OPD register rules: what records a clinic must keep Every register a small OPD keeps, the rule behind it, and how long to keep it.

A clinic in India must keep a medical record for every patient visit, a register of the medical certificates it issues, and the records it needs to hand a patient a copy within 72 hours. Those three come from the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 and bind every registered doctor. A clinic in a state that follows the Clinical Establishments Act also registers every patient and keeps records and statistics for 3 to 5 years. Beyond that, the registers depend on what the clinic does: waste, dispensing, ultrasound in pregnancy, medico-legal cases, and money.

Which registers does a small OPD need?

The table lists each register, the rule that asks for it, the fields the rule names, and the retention period the rule sets. Where a rule sets no period, the table says so and suggests one. Rows marked "if" apply only to clinics that do that work.

Our free OPD register format prints a daily front-desk register on A4 landscape: token, time, patient, age and sex, phone, new or repeat, doctor, fee and payment mode. It is the attendance register, not the clinical record or the certificate register, which you keep separately.

What goes in the OPD register and patient record?

Regulation 1.3.1 of the 2002 regulations reads: "Every physician shall maintain the medical records pertaining to his / her indoor patients for a period of 3 years from the date of commencement of the treatment in a standard proforma laid down by the Medical Council of India and attached as Appendix 3." The rule is written for admitted patients and no regulation sets a separate period for OPD visits. Our post on how long to keep medical records explains why 3 years is the sensible floor for an OPD and why most clinics keep records longer.

Appendix 3 gives the fields:

• Name of the patient, age, sex, address and occupation.
• Date of first visit.
• Clinical note (summary) of the case and provisional diagnosis.
• Investigations advised, with reports, and the diagnosis after investigation.
• Advice, follow-up, date and observations.
• Signature in full and name of the treating physician.

In a paper clinic the desk register is the index (date, serial number, name, age, sex, mobile, doctor seen) and the record holds the clinical note; put the serial number on both. Regulation 1.4.1 also asks for your registration number "in all his prescriptions, certificates, money receipts", so check the printed pad.

What the Clinical Establishments standard adds

If your state follows the Clinical Establishments (Registration and Regulation) Act, 2010, section 12(1)(iii) makes "provisions for maintenance of records and reporting as may be prescribed" a condition of registration. The National Council for Clinical Establishments has published minimum standards by type of clinic. The one for a consultation-only clinic, CEA/Clinic-008, says in its process section: "Every patient visiting the clinic shall be registered." It then asks that during assessment "the patient findings, medications and investigations should be documented with working diagnosis, legibly in the assessment/OPD prescription with the signature of the consultant/ Specialist / super Specialist with date and time."

Its record section, 9, has three parts. 9.1: "Every Clinical Establishment shall maintain medical records of patients treated by it and health information and statistics in respect of national programmes and furnish the same to the district authorities in form of quarterly reports." 9.2: "Copies of all records and statistics shall be kept with the clinical establishment concerned for at least 3 or 5 years or in accordance with CEA act rules." 9.3 asks for information during an emergency, disaster or epidemic. The standard for a clinic with a dispensary, CEA/Clinic-009, has similar clauses (its 9.2 ties the period to "any other relevant Act in force") and adds a line, "Medicine Records and Registers".

Two lines of the Clinical Establishments (Central Government) Rules, 2012 also touch records. Rule 9(iv) asks establishments to "maintain and provide Electronic Medical Records or Electronic Health Records of every patient as may be determined and issued by the Central Government or the State Government". Rule 9(v) asks every establishment to "maintain information and statistics in accordance with all other applicable laws". Which states follow the central Act is in our Clinical Establishments Act states list; states with their own Acts have their own record rules.

What is the Register of Medical Certificates?

Regulation 1.3.3 is the one most small clinics miss: "A Registered medical practitioner shall maintain a Register of Medical Certificates giving full details of certificates issued. When issuing a medical certificate he / she shall always enter the identification marks of the patient and keep a copy of the certificate. He / She shall not omit to record the signature and/or thumb mark, address and at least one identification mark of the patient on the medical certificates or report." The certificate itself follows Appendix 2.

A workable register has columns for a serial number, date, patient name, address, identification mark, the purpose of the certificate (sick leave, fitness, other), the period it covers, and the patient's signature or thumb mark. Keep the office copy of each certificate behind the register, numbered the same. The regulation sets no retention period; keeping it as long as the patient records is the simplest rule. Our free medical certificate format prints a certificate with these fields.

Do you need a register of records requests?

No rule names one, but it is the easiest proof of compliance with regulation 1.3.2: "If any request is made for medical records either by the patients / authorised attendant or legal authorities involved, the same may be duly acknowledged and documents shall be issued within the period of 72 hours." Regulation 7.2 treats not keeping records, together with refusing them within 72 hours, as misconduct. A line with the date and time of the request, who asked, what was given and when settles later disputes. The same log works for a second opinion request under the patient rights charter.

Which bio-medical waste records does a clinic keep?

Rule 14(1) of the Bio-Medical Waste Management Rules, 2016 (G.S.R. 343(E), 28 March 2016) says: "Every authorised person shall maintain records related to the generation, collection, reception, storage, transportation, treatment, disposal or any other form of handling of bio-medical waste, for a period of five years". Rule 13(1) asks every occupier to "submit an annual report to the prescribed authority in Form-IV, on or before the 30th June of every year". Form IV has a line for a non-bedded facility: "Clinic or Blood Bank or Clinical Laboratory".

