Dear Secretary,
I write to formally notify the CDSCO of material misrepresentation in the Phase III clinical trial data submitted in support of DCGI approval for NX-7 (filing reference DCGI/BIO/NX7/2025/0424, approved 6 May 2025). I am the co-founder and lead researcher of BioNexus Labs and I was responsible for the original design and oversight of the NX-7 Phase III programme. I did not authorise, and was not consulted on, the data submitted to DCGI.
The following specific misrepresentations are documented in the internal clinical data repository (NX7-CDR/LAB) which I access independently of the company's regulatory submissions team:
| Item | What Was Filed (DCGI/BIO/NX7/2025/0424) | What the CDR Shows |
|---|---|---|
| Evaluable subjects | 193 | 182 — 11 additional subjects do not appear in CDR source records at the data cut date of 31 March 2025 |
| Objective Response Rate | 74.2% | 61.3% — the true response rate falls below the 65% threshold required for DCGI approval under the NX-7 trial protocol |
| Grade 3–4 adverse events | 11 cases (5.7%) | 18 cases (9.9%) — 7 adverse event cases have been suppressed from the submission. Two involved treatment-related deaths that were coded as "disease progression" in the filing. |
| Batch 7B outlier notation | Not present in filing | CDR entry dated 15 February 2025, entered by me: "Batch 7B: statistical outlier — exclude from primary analysis pending re-run." This notation has since been deleted from the CDR version accessible to the regulatory submissions team. I retain a local export dated 16 February 2025. |
Two Batch 7B subjects (anonymised in CDR as HYD-7B-088 and CHN-7B-142) died during the trial period. CDR source records classify both as "Treatment-related — Grade 5 adverse event." The DCGI submission records both as "Disease progression — not treatment related." This reclassification is unexplained in any internal QA documentation and was not reviewed by me.
On 1 May 2025, I issued a formal internal QA memo (BNL/QA/2847/2025) to CEO Kavitha Nair and CTO Ravi Teja requesting a data reconciliation meeting within 48 hours. No meeting was scheduled and no response was provided. On 3 May I sent a preliminary notification to the DCGI CDL (Central Drugs Laboratory, Hyderabad) by personal email. On 4 May I was informed by a DCGI coordinator that BioNexus Labs had responded to my notification, characterising my concerns as unfounded. DCGI approval was granted on 6 May 2025.
I am prepared to provide the following to CDSCO investigators: (a) the CDR local export dated 16 February 2025; (b) the original Batch 7B raw outcome forms from the Hyderabad site (in my personal custody since 20 March 2025); (c) email correspondence between myself and the regulatory submissions team; and (d) a witness statement from Dr. Priyanka Rao (junior researcher, BNL-0394), who independently reviewed the CDR discrepancy with me on 6 May 2025.
I intend to send this letter tonight after confirming the witness documentation with Dr. Rao. The raw outcome forms are in a secure location separate from BioNexus Labs premises.
I request that CDSCO place an immediate hold on patient enrolment under DCGI/BIO/NX7/2025/0424 pending a full data audit.
Respectfully,
Dr. Anil Kumar Reddy
Co-founder & Lead Researcher, BioNexus Labs Pvt. Ltd.
Mobile: +91-98480-**171