There is no single clinic licence in India. What people call clinic registration is a set of separate permissions from different authorities, under different laws, on different renewal cycles, and only some apply to any one practice. A consulting-only paediatrician in a rented room and a four-doctor polyclinic with an ultrasound and a dispensing counter end up with very different stacks of paper.
The fastest way through is to answer five questions about what your clinic does, then collect only what those answers trigger.
Do you practise medicine yourself, and under which council?
Is the premises a clinical establishment in your state's eyes?
Do you hand medicines to patients, and to whom?
Do you generate any clinical waste at all?
Do you have an ultrasound machine, or employ staff, or sell anything taxable?
Your own registration with the state medical council
This is the one that travels with you, not with the building. Section 34 of the National Medical Commission Act, 2019 bars anyone not enrolled in the State Register or the National Register from practising as a qualified medical practitioner, from holding a post meant for a physician or surgeon, from signing a medical or fitness certificate, and from giving expert medical evidence. Contravention carries up to a year's imprisonment, a fine up to ₹5 lakh, or both.
Associate doctors and visiting consultants belong in this file too: many establishment forms ask for a council certificate for every clinician on the premises.
Establishment registration for the premises
In states that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, a one-room clinic run by a single doctor is covered, through a provisional and then a permanent route. Several large states have not adopted it and regulate clinics under their own laws instead. Our article on Clinical Establishment Act registration works through which list your state is on and what the application asks for. Do this one first: it is the registration most other bodies ask to see a copy of.
Drug licence, or the Schedule K exemption
This is the question people get wrong most often. The answer sits in Schedule K of the Drugs and Cosmetics Rules, 1945, read with Rule 123.
Entry 5 exempts drugs supplied by a registered medical practitioner to their own patient from the whole of Chapter IV of the Act and the Rules, which is where the sale licence sits. The boundary is written into the entry: it applies provided the practitioner is not keeping an open shop, not selling across the counter, and not otherwise trading in drugs to a degree that would make Chapter IV apply.
It is not unconditional either. Buy only from a licensed dealer or manufacturer, and keep purchase records showing drug names and quantities with batch numbers and the manufacturers' names and addresses, open to inspection. For anything containing a Schedule G, H or X substance, the medicine carries your name and address, and at supply you record the medicine, dose, patient name, date and prescriber.
Cross that boundary by selling to anyone with another doctor's prescription and you are a retail pharmacy, needing a retail drug licence and a registered pharmacist. Our guide to clinic pharmacies covers what changes on that side of the line.
Biomedical waste authorisation
Every clinic generating clinical waste needs authorisation from the State Pollution Control Board, or the Pollution Control Committee in a Union Territory. Rule 10 of the Bio-Medical Waste Management Rules, 2016 applies "irrespective of the quantity", so there is no small-clinic exemption, and for a non-bedded clinic it is one time, not an annual renewal. Segregation, records and the annual return are in our companion piece on biomedical waste.
PCPNDT, if there is any ultrasound in the building
Section 18 of the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 stops a Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic operating unless registered with the Appropriate Authority. Section 19 requires the certificate to be renewed as the Rules prescribe, and displayed.
Treat this as the highest-stakes item here. Section 23 punishes a medical professional who contravenes the Act with up to three years in prison and a fine up to ₹10,000 for a first offence, rising to five years and ₹50,000 on a later conviction. The Appropriate Authority also reports the name to the State Medical Council, which may suspend registration during prosecution and remove the name for five years on a first conviction, permanently after that. A gynaecologist with a bedside scanner is inside this Act.
Fire clearance
There is no national fire NOC rule for clinics. Requirements come from state fire safety rules and the National Building Code, read with local bye-laws, and whether they bite depends on the building, its height and its occupancy classification. NABH's fire safety advisory asks healthcare organisations to obtain valid NOCs from their state fire department, then adds a branch for facilities where a fire NOC is not applicable. Put the question to your own state fire service.
Shops and establishments, if you employ anyone
Labour registration is state law and the thresholds differ. Maharashtra requires an employer with ten or more workers to register online in Form A, while an establishment with fewer than ten only files an intimation of commencement of business in Form F. Other states set different numbers and define "commercial establishment" differently, so whether a doctor's clinic is inside it is a state-by-state question. Check your own state's Act before assuming you are outside.
GST registration
Health care services by a clinical establishment are exempt under Sl. No. 74 of Notification 12/2017-Central Tax (Rate), and a person dealing exclusively in wholly exempt supplies need not register at all. A consulting-only practice usually has nothing to do here.
That changes the moment you make taxable supplies. Dispensing medicines, selling devices or consumables, or renting space to a diagnostic partner are taxable, and the threshold is an aggregate turnover of ₹20 lakh, or ₹10 lakh in special category states. Medicines moved from 12% to 5% on 22 September 2025, so check your item master reflects that.
Keeping the stack from going stale
Most of these are one-off projects, and the failures are renewal failures: a certificate nobody diarised, a lease renewed but never sent to the registering authority, a lapsed technician's certificate.
Software files none of this. ExaHealth does not submit applications, does not talk to a pollution board and does not maintain your licence file. What it holds is the clinical record several of these authorities eventually ask about: consultations stored against the patient with history and documents loaded, e-prescriptions written from a medicine list instead of free text, one-tap invoices and payment reports, role-based access so a receptionist books without seeing medical notes, an audit trail of who opened a record and when, and data encrypted and hosted in India. When an inspection asks what was recorded on a given date, that part is a search.
For everything else, one page in a folder with eight lines on it, each naming the issuing authority and the expiry date, does more good than any system. To see the records side, take a look at what ExaHealth does for doctors.
Sources
Only a person enrolled in the State Register or the National Register may practise medicine…
The Clinical Establishments (Registration and Regulation) Act, 2010 applies only in states…
Bio-medical waste authorisation applies to clinics irrespective of quantity, in Form II to…
Fire NOC is set by state rules and is not universal; NABH's own advisory contemplates it…
Shops and establishments registration varies by state; Maharashtra used as a named example
Frequently Asked Questions
I only consult and never dispense. How many of these do I need?
Usually three: your own state medical council registration, establishment registration under your state's law, and biomedical waste authorisation if you generate any clinical waste, which most consulting rooms do. GST registration will not apply while all your supplies are exempt health care services, and a drug licence will not apply at all.
Does a clinic need a drug licence to keep medicines in the consulting room?
Not if you only supply them to your own patients. Schedule K, entry 5 of the Drugs and Cosmetics Rules exempts that, provided you are not keeping an open shop or selling across the counter, you buy only from licensed dealers or manufacturers, and you keep the purchase and supply records the Schedule requires. Once you sell to the general public, you need a retail drug licence.
Which of these is the one people forget?
Biomedical waste authorisation, because there is no bed count or waste quantity below which it stops applying, and because it is the only one on the list issued by a pollution board and not a health department, so it is easy to leave off a checklist made of health-department items.
Do I need a fire NOC for a two-room clinic?
There is no national answer. It depends on your state's fire safety rules, the building and its classification. NABH's advisory to healthcare organisations recognises that a fire NOC may not be applicable to some facilities, and asks those organisations to justify why. Put the question to your state fire service in writing so you have the answer on file.
What happens to my registrations if I open a second location?
Most of them are tied to the premises, not to you, so the new address needs its own establishment registration, its own waste authorisation and its own fire clearance where applicable. Your council registration carries across. Under the biomedical waste rules, a material change at an existing site also has to be intimated with a fresh Form II, so adding a procedure room at the old clinic is not a silent change either.