The Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994

EXTRAORDINARY

PUBLISHED BY AUTHORITY

No. 1] NEW DELHI, MONDAY, JANUARY 1,1996/PAUSA 11, 1917 1 GI/96 (1)

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18 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Family Welfare) NOTIFICATION New Delhi, the 1st January, 1996 G.S.R. 1(E).—In exercise of the powers conferred by section 32 of tho Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994), the Central Government hereby makes the following rules, namely:—

1. (1) These rules may be called the Pre-natal Diagnostic Tech- niques (Regulation and Prevention of Misuse) Rules, 1996.
2. (2) They shall come into force on the date of their publication in tho Official Gazette.

otherwise requires,—

1. (a) "Act" means The Pre-natal Diagnostic Tech- niques (Regulation and Prevention of Mis-

use) Act, 1994 (57 of 1994);

1. (b) "employee" means a person working in or employed by a Genetic Counselling Centre, a Genetic Laboratory or a Genetic Clinic, and includes those working on part-time, contractual, consultancy, honorary or on any other basis;
2. (c) "Form" means a Form appended to these rules;
3. (d) "Schedule" means a Schedule appended to these rules;
4. (e) "section" means a section of the Act ; i?T
5. (f) words and expressions used herein and not defined in these rules but defined in the Act, shall have the meanings, respectively, assig- ned to them in the Act.

1. (1) The minimum qualifications of tho employees, the minimum equipment and minimum place for a Genetic Coun- selling Centre, Genetic Laboratory and Genetic

Oli"ic shall bs as specified in Schedules I, II and III.

1. (2) Where an institute, hospital, nursing home, or any place, by whatever name called, provides

services jointly of Genetic Counselling Centre, Genetic

Laboratory and Genetic Clinic, or any combination of thess, it shall conform to the requirements o> specified in Schedules 1, II £;nd III.

Genetic Laboratory and Genetic Clinic—(1) An

application or registration shall fc made to the Appro-

priate Authority, in duplicate, in Form A.

1. (2) The Appropriate Authority, or any person in his office authorised 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 lator than the next working day if received by post,

1. (1) Every application for registration under rule 4 shall be accompanied by an application fee of :—
   • (a) Rs. 2000.00 for Genetic Counselling Centre;
   • (b) Rs. 3000.00 for Genetic Laboratory;
   • (c) Rs. 3000.00 for Genetic Clinic; and
   • (d) Rs. 4000.00 for an institute, hospital, nursing

home, or any place providing jointly the services of a

Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic or any combination of such Centre, Laboratory or Clinic.

1. (2) The application fee shall be paid by a demand draft drawn in favour of the Appropriate Authority, on any scheduled bank located at the headquarters of the Appropriate Authority. 6, Certificate of registration.—(1) Tho Appro- priate Authority shall, after making fuoh enquiry and after satisfying itself that the applicant has com- plied with all the requirements, plpxe the applicatior before the Advisory Committee for its advice.
2. (2) Having regard to the advice of the Advisory Committee the Appropriate Authority shall grant a certificate of registration, in duplicate, in Form B to the applicant. One copy of the certificate of

Clinic at a conspicuous place at its place of business. Provided that tlw Appropriate Authority may

specified pre-natal diagnostic tests or procedures, depending on the availability of place, equipment and qualified employees, and standards maintained by such laboratory or clinic.

1. (3) If, after enquiry and after giving an oppor-

tunity of being heard 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 such rejection to the applicant as specified in Form C.

1. (4) An enquiry under sub-rule d), including ins- pection at the premises of the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, shall, be earned out only after due notice is given to the applicant by the Appropriate Authority.
2. (5) Grant of certificate of registration or rejection of application for registration shall be communi- cated to the applicant as specified in Form B or Form C, as the case may be, wiihin a period of ninety days from the date of receipt of application for registration.
3. (6) The certificate of registration shall be non- transferable. In the event of change of ownership or change of management or on ceasing to function as a Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, both copies of the certificate of registration shall be surrendered to the Appropriate Authority.
4. (7) In the event of change of ownership or change of management of the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, the new owner or manager of such Centre, Laboratory or Clinic shall apply afresh for grant of certificate of regis- tration.

