PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES PROHIBITION OF SEX SELECTION RULES, 1996
(1) These rules may be called the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996.]
(2) They shall come into force on the date of their publication in the Official Gazette.
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1. Vide G.S.R. 1 (E), dated 1st January, 1996, published in the Gazette of India, Extra., Pt. II, Sec. 3 (i), dated 1st January, 1996.
2. Subs. by G.S.R. 109(E), dated 14th February, 2003 (w.e.f. 14-2-2003).
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In these rules, unless the context otherwise requires,—
(a) “Act” means The Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994)†;
(b) “employee” means a person working in or employed by a 1[Genetic Counselling Centre, a Genetic Laboratory or a Genetic Clinic, or an Ultrasound clinic and imaging centre] and includes those working on part-time, contractual, consultancy, honorary or on any other basis;
(c) “Form” means a form appended to these rules;
2[***]
(e) “section” means a section of the Act;
(f) words and expressions used herein and not defined in these rules but defined in the Act, shall have the
(1) Any person being or employing
(i) A gynaecologist or a paediatrician having six months experience or four weeks training in genetic counseling or
(ii) A medical geneticist, having adequate space and educational charts/models/equipments for carrying out genetic counseling may set up a genetic counseling center and get it registered as a genetic counseling center.
(2) (a) Any person having adequate space and being or employing
(i) a Medical Geneticist and
(ii) a laboratory technician having a B.Sc. Degree in Biological Sciences or a degree or diploma in medical laboratory course with at least one year experience in conducting appropriate prenatal diagnostic techniques, tests or procedures may
(1) No organization including a commercial organization or a person, including manufacturer, importer, dealer or supplier of ultrasound machines/imaging machines or any other equipment, capable of detecting sex of foetus, shall sell, distribute, supply, rent, allow or authorize the use of any such machine or equipment in any manner, whether on payment or otherwise, to any Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic, Imaging Centre or any other body or person unless such Centre, Laboratory, Clinic, body or person is registered under the Act.
(2) The provider of such machine/equipment to any person/body registered under the Act shall send to the concerned State/UT Appropriate Authority and to the Central Government, once in three months a list of those to whom the machine/equipment has been provided.
(
(1) An application for registration shall be made to the Appropriate Authority, in duplicate, in Form A, duly accompanied by an Affidavit containing
(i) an undertaking to the effect that the Genetic Centre/Laboratory/Clinic/ Ultrasound Clinic/Imaging Centre/combination thereof, as the case may be, shall not conduct any test or procedure, by whatever name called, for selection of sex before or after conception or for detection of sex of foetus except for diseases specified in Section 4(2) nor shall the sex of foetus be disclosed to any body; and
(ii) an undertaking to the effect that the Genetic Centre/Laboratory/Clinic/ combination thereof, as the case may be, shall display prominently a notice that they do not conduct any technique, test or procedure etc. By whatever name called, for detection of sex of foetus or for selection of sex be
(1) Every application for registration under rule 4 shall be accompanied by an application fee of—
(a) Rs. 3000.00 for Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic or Imaging Centre.
(b) Rs. 4000.00 for an institute, hospital, nursing home, or any place providing jointly the service of a Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic, Ultrasound Clinic or imaging Centre or any combination thereof:
Provided that if an application for registration of any Genetic Clinic/Laboratory/Centre, etc., has been rejected by the Appropriate Authority, no fee shall be required to be paid on re-submission of the application by the applicant for the same body within 90 days of rejection. Provided further that any subsequent application shall be acc
(1) The Appropriate Authority shall, after making such enquiry and after satisfying itself that the applicant has complied with all the requirements, place the application before the Advisory Committee for its advice.
(2) Having regard to the advice of the Advisory Committee the Appropriate Authority shall grant a certificate of registration, in duplicate, in Form B to the applicant. One copy of the certificate of registration shall be displayed by the registered 1[Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound clinic or Imaging centre] at a conspicuous place at its place of business:
Provided that the Appropriate Authority may grant a certificate of registration to a Genetic Laboratory or a Genetic Clinic to conduct one or more specified pre-natal diagnostic tests or procedures, depending on the availability
Every certificate of regtistration shall be valid for a period of five years from the date of its issue.
.—(1) An application for renewal of certificate of registration shall be made in duplicate in Form A, to the Appropriate Authority thirty days before the date of expiry of the certificate of registration. Acknowledgement of receipt of such application shall be issued by the Appropriate Authority in the manner specified in sub-rule (2) of rule 4.
(2) The Appropriate Authority shall, after holding an enquiry and after satisfying itself that the applicant has complied with all the requirements of the Act and these rules and having regard to the advice of the Advisory Committee in this behalf, renew the certificate of registration, as specified in Form B, for a further period of five years from the date of expiry of the certificate of registration earlier granted.
(3) If, after enquiry and after giving an opportunity of being heard to the a
(1) Every Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre shall maintain a register showing, in serial order, the names and addresses of the men or women given genetic counselling, subjected to pre-natal diagnostic procedures or pre-natal diagnostic tests, the names of their spouse or father and the date on which they first reported for such counselling, procedure or test.]
(2) The record to be maintained by every Genetic Counselling Centre, in respect of each woman counselled shall be as specified in Form D.
