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Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Rules, 2003
Date 19/10/11/06/45  Author Infrosoft Health Content Team  Hits 987  Language Global
G.S.R.109(E).-    In exercise of the powers conferred by section 32 of the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994), the Central Government hereby makes the following amendments to the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996.


Rule 1- Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Rules, 2003.

 (1)  These may be called the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Rules, 2003.

  (2)  They shall come into force on the date of their publication in the official gazette.

Rule 2- Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996.

     In the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996 (hereinafter referred to as the said rules) in rule 1, for sub-rule (1) the following sub-rule shall be substituted, namely:-

 “(1) These Rules may be called the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996.”

Rule 3 - The qualifications of the employees, the requirement of equipment for a Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre

       In the said rules, in rule 2, clause (d) shall be omitted.

        In the said rules, for rule 3 the following rule shall be substituted, namely:-

 “The qualifications of the employees, the requirement of equipment etc. for a Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre shall be as under: 

(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 geneticists,

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 set up a genetic laboratory.

 
    (b) Such laboratory should have or acquire such of the following equipments as may be necessary for carrying out chromosomal studies, bio-chemical studies and molecular studies:-

        (i) Chromosomal studies:

              (1) Laminar flow hood with ultraviolet and fluorescent light or other suitable culture hood.

              (2) Photo-microscope with fluorescent source of light.

              (3) Inverted microscope.

              (4) Incubator and oven.

              (5) Carbon dioxide incubator or closed system with 5% CO2 atmosphere.

              (6) Autoclave.

              (7) Refrigerator.

              (8) Water bath.

              (9) Centrifuge.

             (10) Vortex mixer.

             (11) Magnetic stirrer.

             (12) pH Meter.

             (13) A sensitive balance (preferably electronic) with sensitivity of 0.1 milligram.

             (14) Double distillation apparatus (glass).

             (15) Such other equipments as may be necessary.

         (ii) Biochemical studies: (requirements according to tests to be carried out)
 
             (1) Laminar flow hood with ultraviolet and fluorescent light or other suitable culture hood.

             (2) Inverted microscope.

             (3) Incubator and oven.

             (4) Carbon dioxide incubator or closed system with 5% CO2 atmosphere.

             (5) Autoclave.

             (6) Refrigerator.

             (7) Water bath.

             (8) Centrifuge.

             (9) Electrophoresis apparatus and power supply.

            (10) Chromatography chamber.

            (11) Spectro-photometer and Elisa reader or Radio-immunoassay system (with gamma beta-counter) or fluorometer for various biochemical tests.

            (12) Vortex mixer.

            (13) Magnetic stirrer.

            (14) pH meter.

            (15) A sensitive balance (preferably electronic) with sensitivity of 0.1 milligram.

            (16) Double distillation apparatus (glass).

            (17) Liquid nitrogen tank.

            (18) Such other equipments as may be necessary.

           (iii) Molecular studies:

             (1) Inverted microscope.

            (2) Incubator.

            (3) Oven.

            (4) Autoclave.

            (5) Refrigerators (4 degree and minus 20 degree Centigrade).

            (6) Water bath.

            (7) Microcentrifuge.

            (8) Electrophoresis apparatus and power supply.

            (9) Vertex mixer.

           (10) Magnetic stirrer.

           (11) pH meter.

           (12) A sensitive balance (preferably electronic) with sensitivity of 0.1 milligram.

           (13) Double distillation apparatus (glass).

           (14) P.C.R. machine.

           (15) Refrigerated centrifuge.

           (16) U.V. Illuminator with photographic attachment or other documentation system.

           (17) Precision micropipettes.

           (18) Such other equipments as may be necessary.

(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, Imaging Specialist, Radiologist or Registered Medical Practitioner having Post Graduate degree or diploma or six months training or one year experience in sonography or image scanning, or.

           (c) A medical geneticist.

may set up a genetic clinic/ultrasound clinic/imaging centre.

      (2) The Genetic Clinic/ultrasound clinic/imaging centre should have or acquire  such of the following equipments, as may be necessary for carrying out the tests or procedures  -

            (a) Equipment and accessories necessary for carrying out clinical examination by an obstetrician or gynaecologist.

           (b) An ultra-sonography machine including mobile ultrasound machine, imaging machine or any other equipment capable of conducting foetal ultrasonography.

           (c) Appropriate catheters and equipment for carrying out chorionic villi aspirations per vagina or per abdomen.

           (d) Appropriate sterile needles for amniocentesis or cordocentesis.

           (e) A suitable foetoscope with appropriate accessories for foetoscopy, foetal skin or organ biopsy or foetal blood sampling shall be optional.

           (f) Equipment for dry and wet sterilization.

           (g) Equipment for carrying out emergency procedures such as evacuation of uterus or resuscitation in case of need.

           (h) Genetic Works Station.”.

New rule 3A: Sale of ultrasound machines/imaging machines 

       In the said rules, after rule 3 a new rule 3A shall be inserted as follows, namely:- 

“3A.Sale of ultrasound machines/imaging machines:


        (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 Counseling 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.

