India's prior intimation route for export BA/BE studies: what acknowledgement changes

Speaking at iPHEX 2026 in September, CDSCO Joint Drug Controller Dr Ranga Chandrashekhar described a regulator reviewing its approval pathway for steps where it can step back without weakening quality. Two examples were reported: manufacture for testing and analysis moving from prior approval to prior intimation, and, for bioavailability and bioequivalence studies, standardised study designs that allow prior intimation for data generated for export (ANI).

For Indian BA/BE CROs, the second point is already practice rather than policy. The New Drugs and Clinical Trials (Second Amendment) Rules, 2026 were notified on 21 January 2026 as G.S.R. 50(E), and CDSCO has published FAQs on the prior intimation mechanism. According to CDSCO's implementation circular of 20 April 2026, the online route on the SUGAM portal has operated since 21 April 2026. The details below are taken from those two documents, and anyone relying on the route should read them in full.

What the route covers

Prior intimation applies to a narrow class of studies: export-only, single-dose, two-period, two-sequence, two-treatment crossover BA/BE studies of eligible oral drugs in normal healthy adult volunteers, with a sample size of at least 18. The drug has to be approved in India or in one of the named reference markets: the US, the EU, Japan, Australia, Canada or the UK. Cytotoxic, hormonal, narcotic and psychotropic drugs are excluded, as are drugs with a narrow therapeutic index and drugs with highly variable pharmacokinetics.

The intimation is made on Form CT-05 through SUGAM, and it has to include approval from an ethics committee registered with the Central Licencing Authority under Rule 8 of the NDCT Rules. That committee keeps separate records of its review and approval of these studies, and the Central Licencing Authority reviews those records when the committee's registration comes up for renewal. Studies outside these limits continue to need prior permission.

What acknowledgement changes before study initiation

For an eligible study, the acknowledgement generated on SUGAM replaces the standard prior-permission pathway. The study does not wait for a CDSCO reviewer to examine the application and grant permission before volunteers are dosed.

That does not mean the study is unreviewed. A registered ethics committee still reviews and approves it, and CDSCO's oversight continues through the committee's records and its own powers to suspend or cancel. What changes is where the eligibility case is made. Under prior permission, a reviewer would read the application and could question whether the study belonged in a simplified category. Under prior intimation, the sponsor and the CRO have to establish and document eligibility before the CT-05 is filed, because the acknowledgement records what was intimated rather than a judgement on it.

The FAQs add two points that affect planning. Changes are not accepted after acknowledgement (Q17), so a protocol that needs amending after filing is not a routine matter; teams should seek CDSCO's clarification before proposing any change. And an acknowledgement is normally valid for one year (Q15), subject to suspension or cancellation, with extension only in exceptional circumstances.

Two eligibility judgements that need a written basis

Most of the eligibility conditions are simple facts: the design, the population, the dose, the reference market. Two are judgements.

Highly variable pharmacokinetics. Neither G.S.R. 50(E) nor the FAQs give a numerical threshold for when a drug counts as highly variable. Teams should record the evidence they relied on, such as published studies, pilot data or product-specific guidance from the target market, and the reasoning that led them to treat the drug as eligible. Where a molecule is close to the line, the safer course is to ask CDSCO before filing.

Narrow therapeutic index. Regulators do not all publish the same list, and a drug treated as narrow therapeutic index in one market may not be in another. The file should show which list or rationale the team relied on.

A short eligibility note, signed off before filing and kept with the protocol, gives the CRO an answer if CDSCO, the ethics committee, an inspector or the sponsor's own auditor asks later why the study took this route.

Import is a separate step

Prior intimation covers the conduct of the study. It does not cover bringing study drugs into India. Importing the test or reference product still needs a separate application on Form CT-16 and prior approval (FAQ Q22). CDSCO's notice of 22 May 2026 set out an interim procedure for these import applications through the National Single Window System. The time a study can save depends on how well the eligibility case is prepared, how quickly acknowledgement follows, and how the import permission runs alongside it.

The review still happens downstream

Export BA/BE data is generated to support an ANDA in the US or a generic application in Europe or elsewhere, and those reviewers will read the protocol, the report and the bioanalytical data, and may inspect the site.

That makes consistency across documents more important, not less. The design and population in the CT-05 filing, the protocol the ethics committee approved, and the final clinical study report should describe the same study. When the CRO's report and the sponsor's Module 5 summary are written by different people months apart, a small inconsistency, such as a different sampling schedule in a synopsis or an exclusion criterion dropped from a summary table, can become a query at the receiving agency. We have written before about how correct numbers can still describe the wrong population; the same discipline applies here.

What this means for CRO and sponsor teams

The route removes the prior-permission stage for a defined class of export studies. It keeps ethics committee review and CDSCO oversight, and it moves the work of showing that a study qualifies to the people running it. For most teams that means three habits: a written eligibility note before any CT-05 is filed, one controlled version of the protocol that the filing, the ethics committee and the report all point to, and a final check that the study report describes the study that was intimated.