Section 3 in The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996
3. Minimum requirements.
- [The qualifications of the employees, the requirement of equipment, etc., for a Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre shall be as under.- [Substituted by G.S.R. 109(E), dated 14.2.2003 (w.e.f. 14.2.2003).](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 pre-natal 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 betacounter) 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 or imaging specialist or registered medical practitioner having Post Graduate degree or diploma or six months training duly imparted in the manner prescribed in the "the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) (Six Months Training) Rules, 2014; 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.](3)[ Each medical practitioner qualified under the Act to conduct ultrasonography in a genetic clinic/ultrasound clinic/imaging centre shall be permitted to be registered with a maximum of two such clinics/centres within a district. The consulting hours for such medical practitioner, shall be clearly specified by each clinic/centre.] [Inserted by Notification No. GSR 418 (E) dated 4.6.2012 (w.e.f. 1.1.1996)][3-A. Sale of ultrasound machines/imaging machines. [Inserted by G.S.R. 109(E) dated 14.2.2003 (w.e.f. 14.2.2003).](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.][3B. Regulation of portable machines - (1) The use of portable ultrasound machine or any other portable machine or device which has the potential for selection of sex before conception or detection of sex during pregnancy shall be permitted only in the follOWing conditions, namely :-(a)the portable machine being used, within the premises it iS registered, for providing services to the indoor patients,(b)as part of a mobile medical unit, offering a bouquet of other health and medical services,Explanation.- For the purpose of this sub-rule, the expression "other health and medical services" means the host of services provided by the mobile medical unit which may include the following, namely:-(i)Curative(a)Referral of complicated cases;(b)Early detection of TB, Malaria, leprosy, Kala-Alar and other locally endemic communicable diseases and non communICable diseases such as hypertension diabetes, cataract cases etc;(c)Minor surgical procedures and suturing;(d)Specialist services such as O and G Specialist, Paediatrician and Physician;(ii)Reproductive and Child Health Services(a)Ante natal check up and related services;(b)Referral for complicated pregnancies;(c)Promotion of institutional deliveries;(d)Post-natal check up;(e)Immunization clinics;(f)Treatment of common childhood Illness;(g)Treatment of Reproductive Tract Infection or Sexually Transmitted Infections;(h)Adolescents care such as lifestyle education, counselling, treatment of minor aliments;(iii)Family Planning Services(a)Counselling for spacing and permanent method;(b)Distribution of contraceptives;(iv)Diagnostic(a)Investigation facilities like haemoglobin, urine examination;(b)Clinical detection of leprosy tuberculOSIS or endemic diseases;(c)Screening of cancer etc.;(v)Specialised facilities and services(a)X-ray;(b)ECG;(c)Ultrasound test;(vi)Emergency services and care in times of disaster or epidemic or public health emergency or accidents etc.(2)Regulation of services to be offered by Mobile Genetic Clinic-(a)A Mobile Genetic Clinic shall operate and offer pre-natal diagnostic techniques, only as part of a Mobile Medical Unit offering a bouquet of other health and medical services, on urban slums or rural or remote or hilly or hard to reach areas for improved access to health care services by underserved populations.(b)The machine under no circumstances shall be used for sex determination of the foetus(c)The stand alone mobile ultrasound clinic offering only pre-natal diagnostic facilities are prohibited(d)The mobile medical unit offering diagnostic services shall have adequate space for providing the facilities to patients.]
