Provided that provisions of sub-section (3) shall not apply to semen or sexed semen imported with due permission from the concerned department of Government of India.

Registration of embryo bank or embryo transfer technology or in-vitro fertilization laboratory

1. (1) Within three months from the date of commencement of this Act, no premises shall be used or intended to be used to establish and operate an embryo bank or embryo transfer technology or in-vitro fertilization laboratory for production and transfer of embryos without obtaining a certificate of registration from the Animal Breeding Regulatory Authority.
2. (2) Any person who desires to establish or operate a new embryo bank or embryo transfer technology or in-vitro fertilization laboratory shall make an application for registration or renewal to the Animal Breeding Regulatory Authority in such form, along with such fee, as may be prescribed.
3. (3) The existing embryo bank or embryo transfer technology or in-vitro fertilization laboratory shall apply to the Animal Breeding Regulatory Authority for grant of certificate of registration in such form, along with such fee, as may be prescribed within three months from the date of commencement of this Act.
4. (4) Applicants intending to set up a new embryo bank or embryo transfer technology or in-vitro fertilization laboratory or the existing embryo bank or embryo transfer technology or in-vitro fertilization laboratory, shall apply in such form, along with such fee, as may be prescribed for a provisional certificate of registration to meet the conditions specified in sub-section (6). The provisional certificate of registration shall be valid for a period of twenty-four months. It may be extended for a further period of twelve months on the request of the applicant, in writing on payment of such fee, as may be prescribed.
5. (5) For the grant of permanent certificate of registration for a new embryo bank or embryo transfer technology or in-vitro fertilization laboratory or the existing embryo bank or embryo transfer technology or in-vitro fertilization laboratory, the applicant apply in such form, along with such fee, as may be prescribed, to the Authority for inspection within the above twenty-four months. The Animal Breeding Regulatory Authority shall there upon, send a committee of experts from the consultative panel for such inspection.
6. (6) The Animal Breeding Regulatory Authority, after satisfying itself that,-
   • (A) the embryo bank or embryo transfer technology or in-vitro fertilization laboratory,-
     • (i) has such premises for the quarantine of donor animals, as may be specified by the Animal Breeding Regulatory Authority or the Government of India;
     • (ii) has such premises for the rearing and housing of donors animals and the collection, processing, quality control, storage, distribution and quarantine of embryo, as may be specified by the Animal Breeding Regulatory Authority or the Government of India; and
     • (iii) has such premises for the storage of embryos, as may be specified by the Animal Breeding Regulatory Authority or the Government of India;
   • (B) every donor animal, used for embryo transfer technology or in-vitro fertilization,-
     • (i) has tested negative to such tests, as may be specified by the Animal Breeding Regulatory Authority or the Government of India,-
   • (a) prior to its entry to quarantine station;
   • (b) during quarantine period at a quarantine station;
   • (c) during rearing at a rearing station; and
     • (ii) is free of reproductive abnormalities and disease and has no conformational or known genetic defects;
     • (iii) conforms to breed characteristics of the breed and meets such minimum standards for various traits in terms of quantity and quality, as may be specified by the Animal Breeding Regulatory Authority or the Government of India;
   • (C) the embryo or embryo transfer technology or in-vitro fertilization laboratory shall maintain accurate pedigree and performance records of the donor animals, whose oocyte or ovum or embryo it produces, stores, sells, distributes or proposes to distribute for embryo transfer in such format, as may be prescribed,- shall grant the certificate of registration to a new or existing embryo or embryo transfer technology or in-vitro fertilization laboratory clearly specifying the name and address of the embryo or embryo transfer technology or in-vitro fertilization laboratory, registration number of the embryo or embryo transfer technology or in-vitro fertilization laboratory, unique identification number of certified donors animals to be used for embryo production, name of the in-charge of the station or laboratory on such terms and conditions, as it may deem fit.
7. (7) The certificate of registration granted to embryo or sexed embryo or embryo transfer technology or in-vitro fertilization laboratory under this section shall be valid for a period of three years from the date of its issue.
8. (8) The embryo or embryo transfer technology or in-vitro fertilization laboratory shall, in such form, along with such fee, as may be prescribed, apply for renewal of registration to the Animal Breeding Regulatory Authority at least three months before the expiry of the certificate of registration. The Animal Breeding Regulatory Authority after satisfying itself that the conditions specified in sub-section
9. (6) with regard to certificate of registration have been adhered to, shall renew the registration for a further period of three years, within three months from the date of receipt of application. If the renewal certificate is not issued within three months, approval shall be deemed to have been accorded, unless communicated otherwise.
10. (9) Any new animal donors that meets the standards for embryo production shall not be inducted in the embryo transfer technology or in-vitro fertilization laboratory for embryo production without necessary certification from the Animal Certification Authority.
11. (10) Death or culling of certified animal shall be informed to the Animal Breeding Regulatory Authority forthwith with a copy of report stating therein the cause of death and frozen embryo stock available of that animal at the time of the death of the animal to the Animal Certification Authority.
12. (11) The Animal Breeding Regulatory Authority may, after giving the applicant an opportunity of being heard and for reasons to be recorded in writing, refuse to grant or renew the certificate of registration.
13. (12) The Animal Breeding Regulatory Authority shall send a committee of experts to inspect an embryo or sexed embryo or embryo transfer technology or in-vitro fertilization laboratory as and when desired, but atleast once in a year, to ensure compliance of the conditions specified in the certificate of registration.