Pre-Conception and Pre-Natal… Bare Act

The source publishes this enactment as a single document rather than provision by provision, so the whole text is below and there are no per-section pages for it. Nothing has been shortened.

Type	Rules
Year	1994
Jurisdiction	State of Uttar Pradesh
Status	In force as published by the source
Text	Published as one document, as the source published it
Subjects	constitutional

THE PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES (PROHIBITION OF SEX SELECTION) RULES, 1996 [GSR L(E), dt. L-1- -1996, r r.e.f. 1,-1,-19961 [As amended oide GSR 492(E), dt. 22-5-2017, uD.e.f. 23-5-2017] In exercise of the powers conferred by section 32 of the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act,1994 (57 of L994), the Central Govemment hereby makes the following rules, namely:-

1. Shorf title and commencement 111f; ftese Rules may be called the Pre-conception and Pre-natal Diagnostic Teclrniques (Prohibition of Sex Selection) Rules, 1995.1

(2) They shall come into force on the date of their publication in the Official Gazette.

2. Definitions In these rules, unless the context otherwise requires,-

(a) "Act" means the Pre-natal Diagnostic Techniques (Regulation and Preverrtionof Misuse) Act,l994(57 of 194)';

(b) "employee" means a person working in or employed by a 3[Genetig Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre], and includes those working on part-time, contractual, consultancy, honorary or on any otherbasis;

(e) "section' means a section of the Ac!

(f) words and expressions used herein and not defined in these rules but defined in the Act, shallhave the meanings, respectively assigned to them intheAcU s11g1 -Mobile Medical IJnit" means a mobile vehicle which provides specialized facilitiesforthepatients,requiringbasicspecialistservicesand SubstitutedvideGSR 109(E),dt. 1*2-2003,w.e.f .14-2-2003.Piortosubstitutionsub-rule (1) stood asunder: "(1) These rules may be called the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules,1995." Now "The Pre-conception and Pre-natal Diagrrostic Techniques (Prohibition of Sex Selection) Act, 1994 (57 of7994)." Substituted for "Genetic Counselling Centre, Genetic Labortory and Genetic Clinic" vide GSR 109(E), dt. 74-2-2O03, w.e.l. 74-2-2003. Omitted, ibid. Prior to omission clause (d) stood as under: "(d) "Schedule" means a Schedule appended to these rules." lnserted vide GSR 80(E), dt. 7-2-2072,w.e.f .9-2-2012. 2 3 4 5 RULE 3 THE PRE-CONCEPTION AND PRE-NATAL.......RULES 1e96 23 provides improved access to healthcare facilities and eouitable distribution of health services at the doorsteps, across trr" iorrfr, especially in the underserved areas.

(h) "Mobile Genetic Clinic" me.uls a mobile medical unit where ultrasound machine or imaging machine or scanner or other equipment capable of determining sex of the foetus or a portable equipment which has the potential for detection of sex during pregnancy or ielection of sex before - conception is used.] '[3. Minimumrequirements _ Th9 gualificationsof theemployees,therequirementof equipmentetc. foraGenetic Counselling lentre, Genetic Laboratory, Genetii Clinic, Ultraiound Clinic and Imaging Centre shall be as under:

(1) Anypersonbeing or employing-

(i) a gynaecologist or a paediatrician having six months'experience or four weeks'training in genetic counselling; 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 Geneticis! and

(ii) a laboratory techniciarl having a B.Sc. degree in Biological Sciences or a degree or diploma in medical laboratorycoursewithatleastone 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) lrvertedmicroscope.

(4) Lrcubatorandoven.

(5) Carbon dioxide incubator or closed system with 5% COz atmosphere.

(6) Autoclave.

(7) Refrigerator.

(8) Waterbath.

(9) Centrituge.

(10) Vortex mixer.

(11) Magnetic strirrer.

(12) pHmeter. 1 Substituted vide GSR 109(E), dt. t4-z-z0og,w.e.f. L4-z-2009. 24 ITIE PRE-CONCEPTION AND PRE-NATAL.......NLES, B6 RUI,E 3

(13) ffiilrrr*: balance (preferably electronic) with sensitivitr

(14) Double distillation aPParatus (glass).

(15) Such other equipments as may be necessary.

(ii) Biochemical studies : (requirements accordi^g to tests tobe 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% COz atmosphere.

(5) Autoclave.

(6) Refrigerator. @ Waterbath.

(8) Centritug".

(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) ffiilrrf,:balance (preferably electronic) with sensitivity of 0.1

(16) Double distillation aPParatus (glass). $n 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) ffii?rfJ: balance (preferably electronic) with sensitivity of 0.1

(13) Double distillation aPParatus (glass).

(14) P.C.R. machine.

(15) Refrigerated centrifuge. RULE 3A IHE PRE-CONCEPTION AND PRE-NATAL... .... RULES Lee6 25

(15) 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 abdomerl chorionic villi biopsy, amniocentesis, cordocentesG foetoscopy, foetal skin or org.rn brop"y or foetal blood sampling etc. unaer . supervision of an experimced gynaecologist in these fields; or '[O) a sonologist or imaging specialist or registered medical practitioner having Pgst Graduate degree or diploma or six months, triining duly imparted in the manner prescribed in the -the pre-conception and Pre-natal Diagnostic Tedrniques (Prohibition of sex selection) (six Months Training) Rules,2014; orl

(2) The Genetic Clinic/ultrasound clinic/imaging cenke should have or acquire such of the following equipments, as may be necessary for carrying out the tests orprocedures-

(a) Equipment and accessories necessary for carrying out clinical examination by an obstetrici.m or g]rrnecologist.

(b) An ultra-sonography machine including mobile ultrasound machine, i-agrog maddne or any other equipment capable of conducting foetal ultrasono$aphy.

(c) Appropriatecathetersandequipmentforcarryingoutchorinoicvilli aspirations per vagina or per abdomen. Appropriate sterile needles for amniocentesis or cordocentesis. A suitable foetoscoPe with appropriate accessories for foetoscop/, foetal skin or organbiopsy or foetal blood sampling shallbe optio;;I. Equipment for dry and wet sterilization. Equipment for carrying out emergency procedures such as evacuation of uterus or resuscitation in case of need.

(h) Genetic Works Station.l 211s; racrr medical practitioner qualified under the Act to conduct ulkasonography in a genetic clinic/ultrasound clinic/i*ugirg centre shall be permitted to be registered with a maximum oI tio such clinics/centres within a district. The consulting hours for such medical e_ practitioner, shall be clearly specified by each clinic/centre.] '[gA. Sde of ultrasound machines/imiging machiries

(1) No organizationincluding a commercial organization or a persorL including manufacturer, importer, dealer or supplier of ultrasound machines/ihaging machinel or any-other equipment, capable of detecting sex of foetus, shall sell, disdbrite, supplp rent, allow or authorize the use of any such machine or equipment i, any *rifi; Substituted vide GSR t3(E), dt. 9 -1,-20'!,4, w.e. f. 10-1-2014. Inserted vide GSR 418(E), dt. M-20'!.2,w.e.f. 5-6-2012. Inserted vide GSR 1 09(E), dt. 14-2-2009, w.e.f. t4-2-2009.

(d)

(e) (0 G) 1 2 3 26 TTIE PRE-CONCEPTION AND PRE-NATAL.......RULES 1996 RULE 38 whether on payment or otherwise, to any Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic, hug.g Centre or any other body or person unless such Cenke, Laboratory, Clinic, body or person is registered under the Act.

(2)Theproviderof sudrmachine/equipmenttoanyperson/bodyregisteredunder the Act shall send to the concemed State/UT Appropriate Authority and to the Central Govemment, onceinthree months a list of thosetowhomthemachine/equipmenthas beenprovided.

(3) Any organization or person, including manufacturer, importer, dealer or supplier of ultrasound madrines/imaging machines or anyotherequipmentcapable of detecting sex of foetus selling, distributing, supplying or authorising, in any manner, the use of any sudr machine or equipment to any Genetic Counselling Centre, Genetic Laboratory, Gerretic Clinic, Ultrasound Clinic, hugi.g 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, Imagmg Centre or.uly other body or person purchasing or getting authorisation for using such machine/equipmentthatthemachine/equipmentshallnotbe used for detection of sex of foetus or selection of sex before or after conception.] tlgn. Regulation of portable machines

(1) Theuse of portableultrasound machine oranyotherportablemachine or device whichhasthepotential for selection of sexbefore conceptionor detection of sex during pregnancy shallbe pennitted only in the following conditions, namely-

(a) the portable madrine 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-rulg the expression "other health and medical services" means the host of services providedbythe mobile medical unitwhich may include the following, namely:-

(i) Curatioe

(a) Referal of complicated cases;

(b) Early detection of TB, Malaria, Leprosy, Kala-Azar and other locally endemic communicable diseases and non-communicable diseases such as hypertension diabetes, cataract cases etc.;

(d) Specialist services such as O and G Specialist, Paediatrician and Physician;

(ii) Rqtoiluctioe and Chilil Health Sertices

(a) Ante natal dreck up and related services;

(b) Referral for complicated pregnancies;

(d) Post-natalcheckup;

(e) Immunizationclinics;

(f) Treatnentof commonchildhoodillness; 1 Inserted vide GSR 80(E), dt.7-2-2012, w.e.f. 9-2-2012. RULE 4 THE PRE-CONCEETION AND PRE-NATAL...... .RULES 1ee6 27

(g) Treatment of Reproductive Tract [rfection or Sexually Transmitted Infections;

(h) Adolescents care such as lifestyle education, counselling, treatment of minor ailments.

(iii) Po*i1, Planning Sentices

(a) Counselling for spacing and permanent method;

(b) Distribution of contraceptives.

(io) Diagnostic

(a) Lrvestigation facilities like haemoglobin, urine examination;

(b) Clinical detection of leprosy tuberculosis or endemic diseases;

(o) Specialiseil facilities and sentices

(a) X-ray;

(b) ECG;

(oi) Emeryency sentices and care in items 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 tqhniques, only as part of a Mobile Medical unit olfering a bou[uet of other health and medical services, in urban slums or r*i o. r"rriot" o, hilly or hard to reach areas for improved access to health care services by underserved populations.

