ART Rules
[To be published in the Gazette of India, Extraordinary, Part II, Section-3, Sub section (ii)]
Government of India
Ministry of Health and Family Welfare
(Department of Health Research)
Notification
New Delhi, the March 2022
G.S.R … (E) In exercise of the powers conferred by Section 42 of the Assisted
Reproductive Technology (Regulation) ACT 2021, except as respects things done or
omitted to be done before such supersession, the Central Government hereby makes the
following rules namely:
1. Short Title and Commencement
1.1 These rules may be called the Assisted Reproductive Technology
(Regulation) Rules, 2022.
1.2 They shall come into force on the date of their publication in the Official
Gazette.
2. Definition
In these rules, unless the context otherwise requires:
2.1 ‘act’ means the Assisted Reproductive Technology (Regulation) Act, 2021;
2.2 ‘form’ means a form appended to these rules;
2.3 ‘section’ means a section of the Act;
2.4 ‘words’ and ‘expression’ used herein and not defined in these rules but defined
in the Act, shall have the meaning, respectively, assigned to them in the Act;
2.5 ‘ART’ means Assisted Reproductive Technology;
2.6 ‘collection” means the collection of sperms from Males without any surgical
procedure.
2.7 “storage” means the procedure adopted for storage of gametes or embryos or
ovarian tissues
3. The other powers and functions of the National Board under clause (g) of
section 5
3.1 The National Board shall, subject to provisions of this Act, rules and regulations
made there under, take measures to develop new policies in the area of assisted
reproductive technology and to assist the State Boards in accreditation,
supervision and regulation of services of assisted reproductive technology clinics
and banks in the country.
Page 1 of 96
, ART Rules
3.2 To encourage and promote training and research in the field of assisted
reproduction.
3.3 To assist the central government in issuing guidelines, notifications and orders
pertaining to Assisted Reproductive Technology.
3.4 Any other activities as directed by central government.
4. The other powers and functions of the State/UT Boards under clause (b) of
sub-section (2) of Section 8
4.1 The State/UT Board shall, subject to provisions of this Act, rules and regulations
made there under, shall assist the National Board to develop new policies in the
area of assisted reproductive technology.
4.2 The State/UT Board shall supervise the accreditation and regulation of services
of assisted reproductive technology clinics and banks in their respective
states/UTs.
4.3 Any other activities as directed by central government.
5. Annual Report
The National /State Board shall prepare as per the prescribed format, its annual
report, giving a full account of its activities during the previous financial year, and
submit a copy to the Central / State Government.
6. Other functions of the National Registry under clause (d) of section 11
6.1 National Registry shall undertake analysis and management of the data provided
to it as per the Act. The National Registry may involve other central government
institute/s for the analysis and management of this data.
6.2 Any other activities as directed by central government/National Board.
7. Other functions of the Appropriate Authority under clause (h) of section 13.
7.1 In case required advisory committee may be constituted for addressing local
issues related to ART clinics and banks.
7.2 Any other activities as directed by the Central Government, National Board, State
Board.
8. Other powers of Appropriate Authority clause (d) of sub-section (1) of
section 14.
8.1 Appropriate Authority will have the power to question any person involved in
violation of the provisions of the Act and take necessary action as per section 14
of the Assisted Reproductive Technology (Regulation) Act, 2021.
8.2 Any other powers as delegated by the Central Government, National Board, State
Board.
Page 2 of 96
, ART Rules
9. Code of conduct to be observed by Appropriate Authority
9.1 All Appropriate Authorities notified under the Act, inter-alia, shall observe the
following code of conduct with respect to the Advisory Committee: -
9.1.1 ensure that a person who is the part of investigating machinery in cases
under ART (Regulation) Rules, 2022, shall not be nominated or
appointed as a member of the Advisory Committee;
9.1.2 ensure that no person shall participate as a member or a legal expert of
the Advisory Committee if he or she has conflict of interest;
9.2 All Appropriate Authorities notified under the Act, inter-alia, shall observe the
following code of conduct for processing complaints and investigations, namely: -
9.2.1 maintain appropriate diaries in support of registration of each of the
complaint or case under the Act;
9.2.2 attend to all complaints and maintain transparency in the follow-up action
of the complaints;
9.2.3 initiate investigation on each of the complaint within twenty-four hours of
receipt of the complaint and complete the investigation within seven
working days of receipt of such complaint.
