Who can perform ultrasound? HC major relief to MS surgery, MBBS doctor having 15 years sonology experience

Jammu: Providing relief to two doctors, the Jammu and Kashmir and Ladakh High Court has stated that medical professionals who are recognized under Indian Medical Council Act, 1956 and who also possess experience of not less than two years in the field of sex selection or pre-natal diagnostic techniques would not be required to undergo any training or competency based assessment test.

Declaring that such doctors fall under the ambit of the term "Medical Geneticist", the HC bench further mentioned that they are exempted from the operation of Preconception and Pre-natal Diagnostic Techniques (Prevention of Sex Selection) (Six Months Training) Rules, 2014.

The HC bench was considering the plea of two doctors among whom the first petitioner completed MBBS and MS Surgery and who has an extensive professional experience of more than five decades- including experience of almost three decades in the field of sonography. The second petitioner doctor also completed MBBS and thereafter gathered an experience of fifteen years in the same field of sonography.

Meanwhile, the Government authorities issued a notification dated 26th September, 2022 and decided that the doctors will have to undergo and qualify an examination as per the Preconception and Pre-natal Diagnostic Techniques (Prevention of Sex Selection) (Six Months Training) Rules, 2014, as amended by (Amendment) Rules, 2020.

The doctors challenged the notification primarily on the ground that it violated the PCPNDT Act 1994 and the concerned rules. Approaching the Court, the doctors sought a direction to the government authorities not to put MBBS doctors with two years of experience in the field of sex selection and pre-natal diagnostic techniques to competency based test. They argued that in terms of Section 2(g) of the 1994Act, they are exempted and are not required to qualify such test. 

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It was claimed by the petitioner doctors that they are running their ultrasound clinics/imaging centres on the basis of the registration granted by the appropriate authority (Chief Medical Officer) under Section 19(1) of the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994.

Taking note of the registration of the doctors, the court noted that the petitioner doctors were operating their ultrasound clinics/imaging centres since 2012 on the basis of valid registration granted by the authorities under the 1994 Act. Therefore, both the doctors have medical qualification recognized under Indian Medical Council Act and they have acquired more than two years of experience in the field of Pre-natal Diagnostic Techniques.

Referring to this, the counsel for the doctors argued that the being MBBS and having more than two years experience in the field of Pre-natal Diagnostic Techniques, the petitioners are medical geneticists, a term that is defined in Section 2(g) of 1994 Act. This came to be extended to the Union Territory of J&K w.e.f. 31.10.2019 when the Jammu & Kashmir Reorganization Act, 2019 was enforced.

It was argued that a medical geneticist is not required to undertake any competency based test under the 2014 Rules. However, the concerned notification demanded all the registered medical practitioners including the petitioners to fill in the application form and pay the examination fee of Rs 10,000. This is not sustainable in law, argued the counsel for the petitioner.

On the other hand, the Government authorities argued that only a qualified registered practitioner can be engaged in genetic clinic, ultrasound clinic or Imaging centre. As per Rule 3(3)(1) (b) & 9c) of the PCPNDT Rules 1996, such doctors must have Post Graduate degree or diploma or six months training duly imparted in the manner prescribed under the 2014 Rules.

It was further submitted that in terms of Rule 6(2) of the 2014 Rules, all existing registered medical practitioners who are conducting ultrasound procedures in genetic clinic or Ultrasound Clinic or Imaging Centre on the basis of one year experience or six months training are exempted from undertaking such training under 2014 Rules provided they are able to qualify the competency based assessment test. Referring to this, the government authorities argued that in cases of those doctors who fail to clear the test, six months training envisaged under the 2014 Rules would be required.

After considering the arguments of both the parties, the bench opined,

"I am of the view that a medical geneticist', as defined in Section 2(g) of the 1994 Act, is not required to undertake any training or qualify competency based assessment as specified in Schedule II of the 2014 Rules. The petitioners and those doctors, who possess one of the medical qualifications recognized under the Indian Medical Council Act, 1956 and have experience of not less than two years in the field of sex selection or pre-natal diagnostic techniques, would fall within the ambit of term "medical geneticist" and, therefore, shall not be under an obligation to undergo any training or competency based assessment test. They are exempted from the operation of 2014 Rules. The view I have taken and the conclusions I have drawn herein above are based upon a plain but careful reading of the relevant provisions of 1994 Act and the Rules framed thereunder."

The bench also discussed at length the law on different qualifications and equipment required for setting up Genetic Counselling Centre laboratory/Clinic/Ultrasound Clinic/Imaging Centre etc. Describing the qualification of persons who can set up such clinics, the bench referred to Rule 3(3)(1) under PNDT Act.

As per the concerned rules, the following categories are entitled to open such clinics:

"3(3)(1) Any person having adequate space and being or employing-

(a) Gynaecologist having experience of performing at least 20 procedures in chorionic villi aspirations per vagina or per abdomen, chorionic villi biopsy, amniocentesis, cordocentesis foetoscopy, foetal skin or organ biopsy or foetal blood sampling etc., under supervision of an experienced gynaecologist in these fields or

(b) A Sonologist or imaging specialist or registered medical practitioner having Post Graduate degree or diploma or six months training duly imparted in the manner prescribed in the "the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) (Six Months Training) Rules, 2014; or

(c) A medical geneticist, may set up a genetic clinic/ultrasound clinic/imaging centre."

Therefore, the bench opined that it is "beyond any pale of doubt that a medical geneticist, as defined in Section 2(g) of the 1994 Act, is a person qualified to set up Genetic Clinic/Ultrasound Clinic/Imaging Centre". Further the court observed that a medical geneticist, as defined in Section 2(g), would include a person who possesses the following qualifications:

i) Degree or Diploma in genetic science in the fields of sex selection and pre-natal diagnostic techniques; or

ii) A person possessing one of the medical qualifications recognized under the Indian Medical Council Act, 1956 and possesses experience of not less than two years in any of these fields i.e. either in sex selection or in pre-natal diagnostic techniques; or

iii) A post-graduate degree in biological sciences with experience of not less than two years in the fields of either sex selection or prenatal diagnostic techniques

The bench further explained that

"From a reading of Rule 6 in conjunction with Section 3 of 1994 Act and definition of "medical geneticist" given in Section 2(g) thereof as also Rule 3 of the 1996 Rules, it becomes abundantly clear that six months training under 2014 Rules is required for the registered medical practitioner other than a Medical Geneticist, a Sonologist or Imaging Specialist, and a gynecologist having experience of performing atleast 20 procedures in 20 procedures in chorionic villi aspirations per vagina or per abdomen, chorionic villi biopsy, amniocentesis, cordocentesis foetoscopy, foetal skin or organ biopsy or foetal blood sampling etc., under supervision of an experienced gynaecologist in these fields."

On the basis of these observations, the court allowed the plea and quashed the impugned notification insofar as it pertains to the petitioner doctors. The Court further noted that

"a declaration is issued that the petitioners being medical geneticist running their genetic clinics/ultrasound clinics for the last several years are not required to undertake any six months training or to qualify competency based assessment as specified in Schedule II of the 2014 Rules."

"The respondents shall, accordingly, process the cases of the petitioners for renewal/re-issue of certificate of registration in their favour provided they fulfill and comply with other requirements of the 1994 Act and the Rules framed thereunder," further read the order.

To read the order, click on the link below:

https://medicaldialogues.in/pdf_upload/high-court-of-jammu-and-kashmir-192185.pdf

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