USFDA Ac­cuses In­dian CRO Sem­ler of Data Ma­nip­u­la­tion

Ma­nip­u­la­tion of data found in stud­ies filed by drug mak­ers for reg­u­la­tory ap­proval

The Economic Times - - Companies: Pursuit Of Profit - Prabha.Ragha­van @times­group.com

New Delhi: The US Food and Drug Ad­min­is­tra­tion (USFDA) has pulled up an In­dian com­pany pro­vid­ing clin­i­cal re­search ser­vices to drug devel­op­ers, ac­cus­ing it of data ma­nip­u­la­tion. The reg­u­la­tor told the com­pa­nies that have filed for drug ap­proval based on data sup­plied by Sem­ler Re­search to re­peat the stud­ies else­where.

This is an­other reg­u­la­tory blow to the In­dian drug in­dus­try, with sev­eral top phar­ma­ceu­ti­cal com­pa­nies al­ready un­der the watch of USFDA for vi­o­la­tion of its man­u­fac­tur­ing stan­dards. The US is the big­gest for­eign mar­ket for In­dia’s phar­ma­ceu­ti­cal in­dus­try.

The lat­est de­vel­op­ment has a re­sem­blance to the ac­tions of the Euro­pean Medicines Agency against Hy­der­abad-based GVK Bio­sciences, which was ac­cused of ma­nip­u­la­tion of data for scores of generic drugs. That is­sue had snow­balled into a govern­ment-level con­tro­versy and de­railed dis­cus­sions re­lated to EU-In­dia FTA.

Ben­galuru-based clin­i­cal re­search or­gan­i­sa­tion (CRO) Sem­ler is named for ma­nip­u­la­tion of data in bioe­quiv­a­lence and bioavail­abil­ity stud­ies that were filed by drug mak­ers for reg­u­la­tory clear­ances. In broad terms, CROs work on projects from phar­ma­ceu­ti­cal com­pa­nies and the data they pro­vide are used in prod­uct fil­ings.

In­spec­tions at Sem­ler be­tween Septem­ber 29 and Oc­to­ber 9, 2015, found sig­nif­i­cant in­stances of mis­con­duct and vi­o­la­tions of fed­eral reg­u­la­tions, in­clud­ing the sub­sti­tu­tion and ma­nip­u­la­tion of study sub­ject sam­ples, the US reg­u­la­tor said.

Aspokesper­son for Sem­ler said the com­pany is in the process of re­view­ing the con­cerns raised. “We have en­gaged high qual­ity con­sult­ing firm to re­view the data and we would be pro­vid­ing a de­tailed re­sponse to th­ese con­cerns with ap­pro­pri­ate steps un­der­taken as ad­vised by the agency,” the spokesper­son told ET.

FDA’s April 20 note in­formed spon­sors — the com­pa­nies for which Sem­ler con­ducted the stud­ies — that the In­dian firm’s stud­ies were not ac­cept­able due to “data in­tegrity con­cerns” and, hence, needed to be re­peated. Th­ese com­pa­nies had filed ap­pli­ca­tions for the ap­proval of new drugs and generic ver­sions. The spon­sors have to re­spond within 30 days with an amend­ment to their ap­pli­ca­tion, ac­cord­ing to a let­ter by the reg­u­la­tor.

The reg­u­la­tor has also sent Sem­ler an “Un­ti­tled Let­ter” de­tail­ing its find­ings re­lated to the fa­cil­ity, ac­cord­ing to the no­ti­fi­ca­tion. The let­ter lists dis­crep­an­cies in the com­pany’s stud­ies, in­clud­ing al­leged re­place­ment of plasma sam­ples of cer­tain sub­jects with those of oth­ers that were al­ready an­a­lysed.

“This sub­sti­tu­tion of sam­ples un­der­mines the re­li­a­bil­ity and va­lid­ity of the an­a­lyt­i­cal meth­ods used at your firm and the study data pro­duced by your firm,” stated the let­ter. The com­pany spokesper­son said the reg­u­la­tor no­ti­fied that it had not iden­ti­fied any se­ri­ous safety con­cerns with the prod­ucts for which it con­ducted the stud­ies. Sem­ler has con­ducted more than 750 drug stud­ies rang­ing in size from 40 to 400 vol­un­teers in var­i­ous ther­a­peu­tic ar­eas for reg­u­la­tory sub­mis­sions, ac­cord­ing to its web­site.

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