Every certificate of

registration shall bs valid for a period of five years

from the date of its issue.

1. (1) An application for renewal of certificate of registration shall be made

in duplicate in Form A, to the Appropriate Authority

thirty days before the date of expiry of the certificate of registration. Acknowledgement of receipt of such-

application shall be issued by the Appropriate Autho

rity in the manner specified in sub-rule (2) of rule 4,

1. (2) The Appropriate Authority shall, after holding an enquiry and after satisfying itself that the applicant

has 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 certi- ficate of registration, as specified iu Form B, for a further period of five years from the drate of expiry of the certificate of registration earlier granted.

1. (3) If, after enquiry and after giving an oppor- tunity of being heard 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 reasons to be recorded in

writing, reject the application for renewal of certi- ficate of registration and communicate such rejec- tion to the applicant as specified in Form C.

1. (4) The fees payable for renewal of certificate registration shall be one half of the fees provided in sub-rule (1) of rule .1
2. (5) On receipt of the renewed certificate of regis- tration in duplicate or on receipt of communication of rejection of application for renewal, both copies of the earlier certificate of registration shall be sur- rendered immediately to tho Approripate Authority by the Genetic Counselling Centre, Genetic Labora- tory or Genetic Clinic.
3. (6) In the evsnt of failure of the Appropriate

Authority to renew the certificate of registration or to

communicate rejection of application for renewal of registration within a period ofn'netydays from the date of rcce'pt of application for renewal of regis-

tration, the certificate of registration shall be deemed

to have been ronewed.

1. (1) Every Genetic Counseling Centre, Genetic Lab- oratory and Genetic Clinic shall maintain a register showing, in serial order, the names and addresses of the women given genetic counselling, subjected to pre-natal diagnostc procedures or pre-natal dia- gnostic tests, the names of their husbands or fathers and the dato on which they first reported for such counselling, procedure or test.
2. (2) The record to bs ma.ntained by every Genetic

CounclLng Centre, in ruspect of each woman counsel-

led, shall be as spec'fled in Form D.

1. (3) The record to be maintained by every Genetic Laboratory, in respect of each woman subjected to any pro-nata] diagnostc test, shall be as specified in Form E.
2. (4) The record to ba maintained by every Genetic

Clinic, in respect of each woman subjected to,any pre-

natal diagnostic procedure, shall be as specified in Form F.

1. (5) The Appropriate Authority shall maintain a

permanent record of applications for grant or renewal

of certificate of registration as specified in Foim H. Letters of intimation of every change of employee, place, address and equipment installed shall also be preserved a permament records.

1. (6) All case relatod-recorus, forms cf consent, laboratory results, microscopic pictures, srnogaphic platos or slides, recommendations and letters shall be preserved by tho Genetic Counselling Centre,

ling, pre-natal diagnostic procedure or pre-natal

diagnostic test, as the case may be. In the event of any

legal proceedings, the records shall be preserved till th? final disposal of legal proceedings, cr till the expiry of the said period of two years, whichever is later.

1. (7) In case the Geretic Counselling Centre or Genetic Laboratory or Genetic Cl ;

nic maintains

fccords en computei or other electronic equipment

20 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)]

a printed copy of the record shall be taken and pre-

served after authentication by a person responsible for such record.

(1) Before conducting any pre-natal- diagnostic procedure, a written consent, as specified

in Form G, in a language the pregnant woman under-

stands, shall be obtained lromher:

Provided that wheie 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 bo necessary for the Genetic Laboratory to obtain

a fresh consent in Form G.

