By industry · Clinics & small hospitals
Registration, bio-medical waste, ultrasound rules, GST and patient data — what a private clinic in India owes, and from when.
Check what applies to your business — free Compliance calendar| What | Applies to | What it involves | Law |
|---|---|---|---|
| Register the clinic | Every clinical establishment — including a clinic run by a single doctor — in states that adopted the 2010 Act; elsewhere under the state's own law | The 2010 Act applies in the states and Union territories that adopted it, including Bihar, Haryana, Rajasthan, Uttar Pradesh and most Union territories. Maharashtra, Karnataka, West Bengal and Delhi register under their own Acts. Running an unregistered establishment under the 2010 Act can cost up to ₹50,000 for a first contravention, ₹2 lakh for a second and ₹5 lakh after that. | Clinical Establishments (Registration and Regulation) Act, 2010, ss. 2(c), 11 & 41 |
| Get bio-medical waste authorisation, and file the annual report | Every clinic that generates bio-medical waste, whatever the quantity | Apply to the State Pollution Control Board for authorisation — one-time for a clinic without beds. Train staff every year, immunise them against hepatitis B and tetanus, keep records for five years, and file the annual report in Form IV by 30 June. | Bio-Medical Waste Management Rules, 2016, rr. 4, 10, 13 & 14 |
| Register any ultrasound machine under PCPNDT | Any clinic with an ultrasound or other imaging machine capable of detecting the sex of a foetus | Register before operating; registration lasts five years and is renewed 30 days before it expires. Display the certificate and the notice that sex determination is prohibited, keep a Form F for every pregnant woman scanned, and report to the Appropriate Authority by the 5th of each month. Offences carry imprisonment. | PCPNDT Act, 1994, ss. 18 & 23; PNDT Rules, 1996, rr. 6–9 & 17 |
| Know which of your services GST exempts | Health care by a clinical establishment or an authorised medical practitioner | Consultation and treatment are exempt. Not exempt: cosmetic and plastic procedures other than reconstructive ones, hair transplants, and a hospital's non-ICU room charges above ₹5,000 a day. | Notification 12/2017-Central Tax (Rate), entry 74; Notification 04/2022-Central Tax (Rate) |
| Treat patient records as protected data | Every clinic that keeps patient records | The DPDP Act has no separate health category: patient data needs a notice and consent or a permitted use, and section 7(f) allows processing without consent in a medical emergency. Until the Act applies in full, the 2011 SPDI Rules still treat medical records as sensitive personal data. | DPDP Act, 2023, ss. 6 & 7(f); IT (Reasonable Security Practices…) Rules, 2011 |
| License a pharmacy before selling medicines | A clinic that runs a pharmacy or sells medicines over the counter | A retail drug licence (Forms 20 and 21, applied for in Form 19) is needed to sell. A doctor supplying medicines to their own patients, without keeping an open shop, needs no sale licence. | Drugs and Cosmetics Rules, 1945, Forms 19–21 and Schedule K |
| Keep and share records the way the medical council requires | Every registered medical practitioner | Keep in-patient records for three years, supply them within 72 hours of a request, and show your registration number in the clinic and on prescriptions, certificates and receipts. | IMC (Professional Conduct, Etiquette and Ethics) Regulations, 2002, regs 1.3–1.4 |
| What | Applies to | What it involves | Law |
|---|---|---|---|
| Set up a POSH Internal Committee | 10 or more employees — of any kind, including interns and part-timers | Constitute the committee by written order, with an external member, adopt a POSH policy, and file an annual report. | POSH Act, 2013, s. 4 |
| Register for PF and ESI when you cross the threshold | PF from 20 employees; ESI from 10, for staff within the wage ceiling | Deduct and deposit contributions by the 15th of each month for the wages of the month before. | Code on Social Security, 2020 |
| Handle personal data the DPDP way | Any business that collects personal data of customers or employees | A clear notice, valid consent, reasonable security safeguards and breach reporting — enforceable from 13 May 2027. | DPDP Act, 2023, ss. 5, 6 & 8 |
| Get paid within 45 days as a micro or small enterprise | Udyam-registered micro and small enterprises supplying goods or services | A buyer must pay within 45 days of acceptance; after that, compound interest at three times the bank rate runs by law. | MSMED Act, 2006, ss. 15 & 16 |
Yes, where the Clinical Establishments Act, 2010 applies: its definition includes an establishment run by a single doctor (s. 2(c)), and s. 11 bars running one unregistered. In Maharashtra, Karnataka, West Bengal and Delhi the state's own Act decides, and whether a clinic without beds is covered differs — check with your state health department.
No. Health care by a clinical establishment or an authorised medical practitioner is exempt under entry 74 of Notification 12/2017-Central Tax (Rate). Cosmetic procedures, hair transplants and a hospital's non-ICU rooms above ₹5,000 a day are not.
By 30 June every year, in Form IV, to the State Pollution Control Board — for every clinic that generates bio-medical waste, with or without beds (rule 13(1)).
Yes. Section 7(f) of the DPDP Act allows processing to respond to a medical emergency involving a threat to life or an immediate threat to health, without consent.
A checklist, not advice for your business. Several of these duties are set by each state, and most depend on your size and how you are registered — confirm with your CA before relying on any one of them.