(b) The machine under no circtrmstances shall be used for sex determination of the foetus.

(d) The mobile medical unit offering diagnostic services shall have adequate space for providing ttre faeilities to patients.]

4. Registration of r[Genetic Counselling Cintre, Genetic Laboratory, Genetic Clinic,Ultrasound Clinic and Imaging Centrel . . 't-gl An.apalication-for registratio" rftuU be made to the Appropriate Authority, in duplicate, in Form A, duly accompanied by an Affidavit cortuioing-

(i) an underta|1S to the effect that the Genetic Centre/Laboratory /Clittrc/ Ultrasound Clini1/Imaging Centre/Combination thereof, as the casemay be, shall not conduct any test or procedure, by whatever name called, for selection of sex before or after conception or for detection of sex of foetus except for diseases specified in section 4(2) nor shall the sex of foetus be disclosed to anybody;

(ii) an unde*{inq to th9 effect that the Genetic Centre/Laboratory /Clinic/ Combination thereof, as the case may be, shail display prominently a notice that they do not conduct any technique, test or pioiedure etc.iby Substituted for "Genetic Counselling, Genetic Laboratory and Genetic Clinic" vide GSR 109(E), dt. 14-2-2ffi3, w.e.t. 7 +2-2003. Substituted, ibid. Prior to substitution sub-rule (1) stood as under: "(1) An application or registration shall be made to the Appropriate Authority, in duplicate, in Form A',. 1 ) 28 THE PRE-CONCEPTION AND PRE-NATAL.......RULES 1996 RULE 6 whatever name called, for detection of sex of foetus or for selection of sex before or after conception; and] 111lii; ffre registration of a genetic clinic shall also include the registration of eachand everymobile genetic clinic offeringpre-natal diagnostic facilities as part of a medical mobile unit and such a vehicle has to be registered as a mobile genetic unit.]

(2) The Appropriate Authority, or any person in his office authorized in this behalf, shall acknowledge receipt of the application for registration, in the acknowledgement slip provided at the bottom of Form A, immediately if delivered at the office of the Appropriate Authority, or not later than the next working day if received by post. 2[s. application Fee

(1) Every apptcation for registration under rule 4 shall be accompanied by an application fee of:-

(a) 3[Rupees twenty-five thousand] for Genetic Counselling Centre, Gmetic Laboratory, Genetic Clinic, Ulhasound Clinic or Imaging Centre. 1b) 4[Rupees thirty-five thousand] for an institute, hospital, nursing home, or any place providing joinfly the service of a Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic, Ultrasound Clinic or hagog Centre or any combination thereof: PROVIDED that if an application for registration of any Genetic Ctinic/I^aboratory/Cmtre etc., has bem rejected by the Appropriate Authority, no fee shall be required to be paid on re-submission of the application by the applicant for the same body within 90 days of rejection: PROVIDED FURTHER that any subsequent application shall be accompanied with the prescribed fee. Application fee once paid will not be refunded.

(2) The application fee shall be paid by a demand draft drawn in favour of the Appropriate Authority, on any scheduled bank payable at the headquarters of the Appropriate Authority concemed. The fees collected by tre Appropriate Authoritie for registration of Genetic Counselling Centre, Genetic I^aboratory Genetic Clinic, Ultrasound Clinic and Imaging Centre or any other body or person under sub-rule (1), shall be deposited by the Appropriate Authority concemd in a bank account opmed inthename of theofficialdesignationof the AppropriateAuthorityconcemedand shall be utilized by the Appropriate Authority in connection with the activities connected with implemerrtation of the provisions of the Act and these nrles.l

6. Certificateofregistration

(1)TheAppropriateAuthorityshall,aftermakingsuchenquiryandaftersatisfying itseU that the applicant has complied with all the requirements, place the application before the AdvisoryCommittee for its advice.

(2) Having regard to the advice of the Advisory Committee, the Appropriate Authorityshall granta certificate of registration, in duplicate,inForm B to the applicant. One copy of the certificate of registration shall be displayed by the registered '[Genetic 1 kuerted vide GSR 80(E), dt. 7-2-2072,w.e.f .94-2012. 2 Substituted vide GSR 109(E), dt. 74'2-2N3, w.e.t. 752-2N3. 3 Substituted for "Rs. 3,0ffi.00" vide GSR 418(E), dt. *G7n12, w .e.1.96-2012. 4 Substituted for "Rs. 4000.0Cr', ibid. 5 Substituted for "Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic" r'ide GSR 109(E), dt. L 4-2-2003, w.e.l. 7+2-2Cf,3. RULE 6 THE PRE-CONCEPTION AND PRE-NATAL.......RULES L996 29 CounsellingCenke,Geneticlaboratory,GeneticClinic,UltrasoundClinicand Imaging Centre] at a conspicuous place at its place ofbusiness: PROVIDED that the Appropriate Authoritymay grant a certificate of registration to a Genetic Laboratory or a Genetic Clinic to conduct one or more specified pre-natal diagnostic tests or proiedures, depending on the availability of place, equipmmt and qualified employees, and standards maintained by sudr laboratory or dinic. tl(Za) (a) One copy of the certificate of registration shall be displayed by the registered mobile medical unit inside the vehicle at a conspicuous place.

(b) The certificate of registration for sudr unit, shall dearly specify the following:- (I) the area of its operation, whidr shall not exceed the district wherein it is registered;

(tr) the number of portable madrines installed and being used in the vehicle; (Itr) the make and model number of the portable machine; (IV) the regrstration number of the vehicle; (V) full address of the service provider for the mobile medical unit. (2B) The portable equipment used for conducting pre-natal diagnostic test shallbe an integral partof the mobilemedicalunit and suchequipmentshallnotbeused outside such unit under any circumstances. (2C) Lr case of a breakdown of the vehicle of for any other reason due to which the registered unitcannotbe used as a Genetic Clinic, the Appropriate Authority has tobe inforrned within a period of seven days.]

(3) If, afterenquiryand after giving an opportunity of beingheard to the applicant and having regard to the advice of the Advisory Committee, the Appropriate Authority is satisfied that the applicant has not complied with the requirements of the Act and these rules, it shall, for the reasons to be recorded in writing reject the application for registration and communicate sudr rejection to the applicant as specified in Form C. ^ (4) An enquiry under sub-rule (1), induding inspection at the premises of the '[Genetic Counselling Centre, Genetic l^aboratory, Gmetic Clinic, Ultrasound Clinic and Imaging Centre], shall be caried out only after due notice is given to the applicant by the Appropriate Authority.

(5)Grantof certificateofregistrationorrejectionof applicationforregistrationshall becommunicated tottreapplicantas specified inForrrB orFormC,asthe casemaybe, within a period orninety days from the date of receipt of application for registration.

(6) firc certificate of regishation shall be non-transferable. In the event of change of ownership or dtange of managemmt or on ceasing to function as a z[Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre], both copies of the certificate of registration shall be surrendered to the Appropriate Authority.

(7) Irr the event of change of ownership or change of management of the 2[Genetic Counselling Centrg Genetic Laboratory, Genetic Clinic, LJltrasound Clinic and Imaging Inserted vide GSR 80(E), dt. 7-2-2012,w.e.1.9-2-2012. Substituted for "Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic" vide GSR 109@), dt. 'L1-2-2003, rv.e.f. 14-2-2003.

1 .{. 30 THE PRE-CONCEPTION AND PRE-NATAL.......RULES 1995 RULE 9 Centrel, the new owner or uuurager of such Centre, Laboratory or Clinic shall afresh for grant of certificate of registration.

7. Validity of registration APPIY Every certificate of registration shall be valid for a period of five years from the date of its issue.

8. Renewal of registration

(1) An application for renewal of certificate of registration shall be made in duplicateinFormA, tothe Appropriate Authoritythirtydaysbefore the date of expiry of the certificate of registration. Aclorowledgement of receipt of such application shall be issued by the Appropriate Authority in the marurer specified in sub-rule (2) of de a. Q) fhe annropriate Authority shall, afterholding anenquiry and after satisfying itself that tlre applicanthas complied with all the requirements of the Act and these rules and having regard to the advice of the Advisory Committee in this behalf, renew the certificate of registration, as specified in Form B, for a further perid of five years from the date of expiry of the certificate of registration earlier granted.

(3) ff, afterenquiry and after giving an opportunityof beingheard to the applicant and having regard to the advice of the Advisory Committee, the Appropriate Authority is satisfied that the applicant has not complied with the requiremmti of the Act and these rules, it strall, for reasons to be recorded in writing reject the application for renewal of certificate of registration and communicate such rejection to the applicant as specified in Form C.

(4) The feespayable forrenewal of certificate of registration shallbe one-half of the fees provided in sub-rule (1) of rule 5.

(5) On receipt of the renewed certificate of registration in duplicate or on receipt of communication of reiection of application for renewal, both copies of the eadier certificateof registrationslrallbesurrenderedimmediatelytotheAppropriateAuthority by the '[Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasorurd Clinic and Imaging Centrel.

(6) h the everrt of failure of the Appropriate Authority to renew the certificate of registrationortocommunicaterejectionof applicationforrenewalof registrationwithin aperiod of ninetydays fromthe date of receiptof applicationforrenewal of registration, the certificate of registration shall be deemed to have been renewed.

9. Maintenance and presenration of records 211t; E rery Genetic Counselling Centre, Genetic Laboratory, 3[Genetic Clinic including a Mobile Genetic Clinicl, Ultrasound Clinic and Imaging Centre shall maintain a register showing, in serial order, the names and addresses of the men or women given genetic counselling, subjected to pre-natal diagnostic procedures or pre-natal diagnostic tests, thenames of theirspouse orfather and the date onwhichthey first reported for sudr counselling, procedure or test.]

