# Bioequivalence study NOC applications and subsequent approval

Source: https://saideeppharma.com/services/be-noc-application/
Provider: Saideep Pharma Solution, Ghaziabad, Uttar Pradesh, India
Last reviewed: 2026-08-23

A BE NOC is a no objection certificate from CDSCO permitting a bioequivalence study to be conducted, commonly for products intended for export. It requires an approved BA/BE centre, a reviewed protocol, approval from a CDSCO-registered ethics committee, and a test licence covering manufacture of the study batch.

## Forms and terms referenced

- **Form 29**: Test licence for the study batch
- **Ethics Committee**: Registration with CDSCO required before approval

## What has to be in place before the NOC is filed

Four things, and they can be built in parallel. The study has to be sited at a BA/BE centre that CDSCO has approved. The protocol has to be written and internally reviewed. An ethics committee registered with CDSCO has to have granted approval. And the batch to be studied needs a test licence in Form 29.

Applications that arrive with any one of the four missing are held, and the holding period is dead time.

## Protocol review before submission

We read the protocol as a reviewer would. Sample size justification, choice of reference product and its sourcing, washout period, sampling schedule, the bioanalytical method and its validation status, and the statistical plan for the confidence intervals.

The reference product is the recurring problem. Sourcing it, documenting the chain of custody, and demonstrating it is the correct comparator for the intended market is more work than most sponsors budget for.

## After the NOC

The NOC is a permission, not the end of the file. Study conduct has to match the approved protocol, deviations have to be documented, and the report has to be assembled in a form the destination regulator will accept.

We stay on the file through to the study report and any subsequent approval that depends on it, rather than closing out at the NOC.

## What you need to supply

- Draft study protocol and informed consent documents
- Details of the proposed BA/BE centre and its CDSCO approval status
- Ethics committee registration certificate and approval letter
- Test licence in Form 29 for the study batch
- Reference product sourcing documentation
- Bioanalytical method validation report

## Questions we get asked

**When is a BE NOC required?**

Most commonly when a bioequivalence study is being conducted in India on a product intended for export, and in defined domestic situations under the New Drugs and Clinical Trials Rules, 2019. Whether your specific product and market combination requires one should be confirmed before study planning begins.

**Does the ethics committee need to be registered with CDSCO?**

Yes. An ethics committee reviewing a study of this kind must itself be registered with the Central Licensing Authority. Approval from an unregistered committee will not support the application, and this is a common reason files are returned.

**Can the study batch be manufactured under our existing licence?**

Not ordinarily. Manufacture for test, examination or analysis needs a test licence in Form 29 from the State Licensing Authority, which is separate from a commercial manufacturing licence. Plan for it early, because it often sits on the critical path.

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