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

REGD. NO. D.L.—33004/95 The Gazette of India EXTRAORDINARY PART II—Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 1] NEW DELHI, MONDAY, JANUARY 1,1996/PAUSA 11, 1917 1 GI/96 (1) 2 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] 3 4 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(0] 5 6 TttE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] 7 . 8 J™ GAZETTE OF INDIA .EXTRAORDINARY [PART U-SBC. 3(i)) 9 1OT/96—2 10 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(0] 11 12 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] 13 14 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] 15 ] 6 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] 17 1 Gl'9..-3 18 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] MINISTRY OF HEALTH AND FAMILY receipt of the application for registration, in the WELFARE acknowledgement slip provided at the, bottom of Form A, immediately if delivered at the office of the (Department of Family Welfare) Appropriate Authority, or not lator than the next NOTIFICATION working day if received by post, New Delhi, the 1st January, 1996 5. Application Fee.—(1) Every application for G.S.R. 1(E).—In exercise of the powers conferred registration under rule 4 shall be accompanied by an by section 32 of tho Pre-natal Diagnostic Techniques application fee of :— (Regulation and Prevention of Misuse) Act, 1994 (a) Rs. 2000.00 for Genetic Counselling Centre; (57 of 1994), the Central Government hereby makes the following rules, namely:— (b) Rs. 3000.00 for Genetic Laboratory; 1. Short title and commencement.—(1) These (c) Rs. 3000.00 for Genetic Clinic; and rules may be called the Pre-natal Diagnostic Tech- (d) Rs. 4000.00 for an institute, hospital, nursing niques (Regulation and Prevention of Misuse) Rules, home, or any place providing jointly the services of a 1996. Genetic Counselling Centre, Genetic Laboratory and (2) They shall come into force on the date of their Genetic Clinic or any combination of such Centre, publication in tho Official Gazette. Laboratory or Clinic. 2. Definitions. In these rules, unless the context (2) The application fee shall be paid by a otherwise requires,— demand draft drawn in favour of the Appropriate (a) "Act" means The Pre-natal Diagnostic Tech- Authority, on any scheduled bank located at the niques (Regulation and Prevention of Mis- headquarters of the Appropriate Authority. use) Act, 1994 (57 of 1994); 6, Certificate of registration.—(1) Tho Appro- (b) "employee" means a person working in or priate Authority shall, after making fuoh enquiry employed by a Genetic Counselling Centre, and after satisfying itself that the applicant has com- a Genetic Laboratory or a Genetic Clinic, plied with all the requirements, plpxe the applicatior and includes those working on part-time, before the Advisory Committee for its advice. contractual, consultancy, honorary or on any other basis; (2) Having regard to the advice of the Advisory Committee the Appropriate Authority shall grant a (c) "Form" means a Form appended to these certificate of registration, in duplicate, in Form B rules; to the applicant. One copy of the certificate of (d) "Schedule" means a Schedule appended to registration shall bo displayed by the registered Gene- these rules; tic Counselling Centre, Genetic Laboratory or Genetic (e) "section" means a section of the Act ; i?T Clinic at a conspicuous place at its place of (f) words and expressions used herein and not business. defined in these rules but defined in the Act, Provided that tlw Appropriate Authority may shall have the meanings, respectively, assig- grant a certificate of registration to a Genetic Labo- ned to them in the Act. ratory or a Genetic Clinic to conduct one or more 3. Minimum requirements.—(1) The minimum specified pre-natal diagnostic tests or procedures, qualifications of tho employees, the minimum depending on the availability of place, equipment equipment and minimum place for a Genetic Coun- and qualified employees, and standards maintained selling Centre, Genetic Laboratory and Genetic by such laboratory or clinic. Oli"ic shall bs as specified in Schedules I, II and III. (3) If, after enquiry and after giving an oppor- (2) Where an institute, hospital, nursing home, tunity of being heard to the applicant and having or any place, by whatever name called, provides regard to the advice of the Advisory Committee, the services jointly of Genetic Counselling Centre, Genetic Appropriate Authority is satisfied that the applicant Laboratory and Genetic Clinic, or any combination has not complied with the requirements of the Act of thess, it shall conform to the requirements o> and