(2) The record tobemaintainedby everyGenetic Counselling Centre, in respect of eachwoman counselled shallbe as specffied in Form D. Substituted for "Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic" vide GSR 109@), dt. 1L22003, w.e.f . l+2-2N3. Substituted, ibid. Substituted for "Genetic Clinic" vide GSR 80(E), dt.7-2-2012,w.e.f .9-2-2012.

1. 2 3 RULE 10 THE PRE-CONCEPTION AND PRE-NATAL.......RULES 1996 3l 1[(S) Th" record to be maintained by every Genetic Laboratory in respect of each man or womat:t subjected to any pre-natal diagnostic procedure,/technique/test, shall be as specified in Form E.

(a) The record to be maintained by every 2lcenetic Clinic including a Mobile Genetic Clinic], in respect of each man or woman subjected to any pre-natal diagnostic procedure/technique/test, shall be as specified in Form F.]

(5) The Appropriate Authority shall maintain a permanent record of applications for grant or renewal of certificate of registration as specified in Forrr H. Lefters of intimation of every change of employee, place, address and equipment installed shall also be preserved as permanent records.

(6) AII case related records, forms of consent, laboratory results, microscopic pictureg, sonographic plates or slides, recommendations and letters shall be preserved by the'[Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imagrng Centre] for a period of two years from the date of completion of 9ou19elling, pre-natal diagnostic procedure or pre-natal diagnostic test, as the case may be. In the evstt of any legal proceedings, the records shall be preserved till the final disposal of legal proceedin-gs, or till the eipiry of the said period oi turo years, whichever is later. ^- (n hr case the 3[Genetic Counselling Centres or Genetic Laboratory or Genetic Clinic or Ultrasound Clinic or Imaging Centrel maintains records on computer or other elntroni< equipment a printed copy-of the record shall be taken and pieserved after authentication by a person responsible for such record. a1lA; fvery Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Irtugirg Centre shall send a complete report in respect of all pre-conception or Pregnancy related procedures/techniques/tests conducted by them in respect of each month by 5th day of the following month to the concerned Appropriate Authority.l

10. Conditions for conducting pre-natal diagnostic procedures s11t1 nefore conducting preimplantation genetic diagnosis, or any pre-natal diagnostic tgchnlque/test,/procedure such as amniocentesG, chorionic villi biopsy, foetoscopy, foetal skin or organbiopsy or cordocentesis, a written consen! as specihed in Form G, in a language the person undergoing sudr procedure understands, shall be obtained from her/him:] PROVIDED that where a Genetic Clinic has taken a sample of any body tissue or body fluid and sent it to a Genetic Laboratory for analysis or test, it shall not benecessary for the Genetic Laboratory to obtain a fresh consent in Form G. tOal-Fy peryon conducting ultrasonography/image scanning on a pregnant woman shall give a declaration on each report on ultrasonography/image scanning that he/she has neither detected nor disdosed the sex of foetus of the pregnant woman to *y b-dy.. Jhe pregnant wom,rn shall before undergoing ultralonogaphy/image scanning dedare that she does not want to know the sex of her foetus.] -

(2) AII the State Govemments and Union territories may issue translation of Form G inlanguages used in the State orUnionTerritoryand whereno official translation in Substituted vide cSR 109(E), dt. L42-2003, w.e.f . 1.4-2-2cf9. Substituted for "Genetic Clinic" vide GSR 80@), dt.7-2-2072,w.e.t.9-2-2012. Substituted for'Genetic Counselling Centre, Genetic laboratory and Genetic Clinic" vide GSR 1@@), dt. 14-2-2003, w.e.l. 74-2-2N3. hserte4ibid. Substituted, ibid. 1 2 3 4 5 32 THE PRE-CONCEPTION AND PRE-NATAL.......RULES 1996 RULE 12 a language understood by the pregnant woman is available, the Genetic Clinic may translate Form G into a language she understands. tltt. Facilities for inspection

(1) Every Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic, Imaging Centre, nursing home, hospital, institute or any other place where any of the machines or equipments capable of performing any procedure, technique or test capable of pre-natal determination of sex or selection of sex before or after conception is used, shall afford all reasonable facilities for inspection of the place, equipment and records to the Appropriate Authority or to any otherperson authorised by the Appropriate Authority in this behalf for registration of such institutions, by whatever name called, under the Act, or for detection of misuse of such facilities or advertisement therefor or for selection of sex before or after conception or for detection/disclosure of sex of foetus or for detection of cases of violation of the provisions of the Act in any other manner. 2[(Z) fne Appropriate Authority or the officer authorised by it may seal and seize any ultrasound machine, scanner or any other equipment capable of detecting sex of foetus, used by any organisation if the organisation has not got itself registered under the Act. These machines of such organisations shall be confiscated and further action shall be taken as per the provisions of section 23 of the Act.l

12. Procedure for search and seizure 111f ; me appropriate Authority or any officer authorized in this behalf may enter and search at all reasonable times any Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, knag*g Centre or Ultrasound Clinic in the presence of two or more independent witnesses for the purposes of search and examination of any record, register, document, book, pamphlet, advertisement, or any other material object found therein and seal and seize the same if there is reason to believe that it may fumish evidence of commission of an offence ptmishable under the Act.

Explanation: hr these rules-

(1)'Genetic Laborutory /Genetic Clinic/Genetic Counselling Centre' would indude an ultrasound centre/imaging cmtre/nursing home/hospital/ institute or any other place, by whatever name called, where any of the machines or equipments capable of selection of sex before or a{ter conception or performing any procedure technique or test for pre-natal detection of sex of foetus, is used;

(2) 'material object'would include records, machines and equipments; and

(3) 'seize' and 'seizure' would include 'seal' and 'sealing' respectively.]

(2) A list of any document, record, register, book, pamphlet advertisement or any other material object found in the r[Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centrel and seized shall be prepared in duplicate at the place of effecting the seizure. Both copies of such list shall be signed on Substituted vide GSR 109(E), dt. 1*2-20n.3, w.e.l. L4-2-2003. Substituted vide GSR €6(E), dt. 37-5-2011,w.e.f .2-62011. Prior to substitution, sub-rule (2) read as under: "(2) The Appropriate Authority or the officer authorised by it may seal and seize any ultrasound machine, scarmer or any other equipment, capable of detecting sex of foetus, used by any organisation if the organisation has not got itself registered under the Act. These machines of the organisations may be released if such orgaisation pays penalty equal to five times of the registration fee to the Appropriate Authority concemed and gives an undertaking that it shall not undertake detection of sex of foetus or selection of sex before or after conception." Substituted for "Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic" vide GSR lD(E), dt. l*2-20A3, w.e.f . l+2-20(J3. 1 2 RULE 14 THE PRE-CONCEPTION AND PRE-NATAL.......RULES 1ee6 33 everyPage by the Appropriate Authority orthe officer authorized in thisbehalf and by the witresses to the seizure: PROVIDED that the list may be prepared, in the presence of the wibresses, at a place other than the place of seizure if, for reasons to be recorded in writing, it is not practicable to make the list at the place of effecting the seizure.

(3) One copy of the list referred to in sub-rule (2) shall be handed over, under acknowledgement, to the person from whose custody the dorumen! record, register, book, pamphlet, advertisement or any other material object have been seized: PROVIDED that a copy of the list of such document record, register, book, pamphlet, advertisement or other material object seized may be delivered under acknowledgement, or sent by registered post to the owner or mEmager of the l[Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre], if no person acknowledging custody of the document, record, register, book, pamphlet advertisement or other material object seized is available at the place of effecting the seizure.

(4) If any material object seized is perishable in nature, the Appropriate Authority, or the officer authorized in this behalf shall make arrangements promptly for sealing, idenffication and preservation of the material object and also convey it to a facility for analysis or test, if analysis or test be required: PROVIDED that the refrigerator or other equipment used by the l[Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic,IJltrasound Clinic and Imaging Centre] for preserving such perishable material object may be sealed until such time ai arangements can be made for safe removal of such perishable material object and in such eventuality, mention of keeping the material object seized, on the premises of the '[GeneticCounsellingCentre,GeneticLaboratory,GeneticClinic,tntrasoundClinicand hugi.g Centrel shall be made in the list of seizure.

(5) In the case of non-completion of search and seizure operation, the Appropriate Authority or the officer authorized in this behalf.may make arrangements,by way of mounting a guard or sealing of the premises of the r[Genetic CounsellingCentrg Genetic Laboratory, Genetic Clinic, ultrasound Clinic and knugg Centre], for safe keeping, listing and removal of documents, records,book or any other material objecttobe s&ed, and to prgvent any tampering with such documents, records, books or any other materialobject.

13. Intimation of changes in employees, place or equipment Every l[Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre] shall intimate every change of employee, place, address and equipment installed, to the Appropriate Authority z[afleast ihirty aiys in advance of the expected date of such change, and seek re-issuance of certificaie of registration from the Appropriate Authority, with the changes duly incorporated].

14. Conditions for analysis or test and pre-natal diagnostic procedures

(1) No Genetic Laboratory shall accept for analysis or test any sample, unless referred to it by a Genetic Clinic. Substituted for "Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic" vide GSR 109(E), dt. 142-2Co3, w.e.t. l+2-200,3. substitutedfor"withinaperiodof thirtydaysof sudrchange"videGSR4lg(E),dt.+62072,w.e.t,s&2012, 34 THE PRE-CONCEPTION AND PRE-NATAL.......RULES 1996 RULE 18 - - (2)Every_pre-natal diagnosticprocedureshallinvariablybeimmediatelypreceded by locating the foetus and p,lacenta throrrgh ultrasonography, and the |re-natal diagnostic procedure shall be done under direct ultrasonographic monitorin! so as to prevent any damage to the foetus and placenta.

15. Meetings of the Advisory Committees The lteryening period between any two meetings of Advisory Committees constitutedundersub-section (5) of section 17to advisetheAppropriateAuthorityshall not exceed sixty days.

15. Allowances to membens of the Central Supenrisory Board (l-) The ex-offcio members, and other Central and State Govemment officers appointed to the Board will be entitled to Travelling Allowance and Daily Allowance for attending the meetings of the Board as per -the Travelling Allowances Rules applicable to them.

