jftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. L.-33004/99 vlk/kj.k EXTRAORDINARY Hkkx II—[k.M 3—mi&[k.M (i)
PART II—Section 3—Sub-section (i) izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY la- 54] ubZ fnYyh] eaxyokj] iQjojh 4] 2014@ek?k 15] 1935 No. 54] NEW DELHI, TUESDAY, FEBRUARY 4, 2014/MAGHA 15, 1935 ������ और � ���� ��� � ���� अअअअििििधधधधसूससूूसू ननननाााा नई �� ��, 1 जनवरी, 2014 सा. का. िन. 77777777.... ((((अ))))....———— � ����य सरकार, �˘ˇˆ����˙�ˇ� ˝�� ˛°��˙�ˇ� ˜ �� -तकनीक (!��� "� � ˛˜#$�ˆ) अिधिनयम, 1994 (1994 का 57), % धारा 2 }kjk ̨ �& '˜(�) का ˛�*� करते +,, �˘ˇˆ����˙�ˇ� ˝��˛°��˙�ˇ�˜ �� -तकनीक (!���"� �˛˜#$�ˆ) िनयम, 1996 ��˝��° '*ˆ � � �� � �˜�,�˜ -� िलिखत िनयम बनाती ह,ै ./�#̌0: ————
1. (1) इन ˜ ��) का ° ˜12 नाम �˘ˇˆ����˙�ˇ�˝��˛°��˙�ˇ िनदान-तकनीक (!���"� �˛˜#$�ˆ) िनयम, 2014 ह ै।
(2) ये ��3�� �4 उनके ˛ �' % तारीख को ˛�5& 6)�� ।
2. �˘ˇˆ����˙�ˇ�˝��˛°��˙�ˇ िनदान-तकनीक (!���"� �˛˜#$�ˆ) िनयम � �˛7��"� � ���/�न पर ˜ -� ̃�˜8#�˛7���8��3�,��, ./�ˇ#0: ———— [धारा 4 ( ) का परंतुक, िनयम 9 (4) और िनयम 10 (1क) �� ]84 आनुवaिशक ����������������ििििननननकककक////������������ ���� ���� �� ��������������������������ििििननननकककक//// �������� ����������������������� � ������������ }kjk ���� ��������˘ˇ˘ˇ̆ˇ˘ˇ�ˆ��̂ˆ�ˆ����������������˙̇̇̇��������˝̋̋̋����˛̨̨̨°°°°���������˜��̃˜�˜������������ ��������!!!!����""""!�!�!�!�������������#�#�#�#����������������� ��������$$$$˘̆̆̆���� 469 GI/2014 (1) 2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] भभभभाााागगगग कककक : %%%%����#&#&#&#&˛̨̨̨��������####������������''''(((())))����****////जजजजांाांंां ककककेेेे ििििललललएएएए भभभभररररेेेे जजजजाााानेननेेने ककककेेेे ििििललललएएएए
1. आनुवaिशक ˜9��िनक/. �:�°�; <�˜9��िनक/ =��!3�� � ��� का नाम और परूा पता
2. �˜3��:� ���° >��� (�˘ˇˆ����˙�ˇ�˝��˛°��˙�ˇ िनदान-तकनीक (!��� "� � ˛˜#$�ˆ) अिधिनयम, 1994 के अधीन) . रोगी का नाम
4. ? ��3�˜�#�° #� )� %�° >��� ((((क) 3�˜�#��?�)� %�° >���, ˛@�� � %�A�?�(�$ˇ���� मास �4) ([k) 3�˜�#��?˜��)� %�° >���, ˛@�� � %�A�?�(�$ˇ� �����°��4)
5. पित/�@� �/िपता/माता का नाम
6. रोगी का पूरा पता,,,, �˙ ��˘�$�° >���°˜6#, ��� कोई हो,
7. ((((क) ˜"� @�°क (˜"� @�°क का पूरा नाम और पता/ आनुवa˜' �����'ˇ��#�� � ���) }kjk ̃ B�C�D (˜ �'� �����)� *� ˛�7� च क साथ सावधानी-E े �˙�ˇ �� ��˜1# रखना ह)ै ((((ख) ����� �*�� ˜�'�$F/ ˜�� ��˜�F� �/ �˜3��:� 5 #� ̃"� @�°�� G��वसायी जो नैदािनक ˛�H��, � I E� ���6�6, }kjk ���-˜ �'� (�*��� � �˜ �E े'� DJ��ण को मामले क कागज-��) को ˛�7� "� � � °�/� °��ˆ� ��˙�ˇ � � ��˜1#� � ���3� ��6)K (���-˜ �'�°��E � °��L�6 }kjk ˜9��˜ ��4�A � ˝�� 3� "� � � ˜�,� . ?�*ˆ� � �� ��� �˘ˇ�#�� �˜6��� � � �#����)) }kjk जांच के िलए अनुरोध � ��.˜˘˛�#� 6M�6)K
8. ˜�N����3*ˆ�ˇ� %�.�˜ˆ�����˘ˇˆ���� � �°J�#�ह आयु 3 ¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k भभभभाााागगगग खखखख :::: केवल गैर-AH�� � K��˜ �˛�H��/जांच के िलए भरा जाना है
9. ˛�H��� *� � �������˜"� @�°क का नाम