these rules, it shall, for the reasons to be specified in Schedules 1, II £;nd III. recorded in writing, reject the application for 4. Registraticn of Genetic Counselling Centre. registration and communicate such rejection to Genetic Laboratory and Genetic Clinic—(1) An the applicant as specified in Form C. application or registration shall fc made to the Appro- (4) An enquiry under sub-rule d), including ins- priate Authority, in duplicate, in Form A. pection at the premises of the Genetic Counselling (2) The Appropriate Authority, or any person in Centre, Genetic Laboratory or Genetic Clinic, shall, his office authorised in this behalf, shall acknowledge 19 be earned out only after due notice is given to the (5) On receipt of the renewed certificate of regis- applicant by the Appropriate Authority. tration in duplicate or on receipt of communication of rejection of application for renewal, both copies (5) Grant of certificate of registration or rejection of the earlier certificate of registration shall be sur- of application for registration shall be communi- rendered immediately to tho Approripate Authority cated to the applicant as specified in Form B or by the Genetic Counselling Centre, Genetic Labora- Form C, as the case may be, wiihin a period of tory or Genetic Clinic. ninety days from the date of receipt of application (6) In the evsnt of failure of the Appropriate for registration. Authority to renew the certificate of registration or to communicate rejection of application for renewal of (6) The certificate of registration shall be non- registration within a period ofn'netydays from the transferable. In the event of change of ownership date of rcce'pt of application for renewal of regis- or change of management or on ceasing to function tration, the certificate of registration shall be deemed as a Genetic Counselling Centre, Genetic Laboratory to have been ronewed. or Genetic Clinic, both copies of the certificate of registration shall be surrendered to the Appropriate 9. Maintenance and preservation of records.— Authority. (1) Every Genetic Counseling Centre, Genetic Lab- oratory and Genetic Clinic shall maintain a register (7) In the event of change of ownership or change showing, in serial order, the names and addresses of management of the Genetic Counselling Centre, of the women given genetic counselling, subjected to Genetic Laboratory or Genetic Clinic, the new owner pre-natal diagnostc procedures or pre-natal dia- or manager of such Centre, Laboratory or Clinic gnostic tests, the names of their husbands or fathers shall apply afresh for grant of certificate of regis- and the dato on which they first reported for such tration. counselling, procedure or test. 7. Validity of registration.—Every certificate of (2) The record to bs ma.ntained by every Genetic registration shall bs valid for a period of five years CounclLng Centre, in ruspect of each woman counsel- from the date of its issue. led, shall be as spec'fled in Form D. (3) The record to be maintained by every Genetic 8. Renewal of registration.—(1) An application Laboratory, in respect of each woman subjected to for renewal of certificate of registration shall be made any pro-nata] diagnostc test, shall be as specified in in duplicate in Form A, to the Appropriate Authority Form E. thirty days before the date of expiry of the certificate of registration. Acknowledgement of receipt of such- (4) The record to ba maintained by every Genetic application shall be issued by the Appropriate Autho Clinic, in respect of each woman subjected to,any pre- rity in the manner specified in sub-rule (2) of rule 4, natal diagnostic procedure, shall be as specified in Form F. (2) The Appropriate Authority shall, after holding an enquiry and after satisfying itself that the applicant (5) The Appropriate Authority shall maintain a has complied with all the requirements of the Act and permanent record of applications for grant or renewal these rules and having regard to the advice of the of certificate of registration as specified in Foim H. Advisory Committee in this behalf, renew the certi- Letters of intimation of every change of employee, ficate of registration, as specified iu Form B, for a place, address and equipment installed shall also be further period of five years from the drate of expiry preserved a permament records. of the certificate of registration earlier granted. (6) All case relatod-recorus, forms cf consent, laboratory results, microscopic pictures, srnogaphic (3) If, after enquiry and after giving an oppor- platos or slides, recommendations and letters shall tunity of being heard to the applicant and having be preserved by tho Genetic Counselling Centre, regard