Changes in reg­u­la­tions, au­dits and mar­ket de­mand are lead­ing to an in­crease in ex­cit­ing new job op­por­tu­ni­ties within phar­ma­ceu­ti­cal com­pa­nies

India Today - - EXPERT SPEAK - Kr­ishna Prasad Chig­u­ru­pati is man­ag­ing di­rec­tor of Gran­ules In­dia

The global phar­ma­ceu­ti­cal in­dus­try is val­ued at more than $ 960 bn ( IMS Health Mar­ket Prog­no­sis, June 2013) and is ex­pected to grow at a 5.3 per cent for the next five years. While the in­dus­try will grow at a steady pace, it will also wit­ness an in­creased fo­cus on com­pli­ance and man­u­fac­tur­ing.

Qual­ity stan­dards are in­creas­ing through­out the world in­clud­ing in semi- reg­u­lated mar­kets. In ad­di­tion to higher qual­ity re­quire­ments, com­pa­nies are also push­ing man­u­fac­tur­ers to of­fer lower prices. This in­creased pres­sure means Pharma com­pa­nies will need to re­assess their pri­or­i­ties which means cer­tain ca­reer paths in Pharma will see a strong growth in the fu­ture.

Over the past year, In­dian pharma has ex­pe­ri­enced a slew of prod­uct re­calls, warn­ing let­ters and im­port alerts from reg­u­la­tory agen­cies. Reg­u­la­tory bod­ies will fol­low the U. S.

FDA’s lead by in­creas­ing staff pres­ence in In­dia which will re­sult in more sur­prise au­dits. This in­creased scru­tiny means the in­dus­try will ramp- up in­vest­ments to en­sure com­pli­ance.

Pharma com­pa­nies look at com­pli­ance through sev­eral com­po­nents in­clud­ing reg­u­la­tory re­quire­ments, and good man­u­fac­tur­ing prac­tices. In or­der to tackle th­ese chal­lenges, com­pli­ance is bro­ken into sev­eral func­tions such as qual­ity as­sur­ance ( QA), qual­ity con­trol ( QC) and reg­u­la­tory af­fairs ( RA).

While of­fi­cials will fo­cus on com­pli­ance, RA and QA will also be crit­i­cal as com­pa­nies in­crease their reg­u­la­tory fil­ings. Western- based com­pa­nies are look­ing to lower costs by out­sourc­ing to a more cost- ef­fec­tive man­u­fac­tur­ing base such as In­dia. Com­pa­nies will want to have strong RA de­part­ments so they can quickly seize new op­por­tu­ni­ties in­clud­ing tech­nol­ogy trans­fer projects. The in­creas­ingly com­plex world of reg­u­la­tion means that com­pa­nies are al­ways on the prowl for in­di­vid­u­als with solid reg­u­la­tory knowl­edge and the abil­ity to in­ter­act with reg­u­la­tory agen­cies.

While qual­ity stan­dards are in­creas­ing, cus­tomers are con­cur­rently de­mand­ing lower prices. Suc­cess­ful com­pa­nies will be able to of­fer lower prices by fo­cus­ing on im­prov­ing manu- fac­tur­ing ef­fi­ciency through process in­no­va­tion. The in­dus­try will be­gin to look at op­er­a­tional ex­cel­lence as a strate­gic growth tool.

For ex­am­ple, when a man­u­fac­turer pro­duces bil­lions of tablets, a 0.1 per cent in­crease in the pro­duc­tion yield will re­sult in ma­jor cost sav­ings. Peo­ple in Op­er­a­tional Ex­cel­lence ( OE) usu­ally come from a chem­i­cal engineering back­ground and work in teams ded­i­cated to process im­prove­ment. OE roles are highly col­lab­o­ra­tive be­cause the team has to un­der­stand the im­pact of any changes in­clud­ing reg­u­la­tory and qual­ity as­pects. Within the Pharma in­dus­try, OE is still in its in­fancy but it will be­come a crit­i­cal depart­ment as com­pa­nies are forced to con­trol costs.

The In­dian Pharma in­dus­try will con­tinue to of­fer com­pelling ca­reers to for­ward- think­ing pro­fes­sion­als. Em­ploy­ees will have an op­por­tu­nity to work in a dy­namic en­vi­ron­ment that is con­stantly evolv­ing. Given the in­creas­ing com­plex­i­ties within the in­dus­try, suc­cess­ful em­ploy­ees will need to go be­yond pro­vid­ing stan­dard so­lu­tions and will need to think dif­fer­ently so they can of­fer in­no­va­tive so­lu­tions that give their com­pa­nies an ad­van­tage.

A tech­ni­cian mon­i­tor­ing crys­tal­liz­ers at Parac­eta­mol API Fa­cil­ity, Bon­tha­pally

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