USFDA's action follows inspections at the facilities of Ahmedabad-based Synchron and Navi Mumbai-based Panexcell, as well as its own analyses of study data generated at these CROs and submitted in several applicationsThe US drug regulator has asked several pharmaceutical companies to repeat the studies conducted at two Indian contract research organisations (CROs) - Synchron Research Services and Panexcell Clinical Lab - over data integrity concerns.

The US Food and Drug Administration's (USFDA's) action follows inspections at the facilities of Ahmedabad-based Synchron and Navi Mumbai-based Panexcell, as well as its own analyses of study data generated at these CROs and submitted in several applications.

The inspections and data analyses revealed significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to the FDA, the regulator said in a notification which has been reviewed by ET.CROs help pharmaceutical companies conduct phase 1-4 clinical trials for new drugs (NDAs) as well as bioequivalence studies for generic/abbreviated new drug applications (ANDAs). Details of the companies which have conducted studies at Synchron and Panexcell could not be ascertained immediately.

However, as per the USFDA's Orange Book, Emcure Pharmaceuticals, which sponsored a study, has been given a therapeutic equivalence (TE) rating of 'BX', suggesting that data to support the therapeutic effect of its generic drug is not sufficient. Emails sent to Panexcell, Synchron and Emcure Pharmaceuticals remained unanswered till the time of going to press.

Emcure's drug with the active ingredient of oxybutynin chloride (antispasmodics), with an approval date of May 10, 2019, has been given the 'BX' rating. The USFDA has directed the companies which have conducted studies at Synchron and Panexcell to respond within 30 days with their plans to either repeat their bioequivalence studies at a site other than Panexcell or Synchron, or voluntarily withdraw their products from the market.

Last week, the FDA had notified the sponsors of NDAs and ANDAs that clinical and bioanalytical studies conducted by Synchron or Panexcell are not acceptable because of data integrity concerns, and the studies must be repeated.