Dr K Aggarwal & Advocate Ira Gupta
In the matter titled as “All India Ophthalmological Society through its President versus Union of India & Others, WP© No. 12057/2018” vide order dated 09.01.2019, the Hon’ble High Court of Delhi has stayed the operation of the letter dated 01.06.2018 issued by the Union of India to all Principal Secretary Health of All States / UTs to take necessary steps to implement the proposal of registration of all units, which use ultrasound machines for ophthalmology, echocardiography, urology and others under Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 .
Facts of the case
i. The petitioner no.1 (All India Ophthalmological Society) is a registered society and is an association of about 21000 Ophthalmologists across India. Members of the petitioner’s society specialise in eye surgeries such as cataract surgeries and in this process use of ultrasound imaging machines, which have a scanning frequency of about 10 Mhz and a penetration depth of about 60mm.
ii. The petitioners have filed the present petition, inter alia, impugning a letter dated 01.06.2018 whereby respondent no.1 has directed the Principal Secretary Health of All States/UTs to take necessary steps to implement the proposal for registration of all units, which use ultrasound machines for ophthalmology, echocardiography, urology an others under Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (hereafter ‘the Act’). This is premised on the basis that the such machines are also capable of being modified to determine the sex of a foetus.
iii. The said instructions are without jurisdiction and beyond the scope of the Act.
iv. The petitioner’s contention was that Section 18 (5) of the Act, which expressly provides that no genetic Counselling Centre, Genetic Laboratory or Genetic Clinic shall be registered unless the Appropriate Authority is satisfied that such Centre, Laboratory or Clinic is in a position to provide such facilities and maintain such equipment and standards as may be prescribed. In view of the above provisions Ophthalmologist clinics cannot be registered under Section 18 of the Act as they does not maintain the standards as required of a Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic.
Order of the Hon’ble High Court
After hearing all the contentions of the petitioners, the Hon’ble High Court held that there is merit in the contentions of the petitioners and issued notice to all the other parties in the case.
Also, in the meanwhile the Hon’ble Court has stayed the operation of the letter dated 01.06.2018 till the next date of hearing on 27.7.2019.
Other judgments relating to PCPNDT Act
IMA had filed writ petition being WP(C) No. 2721/2014 titled as “India Medical Association versus Union of India & Others before the Hon’ble High Court of Delhi against the provisions of PCPNDT Act and Rules. Thereafter vide order and judgment dated 17.02.2016 the Hon’ble High Court of Delhi was pleased to allow the writ petition filed by the IMA and has held that Section 2(p) of the PCPNDT Act defining a Sonologist or Imaging Specialist, is bad to the extent it includes persons possessing a postgraduate qualification in ultrasonography or imaging techniques. Also, it has been held that if the person seeking registration (a) makes a declaration in the form to be prescribed by the Central Supervisory Board to the effect that the said machine or equipment is not intended for conducting pre-natal diagnostic procedures; (b) gives an undertaking to not use or allow the use of the same for prenatal diagnostic procedures; and, (c) has a “silent observer” or any other equipment installed on the ultrasound machines, as may be prescribed by the Central Supervisory Board, capable of storing images of each sonography tests done therewith, such person would be exempt from complying with the provisions of the Act and the Rules with respect to Genetic Clinics, Genetic Laboratory or Genetic Counseling Centre.
Against the said order and judgment dated 17.02.2016 passed by the Hon’ble High Court of Delhi, two petition titled as the Indian Radiological and Imaging Association versus UOI & Anr., SLP (C) 11046/2016" and "Union of India versus Indian Radiological & Imaging Association & Others, SLP (C) No. 16657/2016" have been filed before the Hon’ble Supreme Court of India. The said petitions are still pending final disposal. The UOI had filed an application for the stay of high court judgment. After hearing the applications, the Hon’ble Supreme Court of India has vide order dated 14.03.2018 stayed the operation of the judgment dated 17.02.2016 passed by the Hon’ble High Court of Delhi in view of the judgement passed by the Hon’ble Supreme Court in the matter titled as “Voluntary Health Association of Punjab v Union of India”.
In the matter titled as “Voluntary Health Association of India versus Union of India,” The Hon’ble Supreme Court of India vide judgment dated 8 November 2016 had issued comprehensive directions for the purpose of effective implementation of the provisions of the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994. The directions issued by this Court are extracted below:
“33. Keeping in view the deliberations made from time to time and regard being had to the purpose of the Act and the far reaching impact of the problem, we think it appropriate to issue the following directions in addition to the directions issued in the earlier order:-
(a) All the States and the Union Territories in India shall maintain a centralized database of civil registration records from all registration units so that information can be made available from the website regarding the number of boys and girls being born.
(b) The information that shall be displayed on the website shall contain the birth information for each District, Municipality, Corporation or Gram Panchayat so that a visual comparison of boys and girls born can be immediately seen.
(c) The statutory authorities if not constituted as envisaged under the Act shall be constituted forthwith and the competent authorities shall take steps for the reconstitution of the statutory bodies so that they can become immediately functional after expiry of the term. That apart, they shall meet regularly so that the provisions of the Act can be implemented in reality and the effectiveness of the legislation is felt and realized in the society.
(d) The provisions contained in Sections 22 and 23 shall be strictly adhered to. Section 23(2) shall be duly complied with and it shall be reported by the authorities so that the State Medical Council takes necessary action after the intimation is given under the said provision. The Appropriate Authorities who have been appointed under Section 17(1) and 17(2) shall be imparted periodical training to carry out the functions as required under various provisions of the Act.
e) If there has been violation of any of the provisions of the Act or the Rules, proper action has to be taken by the authorities under the Act so that the legally inapposite acts are immediately curbed.
(f) The Courts which deal with the complaints under the Act shall be fast tracked and the concerned High Courts shall issue appropriate directions in that regard.
(g) The judicial officers who are to deal with these cases under the Act shall be periodically imparted training in the Judicial Academies or Training Institutes, as the case may be, so that they can be sensitive and develop the requisite sensitivity as projected in the objects and reasons of the Act and its various provisions and in view of the need of the society.
(h) The Director of Prosecution or, if the said post is not there, the Legal Remembrancer or the Law Secretary shall take stock of things with regard to the lodging of prosecution so that the purpose of the Act is subserved.
(i) The Courts that deal with the complaints under the Act shall deal with the matters in promptitude and submit the quarterly report to the High Courts through the concerned Sessions and District Judge.
(j) The learned Chief Justices of each of the High Courts in the country are requested to constitute a Committee of three Judges that can periodically oversee the progress of the cases.
(k) The awareness campaigns with regard to the provisions of the Act as well as the social awareness shall be undertaken as per the direction No.9.8 in the order dated March 4, 2013 passed in Voluntary Health Association of Punjab (supra).
(l) The State Legal Services Authorities of the States shall give emphasis on this campaign during the spread of legal aid and involve the para-legal volunteers.
(m) The Union of India and the States shall see to it that appropriate directions are issued to the authorities of All India Radio and Doordarshan functioning in various States to give wide publicity pertaining to the saving of the girl child and the grave dangers the society shall face because of female foeticide.
(n) All the appropriate authorities including the States and districts notified under the Act shall submit quarterly progress report to the Government of India through the State Government and maintain Form H for keeping the information of all registrations readily available as per sub-rule 6 of Rule 18A of the Rules.
(o) The States and Union Territories shall implement the Preconception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) (Six Months Training) Rules, 2014 forthwith considering that the training provided therein is imperative for realising the objects and purpose of this Act.
(p) As the Union of India and some States framed incentive schemes for the girl child, the States that have not framed such schemes, may introduce such schemes.”
Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA