The Parliament passed the Assisted Reproductive Technology (Regulation) Act, 2021 on December 18, 2021.
Key features of the Act are:
- The Act seeks to regulate and supervise the assisted reproductive technology clinics and the assisted reproductive technology banks, prevention of misuse, safe and ethical practice of assisted reproductive technology services for addressing the issues of reproductive health where assisted reproductive technology is required for becoming a parent or for freezing gametes, embryos, embryonic tissues for further use due to infertility, disease or social or medical concerns and for regulation and supervision of research and development and for matters connected therewith or incidental thereto.
- Under the Act, every assisted reproductive technology (ART) clinic and bank must be registered under the National Registry of Banks and Clinics of India. The Registry is meant to act as a central database for all facilities providing ART services in India, with state governments appointing relevant authorities in their respective states to facilitate the registration process.
- The Registration must be renewed every five years and may be cancelled or suspended if an entity contravenes the provisions of the Act.
- The National Assisted Reproductive Technology and Surrogacy Board to be constituted under the National Board for the purposes of this Act.
- The Central Government may, within a period of ninety days from the date of commencement of this Act, by notification, establish for the purposes of this Act and Surrogacy Act, a Registry to be called the National Assisted Reproductive Technology and Surrogacy Registry.
- The National Registry shall consist of such scientific, technical, administrative and supportive staff and the terms and conditions of their service under the Act.
- The Act enumerates the procedure of registration of Assisted Technology Clinics and Banks, which includes provisions for grant of registration, renewal, suspension or cancellation. The National Board, the National Registry and the State Board shall have the power to, — (i) inspect, any premises relating to assisted reproductive technology; or (ii) call for any document or material, in exercise of their powers and discharge of their functions.
The clinics and banks shall perform the following duties:
- the clinics and banks shall ensure that commissioning couple, woman and donors of gametes are eligible to avail the assisted reproductive technology procedures subject to such criteria as may be prescribed
- the clinics shall obtain donor gametes from the banks and such banks shall ensure that the donor has been medically tested for such diseases as may be prescribed
- the clinics shall make commissioning couple or woman, aware of the rights of a child born through the use of assisted reproductive technology
- every clinic and every bank shall maintain a grievance cell in respect of matters relating to such clinics and banks and the manner of making a compliant before such grievance cell shall be such as may be prescribed
- the clinics shall issue to the commissioning couple or woman a discharge certificate stating details of the assisted reproductive technology procedure performed on the commissioning couple or woman.
Offences and Penalties
- The clinic, or bank or agent thereof, shall not issue, publish, distribute, communicate or cause to be issued, published, distributed or communicated any advertisement in any manner including internet, regarding facilities of sex selective assisted reproductive technology.
- Contravention of provisions shall be punishable with imprisonment for a term of five years, extendable to ten years or with fine which shall not be less than ten lakh rupees but may extend to twenty-five lakh rupees or with both.
- Under the Act, any medical geneticist, gynaecologist, registered medical practitioner or any person shall not—
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- abandon, disown or exploit or cause to be abandoned, disowned or exploited in any form the child or children born through assisted reproductive technology
- sell human embryos or gametes, run an agency, a racket or an organisation for selling, purchasing or trading in human embryos or gametes
- import or help in getting imported in whatsoever manner, the human embryos or human gametes
- exploit the commissioning couple, woman or the gamete donor in any form
- transfer human embryo into a male person or an animal
- sell any human embryo or gamete for the purpose of research
- use any intermediates to obtain gamete donors or purchase gamete donors.
Any contravention of the provisions of clauses (a) to (g) shall be punishable with a fine which shall not be less than five lakh rupees but may extend to ten lakh rupees for the first contravention and for subsequent contravention, shall be punishable with imprisonment for a term which shall not be less than three years but may extend to eight years and with fine which shall not be less than ten lakh rupees but may extend to twenty lakh rupees.