to the advice of the Advisory Committee, the Genetic Laboratory or Genetic Clinic for a pericd of Appropriate Authority is satisfied that the applicant two years fj om the date cf completion of counsel- has not-complied with the requirements of the Act ling, pre-natal diagnostic procedure or pre-natal and these rules, it shall, for reasons to be recorded in diagnostic test, as the case may be. In the event of any writing, reject the application for renewal of certi- legal proceedings, the records shall be preserved till ficate of registration and communicate such rejec- th? final disposal of legal proceedings, cr till the expiry tion to the applicant as specified in Form C. of the said period of two years, whichever is later. (4) The fees payable for renewal of certificate (7) In case the Geretic Counselling Centre or registration shall be one half of the fees provided in Genetic Laboratory or Genetic Cl;nic maintains sub-rule (1) of rule .1 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- pother material object seized may be delive&d under served after authentication by a person responsible acknowledgement, or sent by registered post to the for such record. owner or manager of the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, if no person 10. Conditions for conducting pre-natal diagno- acknowledging custody of the document, record, stic picedures. (1) Before conducting any pre-natal- register, book, pamphlet, advertisement or other diagnostic procedure, a written consent, as specified material object seized is available a ttho place of effect- in Form G, in a language the pregnant woman under- ing the seizure. stands, shall be obtained lromher: (4) If any material object seized is perishable in Provided that wheie a Genetic Clinic has taken a nature, the Appropriate Authority, or the officer aut- sample of any body tissue or body fluid and sent it horised in this behalf shall make arrangements prom- to a Genetic Laboratory for analysis or test, it shall ptly for sealing, identification and preservation not bo necessary for the Genetic Laboratory to obtain of the material object and also convey it to a facility a fresh consent in Form G. for analysis or test, if analysis or test be required: (2) All the State Governments and Union terri- Provided that the refrigerator or other equipment tories may issue translation of Form G in languages used by the Genetic Counselling Centre, Genetic used in the State or Union territory and where no Laboratory or Genetic Clinic for preserving such official translation in a languge understood by the pregnant woui?n is available, the Genetic Clinic may perishable material object may be sealed until such translate Form G into a language sbe understands. time as arrangements can be made for safe removal of such perishable material object and in such event- 11. Facilities for inspection.—Every Genetic uality, mention of keeping the material object seized, Counselling Centre, Genetic Laboratory and on the premises of the Genetic Counselling Centre or Genetic Clinic shall afford I reasonable facilities Genetic Laboratory or Genetic Clinic shall be made for inspection of the place, equipment and records in the list of seizure to the Appropriate Authority or to any other person authorised by the Appropriate Authority in (5) In the case of non-completicn of search and this behalf. seizure operation, the Appropriate Authority or the officer authorized in tin's behalf may make arrange- 12. Procedure for search and seizure—.(1) The ments, by way of mounting a guard or scaling of Appropriate Authority or any officer authorised in the premises of the Genetic Counselling Centre, this behalf may enter and search at all reasonable Genetic Laboratory or Genetic Clinic, for safe keeping, timos any Genetic Counselling Centre, Genetic Lab- listing and removal of documents, records, book cr oratory or Genetic Clinic, in the presence of two or any other material object to be seized, and to pre- more independent and respectable persons, for the , vent any tampering with such documents, records, purposes of section 30. books or any other material object. (2) A list of any document, record, register, book, 13. Intimation of changes ip employees, place or pamphlet, advertisement or any other material object equipment.