(2) The non-official members appointed to, and Members of Parliament elected to, the Board will be entitled to Travelling Allowance and Daily Allowance or attending the meetings of the Board as admissible to non-officia1 and Members of Parliament as the case may be, under the Travelling Allowances rules of the Central Govemment.

17. Publiclnforrration

(1) Every l[Genetic Counselling Centre, Genetic Laboratorp Genetic Clinic, Ultrasound Clinic and hagrng Centrel shall prominently display on its premises a notice inEnglish and inthe locallanguage orlanguages forthe information of thepublic, to the effect that disclosure of the sex of the foetus is prohibited under law.

(2) At least one copy each of the Act and these rules shall be available on the premises of every r[Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and kragi.g Centrel and shall be made available to the clientele on demand for perusal.

(3) The Appropriate Authority, the Central Govemment, the State Govemment, and the Government/Administration of the Union Territory may publish periodically lists of registered l[Genetic Counselling Centres, Genetic Liboraiories, Genetic Clinici, Ultrasound Clinic and Imagrng Centre] and findings from the reports and other information in their possession, for the information of the public and for use by the experts in the field. 2[18. Cod" of Conduct to be observed by persons working at Genetic Counselling Centres, Genetic Laboratories, Genetic Clinics, Ultrasound Clinics, Imaging Centres etc. All persons including the owners, employee or any other persons associated with Genetic Counselling Centres, Genetic Laboratories, Genetic Clinics, Ultrasound Clinics, Imaging Centres registered under the Act/these Rules shall-

(i)notconduct or associatewith, orhelp incarrying outdetection or disclosure of sex of foetus in any manner;

(ii)not employ or cause to be employed any person not possessing qualifications necessary for carrying out pre-natal diagnostic techniques/procedures, techniques and tests including ultrasonography;

(iii)not conduct or cause to be conducted or aid in conducting by himself or through any other person any techniques or procedure for selection of sex Substituted for "Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic" vide GSR 1@(E), dt. 14-2-2003, w.e.f . 74-2-2003. Inserted, ibid. 1 2 RULE 18A THE PRE-CONCEPTION 4NDIRE-N4IAL......RUL ES, 1996 35 maintain dignity, and integriY atall times; observe and implement the provisions of the Act and Rules in a balancedand standardised mannet in'the course of their work; conduct their work in a just meurner without any bias or a perceivedpresumption of guil! before or aftel golception or for detection of sex of foetus except for the purposes specified in sub_section (2) of section 4 of the AcU

(iv)not conduct or cause to be conducted or aid in conducting by himself or thro-u8h an1 other person any techniques or test or procedure under the Act at a place other than a place registered under the i.ct/these Rules;

(v)ensure that no provision or *re act and these Rules are violated i, *ymalrner;

(vi)ensure that the persorL conducting any techniques, test or procedure le.ading to detection of sex of roet"s rlrpuporu"rJt "orr"."d under section 4(2) of the Act or selection of sex before L, u?1", "or,"eption, is informed ttrat such procedures lead to violation of the Act ur,a ti.te"e Rules which are punishable offences;

(vii)help the law gnforcing agencies in bringing to book the violators of theprovisions of the Act and these Rules;

(viii)display his/her name and designation prominentry on the dress worn byhim/her;

(ix)write his/her_nam9 and designation in full under his/her signature;

(x)on no account conduct or allo=w/cause to be conducted female foeticide;(xi)not commitany- other act of professional misconduct.] '[19A. code of conduct to u or""*"a'by dpr.p.ate Authorities -...(1) AlltlEAppropriate Authorities including the State, District and Sub-districtnotified under the A*, inter-aria, shaflobserve ttJr"["*ir"/g;uJ"oa" of conduct,namely:-

(i)

(ii)

(iii)

(iv) refrain from making anycomments which demean individuals on thebasis of gender, race]reli6on;

(v) delegate his or her powers bv administrative order to anv authorisedofficer in his or heribsence "hd pr*;;til"-.;&;#";t";ilffiil: documentary proof for further action. ....(2) All the Appropriate Authorities including the State, District and Sub-districtnotified under the Aci, inter-aria, shan observe tri'" rouo*i"g CoJrr.t for AdvisoryCommittees, namely:-

(i) ensure that the re<onstitution, functions and other rerevant mattersrelated to advisory committee shall be in acco"arr,ce with the provisions of the Advisory Committee Rules, 1996;

(ii) ensure *:l lryr::" who.is the part of investigating machinery in casesunder the pre-co_nception and pre_-natar bia;-r;"tic Techniques(Prohibitionof sex seb&on) Act, 1994 (s z of 799+), itinotbenominated or appointed as a member of the Advisory Commi*ee;

(iii) ensure fug-"_ryres1 of,fir1s up of vacancies in Advisory committeesha[ start at least ninety days b-efore tr,e prouaute daie'or ure occ,rrence or vacancy; 1 Inserted vide GSR 119(E), dt.24-2-zo'!.4,w.e.f. 26-2-201,4. 36 THE PRE-CONCEPTION AND PRE-NATAL.......RULES 1996 RULE 18A

(iv) ensure that no person shall participate as a member or a legal expert of the Advisory Committee if he or she has conflict of interesq

(v) conduct frequent meetings of the Advisory Committee to-expedite.the decisions refarding rene*al, cancellation aird suspension of registration.

(3) All the Appropriate Authorities including the State, District and Sub-district notified under tt d A*) inter-alia, shall observe the-following conduct for processing of complaint and investigation, namely:-

(i) maintain appropriate diaries in support of registration of each of the complaint or case under the Ac!

(ii) attendtoallcomplaintsandmaintaintransparencyinthefollow-upaction of the complaints;

(iii) investigate all the complaints within twenty-four hours ofteceipt of th9' compl#nt and compldte the investigation within forty-eight hours of receipt of such comPlain!

(iv) as far as possible, not involve police for invgtigating cases under the Act as the ca'ses under the Act are tried as complaint cases under the Code of Criminal Procedure, 1973 (zof 1974).

(4) All the Appropriate Authorities including the State, District and Sub-district notified und er the-id,inter-alio shall observe the following conduct for registration and renewal of applications under the Act, namely:-

(i) dispose of the application for renewal and new registration within a period of sevmty days from the date of receipt of application; 111ii1 ensure that no application for fresh registration or renewal of registration is accepted if any case is pending in any court agains! the appliganJ for violation of any provision of the Act and the rules made thereunder].

(5) Atl the Appropriate Authorities including the Statg District and Sub-district notified under Ae A*, inter-alin, shall observe the following conduct for Legal Action, namely:-

(i) ensure that protection and e,xpensses of witress shall be met from the registration amount collected;

(ii) ensure that all the notifications of the Govemment be produced in original in the court and a copy of the same be preserved;

(iii) ensure that while filing the cases, all the papers, records, statements, evidene, panchnama and other material obiects attached to the case file shallbe in original;

(iv) suspend the certificate of registration in the course of taking legal action of seizure and sealing of the facility;

(v) ensure that there shall be no violation of the provisions of the Medical Terrrination of Pregnancy Act, L971 (y of 1971) and the Rules made thereunder while implementing the provisions of the Pre-conception and Pre-natal Diagnostic ledrniques (Prohibition of Sex Selection) Rules, 1995;

(vi) take immediite action for filing appeal, revision or other proceeding in high"" courts in case of order of acquittal within-a period of thirty days brit not later than fifteen days of receipt of the order of acquittal.

(5) All the Appropriate Authorities inchrding the State, District and Sub-district notifiei under U# e'.t, inter'alia, shall submitt- quarterly Progress report to the 1 SubstitutedvideGsR50(E), dt.2*1-2015,w.e.f.2&1-2015.Priortosubstitution,clause(ii)readasunder:- ;ilifensure that no application for fresh registration or renewal is accepted ifany case is pendingin any court against the aPPtcant" RULE 18A TI{E PRE-CONCEPTION AND PRE-NATAL.. ..... RULES tee6 37 Govemmerrt of lrdia through State Govemment and maintain Form H for keeping the information of all the registrations made readily available. .-.(2 Alt-th"-APPropriate Authorities including the State, District and Sub-district notified under the A*) inter-alia, shall observe the-following regulation of ultrasound equipmets, namely:-

(i) monitor the sales and import of ultrasound machines including portable orbuyback, assembled, grft, scrap or demo;

(ii) ensure regular quartely reports from ultrasound manufacturers, dealers, wholesalers and retailers and any person dealing with the sales of ultrasound machines atthe State leve|

(iii) conduct periodical survey and audit of all the ultrasound machines sold and operating in the State or district to identify the unregistered machines;

(iv) file complaint against any owner of the unregistered ultrasound machine and against the seller of the unregistered ultrasound machine.

(8) All the Appropriate Authorities including the State, District and Sub-district notified under the Act, izter-alia,shallobserve the following conductfor inspection and monitoring namely:-

(i) conduct regular inspntion of atl the registered facilities once in every ninety days and shall-preserve the inspection report as documentary evidence-and-u goPy of the same be handed over to the owner of facility inspected and obtain acknowledgement inrespect of the inspection;

(ii) P_lace alltheinspection reports once in three months before the Advisory Committee for follow up action;

(iii) maintainbimonthlyprogressreportcontainingnumber of cases filed and persons convicted, registration made, suspended or cancelled, medical licenses cancelled, suspended, inspections conducted, Advisory Committee leetings held at the district level and quarterly p"ogr""" report at the State leve!

(iv) (a) procur-ethe copy-of the charges framed within seven days and in the case of doctors, the details of the charges framed shall be submitted d,So TY* days of thereceipt of copy of ctrarges framed tottre State MedicalCounci!

