‘A Huge Bo­gey’s Made About Com­pul­sory Drug Li­cences’

The Economic Times - - Companies: Pursuit Of Profit -

A huge bo­gey is be­ing made about In­dia’s po­si­tion on the com­pul­sory drug li­cens­ing sys­tem, says

sec­re­tary of the min­istry of com­merce. She says the gov­ern­ment is tak­ing an ex­tremely con­ser­va­tive view of the pro­vi­sion and the public health re­quire­ments. Speak­ing to

on the side­lines of a phar­ma­ceu­ti­cal con­fer­ence in Mum­bai, Teao­tia says In­dia will not sign any in­ter­na­tional pact if it jeop­ar­dises the In­dian public’s ac­cess to af­ford­able health­care. Edited ex­cerpts:

How do you plan to grow pharma ex­ports from In­dia? We al­ready have an in­dus­try the size of $32 bil­lion and that is just for the phar­ma­ceu­ti­cal prod­ucts. This is one seg­ment where ex­ports is grow­ing at close to 10%. We have a few sec­tors that bucked the trend of last year’s ex­port de­cline, but the phar­ma­ceu­ti­cal in­dus­try stood out as a shin­ing ex­am­ple. Some com­pa­nies grew their ex­ports at over 30%. What we need to see now is to have this scale in ar­eas such as ayurveda, bi­o­log­ics, herbal prod­ucts and de­vices. We are work­ing to en­sure that our in­dus­try takes strong roots. We have to ex­pand the scope of our in­dus­try not as a phar­ma­ceu­ti­cal in­dus­try but health­care in­dus­try, which goes from research, ed­u­ca­tion, clin­i­cal research, med­i­cal de­vices and hos­pi­tal care to drugs. Some of the bio­pharma prod­ucts based on ayurveda are com­pletely unique to In­dia and we want to fo­cus there. This is one sec­tor about which you can­not help but be op­ti­mistic in In­dia. Global pharma lobby groups have spo­ken about ‘un­writ­ten as­sur­ance’ given by In­dia on not is­su­ing com­pul­sory li­cences and that has dis­cour­aged com­pa­nies from ap­ply­ing for new li­cences. Your thoughts?

I be­lieve there is no such as­sur­ance. A huge bo­gey is made about com­pul­sory li­censes. Since the Act (In­dian Patent Act) came into force, only one prod­uct has gone for this. It is ridicu­lous to make such a bo­gey. If there is a public health re­quire­ment, it will need to be ad­dressed and will be looked at ex­tremely con­ser­va­tively as we have done so far. We can­not give such as­sur­ances to any coun­try nor any in­dus­try groups. On the con­trary, com­pa­nies have seen a lot of value in go­ing for vol­un­tary li­cences. The ben­e­fits of partne- ring with In­dian com­pa­nies of­fers ac­cess to other coun­tries, prod­ucts of high­est qual­ity and at the most op­ti­mum pric­ing.

Health ac­tivists say the sup­ply of low-cost drugs to many coun­tries may be com­pro­mised if In­dia agrees be a sig­na­tory to the Re­gional Com­pre­hen­sive Eco­nomic Part­ner­ship and the EU Bi­lat­eral Trade and In­vest­ment Agree­ment... We do not be­lieve in giv­ing any as­sur­ances or un­der­tak­ings at this point of time that would jeop­ar­dise ac­cess of In­dian public to af­ford­able health­care. We are ex­tremely pos­i­tive and ex­tremely prag­matic about both of th­ese agree­ments. We are very in­ter­ested in both th­ese agree­ments.

The USFDA’s mea­sures against In­dian drug mak­ers have been in fo­cus for some time. Will you en­gage at a gov­ern­ment-level dis­cus­sion to han­dle this? As far as the mea­sures taken by FDA are con­cerned, I think reg­u­la­tors have the right to do what they be­lieve is ap­pro­pri­ate in the in­ter­est of the health of their pop­u­la­tion. So, what they do is fair enough. But the is­sue is how well equipped are the In­dian com­pa­nies to re­spond to this. The gov­ern­ment sup­ports our in­dus­try. Not one In­dian com­pany will com­pro­mise on the qual­ity and they are able to meet the re­quire­ments of such very de­mand­ing mar­kets. This is borne out by the fact that for the very year that the FDA made sev­eral in­ter­ven­tions, our growth has been 33% in the same US mar­ket dur­ing the last fi­nan­cial year.

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