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

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 counselling may set up a genetic counselling center and get it registered as a genetic counselling 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 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.

        (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 Counselling 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 Counselling 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.”.

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