IndiaAI · CDSCO Hackathon 2024 Submission

AI-Powered Regulatory
Workflow Automation

ReguAI is an intelligent layer for CDSCO that automates data anonymisation, document summarisation, completeness checks, and version comparison — fully integrated with SUGAM and MD Online portals.

98%
PII Detection Accuracy
80%
Review Time Reduction
100%
DPDP Compliant
4
Core AI Modules
The Problem

CDSCO Processes 100,000+ Regulatory Documents Annually

Manual review of drug applications, SAE reports, and inspection documents is slow, inconsistent, and creates privacy risks. DPDP Act 2023 demands urgent action on data protection.

40%
of SUGAM submissions returned due to missing fields
6 hrs
average time to manually review one drug application
Zero
automated PII compliance checks before DPDP Act 2023
Core Modules

Four AI Engines. One Platform.

DPDP · NDHM · ICMR

Data Anonymisation

PII/PHI De-identification Engine

Automatically detects and removes personally identifiable information from regulatory documents using advanced NLP. Supports Aadhaar, PAN, patient IDs, medical records, names, addresses, and 12+ entity types.

Redact, Mask, Pseudonymize, or Remove
Before/after comparison view
Full DPDP Act 2023 compliance
Supports PDF, DOCX, TXT, CSV, JSON
The Problem

CDSCO receives thousands of documents containing raw patient PII — violating DPDP Act 2023. Manual anonymisation takes days and is error-prone.

ReguAI Solution

ReguAI anonymises an entire document in under 2 seconds with 98%+ accuracy, generating audit-ready compliance reports.

Data Anonymisation
PII/PHI De-identification Engine
Tech Stack

Built for Production. Ready for Integration.

React + TypeScript
Frontend
Tailwind CSS
Styling
Supabase
Auth + Database
NLP / Regex Engine
PII Detection
OpenAI API Ready
Summarisation
SUGAM REST API
Portal Integration
Integration Ready

Seamlessly Connects with CDSCO Portals

ReguAI's API layer is designed to plug directly into SUGAM, MD Online, and PvPI — fetching applications, processing them through AI modules, and posting decisions back.

SUGAM Portal
Drug applications
MD Online
Medical devices
PvPI / IPC
Pharmacovigilance

Ready to Transform CDSCO's Workflow?

Sign in with a demo account to explore all four AI modules — no setup required.