1. (2) All the State Governments and Union terri- tories may issue translation of Form G in languages used in the State or Union territory and where no official translation in a languge understood by the pregnant woui?n is available, the Genetic Clinic may

translate Form G into a language sbe understands.

Every Genetic

Counselling Centre, Genetic Laboratory and Genetic Clinic shall afford I reasonable facilities for inspection of the place, equipment and records to the Appropriate Authority or to any other person authorised by the Appropriate Authority in this behalf.

Appropriate Authority or any officer authorised in this behalf may enter and search at all reasonable timos any Genetic Counselling Centre, Genetic Lab- oratory or Genetic Clinic, in the presence of two or more independent and respectable persons, for the purposes of section 30.

1. (2) A list of any document, record, register, book,

pamphlet, advertisement or any other material object

found in the Genetic Counselling Centre, Genetic

of seizure if, for reasons to be recorded in writing,

1. (3) One copy of the list referred to in sub-rule (2)

shah" be handed over, under acknowledgement, to the

person from whose custody the document, 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 pother material object seized may be delive&d under acknowledgement, or sent by registered post to the

owner or manager of the Genetic Counselling Centre,

Genetic Laboratory or Genetic Clinic, if no person acknowledging custody of the document, record, register, book, pamphlet, advertisement or other

material object seized is available a ttho place of effect-

ing the seizure.

1. (4) If any material object seized is perishable in nature, the Appropriate Authority, or the officer aut- horised in this behalf shall make arrangements prom- ptly for sealing, identification 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 Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic for preserving such perishable material object may be sealed until such time as arrangements can be made for safe removal

1. (5) In the case of non-completicn of search and seizure operation, the Appropriate Authority or the officer authorized in tin's behalf may make arrange- ments, by way of mounting a guard or scaling of the premises of the Genetic Counselling Centre,

Genetic Laboratory or Genetic Clinic, for safe keeping,

listing and removal of documents, records, book cr any other material object to be seized, and to pre- , vent any tampering with such documents, records, books or any other material object.

Every Genetic Counselling Centre,

Genetic Laboratory or Genetic Clinic stwll intimate every change of employee, place, address Mid equip-

ment installed, to the Appropriate Authority within a

perk d of thirty days of such change.

(1) No Genetic Laboratory shall accept for analysis or test any sample, unless referred to it by a Genetic Clinic.

1. (2) Every pre-natal diagnostic procedure shall invariably be immediately preceded by locating the foetus and placenta through ultra scnogrcphy, and the pre-natal diagnostic procedure shall be done under direct ultrasonogrEiphic monitoring so as to prevent any damage to the foetus and placenta.

The intervening period between any two meetings of Advisory Commitiecb constituted under ai.b-.-evtion

1. (5) of section 17 to advise the appropriate Authority shall not exceed sixty days.

(l)The ex-officio members, and other

Central and State Government officers appointed to

the Boird will be entitled to Tiavellmg Allowance and

Daily Allowance tor attending the meetings ol the Borrd as per the Travelling Allowances; rules appli- cable to them.

1. (2) The non-official members appointed to, and Members of Parliament elected to, the Board will be entitled to Travelling Allowance and Daily Allowance

for attending the meetings of the Board as admissible

to non- officials and Members oi" Parliament, as the case may be, under tho Travelling Allowances rules of the Central Government.

1. (1) Eveiy Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic shall prominently display en its premises a

notice in English and in the local language or langu-

ages for the informatton of the public, to the effect

1. (2) At least one copy each of the Act and these rile^ shall be available on the premifes cf every Ge- netic Counseling, Centre, Genetic Laboratory and Genetic Clime, end shall be made available to the cl ; eptcle on demand for persuai.
2. (3) The Appropriate Authority, the Central Government the State Government, and the Govern- ment/Administration of the Union territory may publish periodically lists cf registeied Genetic Counsel- ling Centres, Genetic Laboratores and Genetic

public and ibr use by the experts in the feld. lNo.2301I/59/94-PLYJ K. S. SUGATHAN, Jt. Secy.

