The ART (Regulation) Act, 2021 was meant to address gaps left by ICMR's 2005 guidelines. Critically analyse its implementation challenges.

Q. The ART (Regulation) Act, 2021 was meant to address gaps left by ICMR's 2005 guidelines. Critically analyse its implementation challenges. (15 marks, 250-350 words)

India's fertility care expanded for two decades under the Indian Council of Medical Research's non-statutory 2005 National Guidelines for ART clinics, which carried no penalty for breach [4]. The ART (Regulation) Act, 2021 (Act 42 of 2021) converted this voluntary code into enforceable law [1] — yet its real test lies in enforcement, not enactment.

Gaps the Act genuinely closed - Creates a National and State ART and Surrogacy Board, a National Registry and State Registration Authorities, replacing self-regulation with statutory oversight [1]. - Makes registration of every ART clinic and ART bank compulsory, with penalties and imprisonment for violations — the enforcement teeth 2005 lacked [1]. - Mandates informed consent, donor screening and insurance cover for oocyte donors, embedding safety and ethical practice as legal duty [3].

Implementation challenges - Federal capacity deficit: registration and inspection rest with State Registration Authorities, whose staffing and technical expertise vary widely; health being a State subject, uniform enforcement is difficult [1]. - Exclusionary eligibility: access is limited to married couples and single women within prescribed age caps, leaving single men, live-in and LGBTQ+ persons outside the legal route — a concern flagged during legislative scrutiny [2]. - Donor supply squeeze: restricting a donor to one commissioning couple, with banks as sole intermediaries, risks pushing demand toward unregulated channels [2]. - Affordability: ART remains largely out-of-pocket and absent from public health provisioning, so regulation raises compliance cost without widening access [2]. - Dual compliance burden: overlapping obligations with the Surrogacy (Regulation) Act, 2021 and a common Board complicate clinic-level implementation [5]. - Weak data base: reliable infertility prevalence still rests on survey rounds like NFHS, not a mature national ART registry [6].

The Act is therefore a necessary but incomplete correction — sound in architecture, thin in delivery. Fully staffing State Authorities, operationalising the National Registry, and progressively bringing basic fertility care into public health coverage would convert statutory intent into equitable reproductive rights consistent with Article 21.

(~325 words)

Sources: 1. The Assisted Reproductive Technology (Regulation) Act, 2021 (Act No. 42 of 2021) — India Code — Act number, Boards/Registry/Registration Authorities, mandatory registration and penalties, State-level enforcement structure 2. PRS Legislative Research — Legislative Brief, The Assisted Reproductive Technology (Regulation) Bill — eligibility exclusions, donor restrictions, affordability and access concerns 3. PIB — Cabinet approves the Assisted Reproductive Technology Regulation Bill, 2020 — safe and ethical practice objective, consent/screening/donor insurance provisions 4. ICMR — The ART (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021 — ICMR's pre-statutory guideline role in ART regulation 5. The Surrogacy (Regulation) Act, 2021 (Act No. 47 of 2021) — India Code — companion statute creating overlapping compliance obligations 6. National Family Health Survey, Ministry of Health and Family Welfare — NFHS as the principal survey source for reproductive health estimates