10. K��˜ �˛�H��� � �˜�,�;��'ˇ � (˜ �'� ˜����� ��� ���-˜ �'� DJ���� �4� � ,�E E �,�. ?�*ˆ� � �° �˘ˇ��4�˜�˜ B�C�D� �4�O) (. �:�°* *L�P%�˛°��˙�ˇ� ˜ �� � � ���#˘�� � ���3� ��"�˜6,�3Q�;��R'#�� ������� 6*O� ˜ -� ˜�˜8#� . �:�साउंड के िलए �˘ˇˆ���� � � � �� � ;��'ˇ )� %� ˛˜#˜ ˜ˆ@��कारी सूची ह)ै ((((������������ ����ससससााााउउउउंंंंडडडड ककककेेेे ��������++++���� ˘̆̆̆),),),),��������----���� ˘˛˘˛˘˛˘˛°ˆ°°̂ˆ°ˆ�������� ������� � ���� ��������#�#�#�#����� ससससहहहहीीीी ककककाााा ििििननननशशशशाााानननन ललललगगगगााााएंएएंंएं)))) i. अंत: �˘�ˇ'� और/���.��/� �����˘ˇˆ����˝��T�6��ˇ#�� ���#����� �� � �˜�,�� ii. �˘ˇˆ����A�?� ��A � �(ितिथकरण) iii. U˙�)� %�° >���� ���#����� ��˝��; %�H�QV#� iv. इनसीटू आई.यू.सी.डी. � �°�/�° ˘�˜�#��˘�ˇ���/������˘ˇ˜ �*ˆ)� %�.°P�#�� � �� �������7�� संभािवत �˘ˇˆ���/ .°P���˘ˇ� � �˜"� @°���°��� � v. �*˜ ��9�#W��/ �°��� vi. �˘ˇ��#� � �����)��4�. ?�#X�˛�H�� vii. L����नािलका का आकलन ˝��A # � �ऑस ��T�° viii. �˘�ˇ'�� � �A ���˝����˜° ̂ �ˇ� %�.�˜ˆ��� a ̃˘Y#�� ix. ,< �9�°������˘�ˇ'���*�-˜ �� � %� *Z�° ˘�� �/अिनयिमतता x. �?�°˙�� .˜ �˜�##�[� �� �#�� ��� �, U˙�� ° �" �� �? D�� � ˝�� .��� अिनयिमतताएं तथा उनका . ?�#X�˛�H��� xi. U˙��˝��;° %�fL kfr ���˙ ��� कन xii. ˜� ��.� �� ��˜ ˆ��̌� xiii. °���˙�ˇ ˛°����M+k/ °���˙�ˇ�˜\ ��� ��ḊD � xiv. J���°4D��˛�˜��/ित, �*D�Z�L�!<��˝��.˜ �˜�##�[�(J���°4D��˜˛����, ��:*J���°4D���9�#W��, अिनयिमत अवलंबन, A��) ���˙ ��� कन xv. नािभ-�]? ���˙ ��� कन - ˛��#?तीकरण, °˜�� वेश, ?9� �� , ° ̌��4D, ��˜6 �[� %� ° >����˝��^ �D� %�;�˜��/ित xvi. �˙�ˇ� � �' �3�� ˜ '� ) ���˙ ��� कन 4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] xvii. U˙� %��5˜V, U˙�� � ��3 �˝��U˙�� %� ? '�#�� � ��� )� ���˙ ��� कन xviii. � 3 �˛��6���� �˝��<̇J��9�°�<_����.`��यन xix. �˘ˇˆ���� �� ˜ ° य समापन, बाg~~ K ˜� � � ���`��˜ ˜ �� ˝��"� @� � ; ˜°P �°ˇ � A���3K°� ˜'#� ˛�H��,� ; ��. ?�#X�˛�H�� xx. H�QV�. ? �� �� �˙ � �� (सीवीएस) ; ���ˆ , U˙���9�# नमूनाकरण, U˙��"�ˇ����*J�°�, अमनीयो =��a�?जन, = :��˙D���= � =��a�?जन, ° D)� A��� �� .�˜��/ ��� 3K°�� <��b� *˜��D � ˝�� ;�"���@��क =����˜°���`��1��)�°��. ?�Xud xxi. =��:���Ď��cD �[ का अवलोकन xxii. �˘�ˇ���/�� *�3 D��Q � �������˜"� @�°�/' ���H���˜��/ितयां xxiii. �����#�˛�J�#�° ��/�[��4�. ?° ˆ� /�KF�˜ �.`��यन ।
11. %��Z�˛�H��,� (गैर-AH�� ) (°�?˜"#�˛�H������°6�� ��˜ '� ����, ) i. . �:�साउंड (����..../�/�/�/�����˘ˇ˘ˇ̆ˇ˘ˇ0ˆ00̂ˆ0ˆ����121212123�3�3�3�̆̆̆̆ णणणण:::: . �:�°�; <� ������'ˇ�U˙�� ��!���;��R'#� � �/ ����'ˇ��� �� � � �˜�,� 6M������3�#�� ह ैिसवाय डचने मांसपेशी कूपोषण, .˜#�(L=ko ,�,� �Q��A��� ii. *Z�.��� (˜�˜ B�C�D� �4)
12. �6�#���8�3Q��˘ˇ�#���˜6��/G��˜9�#� %� c*$���.˜˘˛�J�#� %��Z�/�� 1 . �6�#���8�3Q�˛�H��, � %��Z
14. %��Z��K�-AH�� �˛�H��[� ��� ����� (� ,��,�. �:�°�; <�°˜6#�3� "� %�° ˜1J�# ��*Ď)
15. ˛°��˙�ˇ� K��˜ �˛�H��[� � �� ����� *��� ............. °˙˜"#�� ������
