­en­dar year end­ing June 2018, top pharma com­pa­nies and their sub­sidiaries re­ceived 125 fi­nal Ab­bre­vi­ated New Drug Ap­pli­ca­tions (ANDA) ap­provals from US FDA out of the to­tal 323 ANDA ap­provals re­ceived by In­dian pharma com­pa­nies. This re­flects around 39 per cent of the to­tal ap­provals re­ceived by top com­pa­nies be­cause of their higher in­vest­ments in R&D ac­tiv­i­ties. Sim­i­larly, the top com­pa­nies re­ceived 22 ten­ta­tive ap­provals out of the to­tal 71 ten­ta­tive ap­provals from the US FDA by the In­dian com­pa­nies. The ap­proval rate is slightly lower com­pared to first half of 2017, in which US FDA ap­proved a to­tal 387 ANDAs and 85 ten­ta­tive prod­ucts, and out of this In­dian pharma com­pa­nies se­cured 137 ANDA ap­provals and 32 ten­ta­tive ap­provals.

Sun Pharma in­curred an R&D ex­pen­di­ture of Rs 22 bil­lion dur­ing 2017-18, higher than the pre­vi­ous year’s ex­pen­di­ture of Rs 21 bil­lion. Fol­low­ing a sim­i­lar pat­tern, Aurobindo spent Rs 7 bil­lion on R&D which was much more than the last year’s ex­pen­di­ture of Rs 5.5 bil­lion.

On the other hand, Dr Reddy’s Lab­o­ra­to­ries, which had been pass­ing through a chal­leng­ing phase due to US FDA warn­ing let­ters, spent Rs 18 bil­lion for R&D dur­ing 2017-18 as against Rs 19.5 bil­lion in the pre­vi­ous year mark­ing a de-growth of 7 per cent. Like­wise, Lupin in­curred an R&D ex­pen­di­ture of Rs 18.5 bil­lion, lower than the pre­vi­ous year of Rs 23 bil­lion. Ci­pla has main­tained a con­stant pro­file by in­vest­ing around Rs 11 bil­lion for R&D this year as well.

The ma­jor ther­apy ar­eas where pharma com­pa­nies are cur­rently in­vest­ing in­clude on­col­ogy, di­a­betol­ogy, car­di­ol­ogy, gas­troen­terol­ogy and res­pi­ra­tory. It seems likely that even­tu­ally In­dian pharma com­pa­nies will be able to shape so­lu­tions for bring­ing out high qual­ity prod­ucts across the world in these dis­eased ar­eas.

To top it all, the In­dian govern­ment has also

been lend­ing a sup­port­ing hand to the re­search and de­vel­op­ment for the last two to three decades. The Depart­ment of Sci­ence and Tech­nol­ogy (DST) has been oper­at­ing Drugs and Phar­ma­ceu­ti­cals Re­search Pro­gramme to syn­er­gise the strengths of pub­licly funded R&D in­sti­tu­tions and In­dian Phar­ma­ceu­ti­cal In­dus­try. Re­cently, the govern­ment has pro­posed over Rs 460 crore sup­port for the

de­vel­op­ment of pharma in­dus­try with an aim to re­duce cost of bulk drugs and med­i­cal de­vices through set­ting up of com­mon fa­cil­ity cen­tres and to help small and medium-sized en­ter­prises (SMEs) up­grade tech­nol­ogy.

In the com­ing pages we will be cov­er­ing the R&D in­vest­ments and ac­tiv­i­ties of the top 10 pharma com­pa­nies dur­ing the fi­nan­cial year 2017-18.

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