Topic guide
Specialty clinic compliance in India
Most clinics need only the basic licences. But some hit a second layer of specialty-specific compliance because of what they actually do: an IVF clinic, a clinic with an X-ray machine, a diagnostic lab, or an Ayurveda practice each carries an extra rulebook a general consulting clinic never touches. This hub pulls those extra regimes into one place.
Start with the pillar for the map of which regimes apply to you, then read the deep guide for the one that does. These rules are state-variable and evolving, so treat the guides as a starting point and confirm every specific with the relevant authority before you act.
Start here
Pillar guide
Specialty clinic compliance in India: the rules beyond the basics
Beyond basic licences, some clinics hit extra regimes: ART for IVF, AERB for X-ray, NABL for labs, AYUSH rules, PCPNDT for ultrasound. Map which apply to you.
Go deeper
Compliance
ART Act registration for IVF and fertility clinics
Every IVF and fertility clinic and ART bank must register under the ART (Regulation) Act 2021 on the National Registry. Levels, records, consent, sex selection.
· 6 min read
Compliance
AERB registration for clinic and dental X-ray machines
Any clinic with an X-ray, including dental units, needs AERB consent via the eLORA portal before use. Who needs it, the steps, RSO and room approval.
· 5 min read
Compliance
NABL accreditation for diagnostic labs in India
NABL accredits medical labs against ISO 15189. Voluntary but often required for insurer and scheme empanelment. What it is, why it matters, and how to start.
· 6 min read
Compliance
Running an AYUSH clinic in India: registration and rules
An AYUSH clinic needs two layers: register as a practitioner with the right council (NCISM or NCH), then hold the usual clinic licences on top.
· 5 min read
Compliance
PCPNDT registration for clinics using ultrasound
Any clinic with an ultrasound or imaging machine must register under the PC&PNDT Act 1994. Who needs it, the process, Form F, validity and penalties.
· 4 min read
Compliance
Do clinics need a drug license to dispense medicines?
When a clinic needs a retail drug license, the doctor's-own-dispensing exemption and its limits, and what Form 20 and Form 21 actually cover.
· 4 min read
Compliance
NABH entry-level certification for small clinics in India: a plain-English guide
NABH entry-level certification is a voluntary quality recognition for small clinics, not a statutory licence. Here is who needs it and how it works.
· 5 min read
Compliance
Why insurers now ask clinics for NABH: cashless empanelment and entry-level certification
How NABH entry-level certification can support TPA and insurer empanelment for cashless, what documents and audits to expect, and whether it is worth it.
· 5 min read
Frequently asked questions
- What is specialty clinic compliance?
- It is the extra layer of registration and accreditation that only some clinics hit because of their services, on top of the basic licences every clinic needs. Examples are ART registration for IVF, AERB licensing for X-ray, NABL accreditation for labs, AYUSH practitioner rules, and PCPNDT for ultrasound.
- How do I know which specialty rules apply to my clinic?
- Work from what your clinic actually does. An ultrasound triggers PCPNDT, an X-ray or CT triggers AERB, a diagnostic lab points to NABL, IVF triggers the ART framework, and an AYUSH system changes which council you register with. Most clinics hit none of these. The pillar guide has a map.
- Do these specialty registrations replace the basic licences?
- No. They sit on top. An IVF clinic still needs clinical-establishment registration, biomedical-waste handling, and GST where applicable, plus its ART registration. The layers add up rather than substitute, and the slow specialty approvals are the ones to start early.
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