Menstrual and Reproductive Health Product Regulation: What Gynaecologists Should Know
In February 2026, the Supreme Court of India declared menstrual health and hygiene an inseparable part of the constitutional right to life and dignity under Article 21, directing authorities to improve access to safe products, particularly for girls in schools. That ruling landed against a regulatory backdrop that gynaecologists are often better placed than patients to understand: sanitary napkins and period products in India are now subject to mandatory quality certification, but chemical ingredient disclosure remains largely voluntary.
BIS Certification Is Now Mandatory, Not Optional
Since November 2024, sanitary napkins, reusable sanitary pads, and baby diapers have been brought under mandatory Bureau of Indian Standards certification through the Medical Textiles (Quality Control) Order, meaning manufacturers must obtain ISI mark certification under IS 5405 before these products can be legally sold in India. The current governing standard, IS 5405:2025, specifies testing requirements covering liquid absorption capacity, skin compatibility, microbial safety, side-leakage prevention, and adhesive bonding performance.
This is a meaningful shift from the earlier position, where BIS had only issued voluntary guidance on product usage since 1980 without mandating safety testing. Compliance now extends beyond the finished product to raw materials and the manufacturer’s own testing facilities, since certain BIS standards for sanitary napkin components, such as cotton gauze, must independently conform to their own referenced standards.
The Chemical Disclosure Gap That Remains
Despite mandatory BIS certification for physical safety and performance parameters, India has no requirement compelling manufacturers to disclose the full ingredient list of sanitary napkins on packaging. Because sanitary products have historically been treated as everyday personal-care items rather than as medical products requiring ingredient transparency, testing for the toxicity of specific chemical components, including materials linked in some studies to endocrine disruption or carcinogenic risk, is not mandated the way it might be for a regulated drug or medical device.
This stands in contrast to markets like the United States, where the FDA classifies tampons and certain intravaginal menstrual products as medical devices subject to premarket and postmarket controls, and where several individual states have begun mandating ingredient labelling independently of federal rules.
Menstrual Cups and Other Insertable Products
Menstrual cups, typically manufactured from medical-grade silicone, occupy a somewhat different regulatory position than external absorbent products, since their insertable design and direct mucosal contact raise different safety considerations around material biocompatibility. Awareness and correct usage of menstrual cups remain comparatively low among Indian users, including among some healthcare trainees, which has direct implications for the counselling gynaecologists provide when patients ask about switching from disposable pads to reusable alternatives.
Because India’s mandatory BIS framework is centred on sanitary napkins and diapers rather than a comprehensive intravaginal device standard, gynaecologists recommending menstrual cups to patients are relying more on general medical-grade silicone safety and individual product reputation than on a dedicated Indian regulatory certification specific to menstrual cups.
What Gynaecologists Can Usefully Tell Patients
Patients asking whether a sanitary product is safe can be reassured that mandatory BIS certification since late 2024 means most branded products sold in India have cleared testing for absorption performance, microbial safety, and skin compatibility. At the same time, patients concerned about specific chemical exposure, particularly those with a history of allergic reaction or sensitive skin, should be told that full ingredient disclosure is not currently mandated in India, so a lack of listed ingredients on packaging does not necessarily indicate non-compliance.
For patients using unbranded or locally manufactured napkins, particularly relevant in lower-income and rural settings the Supreme Court’s ruling specifically addressed, gynaecologists are well placed to flag that quality assurance is less consistent outside BIS-certified branded products, and that recurrent irritation, infection, or allergic reaction with a specific product warrants both clinical evaluation and a product switch.
Conclusion
India’s menstrual product regulation has moved meaningfully forward on physical safety standards while still lagging on chemical transparency, a gap the Supreme Court’s 2026 ruling has put back on the national agenda. Gynaecologists are often the first clinical touchpoint for a patient’s product-related concern, and understanding exactly what BIS certification does and does not guarantee helps frame that conversation accurately.
Researched Resources
1. India’s Apex Court Declares Menstrual Health and Hygiene a Fundamental Right
2. BIS Certification for Sanitary Napkins & Period Products in India (IS 5405:2025)
3. Medical Textiles (Quality Control) Order, 2023: Impact Analysis for Personal Hygiene Products
Disclaimer: This article is for general informational and educational purposes and reflects India’s menstrual product regulatory framework as understood at the time of writing; BIS standards and disclosure requirements continue to evolve. It is not regulatory or clinical advice, and specific patient concerns should be addressed through individual clinical assessment.
Vivek Chaudhary is a Technical Content Developer specializing in healthcare, health technology, and digital healthcare business solutions. He creates research-driven, SEO-focused content for doctors, clinics, hospitals, healthcare professionals, and patients, covering topics such as healthcare technology, patient engagement, clinic management, digital communication, and online visibility.
