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The Medical Termination of Pregnancy Act and Rules
The Pre-Natal Diagnostic Techniques (PNDT) Act and Rules
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Maternity Benefit Act and Rules
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  Indian Laws and Regulations Related to Health
Pre-Natal Diagnostic Techniques Rules, 1996 - SCHEDULE II

Definitions

Minimum requirements

Registration of Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic

Maintenance and preservation of records

Conditions for conducting prenatal diagnostic procedures

Facilities for inspection, Procedure for search and seizure

Intimation of changes in employees, place or equipment

Conditions for analysis or test and prenatal diagnostic procedures

Meetings of the Advisory Committees, Allowances to members of the Central Supervisory Board

Public Information

SCHEDULE I

SCHEDULE II

SCHEDULE III

SCHEDULE III

FORM A

FORM B

FORM C

FORM D

FORM E

FORM F

FORM G

FORM H

SCHEDULE II - REQUIREMENTS FOR REGISTRATION OF A GENETIC LABORATORY
[See Rule 3(1)]

 A. PLACE
            A room with adequate space for carrying out tests.

 B.EQUIPMENT
         These are categorized separately for each of the under-mentioned studies.

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 (preferable electronic) with sensitivity of 0.1 milligram.

(14)  Double distillation apparatus (glass).

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 betacounter) or fluorometer for various biochemical test.

(12)  Vortex mixer.

(13)  Magnetic stirrer.

(14)  PH meter.

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

(16)  Double distillation apparatus (glass).

(17)  Liquid nitrogen tank.

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)   Vortex mixer.

(10) Magnetic stirrer.

(11) PH meter.

(12) A sensitive balance (preferable 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.

C.EMPLOYEES 

(1)   A Medical Geneticist.

(2)   A laboratory technician having a B.Sc. degree in Biological Sciences or a degree or a diploma in medical laboratory course with at least one year’s experience in conducting appropriate pre-natal diagnostic tests.

 

 

 

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