        (3) Any organization or person, including manufacturer, importer, dealer or supplier of ultrasound machines/imaging machines or any other equipment capable of detecting sex of foetus selling, distributing, supplying or authorizing, in any manner, the use of any such machine or equipment to any Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic, Imaging Centre  or any other body or person   registered under the Act shall take an affidavit from the Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic, Imaging Centre or any other body or person purchasing or getting authorization for using such machine /equipment that the machine/equipment shall not be used for detection of sex of foetus or selection of sex before or after conception.”.

Rule 4 - An application for registration shall be made to the Appropriate Authority, in duplicate, in Form A, duly accompanied by an Affidavit

  In the said rules, in rule 4 for sub-rule (1) the following sub-rule shall be substituted, namely:-

 “(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 before or after conception.”.

Rule 5 - Application Fee

    In the said rules, for rule 5, the following rule shall be substituted, namely:-

 Application Fee – (1) Every application for registration under Rule 4 shall be accompanied by an application fee of :-

 (a) Rs.3000.00 for Genetic Counseling 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 Counseling 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 accompanied with the prescribed fee.  Application fee once paid will not be refunded.

 (2) The application fee shall be paid by a demand draft drawn in favour of the Appropriate Authority, on any scheduled bank payable at the headquarters of the Appropriate Authority concerned. The fees collected by the Appropriate Authorities for registration of Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre or any other body or person under sub-rule (1), shall be deposited by the Appropriate Authority concerned in a bank account opened in the name of the official designation of the Appropriate Authority concerned and shall be utilized by the Appropriate Authority in connection with the activities connected with implementation of the provisions of the Act and these rules.”.

 Rule 9 – With Reference to Rule 1, 3, 4, 7    

 In the said rules, in rule 9, -

 (a) for sub-rule (1), the following sub-rule shall be substituted, namely:-

        “(1) Every Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centres shall maintain a register showing, in serial order, the names and addresses of the men or women given genetic Counseling, 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 Counseling, procedure or test.”; 

(b) for sub-rule (3), the following sub-rule shall be substituted, namely:-

      “(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.”;

 (c) for sub-rule (4), the following sub-rule shall be substituted, namely:-

       “(4) The record to be maintained by every Genetic Clinic, in respect of each man or woman subjected to any pre-natal diagnostic procedure/technique/test, shall be as specified in Form F.”;

 (d) after sub-rule (7), the following sub-rule shall be inserted, namely:-

 “(8) Every Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centres shall send a complete report in respect of all pre-conception or pregnancy related procedures/ techniques/tests conducted by them in respect of each month by 5th day of the following month to the concerned Appropriate Authority.”

Rule 10 – With Reference to Rule 1

In the said rules, in rule 10, -

 (a) for sub-rule (1), the following sub-rule shall be substituted, namely:-

    “(1) Before conducting preimplantation genetic diagnosis, or any pre-natal diagnostic technique/test/procedure such as amniocentesis, chorionic villi biopsy, foetoscopy, foetal skin or organ biopsy 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.”;

 (b) after sub-rule (1), the following new sub-rule (1A) shall be inserted, namely:-

 “(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.  The pregnant woman shall before undergoing ultrasonography/image scanning declare that she does not want to know the sex of her foetus.”.

 Rule 11 - Facilities for inspection

In the said rules, for rule 11, the following rule shall be substituted, namely:-

 Facilities for inspection.-

(1) Every Genetic Counseling 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 authorized 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 therefore 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) The Appropriate Authority or the officer authorized by it may seal and  seize any ultrasound machine, scanner or any other equipment, capable of detecting sex of foetus,  used by any Organization if the Organization has not got itself registered under the Act.  These machines of the Organizations may be released if such Organization pays penalty equal to five times of the registration fee to the Appropriate Authority concerned and gives an undertaking that it shall not undertake detection of sex of foetus or selection of sex before or after conception.”.

Rule 12 - Procedure for search and seizure     

In the said rules, in rule 12 for sub-rule (1), the following sub-rule shall be substituted, namely:-

 “12. Procedure for search and seizure. -  (1) The Appropriate Authority or any officer authorized in this behalf may enter and search at all reasonable times any Genetic Counseling 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 Counseling 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 selection of sex before or after conception or performing any procedure, technique or test for pre-natal detection of sex of foetus, is used;

(2) ‘material object’ would include records, machines and equipments; and

(3)  'seize’ and ‘seizure’ would include ‘seal’ and ‘sealing’ respectively.”

Code of Conduct      

In the said rules, after rule 17, the following rules shall be inserted, namely:-

Code of Conduct to be observed by persons working at Genetic Counseling Centres, Genetic Laboratories, Genetic Clinics, Ultrasound Clinics. Imaging Centres etc.

 All persons including the owner, employee or any other persons associated with Genetic Counseling 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 ultrasonography;

(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 sub-section (2) of section 4 of the Act;

(iv)   not conduct or cause to be conducted or aid in conducting by himself or through any other person any techniques or test or procedure under the Act at a place other than a place registered under the Act/these Rules;

(v)    ensure that no provision of the Act and these Rules are violated in any manner;

(vi)   ensure that the person, conducting any techniques, test or procedure leading to detection of sex of foetus for purposes not covered under section 4(2) of the Act or selection of sex before or after conception, is informed that such procedures lead to violation of the Act and these Rules which are punishable offences;

(vii)  help the law enforcing agencies in bring to book the violators of the provisions of the Act and these Rules;

(viii) display his/her name and designation prominently on the dress worn by him/her;

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