—Every Genetic Counselling Centre, found in the Genetic Counselling Centre, Genetic Genetic Laboratory or Genetic Clinic stwll intimate Laboratory or Genetic Clinic and seized shall be pre- every change of employee, place, address Mid equip- pared in duplicate at the place of effecting the seizure. ment installed, to the Appropriate Authority within a Both copies of such list shall be signed on every page perk d of thirty days of such change. by the Appropriate Authority or the officer authorised in this behalf and by the witnesses to the seizure: 14. Conditions for analysis or test and pre-natal diagnostic procedures. (1) No Genetic Laboratory Provided that the list may be prepared, in the pre- shall accept for analysis or test any sample, unless sence of the witnesses, at a place other than the place referred to it by a Genetic Clinic. of seizure if, for reasons to be recorded in writing, it is not practicable to make the list at the place of (2) Every pre-natal diagnostic procedure shall effecting the seizure. invariably be immediately preceded by locating the foetus and placenta through ultra scnogrcphy, and (3) One copy of the list referred to in sub-rule (2) the pre-natal diagnostic procedure shall be done shah" be handed over, under acknowledgement, to the under direct ultrasonogrEiphic monitoring so as to person from whose custody the document, record, prevent any damage to the foetus and placenta. register, book, pamphlet advertisement or any other material object have been seized: 15. Meetings of the Advisory Committees.—The intervening period between any two meetings of Provided that a copy of the list of such document, Advisory Commitiecb constituted under ai.b-.-evtion record, register, book, pamphlet, advertisement or 21 (5) of section 17 to advise the appropriate Authority notice in English and in the local language or langu- shall not exceed sixty days. ages for the informatton of the public, to the effect that disclosure of the sex of the foetus is prohibited 16. Allowances to members of the Central Super- under 1 aw. "/ visory Board.—(l)The ex-officio members, and other Central and State Government officers appointed to (2) At least one copy each of the Act and these the Boird will be entitled to Tiavellmg Allowance and rile^ shall be available on the premifes cf every Ge- Daily Allowance tor attending the meetings ol the netic Counseling, Centre, Genetic Laboratory and Borrd as per the Travelling Allowances; rules appli- Genetic Clime, end shall be made available to the cable to them. cl;eptcle on demand for persuai. (2) The non-official members appointed to, and (3) The Appropriate Authority, the Central Members of Parliament elected to, the Board will be Government the State Government, and the Govern- entitled to Travelling Allowance and Daily Allowance ment/Administration of the Union territory may for attending the meetings of the Board as admissible publish periodically lists cf registeied Genetic Counsel- to non- officials and Members oi" Parliament, as the ling Centres, Genetic Laboratores and Genetic case may be, under tho Travelling Allowances rules Clinics and fndings from the reports and other inlor- of the Central Government. mation in their possession, for the information of the public and ibr use by the experts in the feld. 17. Public Information.—(1) Eveiy Genetic Counselling Centre, Genetic Laboratory and Genetic lNo.2301I/59/94-PLYJ Clinic shall prominently display en its premises a K. S. SUGATHAN, Jt. Secy. SCHEDULE T [See rule 3(1)] REQUIREMENTS FOR REGISTRATION OF A GENETIC COUNSELLING CENTRE A. PLACE A room with an area of seven (7) square metres. B. EQUIPMENT Educational charts/models. C. EMPLOYEES : Any one of the following :— (1) Medical Geneticist. (2) Gynaecologist with 6 months experience, in genetic counselling, or having completed 4 weeks' having in genetic counselling. (3) Paediatrician with 6 months experience in genetic counselling, or having completed 4 weeks' tiaining in genetic counselling. SCHEDULE II [See rule 3(1)] BBQUIREMENTS FOR REGISTRATION OF A 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- 23 SCHEDULE III [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. Name of the applicant (specify Sh./Smt./Kum./Dr.) 2. Address of the applicant 3. Capacity in which applying (specify owner/partner/managing director/other-to be stated) 4. Type of facility to be registered (specify Genetic Counselling Centre/Genetic Labo- ratory/Genetic Clinic/any combination of these) 5. 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 6 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. 7. Type of Institution (Govt. Hospital/Municipal Hospital/ Public Hospital/Private Hospital/Private Nursing Home/ Private Clinic/Private Laboratory/any other to be stated. 8. 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 9. (a) Space available for the Counselling Centre/Clinic/ Laboratory give total work area excluding lobbies. waiting rooms, stairs etc. and enclose plan) 10. Equipment available with the make and model of each equipment. List to be attached on a separate sheet). 