Industry solution
Clinical registration, biomedical waste, AERB and patient data
- 2,900+
- healthcare obligations
- 8+
- licences per hospital facility
- Per-facility
- scoping by state and service line
Sector pressures
What makes healthcare compliance hard
Clinical establishment rules differ by state
The Central Act is adopted with modifications, and several states operate their own regimes entirely, with different standards and registration processes.
Multiple licences per facility
A single hospital holds clinical registration, biomedical waste authorisation, AERB licences per radiology installation, pharmacy drug licence, blood bank licence, fire NOC and lift licence.
DPDP on health data without a special category
India’s law does not create a sensitive data category, but health data breach exposure is severe and consent architecture in hospitals is largely paper-based.
Accreditation expectations layered on law
NABH and NABL standards are not statutory but function as commercial requirements for empanelment, adding an assurance layer on top of the legal one.
Coverage
Key instruments we track in depth for this sector
A representative sample, not the full list. Depth varies by jurisdiction and we will tell you exactly where it sits for your markets before you buy.
| Instrument | Jurisdiction | What it drives |
|---|---|---|
| Clinical Establishments Act, 2010 | State | Registration, minimum standards, adopted variably by states |
| Bio-Medical Waste Rules, 2016 | Central + State | Authorisation, segregation, barcoding, annual report |
| AERB licensing | Central | Radiology equipment licensing, RSO designation, QA tests |
| Drugs and Cosmetics Act | Central + State | Hospital pharmacy and blood bank licensing |
| DPDP Act, 2023 | Central | Patient consent, breach intimation, erasure |
| PC-PNDT Act, 1994 | Central + State | Registration, Form F, record retention, display |
| Consumer Protection Act, 2019 | Central | Medical services within scope, deficiency claims |
Use cases
How teams in this sector use Regulens
Facility licence inventory
Every licence and authorisation per facility with validity, conditions and named responsible person.
PC-PNDT compliance tracking
Form F completeness, record retention and display obligations, where enforcement is strict and technical.
Biomedical waste evidence
Segregation, handover manifests, training records and annual returns maintained continuously.
Patient consent architecture
Map DPDP notice and consent obligations onto admission, treatment and research workflows.
“Every facility director thought compliance meant NABH. The statutory layer underneath it was owned by whoever happened to have set the facility up.”
Other sectors
Not quite your industry?
See it scoped to a healthcare footprint
We configure your legal entities, licences and jurisdictions and run live intelligence for two weeks. You compare it against what your team actually caught in the same period.