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Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996

 SCHEDULE III - REQUIREMENTS FOR REGISTRATION OF A GENETIC CLINIC

[See Rule 3(1)]

  A.PLACE
             A room with an area of twenty (20) square metres with appropriate aseptic arrangements.

 B.EQUIPMENT
 

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

       (2)     Equipment, accessories necessary for other facilities required for operations envisaged in the Act.

                      (a)    An ultra-sonography machine.*

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

                      (c)     Appropriate sterile needles for amnicentesis or cordocentesis.*

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

              (* These constitute the minimum requirement of equipment for conducting the relevant procedure)

        (3)      Equipment for dry and wet sterilization.

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

 C.EMPLOYEES 

 (1)     A gynaecologist with adequate experience in pre-natal diagnostic procedures (should have performed at least 20 procedures under supervision of a gynaecologist experienced in the procedure which is going to be carried out, for example chorionic villi biopsy, amniocentesis, cordocentesis and others indicated at B above).

 (2)     A Radiologist or Registered Medical Practitioner for carrying out ultrasonography. The required experience shall be 100 cases under supervision of a similarly qualified person experienced in these techniques.

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