16. K��˜ �˛�H��[/3� "��4��#�����Z��Z� .˜ �˜�##�� � �Aˆ�������˘ˇ� � �˜"� @° %�� °��� � � �˜�,� *Z�;��'ˇ � तारीख : 4�4�4�4�5555%%%%����""""6666����������������°�°�°�°�77778888////��������''''����""""0000������������8888����####%%%%//// """"��������4�4�4�4� %%%%ककककृृृृतततत ����˙̇̇̇''''����/�/�/�/� �������� 9�9�9�9�))))���� ����))))%%%%���� ����6666���� #&#&#&#&̨̨̨̨ ��������####�������� ����''''(((())))����****���� ����6666���� ककककरररर ररररहहहहाााा है,,,,हैहहैै ककककाााा नननन मममम,,,, ....4�4�4�4�----�: ���� ���� ���� %%%%ाााा ��� ":"::"" ;;;;"""" """" ����4�4�4�4� ककककररररणणणण��/�न : � �� ���� ििििहहहहतततत मुममुुमुहहहहरररर<�<�<�<�))))� सससस भभभभाााागगगग गगगग :::: ������� � ������������====((((��������������������''''(((())))����+�+�+�+�////जजजजांाांंां ककककररररनेननेेने ककककेेेे ििििललललएएएए भभभभरररराााा जजजजााााननननाााा हैहहैैहै
17. ˛�H��[� *� � �������˜"� @�°क का नाम
18. �� � � � आनुवaिशक/ ������� ���˘� �� �ˇ � �ˆ˙�˝˙ (��°�˜ ! ��) 5 ¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k िनदान का आधार (िनदान के उिचत आधार पर सही का िनशान लगाए)ं (क) ˜9�˜ � (ख) जैव रसायिनक (ग) कोिशका आनुवaिश %� (घ) .��� (;��6���/ˇ�˜�� ���˜"� @°�� ˜�F� , . �:�°�� *L�P%�A���- ˜�˜ B�C�D� �4
19. K��˜ �˛�H��� � �˜�,�;��'ˇ �(;��?9�#�;��'ˇ ����सही का िनशान लगाए)ं (क) ˜ -� ˜�˜8#�°˜6#��˙��̌#X�° #� �
(i) �?�°˙���˜� �� (ii) उपापचयी िवकार
(iii) 3���जात िवषमता (iv) मानिसक िन:'9�#ता
(v) 6��*b��*िबनोपैथी (vi) यौन संबंधी िवकार
(vii) एकल जीन िवकार (viii) *Z�.��� (˜�˜ B�C�D� �4) ख. अिधक मातृआयु ( 5 �$)̌ ग. माता/िपता/ सहोदर भाई या बहन को आनुवaिशक रोग (˜�˜ B�C�D� �4) घ. .��� (˜�˜ B�C�D� �4)
20. �6�#���8�˜3° *��˘ˇˆ����˙�ˇ�˝��˛°��˙�ˇ�˜ �� �# � �(!���"� �˛˜#$�ˆ) अिधिनयम, 1994 �4� ˜�˜6#�˛7��N��4��˘ˇ�#���˜6��/G��˜9�#� %�°6�˜#�.˜˘˛�J�#� %��Z�6�K
21. %��Z�AH�� �˛�H��,� (समुिचत पर सही का िनशान लगाए)ं i. ,fEu�*°4D�˜°° ii. * �d˜ �˜� ���,°˜���' � iii. U˙��Q��*J�°� iv. *�<*°4D �˜°° v. *Z�.��� (˜�˜ B�C�D� �4)
22. AH�� �˛�H��� %� *Z�3 D�#�,� (˜�˜ B�C�D� �4) 2 . ˜°P� �'� %��Z�.��� जांच ( 5 ������ˇ � �4, �������˙�6*) i. �?�°˙����.`��यन ii. 3K���°��˜ �.`��यन iii. A�˜� �.`��यन iv. �˙�ˇ�˛@���*���!���˜ �� � v. *Z�.��� (˜�˜ B�C�D� �4)
24. %��Z�˛�H��[/ 3� ")� ��� �����( %��Z�AH�� �3� "/˛�H��[� %�° ˜1J�#� ��*Ď)
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1. (1) These rules may be called the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Amendment Rules, 2014.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996, for Form F, the following Form shall be substituted: [See Proviso to Section 4(3), rule 9(4) and rule 10(1A)] FORM FOR MAINTENANCE OF RECORD IN CASE OF PRENATAL DIAGNOSTIC TEST /PROCEDURE BY GENETIC CLINIC/ULTRASOUND CLINIC/IMAGING CENTRE Section A:To be filled in for all Diagnostic Procedures/Tests
1. Name and complete address of Genetic Clinic/Ultrasound Clinic/Imaging centre:__________
2. Registration No. (Under PC& PNDT Act, 1994)____________________________________
3. Patient’s name _________________________________________Age________________
4. Total Number of living children :_______________________________________________
(a) Number of living Sons with age of each living son (in years or months):
(b) Number of living Daughters with age of each living daughter (in years or months) :
5. Husband’s /Wife’s/ Father’s / Mother’s Name :____________________________________
6. Full postal address of the patient with Contact Number, if any_________________________