11. (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 12. Names, qualifications, experience and registration num- ber of employees. May be furnished as an enclosure. (Refer Schedules I, II or III) 13. 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. 14. For renewal applications only : (aj Registration No. )b) Date of issue and date of expiry oi' existing certi- ficate of registration. 15. List of Enclosures : Please attach a list of enclosures giving the supporting documents enclosed to this application. ( -) Namt and signature of applicant Date : Place : 25 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 rcspecfof 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 signatui0 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. 27 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 .d [r 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. Patient's name 2, Age 3. Husband's/Father's name 4. Full address with Tel. No. if any 5. Referred by (Full name and address of Doctor(s) with registration No.(s) (Referral note to be preserved carefully with case papers) 6. Last menstrual poricd/ weeks of pregnancy 7. 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) 8, 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)] (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) 9-Procedure advised* (0 Ultrasound CO Amniocentesis (iii) Chorionic VilH biopsy (iv) Fouioscopy (v) Fectal skin or organ biopsy (vi) Cordocentesis (vii) Any other (specify) 10. Laboratory tests to be carried out (i) Chromosomal studies (ii) Biochemical studies (iii) Molecular studies 11. Result of prenatal diagnosis: Normal/Abnormal If abnormal give details. 12. Was MTP advised? 13. Name and address of Genetic Clinic* to which patient referred. 14. 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. Patient's name 2., Age 3. Husband's/Father's name 4. Full address with Tel. No., if any 5. Referred by/sample sent by (full name and address of Genetic Clinic (Referral note to be preserved care- fully with case paper). 6. Type of samplo : Maternal blood/Chorionic villus sample/amniotlc fluid/Foetal blood or other foetal tissue (Specify) 29 7. 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) 8. Laboratory tests carried out (give details) (i) Cromosonial studies (ii) Biochemical studies (iii) Molecular studies 9. Result of pre-natal diagnosis: Normal/Abnormal if abnormal, give details 10. Date(s) on which tests carried out The results of the prc-nata [diagnostic tests were conveved 1c? on. Date Name, signature and Registration number of the Medical Geneticist Form F [Sec role 9 (4)] NAME, ADDRESS AND REGISTRATION NO. Of GENETIC CLINIC RECORD TO BE MAINTAINED BY THE GENETIC CLINIC ], Patient's name 2. Ago 3. Husband's/Father's name 4. Full Address with Tel. No., if any 5. Referred by (full name and address ofdoctor(s)/Genetic Counselling Centre (Referral note to be preserved cavefolly with case papers). 6. Last menstroal period/ weeks of pregnancy. 7. 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. 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) 9. 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) 10 Any complication of procedure—please specify 11. Laboratory tests recommended* (i) Chromosmal studies (ii) Biochemical studios (iii) Molecular studies Result of pre-natal diagnostic procedure and specify Normal/AbnormBl 12. abnormality detected, if any- 13. Was MTP advised/cenducted 14. Date(s) on which procedures carried out. 15. Date on which MTP carried out. 16. Date on which consent obtained. 17. The result of prt-natal diagnostic procedure were convoyed to on Name, signature and Regstration number of the Dato Gynaocologjst/Radiologist/Regi8tered Medical Prac- Place titioner • Strike out whichever is not appliable or not necessary. FORM G [See rule 10)] FORM OF CONSENT l wife/daughter of t age years residing at hereby state that I hav« boon explained fully the probable side effects and after effeots of the pre-natal diagnostic 31 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. SI. No. 2. File number of Appropriate Authority. 3. Date of rectipt of application for grant of registration. 4. Name, Address, Phone/Fax etc, of Applicant. 5. Name and address (cs) of Genetic Counselling Centre*/ Genetic Laboratoy*/ Genetic Clinic* 6. Date on which case considered by Advisory Committee and recommendation of Advisory Committee, in summary. 7. Outcome of application (state granted/rejected/and date of issue of orders). 8*Registration number allotted and date of expiry of re- gistration. 9. Renewals (date of renewal and renewed upto) 10. File number in which renewals dealt. 11. 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