GENETIC LABORATORY A. PLACE A room with adequate space for carrying out tests. B. EQUIPMENT These are categorised separately for each of the undermentioned studies. Chromosomal studies : (1) Laminar flow hood witli ultraviolet and fluorescent light or other suitable culture hood. (2) Photo-micrc-iCepe with fluorescent source of Hght. 22 THE GAZETTE OF INDIA: EXTRAORDINARY [PART U~SEC. 3(i)] (3) Inverted nrcroscope. (4) Incubator and oven (5) Carbon dioxide incubator or closod system with 5% CO? atmosphere. (6) Autoclave. (7) Refrigerator. (8) Water bath. (9) Centrifuge. (10) Vortex mixer (11) Magnetic strirrer. (12) pH meter. (13) A sensitive balance (preferably electronic) with sensitivity of 0.1 miligram. (14) Double distillation apparatus (glass). Biochemical studies : (lequircments according to tests to bo carried out) (1) Laminar flow hood with ultraviolet and fluorescent light or other suitable culmre hood. (2) Inverted microscope. (3) Incubator and oven (4) Carbon dioxide incubator or closed system with 5% GO^ atmosphere. (5) Autoclave. (6) Refrigerator. (7) Water bath (8) Centrifuge. (9) Electrophorcsis apparatus and power supply. (10) Chromatography chamber. (11) Spxtro-photometer and Llisa reador or Radio -imrminoassay system (with gamma beta-counter) or fluoro- ineter for various biochemical tests. (12) Vortex mixer, 13) Magnetic stirrer. (14) pH meter. (15) A sensitive balance (preferably electronic) with sensitivity of 0.1 miligram. (16) Double, distillatico appratus (glass). (17) Liquid nitrogen tank. Molecular studies : (1) Inverted microscope- (2) Incubator. (3) Oven. (4) Autoclave. (5) Refrigerators (4 degree and minus 20 degree Centigrade) (6) Water bath, (7) Microcentrifuge. (8) tlectrophoresis appratus and power supply. (9) Vortex mixer. (10) Magnetic stirrer. (11) pH meter. (12) A sensitive balance (preferably electronic) woth sensitivity of 0.1 miligram. (13. Double distillation apparatus (glass) (14) P.C.R. machine. (15) Rofrigerated centrifuge. (16) U.V. Illuminator with photographic attachment or other documentation system. (17) Precision micropipettos. C. EMPLOYEES : (1) A Medical Geneticist (2) A laboratory te chnician having a B.S.c. degree in Biological Sciences or a degree or a diploma in medical laboratory course with at least one year's experience in conducting appropriate pre-natal diagnostic tests-