(b) procure the certified copy of the order of conviction as soon .rs possible and in thecase of convictionof the doctors, the certified copy of the order of conviction shall be submitted within seven daysf the receipt of copy of the order of conviction. ....(9) All.the-Appropriate Authorities including the State, District and Sub-district notitied under the Act, izter-alia,shatl,observe thefollowingconductfor accountabilit5r, namely:-

(i) obtaln prior sanction or approval of the Government of India for anv resolution conceming the iiriplementation of the provisions of the AcU'(ii) take action, if any, required under the Act and immediatelv on receiot of notice under clause (b) of sub-section (1) of section 28 of th6 Act anaifne or she fails to do so, shall not be entitlid for the protection under section 31 of the said Act and defend the case in his or her own capacitl;d ,i his or her own cost. .."119) Alt.th" Appropriate Authorities including the Stats District and Subdistrict noutied under the Act, inter-alia, shall follow lhe following financial guidance,namely:- 38 THE PRE-CONCEPTION AND PRE-NATAL.......RULES 1996 RULE 19A

(i) maintain a separate and independent bank account operated by officers, at all levels;

(ii) ensure transparenry and adherence to standard Govemment financial norms for disbursement of money.l '[tg. Appeals

(1)Anybodyaggrievedbythedecisionof theAppropriateAuthorityatsubdistrict level may appeal to the Appropriate Authority at district level within 30 days of the order of the sub-districtlevel Appropriate Authority.

(2) Anybody aggrieved by the decision of the Appropriate Authority at district level may appeal to the Appropriate Authority at State/UT level within 30 days of the order of the District level Appropriate Authority.

(3) Each appeal shall be disposed of by the District Appropriate Authority or by the State/UnionTerritoryAppropriate Authority, as the case maybe, within 50 days of its receipt.

(4) If an appeal is not made within the time as prescribed under sub-rule (1), (2) or

(3), the Appropriate Authority under that sub-rule may condone the delay in case he/she is satisfied that appellant was prevented for sulficient cause from making such appeal.I '[tgl. The manner for filing and disposal of the appeal under clauses (i) and (ii) of section 21 of the Act

(1) (a) The Cmtral Govemment may, by notification in the Official Gazette, appoint a Central Appellate Authority for each of the Union territories, for the purpose of hearing appeal against the order of the Central Appropriate Authority or the Union territory Appropriate Authority. O) The Central Appellate Authority shall consist of an officer not below the rank of the Unionterritory Appropriate Authority.

(2) (a) TheStateGovemmentmay,bynotificationintheOfficialGazette,appoint a State Appellate Authority for the whole State, for the purpose of appeal against the order of State Appropriate Authority.

(b) The State Appellate Authority shall consist of the Principal Secretary, Health and Family Welfare or an officer not below the rank of the State Appropriate Authority as notifiedby the State Government.

(3) (a) An appeal against the order of suspension or cancellation of registration passed by the Central Appropriate Authority or the Union territory Appropriate Authority shall lie with the Central AppelLate Authority.

(b) An appeal against the order of suspension or cancellation of registration passed by the State Appropriate Authority shall lie with the State Appellate Authority appointed by the State Govenrmerrt.

(a) An appeal to the Central AppellateAuthority orthe StateAppellateAuthority slmll-

(a) be made in the form of a memorandum of appeal specffied in Form-I;

(b) be accompanied by an Affidavit explaining the facts of the case, specified inForrr-J and Substituted vide GSR L09(E), dt.'1.4-2-2003, w.e.f. 1.4-2-2003. Inserted vide GSR 492(E), dt.22-5-2017, w.e.f. 23-5-2017. L 2 RULE L9A THE PRE.CONCEPTION AND PRE-NATAL....... RULES 1ee6 39

(5) Every_appeal b"fl.:.t.Ce1[al Appgllate Authority or the Srate AppeltateAuthority shall be supported bythe following documents, nairely:_

(a) self-certified copies of orders or documents againstwhich appeal isbeing preferred;

(b) copies of documents relied upon by the appellan!

(d) syropsis containing particurars of events and rist of documents. . . (6) Erery appeal shall be filed within a period of thirty days of the date of receipt of the order against which the appeal is prefirred: PROVIDED thatthe Central Appellate Authority or the StateAppellate Authority 1ay allow the appealafter the period of thirty days, ir tn"r" i, u ,Jficielt "u..se for notfiling the appeal within the said period.

(7) The Cmtral App:[:l" fu$ority orthe state Appeflate Authority shall issuenoticetotherespondent,whicrrshalbeservedinanyof tie'fo[r*irr!*oa.i",*-"ry^_

(a) servicebythe appellan! or

(b) byhand delivery (dasti); or

(d) by electronic mail of fax.

(8) (a) The Central or thejtatg frpglate Aurhority shall hear the parties onreceip of the appeal and shallintimate the daieof hearingwhictr shallbe seven days before the date of hearing by e'mail or couriei at the address mentioned in the appeal.

(b) The appeJl::nt may.present T-persgn or_tlrough his duly authorised legal representative, at the time of hearing of the afpeal.

(c) If the apperlant.fails to appear before the Central Appellate Authority orthe state Apperate Authoritv on the specific d"d,'tL" appear may bedismissed for default.

(d) The Central Apqe{ate Authority 9r the ltate Alpelrate Authori ty may,rrrffi* :ly_rs stro:yn, atany stage of upp"ri, S";iti_ to Uru p_fi"" or to any of them *{ *y from.time t9 tirne adjloum *," r,ea"ing'oithe appeal for reasons tobe recorded inwriting: PROVIDED that more than three adjoumments shall not be given to theappellant. G) me arpr.d shalt be dispo.ed of within a period of sixty days from the date of filing of the appell ^,..irJ3"^ffl1_1,!*rateAuthoriryortheStateAppellateAuthorityshalldispose9r me 3p.Peal oy passing.S spelkils order in writing ;d issue under'the seat oi theCentralAppellateAuthoriryi"tl,gsLtgapp"u"tea.r'tr,oJtyaJyf"Le",ticatedbythe officer authorised bv the cen!{ Appellatiiuthorily o1*,Jsi"tl Appelate Authorityfor this purpose witirin a period orii*ty aays Lom *re date of receipt of the appeal.l 40 THE PRE-CONCEPTION AND PRE-NATAL.......RULES, 1996 FORM-I FORM.I [Refer rule 19A(4Xa)] BEFORE THE CENTRAL APPELLATE AUTHORITY ORTHE STATE APPELLATE AUTHORITY APPEALNO ./20,,.,..,, Irr the matter of: NAME AND ADDRESS OF APPELLANT Appellant VERSUS NAME AND ADDRESS OF THE AUTHORITY WHOSE ORDERIS CHALLENGED Respondent Most respectfrrlly showeth: The above mentioned appellant appeals against the order passed by the................ ........, concerned Appropriate Authority at ...........'...... (Name of place and address) against the appellant in (details of the case if any) dated..................... and sets forth the following grounds of objection of the order appealed:- i.. Particulars of the order including number of order, if any, against which the appeal is Preferred

2. Brief facts of the case

3. Findings of the Appropriate Authority challenged

4. GroundsofaPPeal

5. Copy of the order enclosed along with all the documents relied uponby the Appellant Any other information/documents in suPPort of appeal Prayer That the appe[ant, therefore prays for the reasons stated above and as may be argued at the time of hearing, the records and PrTeedings be called for, this appeal be allowed, the order under the apPeal be set aside and quashed, and order deemed just and proper may kit dly be passed in favo,r of the aPPellant' signat,re of the Appellant Place Date Verification I,................... ..... doherebyverifythatthecontentsof para """.'""""""' to ..................... are true and correct to the best of my knowledge and belief and no part is false and nothing material has been concealed therein. Signature of the APPellant

7. APPENDIX-A THE PRE-CONCEPTION AND PRE-NATAL.......RULES ree6 41 FORMJ [Refer rule 19A(4Xb)] PROFORMAAFFIDAVTT BEFORE THE CENTRAL APPELLATE AUTHORITY ORTHE STATE APPELLATE AUTHORITY In the matter of: NAME OF THE APPELLANT VERSUS CONCERNED APPROPRIATE AUTI{ORITY Appellant Respondent Appellant Respondent AFFIDAVIT I................... .S/oD/o aged............ R/o .............. ... do hereby solemnly declare as under: L. That I am the Appellant in the captioned matter filed before the Appellate Authority and aware of all the facts and circumstances of the case, hence competmtto swear this affidavit.

2. That the accompanying Memo of Appeal has been drafted by my counsel under myinstruction and the same hasbeenunderstoodbyme, the same may be read as the part and parcel of this affidavit, and the same has not been repeated here for the sake ofbrevity. Deponent Verification Verified on this duy ..................... of ..................... (month and year) that the contents of the appeal are true and correct on the basis of my knowledge/records/documerrts/ legal advice received from the counsel and nothing material has been concealed therefrom. Deponent APPENDIX-A fRefer RuIe 19A@)(c)] BEFORE THE CENTRAL APPELLATE AUTHORITY ORTHE STATE APPELLATE AUTHORITY In the matter of: NAME OF THE APPELLANT VERSUS CONCERNED APPROPRIATE AUTHORITY Index Signature of the Appellant S.No. Particulars Page No. 42 T: HE PRE-CONCEPTION AND PRE-NATAL. . . . . . . RUL ES, 199 6 SCHEDULE I Synopsis Date Particulars of eaents Signature of the Appellant LISTOFDOCUMENTS S. No. Particulars Pages Signature of the Appellant l pcneoute t [Refer rule i(L)l REQUIREMENTS FOR REGISTRATION OF A GENETIC COUNSELLING CENTRE A.PLACE A room with an area of sanen (7) square metres. B.EQUIPMENT Educational char ts I models. C.EMPLOYEES Any one of the following: -

(1) Medical Geneticist.

(2) Gynaecologist with 5 months' experience, in genetic counselling, or haoing completed 4 weeks' training in ganetic counselling.

(3) Paediatrician with 6 months' experienu in genetic counselling, or haoing completed 4 weeks' training in genetic counselling. 1 ltalicised Schedul€s I, tr and IU omitted vide GSR 109(E), dt. 14-2-2003, w.e.f. 14,2-2N3.

SCHEDULE II THE PRE-CONCEPTION AND PRE-NATAL..... ..RULES,1996 43 SCHETruLE il [Refer rule j(l.)l REQU/REMENTS FOR REGTSTRATTON OF A GENETIC LABORATORY A.PLACE A room utith adequate space for carrying out tests. B.EQUIPMENT These are categoriseil separately for each of the under-mentioned studies. Chromosomal studies:

(1) Laminar flow-hood with ultraoiolet and fluorescent light or othn suitable culture hood.

