Demystifying the Regulatory Framework of IVF in India

Introduction

A recent study by the Lancet highlighted the decreasing fertility rate globally as well as in India. The findings of the study revealed that from 1950 to 2021, the total fertility rate globally decreased by nearly 50% and in India, it decreased by more than 70%1. The rise in fertility issues is caused by a combination of factors such as shifts in marital timelines, lifestyle changes, medical conditions such as polycystic ovary syndrome and endometriosis, and the prevalence of factors detrimental to fertility, such as obesity, stress, smoking, and pollution.

Advancements in the healthcare sector have led to the establishment of a flourishing fertility industry in India with Assisted Reproductive Technologies (“ART”) such as In-Vitro Fertilisation (“IVF”) being one of the most sought-after treatments for fertility issues. This note analyses the IVF sector in India and the regulatory framework surrounding it.

The IVF Industry: A Booming Haven

The Indian IVF industry is one of the fastest-growing sectors globally, with over 2,500 fertility clinics across the country and an impressive CAGR of 16.5% from 2023 to 2030.2 State-of-the-art medical infrastructure and cost-effective services are the key drivers of the Indian IVF industry. The industry has seen an increase in several strategic investments in key players such as Indira IVF, Nova IVF and Ferty9 Fertility Centre. Approximately 2 million patients from around 76 countries visit India for medical, wellness, and IVF treatments, generating $6 billion for the industry, which is expected to increase to $13 billion by 2026.3

The Legal Matrix of IVF

The first IVF baby in India was born in 1978, but for decades, there was no regulatory framework governing IVF and the IVF service providers. With no proper legal mechanisms in place, unethical actions such as DNA mismatches, unethical sourcing, and use of gametes, sex determination, etc. went unchecked.

The first measures undertaken to regulate IVF in India were through the National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India, 2005. These guidelines provided for the registration of IVF clinics, the code of practice, the responsibilities of medical practitioners, the basic infrastructure required in the IVF facilities. However, the  guidelines did not define any penalty for non-compliance and leaving several healthcare professionals could not be held accountable for lapses that were committed. 

Recognising the need to regulate ART in India, the Assisted Reproductive Technology (Regulation) Act, 2021 (“Act”) and the corresponding Assisted Reproductive Technology (Regulation) Rules, 2022 (“Rules”) were introduced. The Act established regulatory authorities at the national and state levels to ensure the implementation of the legal framework.

Key Provisions of the ART Act

  1. Eligibility Criteria: IVF treatment can be availed by a woman or a commissioning couple defined as a married couple 4 unable to conceive after one year of unprotected coitus or where one partner is facing any fertility issues. Age limits for treatment are 21-50 years for women and 21-55 years for men, while for gamete donors, it is 21-55 years for men and 21-35 years for women.5
  1. Duties of ART Service Providers: ART service providers must ensure professional counselling about the procedure, the risks and complications involved, costs, obtain written consent, and provide the option to withdraw consent before embryo implantation. The Act prohibits sex determination of the child. 
  1. Children’s Rights:  The Act states that children born through ART procedures shall be deemed to be biological children of the commissioning couple/woman and be entitled to all rights and privileges. The donors shall  have no parental rights over the child born using such donor’s gamete. A child born through IVF can only avail medical or genetic information of the donor or its genetic parent.
  1. Registration: ART clinics and banks must register themselves. The framework provides a distinction between service providers and the registration processes for ART banks and clinics, encompassing grant, renewal, suspension, and cancellation of registration. 
  2. Penalties: The Act imposes stringent penalties to serve as a deterrent, with fines ranging from INR 5-10 lakhs for initial contraventions and imprisonment accompanied by fines ranging from INR 8-10 lakhs for subsequent violations.6 For offences committed by clinics and banks, the executive head of the establishment shall also be culpable.7

Conclusion

The landscape of IVF procedures and the corresponding industry in India has evolved significantly in the last decade. There has been an upswing in awareness about IVF in India through various channels. The introduction and implementation of the legal framework have fostered greater transparency and ensured patient safety. This has contributed to the overall growth and reliability of the IVF industry in India which makes it a booming industry for private investments. The combination of heightened awareness and improved governance is shaping a more promising future for the IVF industry.


[1] Global fertility in 204 countries and territories, 1950–2021, with forecasts to 2100: a comprehensive demographic analysis for the Global Burden of Disease Study 2021, Lancet, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00550-6/fulltext#seccestitle170

[2] https://www.expresshealthcare.in/news/indias-fertility-sector-a-promising-avenue-for-investment-and-growth/440262/

[3]https://www.thehindubusinessline.com/news/after-being-a-pharma-hub-india-is-now-a-medical-tourism-destination-finance-minister/article66301970.ece

[4]Section 2(n), Assisted Reproductive Technology (Regulation) Act 2021

[5]Section 27, Assisted Reproductive Technology (Regulation) Act 2021.

[6]Section 33(2), Assisted Reproductive Technology (Regulation) Act 2021.

[7]Section 37, Assisted Reproductive Technology (Regulation) Act 2021.