[See rule 3(1)1 REQUIREMENTS FOR REGISTRATION OF A GENETIC CLINIC A. PLACE A room with an area of twenty (20) square metres with appropriate aseptic arrangements. B. EQUIPMENT (1) Equipment and accessories necessary for carrying out clinical examination by an obstertician/gyn aeco- logist. (2) Equipment, accessories, materials and other facilities required for operations envisaged in the Act. *(a) An ultra-sonography machine. *(b) Appropriate cathethers and equipment for carrying out chorionic villi aspirations per vagina or per abdomen. *(c) Appropriate sterile needles for amniocentesis or cordocentcsis. (d) A suitable foetoscope with appropriate accessories for foetoscopy, foetal skin or organ biopsy or foetal blood sampling shall be optional. (3) Equipment for dry and wet sterilization . (4) Equipment for carrying out emergency procedures such as evacuation of uterus or resuscitation in case of need. C. EMPLOYEES (1) A gynaecologist with adequate experience in pre-natal diagnostic procedures (should have performed at- least 20 procedures under supervision of a gynaecologist experienced in the procedure which is going to be carried out, for example chorionic villi biopsy, amniocentesis, cordocentesis and others as indicated at B above). (2) A Radiologist or Registered Medical Practitioner for carrying out ultrasonography. The required ex- perience shall be 100 cases under supervision of a similarly qualified person experienced in these techniques ""These constitute the minimum requirement of equipment for conducting the relevant procedure FORM A [See rules 4(1) and 8(1)] (TO BE SUBMITTED IN DUPLICATE) WITH SUPPORTING DOCUMENTS AS ENCLOSURES. ALSO IN DUPLICATE FORM OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION OF A GENETIC COUNSE LLING CENTRE/GENETIC LABORATORY/GENETIC CLINIC* 1. 2. 3. 4. 5. Name of the applicant (specify Sh./Smt./Kum./Dr.) Address of the applicant Capacity in which applying (specify owner/partner/managing director/other-to be stated) Type of facility to be registered (specify Genetic Counselling Centre/Genetic Labo- ratory/Genetic Clinic/any combination of these) Full name and address/addresses of Genetic Counselling Centre/Genetic Laboratory/Genetic Clinic with Tele- phone/TelegraphicTelx/Fax E-mail numbers. 2* THE GAZETTE OF INDIA: EXTRAORDINARY [PART IJ-r^pc 3(i)1 7. 8. 9. 10. 11. 12. 13. 14. 15. Type of ownership and organisation (specify individual ownersbip/partnership/company/co-operative/any other) In case of type of organisation other than individual ownership, furnish copy of articles of association and names and addresses of other persons responsible for management, as enclosure. Type of Institution (Govt. Hospital/Municipal Hospital/ Public Hospital/Private Hospital/Private Nursing Home/ Private Clinic/Private Laboratory/any other to be stated. Specific prenatal diagnostic procedures/tests for which approval is sought (for example amniocentesis, chorionie villi aspiration/chromosomal/biochemical/molecular studies etc). Leave blank if registration sought for Genetic Councellin; Centre only (a) Space available for the Counselling Centre/Clinic/ Laboratory give total work area excluding lobbies. waiting rooms, stairs etc. and enclose plan) Equipment available with the make and model of each equipment. List to be attached on a separate sheet). (a) Facilities available in the Counselling Centre. (b) Whether facilities are available in the Laboratory/ Clinic for the following tests; (i) Ultrasound (ii) Amniocentesis (iii) Chorionie villi aspiration (iv) Foetoscopy (v) Foetal biopsy (vi) Cordocenteds (c) Whether facilities are available in the Laboratory Clinic for the following : (i) Chromosomal studies (ii) Biochemical studies (iii) Molecular studies Names, qualifications, experience and registration num- ber of employees. May be furnished as an enclosure. (Refer Schedules I, II or III) State whether the Genetic Co&nselling Centre,Genetic Laboratory/Genetic Clinic* qualifies for registration in terms of minimum requirements laid down in Schedule I, II and III and if not, reasons theiefoi. For