7. (a) Referred by (Full name and address of Doctor(s)/ Genetic Counseling Centre):_________________________________________________________________ (Referral slips to be preserved carefully with Form F)
(b) Self-Referral by Gynaecologist/Radiologist/Registered Medical Practitioner conducting the diagnostic procedures: ________________________________________ (Referral note with indications and case papers of the patient to be preserved with Form F) (Self-referral does not mean a client coming to a clinic and requesting for the test or the relative/s requesting for the test of a pregnant woman)
8. Last menstrual period or weeks of pregnancy :_____________________________________ Section B: To be filled in for performing non-invasive diagnostic Procedures/ Tests only
9. Name of the doctor performing the procedure/s : ___________________________ 8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
10. Indication/s for diagnosis procedure ____________________________________________ (specify with reference to the request made in the referral slip or in a self -referral note) (Ultrasonography prenatal diagnosis during pregnancy should only be performed when indicated. The following is the representative list of indications for ultrasound during pregnancy. (Put a “Tick” against the appropriate indication/s for ultrasound) i. To diagnose intra-uterine and/or ectopic pregnancy and confirm viability. ii. Estimation of gestational age (dating). iii. Detection of number of fetuses and their chorionicity. iv. Suspected pregnancy with IUCD in-situ or suspected pregnancy 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 of amenorrhea. ix. Any suspected adenexal or uterine pathology/abnormality. x. Detection of chromosomal abnormalities, fetal structural defects and other abnormalities and their follow-up. xi. To evaluate fetal presentation and position. xii. Assessment of liquor amnii. xiii. Preterm labor / preterm premature rupture of membranes. xiv. Evaluation of placental position, thickness, grading and abnormalities (placenta praevia, retro placental hemorrhage, abnormal adherence etc.). xv. Evaluation of umbilical cord – presentation, insertion, nuchal encirclement, number of vessels and presence of true knot. xvi. Evaluation of previous Caesarean Section scars. xvii. Evaluation of fetal growth parameters, fetal weight and fetal well being. xviii. Color flow mapping and duplex Doppler studies. xix. Ultrasound guided procedures such as medical termination of pregnancy, external cephalic version etc. and their follow-up. xx. Adjunct to diagnostic and therapeutic invasive interventions such as chorionic villus sampling (CVS), amniocenteses, fetal blood sampling, fetal skin biopsy, amnio-infusion, intrauterine infusion, placement of shunts etc. xxi. Observation of intra-partum events. xxii. Medical/surgical conditions complicating pregnancy. xxiii. Research/scientific studies in recognized institutions.