9.3 All Appropriate Authorities notified under the Act, inter-alia, shall follow the
following financial guidance, namely:
9.3.1 maintain a separate and independent bank account operated by two
officers jointly;
10. ART Clinics and Banks
10.1 Levels of ART Clinics
10.1.1 Level 1 ART Clinic
These would be ART clinics where preliminary investigations are carried
out including diagnosis of type, cause of infertility and only IUI is carried
out as part of treatment.
10.1.2 Level 2 ART Clinic
These would be ART clinics where all/advanced investigations,
diagnostic and therapeutic procedures in ART are carried out. Such
clinics may also undertake research.
10.2 ART Banks
10.2.1 ART banks will be responsible for screening, collection and registration
of the semen donor and cryopreservation of sperms.
Page 3 of 96
, ART Rules
10.2.2 The screening and registration of oocyte donor.
10.2.3 The ART banks may operate as Semen banks or oocyte banks or both.
10.2.4 ART Banks will maintain the records/data of all the donors and will
regularly update the National Registry as per Section 23, 27, 28 of the
Assisted Reproductive Technology (Regulation) Act, 2021.
11. Qualification of the employees in ART Clinics and Banks
Minimum requirement of staff and their qualification for the two levels of ART
clinics and the ART Banks shall be as specified in Schedule I, Part-1.
12. The format for granting of licenses to the clinic or bank by the appropriate
authority under sub-section (2) of section 14;
The format for granting license to ART clinics and banks is specified under Form 1
& 2.
13. The form and manner in which an application shall be made for registration
and fee payable thereof under sub-section (2) of section 15;
An application for registration shall be made by the ART Clinics to the
Appropriate Authority in duplicate, in Form 3 and by the ART Banks in Form 4.
Every application for registration shall be accompanied by an application fee of: -
i) Rupees 1,00,000 for Level 1 ART Clinic
ii) Rupees 5,00,000 for Level 2 ART Clinic
iii) Rupees 1,00,000 for ART Bank
PROVIDED that if an application for registration of any ART clinic or ART bank
has been 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.
PROVIDED FURTHER that such establishments in the Government run institutes
will not pay for application.
14. The facilities and equipment’s to be provided and maintained by the clinics
and banks under sub-section (4) of section 15.
14.1 Equipment in the ART clinics and Banks shall conform to the requirement as
specified in Schedule 1, Part 2.
14.2 Minimum physical infrastructure/facilities for ART clinics shall conform to the
requirement as specified in Schedule I, Part-3.
Page 4 of 96
[To be published in the Gazette of India, Extraordinary, Part II, Section-3, Sub section (ii)]
Government of India
Ministry of Health and Family Welfare
(Department of Health Research)
Notification
New Delhi, the March 2022
G.S.R … (E) In exercise of the powers conferred by Section 42 of the Assisted
Reproductive Technology (Regulation) ACT 2021, except as respects things done or
omitted to be done before such supersession, the Central Government hereby makes the
following rules namely:
1. Short Title and Commencement
1.1 These rules may be called the Assisted Reproductive Technology
(Regulation) Rules, 2022.
1.2 They shall come into force on the date of their publication in the Official
Gazette.
2. Definition
In these rules, unless the context otherwise requires:
2.1 ‘act’ means the Assisted Reproductive Technology (Regulation) Act, 2021;
2.2 ‘form’ means a form appended to these rules;
2.3 ‘section’ means a section of the Act;
2.4 ‘words’ and ‘expression’ used herein and not defined in these rules but defined
in the Act, shall have the meaning, respectively, assigned to them in the Act;
2.5 ‘ART’ means Assisted Reproductive Technology;
2.6 ‘collection” means the collection of sperms from Males without any surgical
procedure.
2.7 “storage” means the procedure adopted for storage of gametes or embryos or
ovarian tissues
3. The other powers and functions of the National Board under clause (g) of
section 5
3.1 The National Board shall, subject to provisions of this Act, rules and regulations
made there under, take measures to develop new policies in the area of assisted
reproductive technology and to assist the State Boards in accreditation,
supervision and regulation of services of assisted reproductive technology clinics
and banks in the country.
Page 1 of 96
, ART Rules
3.2 To encourage and promote training and research in the field of assisted
reproduction.
3.3 To assist the central government in issuing guidelines, notifications and orders
pertaining to Assisted Reproductive Technology.
3.4 Any other activities as directed by central government.
4. The other powers and functions of the State/UT Boards under clause (b) of
sub-section (2) of Section 8
4.1 The State/UT Board shall, subject to provisions of this Act, rules and regulations
made there under, shall assist the National Board to develop new policies in the
area of assisted reproductive technology.
4.2 The State/UT Board shall supervise the accreditation and regulation of services
of assisted reproductive technology clinics and banks in their respective
states/UTs.
