MNC Pharma Lobby Pushes for Sin­gle Drug Author­ity Here

Or­gan­i­sa­tion of Phar­ma­ceu­ti­cal Pro­duc­ers of In­dia also wants spe­cial courts for faster dis­posal of patents and IP dis­putes

The Economic Times - - Brands & Companies - CR.Suku­mar@ times­group.com

Hy­der­abad: A lobby group of multi­na­tional phar­ma­ceu­ti­cal com­pa­nies (MNCs) is push­ing for re­plac­ing state-based mul­ti­ple drug author­i­ties with a sin­gle body for more ef­fec­tive pro­tec­tion of in­tel­lec­tual prop­erty (IP) and patents. The Or­gan­i­sa­tion of Phar­ma­ceu­ti­cal Pro­duc­ers of In­dia (OPPI), which rep­re­sents 22 pharma com­pa­nies, in­clud­ing Ab­bott, Pfizer, No­var­tis, Novo Nordisk and Sanofi, also wants spe­cialised pa­tent courts for fast dis­posal of patents and IP dis­putes.

Kan­chana TK, di­rec­tor gen­eral, OPPI, said the gov­ern­ment’s move to dis­man­tle For­eign In­vest­ment Pro­mo­tion Board (FIPB) and au­to­matic for­eign di­rect in­vest­ment (FDI) ap­provals doesn’t serve the in­tended pur­pose un­less drug re­search and de­vel­op­ment (R&D), in­no­va­tion and ex­ports are ad­e­quately in­cen­tivised.

“What is wor­ry­ing global pharma com­pa­nies in In­dia is the IP pro­tec­tion and un­pre­dictabil­ity over ease of do­ing busi­ness,” Kan­chana told ET. “The bud­get did not ad­dress our key ap­peals for a sim­pli­fied reg­u­la­tory regime with­out mul­ti­plic­ity, a sta­ble price con­trol mech­a­nism in con­sul­ta­tion with the in­dus­try, and a sim­pli­fied clin­i­cal tri­als regime.”

OPPI in­sists that the gov­ern­ment should im­me­di­ately look at fast­track­ing poli­cies that im­pact hu­man lives. “De­ci­sions on new ther­a­pies and new drug ap­provals should be fast-tracked by cir­cum­vent­ing the usual reg­u­la­tory process while en­sur­ing safety mea­sures in the form of num­ber of clin­i­cal tri­als and data,” she said. Kan­chana said OPPI wants the gov­ern­ment to also look at re­vamp­ing its teams of tech­ni­cal ex­perts in the drug ap­proval ma­chin­ery, given the emerg­ing tech­nolo­gies and rev­o­lu­tion­ary drug ther­a­pies.

In­sist­ing that In­dia should do away with the mul­ti­plic­ity of state-based drug reg­u­la­tors in the in­ter­est of both pa­tients and global drug in­no­va­tors, Kan­chana said, “State-based drug reg­u­la­tors are not equipped to check be­fore grant­ing man­u­fac­tur­ing ap­provals if the drug was patented by some­one else, lead­ing to pa­tent in­fringe­ment. Sec­ondly, state drug reg­u­la­tors are also not equipped to check if the new drug they are ap­prov­ing for man­u­fac­tur­ing has all the re­quire­ments in place in terms of pa­tient safety like clin­i­cal tri­als”.

Flag­ging con­cerns over ille­quipped state drug reg­u­la­tory bod­ies, Kan­chana said, “We are wor­ried that the states are not equipped with data, which leads to in­fring­ing on pa­tients’ safety and then on patents.” Ac­cord­ing to Kan­chana, pharma com­pa­nies are dis­ap­pointed with the gov­ern­ment’s pro­pos­als in the Bud­get. OPPI is of the view that most of the ini­tia­tives will be­come re­dun­dant un­less se­ri­ous mea­sures are taken to pro­tect in­no­va­tions and patents in In­dia, in­clud­ing set­ting up of some kind of a uni­ver­sal drug author­ity that mon­i­tors drug man­u­fac­tur­ing ap­provals across the states.

“To have sin­gu­lar fo­cus on drug af­ford­abil­ity is not go­ing to solve the prob­lem of ac­cess,” said Kan­chana, adding that the gov­ern­ment should look to spend more on pub­lic health­care in­fras­truc­ture to im­prove ac­cess to health­care.

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