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

25/01/2011 11:18

 New Delhi, the 14th February, 2003

 

 

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

 

 

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.

 

 

1.         (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.

 

2.         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.”

 

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

 

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

 

“3. 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.


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