Ziller Medical Denied Manufacturing Nod for Cervical Cerclage Pessary Over Inadequate Safety Data
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has refused to grant manufacturing permission for the Cervical Cerclage Pessary (Feto Safe) proposed by Ziller Medical Inc., Chennai.
The company had submitted an application seeking approval to manufacture the Cervical Cerclage Pessary (Feto Safe) device in India. The product is designed to provide mechanical support to the cervix during pregnancy, reducing the risk of preterm birth and miscarriage in women with cervical insufficiency.
As part of its application, Ziller Medical Inc. presented clinical investigation data generated on the Indian population, aiming to demonstrate the device’s safety and efficacy profile for local regulatory clearance.
The firm had requested permission to manufacture the said device in the country and presented clinical investigation data generated on the Indian population. After detailed deliberation, the committee opined that the clinical study data produced by the firm was not adequate to demonstrate the safety and performance of the device.
The committee raised the following concerns:
- The selection of population was not appropriate.
- The data produced was not robust to prove patient safety.
- Major adverse events reported were not described properly in terms of maternal and neonatal outcomes.
In view of these concerns, the committee recommended that the firm should generate additional multicentric clinical study data addressing the issues raised by the experts. Accordingly, the applicant has been directed to submit a clinical study protocol for conducting a multicentric study to prove the safety and performance of the device.
The recommendation was made during the 8th SEC (Reproductive) meeting held on September 18, 2025, at CDSCO headquarters in New Delhi.