(2) Photo-microscope withfluorescent source of light.

(3) lruerted microscope.

(4) lncubator andooen.

(5) Carbon-ilioxide incubator or closed system with S%o CO2 atmosphere. 6) Autoclaoe.

(7) Refrigerator.

(8) Waterbath.

(9) Centrifuge.

(10) Vortex mixer. (1.1.) Magnetic stirrer. (L2) pHmeter.

(13) A sensitiae balance (prcferable electronic) utith sensitioity of 0.1 miligram.

(14) Double distillation apparatus (glass). Biochemical stuilies: (requiranents nccording to tests to be carried out)

(1) Laminar flow-hood with ultraoiolet and fluorescent light or othcr suitable culture hood.

(2) lnoertedmicroscope.

(3) lncubator anil oaen.

(4) Carbon-dioxide incubator or closed system with S% COz atmosphere.

(5) Autoclaoe. G) Refrigerator.

(7) Waterbath.

(8) Centrifuge.

(9) Electrophoresis aVparatus and pouer supply. (1.0) Chromatography chamber.

(11) Spectro-photometer and Elisa reader or Radio-immunoassay system (with gamma beta-counter) or fluorometer for oarious biochemical tests.

(12) Vortex mixer. (1il Magneticstirrer.

(14) PHmeter.

(15) Asensitioebalance (preferuble electronic) with sensitiaity of 0.1 miligram.

(16) Double distillation aryaratus (glass).

(17) Liquid nitrogen tank. Molecular studies:

(1) lnoerted miuoscope.

(2) lncubator. 44 TIJE PRE-CONCEPTION AND PRE-NATAL. . .... .RULES, \99 6 SCHEDULE III

(3) Oaen.

(4) Autoclaoe.

(5) Refrigerators (4 degree and minus 20 degree Centrigrade)

(5) Waterbath.

(7) Microcentrtifuge. 6) Electrophoresis apparatus and power supply,

(9) Vortexmixer.

(10) Magneticstirrer. (LL) PHmeter. (1.2) A sensitiae balance (preferable electronic) with sensitioity of 0.1 miligram.

(13) Double distillation apparatus (glass).

(14) P.C.R.machine. (1 5) Refriger ated cmtrifuge.

(16) U.V.Illuminator withphotographic nttachment or other docummtation systern. (L7 ) Precision micropipettes. C,EMPLOYEES: (L) A Medical Geneticist

(2) A laboratory technician haoing a B.Sc. degree in Biological Sciences or a ilegree or a diploma in medical- laboratory course with at least one year's experience in conducting appropriate pr e-nat al diagnostic tests.

SCHEDULE III [Refer rule 3(1)l REQUIREMENTS FOR REGTSTRATTON OF A GENETIC CLIN/C A,PLACE A room with an area of twenty (20) square metres with appropriate aseptic arrangements. B.EQUIPMENT

(1) Equipment and acccssories necessary for carrying out clinical examination by an ob s t etr ician / gy nae colo gis t.

(2) Equipment, accessories, necessary for other facilities required for operations enoisaged in the Act. *(a) An ultra-sonography machine. *b) AVpropriate cathethers and equipment for carrying out chorionic oilli aspirations per tsagina or per abdomen. *(c) Aryropriate sterile needles for amniocentesis or cordocentesis.

(d) A suitable foetoscope with an aypropriate accessories for foetoscopy, foetal skin or organbiopsy or foetalblood sampling shallbe optional.

(3) Equipment for dry and wet sterilization.

(4) Equipment for carrying out emergutcy proceilures such as anacuation of uterus or resuscitation in case of need. C.EMPLOYEES

(1) A Gynaecologist with adequate experience in pre-natal diagnostic proceilures Qhould hnoe performid at leas120 procedures uniler supentision of a Gyryaecg]9gi1t experienced in the procdduVe which is going to be carricd out, for example chorionic oilli biopsy, amniocentesis, cordacentesis and others as indicated nt B abwe).

(2) ARadiologist or Registered Medical Practitioner for carrying out ultrasonography. The required experience shall be 1.00 cases uniler superuision of a similarly qualified puson experienceil in these techniques. FORM A ruE pRE-coNCEpTrON AND PRE-NATAL.......RULES 1996 45 * These constitute the minirnum requirement of equipment for conducting the releaant procedure.l 11roRu I [Refer rules 4(1.) and 8(1)] (To be submitted in Duplicate with supporting documents as enclosures) APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION OF A GENETIC COUNSELLING CENTRE/ GENETIC LABORATORY/GENETIC CLINIC/ TILTRASOUND CLINIC/IMAGING CENTRE

1. Nameoftheapplicant (Indicate name of the organisation sought to be registered)

2. Address of the applicant

3. Type of facilitiy to be registered (Please specify whether the application is for regishation of a Genetic Counselling Centre/ Genetic Laboratory/ Genetic Clinic/Ultrasound Clinic/Imagtng Centre or any combination of these.)

4. Full name and address/addresses of Genetic Counselling Centre/Genetic Labor atory / Genetic Clinic /ultrasound Clinic/Imaging Centre with Telephone/Fax number(s)/Telegraphi c / T elex / E-maiLddress(es). 5' Type of ownership of Organisation (individual ownership/partrership/ company/co-operative/any other to be specified). Lr iase type of organization is other than individual ownership, furnish copy of irticles of association and names and addresses of other persons reiponsible for management, as enclosure.

6. Type of Institution (Govt. Hospital/Municipal Hospital/public Hospital/Private Hospital/private Nursing Home,/private Clinic/Private Laboratory/any other to be stated).

7. specific pre-natal diagnostic procedures/tests for which approval is sought.

(a) Lrvasive (i) amniocentesis/chorionic villi aspiration/ chromosomal/biochemical/molecular studies

(b) Non-[rvasive Ultrasonography Leave blank if registration is sought for Genetic Counselling Centre only.

8. Equipment available with the make and model of each equipment (List to be attached on a separate sheet).

9. (a) Facilities available in the Counselling Centre.

(b) Whether facilities are or would be available in the Laboratory/Clinic for the following tests:

(i) Ultrasound

(ii) Amniocentesis

(iii) Chorionic villi aspiration

(iv) Foetoscopy

(v) Foetalbiopsy

(vi) Cordocentesis 1 substituted vide GSR 109(E), dt. t4-z-zoog,w.e.f. l,+2-zCf,Jg. 45 THE PRE-CONCEPTION AND PRE-NATAL.......RULES 1996 FORMA

(i) Chromosomalstudies

(ii) Biochemicalstudies

(iii) Molecularstudies

(iv) Preimplantationgenetic diagnosis

10. Names, qualifications, experience and regrstration nurrber of employees (may be furnished as .u:r enclosure) LL. State whether the Genetic Counselling Centre/Genetic Labora tory / Genetic Clinic/Ultrasound Clinic/h"g.g centrel qualifies for registration in terms of requirements laid down in rule 3. L2. For renewul "pplications only:

(a) Regrstration No.

(b) Date of issue and date of expiry of existing certificate of registration.

13. List of Enclosures: (Please attach a list of enclosures/supporting documenb attached to this application.) Date: Place : Name, designation and signature of theperson authorised to sign onbetralf of the organisation to be registered. DECLARATION l, Sh./Smt./Kum./Dr. ....... son,/daughter/wife of ................... aged . years residerrt of ................. working as (indicate designation) ......... in (indicate name of the organisation to be registered) ........ hereby declare that I have read and understood the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 19412 and the Pre'natal Diagnostic Tectrniques (Regulation and Preventionof Misuse) Rules,

1996.c I also undertake to explain the said Act and Rules to all employees of the Genetic Counselling Centre/Genetic laboratory/Genetic Clinic/Ultrasound dinic/Imaging centre in respect of whidr registration is sought and to ensure ttrat Act and Rules are fuIly complied with. Date : Place : Name, designation and signature of the person authortzed to sign on behalf of the organisation to be registered Strikeoutwhicheverisnotapplicableornotnecessary. Allencloouresaretobeauthenticatedbysignature ofthe applicant. Read as "The Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (s7 ot1994)" Read as 'The Pre-conception and Pre-natal Diagnostic (Prohibition of Sex Selection) Rules, 1995" 1 2 3 FORM B TI{E PRE-CONCEPTION AND PRE-NATAL.......RULES 19e6 47 ISEAL OF THE ORGANISATTON SOUGITT TO BE REGTSTEREDI ACKNOWLEDGEMENT [Refer rulcs 4(2) anil B(7)] The aPPlication in Form {_in duplicate for grant*/renewal* of registration of Genetic_Counsel,ling Centre*/Genetic Laboratoiy*/Genetic Clinic*/iJltrasound clinic./.ImagingCentre*by...:.....j.....:............... (Nane-andaddressof applicant)hasbeen received by the Appropriate Authority .. On (date). #Ihe list of enclosures attached to the application in Form A has bem verified with the enclosures submitted and found to be correct. OR *On verification it is found that following documents mentioned in the list of enclosures are not acfually enclosed. This -acknowledgement does not confer any rights on the applicant for grant or renewal of registration. Signature and Designation of Appropriate Authority Authority, or authorised person in the Office of the Appropriate Authority Date: Place : *Strike out whichever is not applicable or not necess ary. All enclosures are to be authenticated by signature of the applicant. SEAL] ORIGINAL/DUPLICATE FOR DISPLAY lponm e [Refer rules 5(2),5(5) and 8(2)] CERTIFICATE OF REGISTRATION (Tobe issued in duplicate)

1. In exercise of the powers conferred under section L9(1) of the Pre-natal Diagnostic Techniques (Regulation and prevention of Misuse) Aci, 1gg4 (sz of 1994\,2 the {ppropriate Authority hereby grants registration to the ienetic 9ounselling. Centre*/Genetic Laboratoryl/-Genetic" Clinic*/Ultrasound Clinic*/Imaging centre* named below for purposes of carrying out Genetic Counselling/Pre-natal . Diagnostic - proiedrfres*,/pre-natal" oiagnostic Tests/ultrasonography under the aforesaid Act for a period of five y""r" "r,iirrg or, - 2. This registration is granted subject to the aforesaid Act and Rules framed $:."1"191 and any co-ntraverrtion there6f shall result in suspmsion or cancellation of this Certificate of Registration before the expuy of the said |eriod of five years apart from proseortion. A. Name and address of the Genetic Counselling Centre*,/Genetic Labor atort' / Genetic clinic*/r-Ilhasotrnd Ctinic*/kniging Centre*. B. Pre-natal diagnostic procedures* approved for (Genetic Clinic). Non-[rvasive Substituted vide GSR 109(E), dt. 1.4-2-2003, w .e.f .1.+2-2003. le_aq11'lTh: Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (57 ot 1994)" 1 2 48 THE PRE-CONCEPTION AND PRE-NATAL.......RULES 1996 FORM C

(i) Ultrasound Lrvasive

(ii) Amniocentesis

(iii) Chorionic villi biopsy

(vi) Foetoscopy.

