Europe to suspend about 100 generic drugs after uncovering data 'irregularities' at Indian CRO - Endpoints News

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The Eu­ro­pean Med­i­cines Agency is rec­om­mend­ing the sus­pen­sion of about 100 drugs af­ter find­ing da­ta in­tegri­ty is­sues at an In­dia-based CRO that ran tests for the gener­ic drugs.

The CRO in ques­tion, Syn­chron Re­search Ser­vices, isn’t the first to come un­der the mi­cro­scope for da­ta fail­ings. The FDA and EMA have raised sim­i­lar ques­tions in the past re­gard­ing da­ta find­ings from sev­er­al In­dia-based CROs, in­clud­ing Sem­ler Re­search and GVK Bio­sciences. In the case of Sem­ler, as in the case of Syn­chron, reg­u­la­tors are re­quir­ing the drug spon­sors to re­peat their bioe­quiv­a­lence/bioavail­abil­i­ty stud­ies at an ac­cept­able al­ter­nate study site.

Syn­chron al­so came un­der fire from FDA last Sep­tem­ber over sim­i­lar da­ta con­cerns.

“The rec­om­men­da­tion comes af­ter ir­reg­u­lar­i­ties were found in how the CRO car­ried out bioe­quiv­a­lence stud­ies, which raised se­ri­ous con­cerns about the com­pa­ny’s qual­i­ty man­age­ment sys­tem and the re­li­a­bil­i­ty of da­ta from that site,” the EMA said in a state­ment on Fri­day.

Com­pa­nies with af­fect­ed gener­ic drugs in­clude J&J, San­doz, Vi­a­tris, Te­va, Ju­bi­lant, Wock­hardt, Ac­cord Health­care, Au­ro­ra Bio­far­ma, Strides Phar­ma, Tillomed Phar­ma, Ori­farm Gener­ics, Sta­da, Brill­phar­ma, Mi­cro Labs, ra­tio­pharm, Ben­net Phar­ma­ceu­ti­ca, Med­icair Bio­science Lab­o­ra­to­ries, Pinewood Lab­o­ra­to­ries and more.

But the EMA warned mem­ber states that some of the drugs rec­om­mend­ed for sus­pen­sion “may be of crit­i­cal im­por­tance (e.g. due to lack of avail­able al­ter­na­tives) in a giv­en EU Mem­ber State. There­fore na­tion­al au­thor­i­ties can tem­porar­i­ly post­pone the sus­pen­sion in the in­ter­est of pa­tients. Mem­ber States should al­so de­cide whether re­calls of the af­fect­ed med­i­cines are need­ed in their ter­ri­to­ries.”

As far as what specif­i­cal­ly the reg­u­la­tors are con­cerned with, ac­cord­ing to the FDA’s un­ti­tled let­ter to Syn­chron last year, an in­spec­tion from 2019:

found un­usu­al and un­ex­plain­able study records demon­strat­ing that you en­gaged in prac­tices and process­es that un­der­mined the an­a­lyt­i­cal meth­ods used at your firm. Up­on close re­view of study records from your firm, we con­clude that those prac­tices and process­es re­sult­ed in the sub­mis­sion of fal­si­fied study da­ta to the FDA.

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Europe to suspend about 100 generic drugs after uncovering data 'irregularities' at Indian CRO - Endpoints News
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