1[(3) The record to be maintained by every Genetic Laboratory, in respect of each man or woman subjected to any pre-natal diagnostic procedure/technique/test, shall be as specified in Form E.]
1[(4) The record to be maintained by every
(1) Before conducting preimplantation genetic diagnosis, or any pre-natal diagnostic technique/test/procedure such as amniocentesis, chorionic villli biopsy, foetoscopy, foetal skin or organ biospsy or cordocentesis, a written consent, as specified in Form G, in a language the person undergoing such procedure understands, shall be obtained from her/him:]
Provided that where a Genetic Clinic has taken a sample of any body tissue or body fluid and sent it to a Genetic Laboratory for analysis or test, it shall not be necessary for the Genetic Laboratory to obtain a fresh consent in Form G.
2[(1A) Any person conducting ultrasonography/image scanning on a pregnant woman shall give a declaration on each report on ultrasonography/image scanning that he/she has neither detected nor disclosed the sex of foetus of the pregnant woman to any body. T
(1) Every Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic, Imaging Centre, nursing home, hospital, institute or any other place where any of the machines or equipments capable of performing any procedure, technique or test capable of pre-natal determination of sex or selection of sex before or after conception is used, shall afford all reasonable facilities for inspection of the place, equipment and records to the Appropriate Authority or to any other person authorised by the Appropriate Authority in this behalf for registration of such institutions, by whatever name called, under the Act, or for detection of misuse of such facilities or advertisement therefor or for selection of sex before or after conception or for detection/disclosure of sex of foetus or for detection of cases of violation of the provisions of the Act in any other manner.
(2) Th
(1) The Appropriate authority or any officer authorised in this behalf may enter and search at all reasonable times any Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Imaging Centre or Ultrasound Clinic in the presence of two or more independent witnesses for the purposes of search and examination of any record, register, document, book, pamphlet, advertisement, or any other material object found therein and seal and seize the same if there is reason to believe that it may furnish evidence of commission of an offence punishable under the Act.
Explanation.—In these Rules—
(1) Genetic Laboratory/Genetic Clinic/Genetic Counselling Centre’ would include an ultrasound centre/imaging centre/nursing home/hospital/institute or any other place, by whatever name called, where any of the machines or equipments capable of selecti
Every 1[Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre] shall intimate every change of employee, place, address and equipment installed, to the Appropriate Authority within a period of thirty days of such change.
(1) No Genetic Laboratory shall accept for analysis or test any sample, unless referred to it by a Genetic Clinic.
(2) Every pre-natal diagnostic procedure shall invariably be immediately preceded by locating the foetus and placenta through ultrasonography, and the pre-natal diagnostic procedure shall be done under direct ultrasonographic monitoring so as to prevent any damage to the foetus and placenta.
The intervening period between any two meetings of Advisory Commitees constituted under sub-section (5) of section 17 to advise the Appropriate Authority shall not exceed sixty days.
(1) The ex-officio members, and other Central and State Government officers appointed to the Board will be entitled to Travelling Allowance and Daily Allowance for attending the meetings of the Board as per the Travelling Allowances rules applicable to them.
(2) The non-official members appointed to, and Members of Parliament elected to, the Board will be entitled to Travelling Allowance and Daily Allowance or attending the meetings of the Board as admissible to non-official and Members of Parliament as the case may be, under the Travelling Allowances rules of the Central Government.
(1) Every 1[Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre] shall prominently display on its premises a notice in English and in the local language or languages for the information of the public, to the effect that disclosure of the sex of the foetus is prohibited under law.
(2) At least one copy each of the Act and these rules shall be available on the premises of every 1[Genetic Counselling, Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre], and shall be made available to the clientele on demand for perusal.
(3) The Appropriate Authority, the Central Government, the State Government, and the Government/Administration of the Union Territory may publish periodically lists of registered 1[Genetic Counselling Centres, Genetic Laboratories, Genetic Clinics
All persons including the owners, employee or any other persons associated with Genetic Counselling Centres, Genetic Laboratories, Genetic Clinics, Ultrasound Clinics, Imaging Centres registered under the Act/these rules shall—
(i) not conduct or associate with, or help in carrying out detection or disclosure of sex of foetus in any manner;
(ii) not employ or cause to be employed any person not possessing qualifications necessary for carrying out pre-natal diagnostic techniques/procedures, techniques and tests including ultra-sonography;
(iii) not conduct or cause to be conducted or aid in conducting by himself or through any other person any techniques or procedure for selection of sex before or after conception or for detection of sex of foetus except for the purposes specified in s
(1) Anybody aggrieved by the decision of the Appropriate Authority at sub-district level may appeal to the Appropriate Authority at district level within 30 days of the order of the sub-district level Appropriate Authority.
(2) Anybody aggrieved by the decision of the Appropriate Authority at district level may appeal to the Appropriate Authority at State/UT level within 30 days of the order of the district level Appropriate Authority.
(3) Each appeal shall be disposed of by the District Appropriate Authority or by the State/Union Territory Appropriate Authority, as the case may be, within 60 days of its receipt.
(4) If an appeal is not made within the time as prescribed under sub-rule (1), (2) or (3), the Appropriate Authority under that sub-rule may condone the delay in case he/she is satisf
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