(v) Foetal skin or organ biopsy

(vi) Cordocentesis

(vii) Any other (specify) C. Pre-natal diagnostic tests* approved (for Genetic Laboratory).

(i) Chromosomal studies

(ii) Biochemical studies

(iii) Molecular studies D. A.y other purpose (please specify)

3. Model and make of equipments being used (any change is to be intimated to the Appropriae Authority under rule 13).

4. Registration No. allotted.

5. Period of validity of earlier Cerfficate of Regishation. (For renewed Certificate of Registration only) From.......... To ........... Signature, name and designation of the Appropriate Authority Date: *Strike out whichever is not applicable or necessary. DISPLAY ONE COPY OF THIS CERTIFICATE AT A CONSPICUOUS PLACES AT THE PLACE OF BUSINESS 11roRM c tR fw rules 6(il,6@ nnd 8@l REIECTION OF APPLICATION FOR GRANT/RENEWAL SEAL] OFREGISTRATION In exercise of the powers conferred under section 19(2) of the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994,'the Appropriate Authority.................... herebyreiects the applicationfor grant*/renewal* of registration of the undermentioned Genetic Counselling Centre*/Genetic I-aboratoqf/Genetic CliniC /Ultrasound Clinic* /Imaging Centre*.

(1) Name and address of the Genetic Counselling Centre*/Genetic Laborator5f /Genetic Clinic*/Ultrasound Clinic+/ tmaging Centre*.

(2) Reasons for rejection of application for grant/renewal of registration: Date: Place: Signature, name and designation of the Appropriate Authority with SEAL of Office * Strike out whichever is not applicable or necessary.l Substituted vide GSR 109(E), dt. 14.2-2ffi,w.e.1.L4-2-2Co3. Readas'"ThePre-conceptionandPre'natalDiagnosticTechniques(ProhibitionofSexSelection) Acv1994 (57 otl94t" FORMD THE PRE-CONCEPTION AND PRE-NATAL.......RUL ES, 7996 49 11ronM D tRefer rule 9(2)l MAINTENANCE OF RECORDS BY THE GENETIC COUNSELLING CENTRE

1. Name and address of Genetic Counselling Centre.

2. Registration No.

3. Patient's name

4. Ag"

5. Husband's/Father's name

6. Full address with Tel. No., if any

7. Referred by (Full name and address of Doctor(s) with registration No. (s) (Referral note to be preserved carefully with case papers)

8. Last menstrual period/weeks of pregnancy

9. History of genetic/medical disease in the family (specify) Basis of diagnosis:

(a) Clinical

(b) Bio-chemical

(d) Other (e.g. radiological, ultrasonography)

10. Indication for pre-natal diagnosis A. Previous child/children with:

(i) Chromosomaldisorders

(ii) Metabolicdisorders

(iii) Congenitalanomaly

(iv) Mentalretardation

(v) Haemoglobinopathy

(vi) Sex linked disorders (vi| Single gene disorder

(viii) Any other (specify) B. Advanced maternal age (35 years or above) C. Mother / father / stbli^g having genetic disease (specify) D. Others (specify) LL. Procedure advised2

(i) Ultrasound

(ii) Amniocentesis

(iii) Chorionic villi biopsy

(iv) Foetoscopy

(v) Foetal skin or organ biopsy

(vi) Cordocentesis

(vii) Any other (specify) 1?. Laboratory tests to be carried out 1 Substituted vide GSR 109(E), dt.14-2-2003, w.e.f. 14-2-2W. 2 Strike out whichever is not applicable or necessary. 50 THE PRE-CONCEPTION AND PRE-NATAL.......RULES, L996 FORM E

(i) Chromosomal studies

(ii) Biochemical studies

(iii) Molecular studies

(iv) Preimplantation genetic diagnosis

13. Resultofdiagnosis If abnormal give details. Normal/Abnormal

14. Was MTP advised?

15. Name and address of Genetic Clinic to which patient is referred.

15. Dates of commencement and completion of genetic counseling. Name, Signature and Registration No. of the Medical Geneticist/Gynaecologist/Paediatrician administering Genetic Counselling. Place: Date:] 11roRu e [Refer rute 9(3) MAINTENANCE OF RECORDS BY GENETIC LABORATORY

1. Name and address of Genetic Laboratory

2. RegistrationNo.

3. Patient's name

4. Age

5. Husband's/Father's name

5. Full address with Tel. No., if any

7. Referred bylsample sent by (full name and address of Genetic Clinic) (Referral note to be preserved carefully with case papers)

8. Type of sample : Matemal blood/Chorionic villus sample/amniotic fluid/Foetal blood or other foetal tissue (specify)

9. Specify indication for pre-natal diagnosis A. Previous child/children with

(i) Chromosomaldisorders

(ii) Metabolicdisorders

(iii) Malformation(s)

(iv) Mentalretardation

(v) Hereditaryhaemolyticanaemia

(vi) Sex linked disorder

(vii) Single gene disorder

(viii) Any other (specify) B. Advanced maternal age (35 years or above) C. Mother/father/sibling having genetic disease (specify) D. Other (specify)

10. Laboratory tests carried out (give details) 1 Substituted vide GSR L09(E), dt.14-2-2A03, w.e.f. 14-2-2AW. FORM F THE PRE-CONCEPTION AND PRE-NATAL.... ... RULES 1996 51

(i) Chromosomal studies

(ii) Biochemical studies

(iii) Molecular studies

(iv) Preimplantation gentic diagnosis LL. Result of diagnosis If abnormal give details. Normal/ Abnormal Place : Date:l

12. Date(s) on which tests carried out. The results of the Pre-natal diagnostic tests were conveyed to ..................... oll . Name, Signature and Registration No. of the Medical Geneticist/Director of the Institute *Strikenot whichver is not applicable ornecessary. 11ronu r fRefer prooiso to section 4(3), rules 9(4) and l0(1A)] FORM FOR MAINTENANCE OF RECORD IN CASE OF PRENATAL DIAGNOSTIC TEST/PROCEDURE BY GENETIC CLINIC/ULTRASO:UND CLIMC/IMAGING CENTRE sEcrIoN A : To be filled in for an Diagnostic procedures/Tests

1. Name and -complete address of the Genetic Clinic/Ultrasound Clinic/Imaging Centre:

2. Registration No. (Under PC & PNDT Act, 1gg4)....o....o............................... 3' Patignt'sNam€ t"""""...........oo.............................o.....o......... Age..........o......... 4' Total Number of living childrenr ..........o..o...oo...............oo......o.....o...o.!..............

(a) Number of living Sons with age of each lirirg son (in years or months)1ttttttttt""t"""""o.......................o..o..................1...o...............t.o......

(b) Number of h"Tg Daughters with age of each living daughter (in years or months): .........................................o..oo........................o............o..

5. Husband's/Wrte's/Fathg{s/MotherrsName r .............................o..o.......o.o. 6- Full postal address of the patient with Contact Number, if any ...............

7. (a) Referred by_ (Full name and address of Doctor(s)/Genetic CounsellingCentre): (Refrral slips to be preserueit carefutty with Form F)

(b) Self-Referral by- Gynaecologist/Radiologist/Registered Medical Practitioner conducting the diagnostic procedlrres: ............. (Referral note with indications and case pryers of the patimt to be presmteil withFormF) (self-referral does not mean a client coming to a clinic and requesting for tle teet or the relative/s ..qr"stiig for the test of a pregnantwoman)

8. Last menstrual period or weeks of pregnancy: .................... SECTION B : To be filled in for prefonning non-invasive diagnostic procedures/Tests orly L Substituted vide GsR 77(E),dt. 31-1.-20l4,w.e.f. 4-2-2014. 52 TI{E PRE-CONCEPTIW-NAT@ 1996 FORM F

9. Name of the doctor performing the procedure/s : """"""'

10. Indication /s for diagnosis procedure @pe?fy with reference to the ref,uest made in the refenat slip or in a self referral note) (Ultrasonography prenatal diagnosis during Pregnancy sho-uld only b9 performed"when indicated. Ihe following is the rep:esentative list of indications for ultrasound during PreSnancy. (Put a "Tick" against the appropriate indication/s for ultrasound) iil f" diagnose intra-uterine and/or ectopic Pregnancy and confirm viability.

(ii) Estimation of gestational age (dating)

(iii) Detection of number of foetuses and their chorionicity'

(iv)SuspectedpregnancywithruCDin+ituorsuspectedPregnancy following contraceptive failure/MTP failure'

(v) Vaginal bleeding/leaking.

(vi) Follow-up of cases of abortion.

(vii) Assessment of cervical canal and diameter of internal os'

(viii) Discrepancy between uterine size and period oJ amenorrhea.

