‘Sun Pharma to Stream­line Qual­ity Con­trol Pro­cesses’

Pharma ma­jor has been under USFDA scan­ner over man­u­fac­tur­ing lapses

The Economic Times - - Economy: Macro, Micro & More - Divya.Ra­jagopal @times­group.com

Mum­bai: In­dia’s largest drug maker Sun Pharma, bleed­ing lately for hav­ing been mauled by the USFDA over lax qual­ity con­trol at its plants, has re­set its goals. In­dia’s sec­ond-rich­est man and Sun Pharma MD, Dilip Shanghvi said he is try­ing to stream­line qual­ity con­trol pro­cesses that were over­taken by the merger with Ran­baxy, mak­ing the com­pany the world’s fifth-largest generic drug maker.

“All of a sud­den we be­came twice the size of the com­pany, we have 50,000 em­ploy­ees. That crys­tallised the need for work­ing to­wards a sys­tem, work­ing to­wards tech­nol­ogy em­pha­sis on im­prov­ing IT back­grounds, fo­cussing on is­sues that has af­fected us and also oth­ers in the world in re­gard­ing qual­ity. How do we re­solve prob­lems faster? How do we de­sign our prod­ucts? … this has not hap­pened and we have learnt this over an ex­tended pe­riod of time,” said Shanghvi, ad­dress­ing the In­dian Phar­ma­ceu­ti­cal Al­liance Qual­ity Fo­rum, an an­nual event for in­ter­na­tional reg­u­la­tors and In­dian drug com­pa­nies. Sun Pharma has been under the scan­ner of the US drug reg­u­la­tor for not fol­low­ing the good man­u­fac­tur­ing prac­tice. Shares of Sun pharma, which is one of the most watched stock on the BSE, have lost 24 % since 2015.

“We re­alised we re­quire dif­fer­ent or­gan­i­sa­tion to man­age the in­creas­ing com­plex­ity of man­ag­ing our man­u­fac­tur­ing sites”, Shanghvi ex­plained. “The em­pha­sis and fo­cus was on com­mon qual­ity rather than coun­try spe­cific or geog­ra­phy spe­cific qual­ity. I think the ob­jec­tive is work to­wards en­hanc­ing our ca­pa­bil­i­ties reach­ing to­wards global stan­dard” he added. The merged en­tity has man­aged to stan­dard­ise its qual­ity met­rics across plants on var­i­ous is­sues which im­pact prod­uct qual­ity. How­ever, some con­cerns re­main, Shanghvi said.

“We were on a jour­ney to cre­ate a pa­per­less lab­o­ra­tory process that is di­rectly elec­tron­i­cally cap­tured on sys­tems. In hind­sight, we re­alised we un­der­es­ti­mated the com­plex­ity and the enor­mity of what we were try­ing to do. So that project is al­most 12-15 months be­hind sched­ule”, Shanghvi said.

DIVYA RA­JAGOPAL Sun Pharma MD Dilip Shanghvi with Mathew Thomas, coun­try direc­tor, USFDA In­dia

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