PC-PNDT Act Compliance for Clinics in India: What Every Doctor Must Know

The Pre-Conception and Pre-Natal Diagnostic Techniques (PC-PNDT) Act 1994 was enacted to prevent sex-selective abortions and regulate the use of diagnostic technology. Any clinic in India that owns or operates an ultrasound machine — even for non-obstetric purposes — must comply with this Act.

Who Does PCPNDT Apply To?

The Act applies to any “Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic” — a definition that has been interpreted broadly to include:

• Any clinic, hospital, or nursing home with an ultrasound machine
• Mobile ultrasound services
• Standalone ultrasound/radiology centres
• Clinics where a visiting radiologist uses a portable USG device

If a visiting radiologist brings their own machine to your clinic, your premises must still be registered — the registration covers the place, not just the machine owner.

Registration Requirements

Mandatory Record-Keeping

Every patient who undergoes an ultrasound must sign Form F — which captures:

• Patient name, address, and age
• Referring doctor's name and registration number
• Indication for the ultrasound examination
• Patient's declaration that she is not seeking sex determination
• Clinician's declaration that sex was not disclosed

Form F records must be maintained for 2 years from the date of examination. Form E (equipment maintenance log) must also be maintained. Digital record-keeping is fully accepted by the Appropriate Authority, provided the records are printable on demand during inspection.

Audit & Inspection

The Appropriate Authority may conduct surprise inspections at any time. During an inspection, you must be able to produce:

• Valid registration certificate (Form C) displayed at entrance
• Form F records for all USG examinations in the last 2 years
• Equipment maintenance log (Form E)
• Qualification certificates of all personnel conducting USG
• Signage stating: “Sex determination not done here” in local language

Penalties

For broader compliance context, see our guides on ABDM compliance and setting up a clinic in India.

FAQ

Does PCPNDT apply to portable/handheld ultrasound devices?

Yes. Any device that produces ultrasound images for diagnostic purposes — including handheld pocket ultrasound devices — falls under the Act. Register all devices regardless of size or portability.

What if the ultrasound machine is owned by a visiting radiologist?

The premises must be registered under PCPNDT regardless of who owns the machine. The clinic owner is responsible for ensuring registration is obtained and maintained.

Can I refuse a Form F if a patient refuses to sign?

Yes. Signing Form F is a legal requirement. You should not proceed with the ultrasound examination without a signed Form F. Document the refusal if a patient declines.