The PC-PNDT Act explained for imaging centres: registration, Form F and why ultrasound cannot be outsourced

The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act 1994, usually shortened to the PC-PNDT Act, exists to stop sex determination before birth. It does this by controlling the equipment rather than the intent: every place with a machine capable of detecting foetal sex must be registered, only listed categories of doctor may scan a pregnant woman, every such scan is recorded on a prescribed form, and the district Appropriate Authority receives a monthly return.¹ For an imaging centre, the Act is the most inspected piece of regulation it lives under. For a teleradiology network, it is the reason obstetric ultrasound cannot be outsourced. Both are explained below, with the section and rule numbers so that you can check the primary text.

Registration of the centre

Every genetic counselling centre, genetic laboratory, genetic clinic and ultrasound clinic or imaging centre must be registered with the Appropriate Authority for its district before any machine is used. The application is made on Form A; the fee is ₹3,000 or ₹4,000 depending on the category of establishment; and the certificate is valid for five years, after which it is renewed.¹

Section 3(3) of the Act then ties the activity to the place: no qualified person shall conduct, or aid in conducting, a pre-natal diagnostic technique at any place other than the place registered.¹ The certificate names every doctor who uses the centre's machines, and the IRIA's guidance to its own members is blunt: every specialist sharing a machine must be named on the certificate, and a radiologist should not oblige anyone by scanning at a centre where they are not registered.²

A 2012 amendment to the Rules capped the number of centres a single doctor could be registered at to two per district. The cap has been stayed by some High Courts and applied by others, so its status varies by state; check with the district Appropriate Authority before relying on either position.⁴

Who may perform obstetric ultrasound

Rule 3(3)(1)(b) lists who may perform ultrasound on a pregnant woman: a gynaecologist, or a sonologist, imaging specialist, radiologist or registered medical practitioner who has a postgraduate degree or diploma, or six months of training, or one year of experience in sonography or image scanning.¹ The list is exhaustive. A technician, however experienced, is not on it and cannot scan a pregnant woman. The Madras High Court has held that AYUSH practitioners are not covered either, because the Rule presumes a qualification in modern medicine.³

The point that matters for outsourcing is that the Rule regulates the person who conducts the scan, not the person who writes about it afterwards. The Act's model is that a qualified doctor holds the probe, sees the images in real time, decides what to record and signs the record. There is no separate role of remote interpreter in that model.

Records, Form F and monthly returns

The record-keeping rules are where inspections find most faults, because they apply to every woman, every time.

• Form F for every woman (Rule 9). A Form F is completed for each pregnant woman who undergoes ultrasound or any other pre-natal diagnostic procedure, and is signed by the doctor who performed the scan.¹⁵ An unsigned or incomplete Form F is the most common finding at inspection.
• Two-year retention (Rule 9). All records, charts, forms, reports, consent letters and, specifically, "sonographic plates or slides" are preserved for two years, or until any legal proceedings conclude.¹ Images are part of the record, not an optional extra.
• Monthly report by the 5th (Rule 9). A summary of all Form F records for the month is sent to the Appropriate Authority by the 5th of the following month.¹ A nil return is still a return.
• Staff changes within 30 days (Rule 13). Every change of employee, including a doctor joining or leaving, is intimated to the Appropriate Authority within thirty days.¹
• Declaration on each report (Rule 10(1A)). Any person conducting ultrasonography on a pregnant woman gives a declaration on each report that the sex of the foetus was neither detected nor disclosed.¹ The declaration is by the person who scanned.
• Code of conduct (Rule 18). Do not employ unqualified persons, do not conduct or aid sex determination, and write your name and designation under your signature on every report.¹

Penalties

Section 23 sets out the consequences. A medical practitioner or centre owner who contravenes the Act or the Rules is liable to imprisonment and a fine, with higher penalties on a subsequent conviction. In addition, the practitioner's name is reported to the State Medical Council, which suspends the registration while charges are pending and removes the practitioner from the register on conviction, for a period that increases with repeat offences.¹ The Act also treats anyone who "aids" a contravention as liable, which is why the IRIA warns its members against acting as a "ghost specialist", lending a name or a signature to a centre where they do not practise.²

Two practical consequences follow. First, a breach is a criminal matter, not a licensing one; it is not cured by paying a late fee. Second, the consequences fall on the individual doctor's registration as well as on the centre, so a radiologist who lends a name to a centre's certificate is personally exposed for scans they never performed.

Why teleradiology of obstetric ultrasound does not work

Nothing in the Act prohibits a radiologist in another city from looking at stored ultrasound images and giving an opinion. The problem is that no such arrangement produces a compliant record, for reasons built into the structure of the law rather than any single clause.

1. If a qualified doctor scanned, the remote read is redundant. That doctor, named on the certificate, conducted the scan, signs Form F, gives the Rule 10(1A) declaration and writes the report under their own name and designation. A second report from someone who was not there adds nothing the Act recognises.
2. If a technician scanned, the remote read is evidence of an offence. Rule 3(3)(1)(b) does not allow it. A remote report in that situation is not a workaround; it is documentation that an unqualified person conducted a pre-natal diagnostic technique, with the remote radiologist and the platform both "aiding" it.
3. The platform sits in the evidence chain. Every study, timestamp, user and report on a teleradiology platform is logged. In any prosecution under the Act, that log is the prosecution's exhibit. A network that accepted obstetric ultrasound would be building the case against its own customers.
4. Obstetric ultrasound is operator-dependent. The person scanning decides which planes to acquire and which images to save. Unlike a CT volume, a set of saved ultrasound images cannot be re-interpreted as if the reader had held the probe. The clinical value of a remote read is limited even before the legal problem is reached.

The IRIA's own advice to radiologists covers this from the other side: do not work as a ghost specialist, do not oblige anyone by doing ultrasound at a centre where you are not registered.² The wider position of remote reporting, which is lawful for CT and MRI when a registered radiologist personally interprets the images, is explained in our guide to teleradiology regulations in India.

What Raydiac does

Raydiac reads CT and MRI only. The edge gateway installed at each site is configured to accept those modalities and does not accept ultrasound studies; there is no ultrasound rate card and no ultrasound credential for radiologists on the panel. Obstetric ultrasound will not be added in any future phase, because the Act ties the scan, the record and the report to a named doctor at a registered place, and no remote workflow can satisfy that. A centre that wants both CT reporting from Raydiac and a compliant ultrasound service needs a qualified doctor on site and named on its PC-PNDT certificate for the ultrasound, and the two services do not touch. What Raydiac does collect at onboarding is the site's other registrations, described on the for hospitals page, including the AERB licence for each CT unit, which is covered in our guide to the AERB licence for a CT scanner.

Compliance checklist for a centre

Section and rule numbers above follow the MoHFW Handbook on the PC-PNDT Act and Rules with amendments. Later amendments and state-level circulars may add requirements; the district Appropriate Authority is the source for what applies locally. A centre being set up from scratch will find the PC-PNDT step in context in how to start a diagnostic centre in India.