renewal applications only : (aj Registration No. )b) Date of issue and date of expiry oi' existing certi- ficate of registration. List of Enclosures : Please attach a list of enclosures giving the supporting documents enclosed to this application. ( -) Namt and signature of applicant Date : Place : DECLARATION I, Sh./Smt./Kumi /Dr son/ daughter/wife cf aged years resident of hereby declare that 1 hav; read and understood the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act. 1994(57 of 1994) and the Pre-natal Diagnostic Techniques (Regulation nnd Prevention of Misuse), Rules, 1995 (ii) 1 also undertake to explain the said Act and Rules to all employees of the Genetic Counselling Centre/ Genetic Laboratory/GeneMc Clinic in rcspec f of Which registration is sought and to ousure that Act and rul.s aco fully complied with ( _—) Name and signature oi applicant Date : Place : *Strike out whichever is not applicable or not necessary. All enclosures are to be authenticated by signatui ol the applicant. ACKNOWLEDGEMENT [See rules 4(2) and 8(1)] The application in Form A in duplicate for grnnt*/'rene\val* nf registration of Gcnet'c Counselling Qntrt*/ Genetic Laboratory's/Genetic Cl ; nic* by (Nams and address of applicant) has been received by the Appropratc. Authority on (date). •"The list of enclosures attached to the application in Form A has been verified with the enclosures submtted and found to be correct. OR "On verification it is found that following documents mentioned in the list of enclosures are not actually enclosed. This acknowledgement docs not confer any rghts on the applci,nt for grant or renewal of registration. ( __ ) Signature and Designation of Appropriate Authority, or authorized person in the office of the Appropriate Authority. Date : SEAL •"Strike out whichever is not applicable or noi necessary. 1 GI/96-4 26 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II-SEC. 3(1)) ORIGINAL* DUPLICATE FOR DISPLAY FORM B [See rules 6(2), 6(5) and 8(2) ] CERTIFICATE OF REGISTRATION l,To bs issued in duplicate) 1. In o^rcise of the powers conferred under section 19(1) cf the PrcnEtal Dicgnciit c Techniques (Regulation and Prevention of Misusg Act, 1994 (57 of 1994), the Appr3priate AuLrority he ehy grants vcgistiation to the Gonotic Counsell- ing Cente*/Genotic Li'.bo •Ptory'VGcnetic Cl nic* namud below fc r pui poses of carrying out Genetic Counsc 11 ng*/ Pr-natalE>i:'g::ositic Pr ccdun:s*/Pr<natal Diagnostic Tests* as denned in the aforesaid Act fora period of five years ending on 2. This registration is granted subject to the aforesaid Act and Rules thereunder, and any contravention thereof shall result in suspension or cancellation of this Certificate of Registration before the expiry of the said period of five years. A. Name and address of the Genetic Counselling Centre*/Genetic Laborarory*/Genetic Clinic* B. Name of Applicant for registration C. Prenatal diagnositic procedures approved for (genetic clinic) (i) Ultrasound (ii) Amniocentesis (iii) Chorionic Villi biopsy (iv) Foetoscopy (v) Foetal skin or organ biopsy (vi) Cordocentesis. (vii) Any other (specify) D. Prenatal diagnostic tests* approved (for Genetic Laboratory) (i) Chromosomal studies (ii) Biochemical studies (iii) Molecular studies 3. Registration No. allotted 4. For renewed Certificate of Registration only Period of validity of earlier CertincateFrom , .To of Registration. Signature .namefand designation of the Appropriate Authority Date : SEAL 'Strike out whichever is not applicable or necessary. DISPLAY ONE COPY OF THIS CERTIFICATE AT A CONSPICUOUS PLACE AT THE PLACE OF BUSINESS. FORM C [See rules 6(3), 6(5) and 8(3)] REJECTION OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION In exercise of the powers conferred undci section 19(2) of the Prenatal Diagnostic Techniques (R<xu!et-'cn [r .d Prevention of Misuse) Act, 1994 the Appropriate Authority he tby rejects the application for grant*/rcnewal* of registration of the Genetic Counselling Cerjtre*/Ge:netc Ltbcittav/Guctc Clinic* named below for the reasons stated. Name and address of the Genet c Coousell ng Centre*/Genetic Laboratory*/Gcnetic Cl'nic* Name of Applcant who has applied foi registration Reasons for rejection of application for registration Signature, name and designation of Appropriate Authority Date : SEAL *Strike out whichever is not applicable or necessary. FORM D [See rule 9(2)] NAME ADDRESS AND REGISTRATION. NO OF GENETIC COUNSELLING CENTRE RECORD TO BE MAINTAINED BY THE GENETIC COUNSELLING CENTRE 1. 