Guide
How to start a diagnostic centre in India
What a diagnostic centre must register depends almost entirely on what equipment it installs. A pathology lab and an imaging centre are regulated quite differently, and the two approvals that carry criminal consequences — PCPNDT and AERB — are both triggered by a machine arriving rather than by opening the doors. Decide the equipment list first; the paperwork follows from it.
Draft — pending expert review
This page was prepared from the official sources listed below but has not yet been reviewed by a qualified professional. It is general information, not legal or medical advice.
Two approvals must be in hand BEFORE the equipment is installed, not before it is used: PCPNDT for any ultrasound, AERB for anything emitting ionising radiation. Ordering the machine first is the expensive mistake.
- Decide first
- The equipment list
- Before any ultrasound
- PCPNDT registration
- Before any X-ray or CT
- AERB licence (eLORA)
- Optional but valuable
- NABL accreditation
Start here
Which law registers you depends on your state
As with any clinical establishment, registration is governed either by the central Clinical Establishments Act 2010 or by your own state's legislation — the central Act has been adopted by nineteen States and Union Territories and not by the rest. The nursing home guide sets out that split in full; it applies identically here, and it is worth settling before anything else.
What is specific to diagnostics is that registration is rarely the binding constraint. The equipment approvals are.
By equipment
What each kind of centre actually needs
| If you install | You need | Notes |
|---|---|---|
| Pathology only (no imaging) | State establishment registration · BMW authorisation · trade licence · a qualified pathologist on record | No PCPNDT, no AERB. The simplest path, and the one most independent labs take. |
| Ultrasound (any machine) | Everything above PLUS PCPNDT registration | Required BEFORE installation. A machine capable of sex determination used without it is a criminal offence, not a penalty. |
| X-ray, CT, mammography | Everything above PLUS an AERB licence for equipment and room | Applied for through the eLORA portal. Room shielding is part of what is approved, so it affects the building work. |
| Collection centre only | Establishment registration · BMW authorisation · an agreement with the processing lab | No analytical licence of its own, but the reporting lab's accreditation does not automatically extend to it. |
The serious two
PCPNDT and AERB are not paperwork
PCPNDT. The Pre-Conception and Pre-Natal Diagnostic Techniques Act exists to prevent sex determination, and it treats an unregistered machine as an offence rather than an irregularity. Registration must be in place before an ultrasound is installed or used. Once operating, the obligations are continuous: Form F completed for every prenatal scan, a machine and sonographer register kept current, and a monthly return to the Appropriate Authority. Sonographers must hold the prescribed qualification, and the registration is tied to named individuals and named machines — so a locum or a replacement probe is a change that has to be recorded, not absorbed.
AERB. Anything emitting ionising radiation — X-ray, CT, mammography — is licensed through the Atomic Energy Regulatory Board's eLORA portal, and the licence covers the room as well as the machine. Shielding is part of what gets approved, which means it constrains the building work rather than following it. A radiation safety officer is required at the levels where the rules specify one.
Both approvals take real time — commonly a month or two once a complete application is in. A machine bought before the licence is a machine sitting idle under depreciation, which is why the equipment list belongs at the start of the plan and not the middle.
Accreditation
NABL: optional, and worth being clear-eyed about
NABL accreditation is not a licence and not a legal requirement to operate. What it does is open doors: corporate contracts, insurer and TPA empanelment, and referral relationships frequently require it, and it usually supports better price realisation.
It also imposes real discipline — documented procedures, internal quality control, proficiency testing, calibration records, competence records for each analyst. That is a genuine operating cost, and a laboratory that pursues accreditation purely for the certificate rather than the practice usually finds the surveillance assessment unpleasant. The honest framing is that NABL is a commercial decision with a quality obligation attached, and it is much easier to build those records from opening day than to assemble them retrospectively.
Afterwards
What a working laboratory has to keep
- Bio-medical waste records by colour category, daily, with the annual return to the Pollution Control Board.
- For any prenatal ultrasound, Form F per scan and the monthly return — the single heaviest ongoing record in this list.
- Quality control runs with the acceptance decision recorded, and calibration and maintenance records per instrument.
- Result records that show who entered and who verified each result, kept distinct from one another.
- Patient data handled under the DPDP Act 2023, with consent recorded.
The verification trail matters more than it first appears. A result that has been entered is not a result that has been checked, and a report that does not distinguish the two is a clinical hazard as well as an audit finding.
Official references
- The Clinical Establishments (Registration and Regulation) Act — official portal ↗Ministry of Health and Family Welfare, Government of India
- eLORA — licensing of radiation facilities and equipment ↗Atomic Energy Regulatory Board
- National Accreditation Board for Testing and Calibration Laboratories ↗NABL, Quality Council of India
Requirements, fees and timelines vary by state and change. Confirm current requirements with your own state authority and with AERB before ordering equipment.
Next
Related
- Starting a nursing homeThe bedded-facility path, and which state law governs registration where you are.Read more →
- Westgard rulesThe multi-rule quality control a laboratory judges its control runs against.Read more →
- Software for diagnostic centresOrder to report — accessioning, results, verification and the report itself.Read more →
The lab record that stands up to an assessment