(ix) Any suspected adenexal or uterine pathology/abnorrrality''(x) OiecUonof ctuomosomalabnormalities,fetalstructuraldefectsand other abnormalities and their follow-up'

(xi) To evaluate fetal presentation and position'

(xii) Assessment of liquor amnii. 1xiiil freterrr labor/preterm premature rupture of membranes' (xig fvatuation oi placental position, thickness,- grading- and abnormalities (placenta prlevia, retro placental hemorrhage, abnomral adherence etc.)

(xv) Evaluation of umbilical cord - presentation, insertion, nuchal encirclemerr!number of vessels and presence of trueknot'

(xvi) Evaluation of previous Caesarean Section scars' lxviii nvatuation of fbetal growthparameters, foetal weightand foetal well beit g.

(xviii) Color flow mapping and duplex Doppler studies' '1*ixi Utt""sorrr,a g"if"d procedures such as medical tennination of Pregnancy, er,tema cepf.ufc version etc' and their follow-up' (:o<) iaiirnctto diagnostic and therapeutic invasive interventions sudt as chorionic vill-us sampling (evs), amniocenteses, fetal blood sampling, fetal skin biopsy, amnio-infusiolu intrauterine infusion, placement of shunts etc.

(xxi) Observation of intra-partum events'

(xxii) Medical/surgical conditions complicating Pregnancy'

(xxiii) Research/scimtific studies in recognised institutions.

11. Procedures carried out (Non-Invasive) (Put a "Tick" on the appropriate procedure)

(i) Ultrasound omportant Note : llttrasound b not indicatedtadoisedlperformeil to detimine the sex of foetus except for diagnosis of xx-linked diseases such as Ducheae Mttscular Dystrophy, Hemoplilia A & B etc')

(ii) Anyother(sPecifY) FORM F IHE PRE-CONCEPTTON AND PRE-NATAL.......RULES Lee6 53 Date: Place:

12. Date on which declaration of pregnant wom xr / person was obtained: . . . . . . . .

13. Date on which procgdures carried out : ...........o..............oo....o.......o................ L4. Result of the non-invasive procedure carried out (report in brief of the test including ultrasound carried out) L5. The result of pre-natal diagnostic procedures was conveyed to ..o.............. oI:1. .............

16. Any indication for MTP as per the abnormality detected in the diagnostic procedures/tests.......o................o..............................o......o....o.....................o.r.... Name, Signature and Registration Number with Seal of the Gynaecologist / Ra diolo gist / Registered Medical Practitioner performing Diagnostic Procedure/s SECTION C : To be filled for perfonning invasive Procedures/Tests only

17. Name of the doctor/s performing the procedure/s : ....................

18. History of genetic/medical disease in the family (specify): Basis of diagnosis ("Tick" on appropriate basis of diagnosis):

(a) Clinical (b) Bio-chemical

(c) Cytogenetic (d) other (e.g. ra-diological, ultrasonography etc. - specily) L9. Indication/s for the diagnosis procedure ("Tick" on appropriate indication/s): A. Previous child/children with:

(i) Chromosomal disorders (ii) Metabolic disorders

(iii) Congenital anomaly

(v) Haemoglobinopathy

(iv) Mental Disability

(vi) Sex linked disorders

(vii) Single gene disorder (viii) Any other (specify) B. Advanced maternal age (35 years) c. Mother / father/sibling has genetic disease (specily) D. Other (specify) . . . . . . . . . . . . . . . . o . . o . o. . o o . . . , . . . . . . o . . o . . o. . o . o .. . . . .. . . . . .

20. Date on which consent of pregnant woman/person was obtained in Form G prescribed in PC & PNDT Act, 1994:.................o....o...o.......

21. Invasive procedures carried out ("Tick" on appropriate indication/s)

(i) Amniocentesis

(iii) Foetal biopsy

(ii) Chorionic Villi aspiration

(iv) Cordocentesis

(v) Any other (specrfy)

22. Aty complication / s ofinvasive procedrrre (specify) : .......,.........,......o......

23. Additional tests recorunended (Please mention if applicable)

(i) Chromosomal studies (ii) Biochemical studies

(iii) Molecular studies (iv) Pre-implantation gender diagnosis

24.

(v) Any other (specify) Result of the Procedures/Tests carried out (report in brief of the invasive tests/procedures carrigd out) ..r.......o.......i..!o............r.................,.r.r..o..r.........or Datg on which procedurgs carrigd out: .,...............,..i,o..o..........r.,.....,..oo,.r.r....25. 54 THE PRE-CONCEPTION AND PRE-NATAL... ..RULES 1996 FORMG Date: Place:

26. The result of pre-natal diagnostic procedures was conveyed to ................. Ofl ..................

27. Any indication for MTP as per the abnormality detectred in the diagnostic pfOCedUfes/tests......o...oo.................................................!.r..............o.....oo..o...... Name, Signature and Registration Number with Seal of the Gynaecolo gist / Ra diologist / Registered Medical Practiti oner perfor*i.g Diugnostic Procedure / s SECTION D: Declrration DECLARA'TION OF THE PERSON UNDERC,OING PRENATAL DIAGNOSTIC TEST/PROCEDURE I, Mrs./Mr. .... declare that by undergoing .. Prenatal Diagnostic Test/Procedure. I do not want to know the sex of my foetus. Date Signature/Thumb impression of the person undergoing the Prenatal Diagnostic Test/Procedure Signature of a person attesting thumb impression : .............................. Dated : ................. DECLARATION OF DOCTOR/PERSON CONDUCTING PRE NATAL DIAGNOSTIC PROCEDURE/TEST I,................... (nameofthepersonconducting ultrasonography /image scanning) declare that while conducting ultrasonography/ imagescanningonM/s./Mr .... (nameof thepregnantwoman or the person undergoing pre natal diagnostic procedure,/test), I have neither detected nor disclosed the sex of her foetus to anybody in any manner. Signature..... Date : Name in Capitals, Registration Number with Seal of the Gynaecologist / Radiologist / Registered Medical Practitioner Conducting Diagnostic procedurel 11ronu c [Refer rule 101 CONSENT (For invasive techniques) I, ........................., wlfe/daugher of ................. ....... Age .....yearsresidingat.......... .hereby state that I have been explained fullytheprobable side effects and after effects of thepre-natal diagnostic procedures. I wish to undergo the preimplantation/pre-natal diagnostic technique/test/procedures in my own interest to find out the possibility of any abnormality (i.e. disease/deformity/disorder) in the child I am carrying. 1 Substituted vide GSR 109(E), dt.1,4-2-20A3, w.e.f. 14-2-20A3. FORMH TI{E PRE-CONCEPTIQN AND PRE-NATAL.......RULES 1996 55 I undertake not to terminate the pregnancy procedure/technique/test conducted show the'abince "tdisorder. if the pre-natal disease/ deformity / I understand tl.at the sex of the foetus will not be disclosed to me. I understand that breach of this undertaking will make me liable to penalty as prescribed in the Fre-natal Dagnostic Techniques (Regulation and prevention of Misuse) Act,1994 @T of 1994)l and rules framed thereundlr. Date: Place : Signature of the pregnant woman. I have explained the contents of the above to the patient and her companion (Name Address Relationship ..........) in a language she/theyunderstand. Name, Signature and/Registration Number of Gynaecologist/Mediaal Geneticist/ Radiologist/paediatrician/Director of the Clinic/Centre /Laboratory Date : Narne, Address and Registration number of Genetic Clinic / Institute SEAL] 21ronu x [Rfurule9(S)l MAINTENANCE OF PERMANENT RECORD OF APPLICATIONS FOR GRANT/REIECTION OF REGISTRATION UNDER THE PRE-NATAL DTAGNOSTIC TECHMQUES (REGULATION AND PREVENTTON OF MISUSE) ACT, 19943

1. Sl. No.

2. File number of Appropriate Authority.

3. Date of receipt of application for grant of registration.

4. Name, Address, phone/Fax etc., of Applicant.

5. Name and a_ddress(es) of Genetic Counselling Centre*,/Genetic LaboratorSf /Genetic Clinic*/Ultrasound clinic*/hiaging centre*. 6' Date of consideration by Advisory Committee and recommendation of Advisory Committee, in sumrnary.

7. Outcome of application (state granted/reiected and date of issue of orders - record date of issue of order in Form B or Form C).

8. Registration number allotted and date of expiry of registration.

9. Renewals (date of renewal and renewed upte.

10. File mrmber in whidr renewals dealt.

11. Additionalinformation, if *y. Name, Designation and Signature of Appropriate Authority N-oal']ne rre-conception and he'natal Diagnostic Tectrniques (Prohibition of Sex Selection) Act,tgg4 (57ofl994)". Substituted vide GSR 109(E), dt. ltF2-2m3,w.e.l.l+2_2fr,€,. NOW "THE PRE{OT{CEPTION AND PRE-NATAL DIAGNOsTIC TECHMQI.M EROHIBITION OFsEx SELECTION) AC"t, 199 4.' 1 2 3 55 THE PRE-CONCEPTION AND PRE-NATAL.......RULES, 1996 FORMH Guiilance for Appropriate Authority

(a) Form H is a permanent record to be maintained as a register, in the custody of the Appropriate AuthoritY.

(b) *Means strike out whichever is not applicable.

(c) On renewal, the Registration Number of the Genetic Counselling Centre/Genetic Laboratory/Genetic Clinic/tlltrasound Clinic/Imaging Centre will not drange. A fresh registration Number will be allotted in the event of change of ownership or management.

(d) Registrationnumber shallnotbe allotted twice.

(e) Each Genetic Counselling Centre/Genetic Laboratory/Genetic Clinic/Ultrasound Clinic/Imaging Centre may be allotted a folio consisting of two pages of the Register for recording Form H.

(f) The spaceprovided for'additionalinformation' maybeused forrecording suspension, cancellations, rejection of application for renewal, change of ownership/management, outcome of any legal proceedings, etc.

(g) Every folio (i.e. pages) of the Register shall be authenticated by signature of the Appropriite Authority with date, and every subsequent entry shall also be similarly authenticated.l Note : The Principal Notification was published in the Gazette of India vide No. GSR L(E), dt.l-1-7996 and last ammded vide Noti- No. GSR 50(E), dt. 28-L-20L5.

Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996

The enactment

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