2, 3. 4. 5. 6. 7. 8, Patient's name Age Husband's/Father's name Full address with Tel. No. if any Referred by (Full name and address of Doctor(s) with registration No.(s) (Referral note to be preserved carefully with case papers) Last menstrual poricd/ weeks of pregnancy H ; story of genetic/medical disease : n the family (specify) Basis of diagnosis: (a) Clinical (b) Bio-Chemical (c) Cyto-genetic (d) Other (e.g. radiological) Indication for prenatal diagnosis* A. Previous child/children with: (i) Chromosomal disorders (ii) Metabolic disorders (iii) Congenital anomaly 28 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] 9- 10. 11. 12. 13. 14. (iv) Mental rota idat on (v) Hacmoglcbinopathy (vi) Sex linked disorders (vii) Any other (specify) B. Advanced maternal age (—35 yeEib) C. Mother/father/sibling has genetic disease (specify) D. Others (specify) Procedure advised* (0 Ultrasound CO Amniocentesis (iii) Chorionic VilH biopsy (iv) Fouioscopy (v) Fectal skin or organ biopsy (vi) Cordocentesis (vii) Any other (specify) Laboratory tests to be carried out (i) Chromosomal studies (ii) Biochemical studies (iii) Molecular studies Result of prenatal diagnosis: Normal/Abnormal If abnormal give details. Was MTP advised? Name and address of Genetic Clinic* to which patient referred. Dates of commencement and comp!ct : on of genetic counselling. Name, Signature and Registration No. of the Medical Geneticist/Gynaecologist/ Paediatrician. Date •Strike out whichever is not applicable or not necessary. Form E [See rule 9 (3)] NAME, ADDRESS AND REGISTRATION NO. OF GENETIC LABORATORY RECORD TO BE MAINTAINED BY THE GENETIC LABORATORY 1. 2. 3. 4. 5. 6. Patient's name , Age Husband's/Father's name Full address with Tel. No., if any Referred by/sample sent by (full name and address of Genetic Clinic (Referral note to be preserved care- fully with case paper). Type of samplo : Maternal blood/Chorionic villus sample/amniotlc fluid/Foetal blood or other foetal tissue (Specify) 7. 8. 9. 10. on. Specify indication for prenatal diagnosis (A) Previous Child/children with: (i) Chromosomal disorders (ii) Metabolic disorders (iii) Malformation(s) (iv) Mental retardation (v) Hereditary hacmolytic anaemia (vi) Sex linked disorder (vii) Any other,, (specify) (B) Advanced maternal age (—35 years) (C) Mother/father/sibling has genetic disease (specify) (D) Other/speicfy) Laboratory tests carried out (give details) (i) Cromosonial studies (ii) Biochemical studies (iii) Molecular studies Result of pre-natal diagnosis: Normal/Abnormal if abnormal, give details Date(s) on which tests carried out The results of the prc-nata [diagnostic tests were conveved 1c? Name, signature and Registration number of the Medical Geneticist Date Form F [Sec role 9 (4)] NAME, ADDRESS AND REGISTRATION NO. Of GENETIC CLINIC RECORD TO BE MAINTAINED BY THE GENETIC CLINIC ], 2. 3. 4. 5. 6. 7. Patient's name Ago Husband's/Father's name Full Address with Tel. No., if any Referred by (full name and address ofdoctor(s)/Genetic Counselling Centre (Referral note to be preserved cavefolly with case papers). Last menstroal period/ weeks of pregnancy. History of genetic/medical disease in tho family (specify). Basis of diagnosis: (a) Clinical (b) Bio-C-homital (e) Cyto-gonetic (d) Olliet (e.g. radioingical-specify) 30 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] 8. 9. 12. 14. 15. 16. 