4.3 Any other activities as directed by central government.
5. Annual Report
The National /State Board shall prepare as per the prescribed format, its annual
report, giving a full account of its activities during the previous financial year, and
submit a copy to the Central / State Government.
6. Other functions of the National Registry under clause (d) of section 11
6.1 National Registry shall undertake analysis and management of the data provided
to it as per the Act. The National Registry may involve other central government
institute/s for the analysis and management of this data.
6.2 Any other activities as directed by central government/National Board.
7. Other functions of the Appropriate Authority under clause (h) of section 13.
7.1 In case required advisory committee may be constituted for addressing local
issues related to ART clinics and banks.
7.2 Any other activities as directed by the Central Government, National Board, State
Board.
8. Other powers of Appropriate Authority clause (d) of sub-section (1) of
section 14.
8.1 Appropriate Authority will have the power to question any person involved in
violation of the provisions of the Act and take necessary action as per section 14
of the Assisted Reproductive Technology (Regulation) Act, 2021.
8.2 Any other powers as delegated by the Central Government, National Board, State
Board.
Page 2 of 96
, ART Rules
9. Code of conduct to be observed by Appropriate Authority
9.1 All Appropriate Authorities notified under the Act, inter-alia, shall observe the
following code of conduct with respect to the Advisory Committee: -
9.1.1 ensure that a person who is the part of investigating machinery in cases
under ART (Regulation) Rules, 2022, shall not be nominated or
appointed as a member of the Advisory Committee;
9.1.2 ensure that no person shall participate as a member or a legal expert of
the Advisory Committee if he or she has conflict of interest;
9.2 All Appropriate Authorities notified under the Act, inter-alia, shall observe the
following code of conduct for processing complaints and investigations, namely: -
9.2.1 maintain appropriate diaries in support of registration of each of the
complaint or case under the Act;
9.2.2 attend to all complaints and maintain transparency in the follow-up action
of the complaints;
9.2.3 initiate investigation on each of the complaint within twenty-four hours of
receipt of the complaint and complete the investigation within seven
working days of receipt of such complaint.
9.3 All Appropriate Authorities notified under the Act, inter-alia, shall follow the
following financial guidance, namely:
9.3.1 maintain a separate and independent bank account operated by two
officers jointly;
10. ART Clinics and Banks
10.1 Levels of ART Clinics
10.1.1 Level 1 ART Clinic
These would be ART clinics where preliminary investigations are carried
out including diagnosis of type, cause of infertility and only IUI is carried
out as part of treatment.
10.1.2 Level 2 ART Clinic
These would be ART clinics where all/advanced investigations,
diagnostic and therapeutic procedures in ART are carried out. Such
clinics may also undertake research.
10.2 ART Banks
10.2.1 ART banks will be responsible for screening, collection and registration
of the semen donor and cryopreservation of sperms.
Page 3 of 96
, ART Rules
10.2.2 The screening and registration of oocyte donor.
10.2.3 The ART banks may operate as Semen banks or oocyte banks or both.
10.2.4 ART Banks will maintain the records/data of all the donors and will
regularly update the National Registry as per Section 23, 27, 28 of the
Assisted Reproductive Technology (Regulation) Act, 2021.
11. Qualification of the employees in ART Clinics and Banks
Minimum requirement of staff and their qualification for the two levels of ART
clinics and the ART Banks shall be as specified in Schedule I, Part-1.
12. The format for granting of licenses to the clinic or bank by the appropriate
authority under sub-section (2) of section 14;
The format for granting license to ART clinics and banks is specified under Form 1
& 2.
13. The form and manner in which an application shall be made for registration
and fee payable thereof under sub-section (2) of section 15;
An application for registration shall be made by the ART Clinics to the
Appropriate Authority in duplicate, in Form 3 and by the ART Banks in Form 4.
Every application for registration shall be accompanied by an application fee of: -
i) Rupees 1,00,000 for Level 1 ART Clinic
ii) Rupees 5,00,000 for Level 2 ART Clinic
iii) Rupees 1,00,000 for ART Bank
PROVIDED that if an application for registration of any ART clinic or ART bank
has been 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.
PROVIDED FURTHER that such establishments in the Government run institutes
will not pay for application.
14. The facilities and equipment’s to be provided and maintained by the clinics
and banks under sub-section (4) of section 15.
14.1 Equipment in the ART clinics and Banks shall conform to the requirement as
specified in Schedule 1, Part 2.
14.2 Minimum physical infrastructure/facilities for ART clinics shall conform to the
requirement as specified in Schedule I, Part-3.
Page 4 of 96
