Hyderabad: The recent case of a sperm mix-up at a Hyderabad-based fertility clinic has reignited public debate over the efficacy of India’s Assisted Reproductive Technology (Regulation) Act, 2021 and Surrogacy (Regulation) Act, 2021.
These twin legislations were introduced to regulate fertility treatments and surrogacy practices, but experts warn that implementation gaps continue to put patients, donors, and surrogate mothers at risk.
The incident that raised red flags
In early July, a Hyderabad couple discovered that the sperm used in their in vitro fertilisation (IVF) procedure did not belong to the husband, resulting in an unexpected biological mismatch. The case, now under legal scrutiny, brought into sharp focus the lack of standardised protocols, data handling, and accountability mechanisms in some clinics operating under the guise of registered ART centres.
“This is not just a medical error, it’s a legal and ethical breach,” said Dr Lakshmi Aman, a reproductive rights advocate, speaking to NewsMeter. “It highlights how paperwork alone cannot guarantee regulation unless enforcement mechanisms are strengthened.”
What the ART and surrogacy acts cover
The Assisted Reproductive Technology (Regulation) Act, 2021, governs ART clinics and banks, aiming to prevent exploitation and ensure ethical treatment of all parties involved: the couple, the donor, and the future child. The Surrogacy (Regulation) Act, 2021, in turn, restricts surrogacy to altruistic procedures and bans commercial surrogacy entirely.
Both laws are overseen by a common regulatory structure:
• National Level: National ART and Surrogacy Board
• State Level: State ART & Surrogacy Board and State Appropriate Authority (SAA)
In Telangana, 381 facilities, including two government hospitals, are currently registered under the ART Act.
Where the gaps are
Despite these frameworks, the sperm swap case underscores glaring gaps in clinical oversight and patient grievance redressal. The ART Act mandates registration, inspections, and a five-year certificate validity for ART banks and clinics, but what happens when a clinic is registered yet fails in ethical conduct?
“There is no uniform protocol across states to monitor daily operations or to conduct random audits,” noted Dr Surender Rao, an embryologist. “Once the certificate is issued, the follow-through is weak unless a complaint is lodged.”
ART Act: Key Provisions and Penalties
Some critical points under the ART Act include:
• Age restrictions: Services allowed only to women aged 21–50 and men aged 21–55.
• Prohibition on advertisements for sex-selective ART services.
• Prohibition on selling or trading gametes or embryos.
• Severe penalties:
– Fines ranging from ₹5 lakh to ₹25 lakh
– Imprisonment between 3 and 10 years for repeat violations
Still, legal experts point out that there is limited precedent of penal action being taken unless a case reaches court or media attention.
Surrogacy Act: What is permitted
Under the Surrogacy (Regulation) Act, 2021, only altruistic surrogacy is permitted in India. This means:
• No financial compensation is allowed except for medical and insurance expenses.
• Only Indian citizens (including OCIs) who are legally married and childless can opt for surrogacy.
• Surrogate mothers must be between 25 and 35 years, married, and have at least one child of their own.
• A surrogate can offer to carry a child only once in her lifetime.
“All parties involved, intending couple, surrogate, and medical team, must undergo screenings and submit affidavits to the State Appropriate Authority,” explained Advocate Naresh Kumar, a family law specialist. “But enforcement depends heavily on paperwork, with little field verification.”
Medical criteria and pre-approvals
For a couple to pursue surrogacy, the law requires:
• Medical Indication Certificate from a District Medical Board
• Eligibility and Essentiality Certificates from the State Authority
• Court orders concerning parentage and custody to be filed post-birth
“Most clinics don’t educate couples about these documents,” said a counsellor at a private fertility centre who requested anonymity. “People often assume the clinic is handling everything, until something goes wrong.”
Enforcement vs Reality
Penalties for violations under both Acts include fines up to ₹10 lakh and imprisonment up to 10 years. However, actual enforcement remains limited.
In the sperm swap case, for instance, while an internal probe was launched and the clinic’s license is under review, no official penal action has been confirmed yet by the authorities.
“This incident should be a wake-up call,” said Dr. Lakshmi. “The law is robust on paper, but without digital record tracking, biometric verifications, and regular inspections, it is vulnerable to human error and even manipulation.”
What needs to change
• Unified Registry Oversight: While facilities must apply through a national portal and then submit documents to the state authority, experts suggest centralised dashboards for real-time data tracking could reduce errors.
• Mandatory Patient Rights Charters: Clinics should display detailed rights and obligations for patients and donors.
• Third-party Monitoring: An independent body to audit compliance, apart from state boards, is also being advocated by public health organisations.
The Hyderabad sperm mix-up case is not an isolated incident but a symptom of deeper systemic oversight failure. While the ART and Surrogacy Acts mark significant progress in regulating fertility medicine in India, the implementation and real-time accountability still need urgent strengthening.
Until then, as reproductive rights activist Rekha Sharma puts it, “Hopeful parents and surrogate mothers remain vulnerable to human error wrapped in legal complexity.”
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