11. Procedures carried out (Non-Invasive) (Put a “Tick” on the appropriate procedure) i. Ultrasound (Important Note: Ultrasound is not indicated/advised/performed to determine the sex of fetus except for diagnosis of sex-linked diseases such as Duchene Muscular Dystrophy, Hemophilia A & B etc.) ii. Any other (specify) __________
12. Date on which declaration of pregnant woman/ person was obtained :___________________ ______________________________________________________ ________________________________________________________________________ ___________________________________________________________________________ 9 ¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k
13. Date on which procedures carried out:______________________________________
14. Result of the non-invasive procedure carried out (report in brief of the test including ultrasound carried out)
15. The result of pre-natal diagnostic procedures was conveyed to _____________on______
16. Any indication for MTP as per the abnormality detected in the diagnostic procedures/ tests___________________________________________________________________ Date: Name, Signature and Registration Number with Seal of the Gynaecologist/Radiologist/Registered Medical Practitioner Place: performing Diagnostic Procedure/s SECTION C: To be filled for performing 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. radiological, ultrasonography etc.-specify)
19. 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 (iv) Mental Disability
(v) Haemoglobinopathy (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 (specify) D. Other (specify) __________________________________________________________
20. Date on which consent of pregnant woman / person was obtained in Form G prescribed in PC&PNDT Act, 1994 :________________________________________________________
21. Invasive procedures carried out (“Tick” on appropriate indication/s) i. Amniocentesis ii. Chorionic Villi aspiration iii. Fetal biopsy iv. Cordocentesis v. Any other (specify)
22. Any complication/s of invasive procedure (specify)_______________________________
23. Additional tests recommended (Please mention if applicable)
(i) Chromosomal studies (ii) Biochemical studies
(iii) Molecular studies (iv) Pre-implantation gender diagnosis
(v) Any other (specify)
24. Result of the Procedures/ Tests carried out (report in brief of the invasive tests/ procedures carried out)___________________________________________________________
25. Date on which procedures carried out:___________________________________________
26. The result of pre-natal diagnostic procedures was conveyed to _____________on__________ _____________________________________________________________________________ ________________________________________________ 10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
27. Any indication for MTP as per the abnormality detected in the diagnostic procedures/ tests____________________________________________________________________ Date : Name, Signature and Registration Number with Seal of the Place Gynaecologist/Radiologist/Registered Medical Practitioner performing Diagnostic Procedure/s SECTION D: Declaration DECLARATION OF THE PERSON UNDERGOING 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/Thump impression of the person undergoing the Prenatal Diagnostic Test/ Procedure In Case of thumb Impression: Identified by (Name)____________________________ ___________Age:______Sex:_______ Relation (if any):____________Address & Contact No.:________________________________ Signature of a person attesting thumb impression: __________________Date: ______________ DECLARATION OF DOCTOR/PERSON CONDUCTING PRE NATAL DIAGNOSTIC PROCEDURE/TEST I, _________________________________ (name of the person conducting ultrasonography/image scanning) declare that while conducting ultrasonography/image scanning on Ms./ Mr.____________________ (name of the pregnant woman or the person undergoing pre natal diagnostic procedure/ test), I have neither detected nor disclosed the sex of her fetus to anybody in any manner. Signature: ____________________________ Date: Name in Capitals, Registration Number with Seal of the Gynaecologist /Radiologist/Registered Medical Practitioner Conducting Diagnostic procedure [F No. V.11011/6/2013-PNDT] Dr RAKESH KUMAR, Jt. Secy.
Note : The principal notification was published in the Gazette of India, vide G.S.R 1 (E), dated the 1st January, 1996 and amended vide notification numbers G.S.R 109 (E), dated the 14th February, 2003; G.S.R 426 (E), dated the 31st May, 2011; G.S.R 80 (E), dated the 7th February, 2012; G.S.R 418 (E), dated the 4th June, 2012 and G.S.R 13(E), dated the 9th January, 2014. Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054