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Why it sits on the critical path

Equipment arrives in weeks. Approvals take months.

Facility openings are rarely delayed by supply. They are delayed by a room layout that was never submitted to AERB, a bio-medical waste authorisation nobody applied for, or a drug licence filed without a registered pharmacist on record. We run the licensing track in parallel with the build and the procurement — from the day the site plan is drawn — so the paperwork is ready when the doors are.

Scope

Six approval tracks, one register

These are the only areas we take on. Each is a track we file end to end — application, technical annexures, liaison, inspection, grant, and renewal. If your facility needs something outside these six, we will say so and point you to the right specialist rather than take it on.

Track 01

Drug licences

Filed with the State Food & Drug Administration under the Drugs and Cosmetics Act, 1940 and Rules, 1945. The application itself is short; what decides the timeline is the premises evidence, the qualified-person record and the storage proof. We build all three before filing, which is why queries are rare.

Track 02

Medical device licences

Devices moved from the Drugs regime into the Medical Devices Rules, 2017, and risk classification now decides who licenses you and how much technical evidence is required. We classify each SKU first — Class A, B, C or D — then file only what that class actually needs.

Track 03

AERB radiation approvals

Any facility with an X-ray tube or a radioactive source needs clearance from the Atomic Energy Regulatory Board, filed on the eLORA portal. This is the track that most often stalls an imaging department, because the room has usually already been built by the time anyone reads the safety code. We start at drawing stage instead.

Track 04

PCPNDT registration

Under the Pre-Conception and Pre-Natal Diagnostic Techniques Act, 1994, every machine capable of detecting foetal sex must be registered before it is switched on, and the record-keeping obligation is continuous. Enforcement is district-level and strict — sealed machines and suspended registrations usually follow a paperwork failure, not a clinical one.

Track 05

FSSAI licensing

A hospital kitchen is a food business. Diet kitchens, patient meal services, staff canteens and leased cafeterias each need to sit under the correct FSSAI tier, and inspectors look at the same premises a health officer already visited — with a different checklist.

Track 06

Hospital statutory paperwork

The bulk of the work, and the part that is almost always underestimated. A mid-sized hospital carries between fifteen and thirty live registrations across half a dozen authorities, each with its own renewal cycle, return and inspection. We build the full register for your facility, file what is missing, and hand you a calendar you can audit against.

How the engagement runs

From site plan to grant, in six stages

The same sequence whether we are licensing a single ultrasound machine or opening a 100-bed hospital. What changes is the number of parallel tracks.

Working with local bodies

The rules are national. The practice is local.

Two districts in the same state will ask for different annexures for the same licence. Ward-level health officers, district Appropriate Authorities and regional pollution board offices each have their own filing habits, sitting days and preferred formats. We work to the local practice rather than the circular, and we do not hand you a form and wish you luck — we sit in the queue.

Who we do this for

New builds, expansions and clean-ups

Compliance work usually arrives in one of three shapes: a facility being built, a facility adding a department or a machine, or a facility that has received a notice. We take all three, and the second and third are the more common.

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