The daily bio-medical waste register with monthly figures on a website was narrowed in 2019. G.S.R. 129(E) of 19 February 2019 rewrote rule 4(n) to begin "in case of all bedded health care units". A clinic without beds still keeps the rule 14 records: the common treatment facility's collection slips, weights by colour, the agreement, training and the Form IV copy. The full list and the 2026 amendment are in our bio-medical waste guide for small clinics.

What register is needed if the doctor dispenses medicines?

A doctor who supplies medicines to their own patients without a drug licence relies on entry 5 of Schedule K to the Drugs Rules, 1945. The Supreme Court set out the entry in S. Athilakshmi v. State (15 March 2023). It exempts "Drugs supplied by a registered medical practitioner to his own patient" provided the doctor is not "keeping an open shop", "selling across the counter" or trading in drugs, and it comes with record conditions.

• Purchase records: drugs bought only from a licensed dealer or manufacturer, with "records of such purchases showing the names and quantities of such drugs, together with their batch numbers and names and addresses of the manufacturers", open to a drugs inspector.
• For medicines with a Schedule G, H or X substance, a register entry at the time of supply with "the name of the medicine or ingredients of the preparation and the quantities thereof, the dose prescribed, the name of the patient & the date of supply and the name of the person who gave the prescription".
• The register entry number written on the label of the container, and the label carrying the doctor's name and address.
• The register and any prescription "preserved for not less than two years from the date of the last entry in the register or the date of the prescription".

Regulation 3.7.1 of the 2002 regulations adds that the "Prescription should also make clear if the Physician himself dispensed any medicine." The conditions, the limits and what an inspector checks are in our post on Schedule K and dispensing at the clinic.

What records does PC-PNDT add for a clinic with ultrasound?

Only a clinic registered as an ultrasound clinic or imaging centre under the Pre-Conception and Pre-Natal Diagnostic Techniques Act, 1994 keeps these. Form F is titled "Form for maintenance of record in respect of pregnant woman by genetic clinic/ultrasound clinic/imaging centre" and cites the proviso to section 4(3), rule 9(4) and rule 10(1A). The Tamil Nadu health department's guidance on the Act sums up the rest: a register in serial order with names and addresses of the women and their spouses or fathers and the date they first reported (rule 9(1)); a monthly report "by 5th day of the following month" (rule 9(8)); records kept "for a period of 2 years" under section 29(1), or until any legal proceeding ends; and, where records are kept on a computer, "a printed copy of the record is required to be taken and preserved after authentication" (rule 9(7)).

Registration, renewal and inspection are in our PC-PNDT registration guide.

Do you need a medico-legal case register?

A clinic that sees injuries, burns, poisoning or assault will at some point record a medico-legal case. What must be written, who must be informed and how long the record is kept are covered in a separate post on medico-legal cases in the OPD. Keep MLC entries in their own numbered register, apart from the OPD register, so the record can be produced without exposing other patients.

Which money records count as books of account?

Section 62(1)(a) of the Income-tax Act, 2025 says "Any person carrying on specified profession" shall keep books of account and other documents that let the Assessing Officer compute total income, and section 62(4) lists "medical" as a specified profession. Section 62(3) leaves the list of books, their particulars, the place they are kept and "the period for which such books of account and other documents are to be retained" for the Board to prescribe. Section 2(19) counts books kept in written form, in electronic or digital form or on cloud storage, and print-outs of that data.

The presumptive scheme and audit thresholds are in our post on income tax for doctors under the 2025 Act; ask your CA for the prescribed list. At the desk, the day book and receipt copies come from a daily close across cash, UPI and card.

Can these registers be kept on a computer instead of paper?

Mostly yes, with one exception to watch. Regulation 1.3.4 of the 2002 regulations says "Efforts shall be made to computerize medical records for quick retrieval", and rule 9(iv) of the 2012 central rules names electronic records outright. The Income-tax Act counts digital and cloud books as books of account. The PC-PNDT rules accept computer records but require a printed, authenticated copy to be preserved. None of the other rules quoted here insists on paper.

Once records are digital, the Digital Personal Data Protection Act, 2023 applies to them; our DPDP guide for clinics has the dated checklist, and is EMR mandatory for clinics answers whether you must switch.

A one-afternoon set-up for a clinic's registers

1. Check your patient record against the Appendix 3 fields and add any that are missing to the OPD card or software template.
2. Start a bound, page-numbered Register of Medical Certificates if you do not have one, and file office copies behind it with the same serial number.
3. Add a records request page at the back of the OPD register: date and time, who asked, authority seen, what was given, date given.
4. If your state follows the Clinical Establishments Act, ask the district registering authority which quarterly statistics it expects and in what format.
5. Put the bio-medical waste file together: authorisation, treatment facility agreement, collection slips and last year's Form IV.
6. If you dispense, open a dispensing register with the Schedule K columns and keep purchase bills with batch numbers in one folder.
7. If you do ultrasound in pregnancy, check Form F and the monthly report against the PC-PNDT post before the next inspection.
8. Agree with your CA which books you keep this tax year and where they are kept.
9. Write the retention period on the spine of each register.