How to start a private clinic or healthtech business in India: registrations
Private clinic and healthtech registrations in India: clinical establishment registration, bio-medical waste authorisation, AERB and PCPNDT, GST and DPDP.
Short answer
A private clinic in India must register as a clinical establishment under the central Act or the state's own law, obtain bio-medical waste authorisation from the pollution control board, and get a municipal trade licence and fire clearance where applicable. X-ray needs AERB licensing and ultrasound needs PCPNDT registration. Healthcare services by clinical establishments are GST-exempt. Healthtech platforms must plan for health data protection.
- Clinic registration
- Clinical Establishments Act 2010 or state law
- Bio-medical waste
- Authorisation from State Pollution Control Board
- Diagnostic equipment
- AERB for X-ray, PCPNDT for ultrasound
- GST on healthcare services
- Exempt when provided by clinical establishments
- Doctors
- Must hold valid medical council registration
- Health data
- DPDP Rules 2025 duties from 13 May 2027
Choosing a structure for a clinic or healthtech venture
A single doctor's clinic is commonly run as a proprietorship in the doctor's name. Group practices often use a partnership or LLP, while multi-specialty clinics, diagnostic chains and healthtech platforms usually form a private limited company to raise capital and employ doctors.
Professional registration stays personal: each doctor must hold a valid registration with the National Medical Commission or a state medical council, whatever the business structure. This article covers registrations only and is not medical or clinical advice.
Registrations and licences for a clinic
Which clinical establishment law applies depends on your state. The central Act is in force in some states and Union Territories, while others, such as Maharashtra, Karnataka and Delhi, have their own laws.
| Registration | Issuing authority | When required | Typical validity |
|---|---|---|---|
| Clinical establishment registration | District Registering Authority or state health department | Before operating, including single-doctor clinics where the law covers them | Provisional, then permanent; varies by state |
| Bio-medical waste authorisation | State Pollution Control Board | If the clinic generates bio-medical waste | As per authorisation |
| AERB licence or registration | Atomic Energy Regulatory Board | For X-ray and other radiation equipment | As per AERB approval |
| PCPNDT registration | District Appropriate Authority | For ultrasound or other sex-determination-capable equipment | Fixed term, renewable |
| Retail drug licence | State drug controller | If the clinic runs a pharmacy | Perpetual with retention fee |
| Trade licence and fire NOC | Municipal body and state fire service | Depends on city and building | Varies |
| Shop and establishment registration | State labour department | For staff, in most states | Varies by state |
Which clinical establishment law applies?
The Clinical Establishments (Registration and Regulation) Act 2010 has been in force since March 2012 in Arunachal Pradesh, Sikkim, Mizoram, Himachal Pradesh and all Union Territories except Delhi, and has been adopted by states including Uttar Pradesh, Bihar, Rajasthan, Jharkhand and Uttarakhand. It covers single-doctor clinics. Provisional registration is granted on self-declaration, and permanent registration follows once minimum standards apply.
States with their own laws run separate registration systems, often through the municipal corporation or district health office, with different documents and renewal cycles. Check the law for your district before applying.
Tax rules for clinics and healthtech
Health care services provided by a clinical establishment, an authorised medical practitioner or paramedics are exempt from GST. Cosmetic and elective procedures that are not health care services may be taxable. Medicines sold over the counter through a clinic pharmacy are taxable goods.
Healthtech platforms are different. A platform charging patients or doctors for software, listings or bookings supplies a taxable service at 18%, even if the consultation itself is exempt. If you build software that diagnoses or treats, check whether it falls under CDSCO's medical device rules.
Ongoing compliance and data protection
Keep bio-medical waste segregation records and file the annual report with the pollution control board. Display registration certificates, fee schedules where the law requires, and maintain PCPNDT records meticulously, because violations carry serious penalties.
Patient records are sensitive personal data. Under the DPDP Rules 2025, duties such as security safeguards, prompt breach intimation followed by a detailed report to the Data Protection Board within 72 hours and retention rules apply from 13 May 2027. Teleconsultation must follow the Telemedicine Practice Guidelines issued for registered medical practitioners.
Common pitfalls
Regulators inspect clinics without notice in many districts, so keep originals or certified copies of every registration at the premises and train staff on record-keeping.
- Installing X-ray or ultrasound equipment before AERB or PCPNDT approval.
- Running a pharmacy counter without a separate drug licence and pharmacist.
- Handing bio-medical waste to unauthorised collectors.
- Healthtech platforms assuming their fees are GST-exempt like consultations.
Step by step
- 1Confirm the applicable law
Identify whether the central Act or a state law governs clinics in your district.
- 2Set up the entity
Proprietorship, LLP or company, with doctor registrations verified.
- 3Prepare the premises
Check building approvals, fire safety and space standards.
- 4Apply for clinic registration
File with the registering authority with staff and infrastructure details.
- 5Get waste authorisation
Register with the pollution control board and contract an authorised waste facility.
- 6Equipment approvals
Obtain AERB and PCPNDT approvals before using regulated equipment.
- 7Data and privacy setup
Secure patient records and plan for DPDP obligations.
Related services
Sources
- MoHFW: Clinical Establishments Act FAQs
- Legal 500: A closer look at the DPDP Rules 2025
- Goa Directorate of Food and Drugs Administration: Retail drug licence checklist
Written by the Refogo Editorial Team from the official sources above and checked on 2026-10-31. Laws, rates and due dates change, and authorities often extend deadlines, so confirm your own case with a qualified professional. This is general information, not legal or tax advice. Read our editorial policy or report an error to support@refogo.com.
Common questions
Does a single-doctor clinic need registration?
Under the Clinical Establishments Act, yes, single-doctor establishments are covered. States with their own laws may set different coverage, so check locally.
Are doctor consultation fees subject to GST?
Health care services by clinical establishments and authorised medical practitioners are exempt. Non-healthcare services such as purely cosmetic procedures may be taxable.
Is GST payable by healthtech appointment platforms?
Platform fees for software, bookings or listings are generally taxable at 18%, even though the underlying medical consultation is exempt.