17. Indication for prenatal diagnosis (A) Previous child/children with: (i) Chromosomal disorders (ii) Metabolic disorders (iii) Congenital anomaly (iv) Mental ratardation (v) Haemoglobinopathy (vi) Sex linked disorder (vii) Any other (specify) (B) Advanced maternal age (—35 years) (C) Mother/father/sibling has genet c disease (specify) (D) Other (specify) Procedures carried out (with name and registration No. of Gynoecologist/Radiologist/Registcrcd Medical Practitioner) who performed it. (i) Ultrasound (ii) Aminiocentesis (iii) Chorionic Villi aspiration (iv) Foetal biopsy (v) Cordocentesis (vi) Any other (specify) Any complication of procedure—please specify . Laboratory tests recommended* (i) Chromosmal studies (ii) Biochemical studios (iii) Molecular studies Result of pre-natal diagnostic procedure and specify Normal/AbnormBl abnormality detected, if any- . Was MTP advised/cenducted Date(s) on which procedures carried out. Date on which MTP carried out. Date on which consent obtained. The result of prt-natal diagnostic procedure were convoyed to on Dato Place Name, signature and Regstration number of the Gynaocologjst/Radiologist/Regi8tered Medical Prac- titioner • Strike out whichever is not appliable or not necessary. FORM G [See rule 10)] FORM OF CONSENT l t wife/daughter of age years residing at hereby state that I hav« boon explained fully the probable side effects and after effeots of the pre-natal diagnostic procedures. I wish to undergo the pre-natal diagnostic procedures in my interest to find out the possibility of any abnormality (i.e. deformity or disorder) in the child I am carrying. I undertake not to terminate the pregnancy if the pre-natal procedure and any pre-natal tests conducted show the absence of deformity or disorders. I understand that 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 Pre-natal Dia- gnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994). Date Signature Place 1 have explained the contents of the above consent to the patient and her companion (Name Address relationship ) in a lagnague sho/they understand. Date Name, signature and Registration number of Gynae- cologist Name, address and Registration number of Gene- tic Clinic FORM H [See rule 9(5)] PERMANENT RECORD OF APPLICATION FOR REGISTRATION, GRANT OF REGISTRATION, REJECTION OF APPLICATION FOR REGISTRATION AND RENEWALS OF REGISTRATION 1. 2. 3. 4. 5. 6. 7. 8* 9. SI. No. File number of Appropriate Authority. Date of rectipt of application for grant of registration. Name, Address, Phone/Fax etc, of Applicant. Name and address (cs) of Genetic Counselling Centre*/ Genetic Laboratoy*/ Genetic Clinic* Date on which case considered by Advisory Committee and recommendation of Advisory Committee, in summary. Outcome of application (state granted/rejected/and date of issue of orders). Registration number allotted and date of expiry of re- gistration. Renewals (date of renewal and renewed upto) . File number in which renewals dealt. . Additional information, if any. Name, designation and signature of appropriate Authority 32 THE GAZETTE Q* INDIA: EXTRAORDINARY [PARI II—SKC. 3(i)J Guidance for Appropriate Auihority (a) Form H is a permamont reocrd to be maintained as a register, in the custody of the Appropriate Authority. (b) *means strike out woLher.ts not applicable. (c) Against item 7, record date of issue of order in Form B or Form C. (d) On renewal, the Registration Number of iho Genetic Couselling Centre/Genetic Laboraiory/Oenetic Clinic will not change. A fresh registration Number will bo allotted in the event of change of ownership or management. (c) No registration number shall be allotted twice. (f) Each Genetic Counseling Centre/Genetic Laboratory/Genetic Clinic may be allotted a folio consisting of two facing pages of the Register for reoording Form H. (g) The space provided for 'additional information' may be used for recording suspension, cancellations, rejection of application for renewal, change of ownership/management, outcome of any legal proceedings, etc. (h) Every folio (i.e. 2 pages) of the Register shall be authenticated by signature of the Appropriate Authority; with data, and every subsequent entry shall also be similarly authenticated. Printed by the Manager, Govt, of India Preii, Rinfl Road, Maya Pur!, New DelhI-110064 and Published by the Controller »f Publication!, Delhi-110054, 1996