Medical Textiles
Sanitary Napkins (IS 5405:2019)
Strategic Recommendations for Sanitary Napkins
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Do a Gap Assessment
 Identify all non-certified SKUs. Check labeling, packaging, and manufacturing lines for conformity to IS 5405:2019.
| Section | Details |
|---|---|
| Product Name | Sanitary Napkins. |
| IS Standard | IS 5405:2019. |
| Title of IS | Sanitary Napkins – Specification (Second Revision). |
| Quality Control Order | Medical Textiles (Quality Control) Order, 2024. |
| Notification & Amendments | Notified via S.O. 4634(E), dated 23 October 2024, Amended via S.O. 04(E), dated 1 January 2025 , Second Amendment: S.O. 3526(E), dated 30 July 2025 Supersedes: Medical Textiles (Quality Control) Order, 2023 |
| Final Enforcement Date | For Large & Medium Enterprises: 1 January 2025, For Small & Micro Enterprises: 1 April 2025. |
| Objective & Scope | To ensure hygiene, safety, and performance of sanitary napkins by mandating BIS certification and adherence to IS 5405:2019. |
| Products Covered | Disposable sanitary napkins intended for personal hygiene applications. |
| Exemptions | Disposable sanitary napkins intended for personal hygiene applications. |
| Industries Impacted | Personal Hygiene Product Manufacturers, Nonwoven & Technical Textile Producers, Healthcare & Sanitation Sector. |
| Mandatory Compliance | Conformity to IS 5405:2019, ISI marking required, BIS license under Scheme-I of BIS (Conformity Assessment) Regulations, 2018. |
| Next Steps for Stakeholders | Apply for BIS license, Complete testing in BIS-recognized labs, Declare any non-marked stock for exemption, Ensure ISI marking before sale/import. |
| Legal Framework & Enforcement | Enforced under BIS Act, 2016 by BIS and the Textiles Committee. Includes inspections and certification control mechanisms. |
| Penalties for Non-Compliance | Seizure of non-compliant goods- Suspension or cancellation of license, Fines or imprisonment up to 2 years or both. |
| Conclusion | BIS certification is mandatory for all sanitary napkin products by respective deadlines. The 2024 Order supersedes the 2023 QCO and sets quality benchmarks for hygiene and safety in this essential category. |
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Notification
Sanitary napkins have been notified under the Medical Textiles (Quality Control) Order, 2024, issued via S.O. 4634(E) dated 23 October 2024 by the Ministry of Textiles under the BIS Act, 2016. This Order superseded the earlier QCO of 2023. The notification has undergone two amendments:
- First Amendment via S.O. 04(E) dated 1 January 2025, and
- Second Amendment via S.O. 3526(E) dated 30 July 2025, which revised the exemption timeline for non-marked stock.
Enforcement Timeline
- Large and Medium Enterprises must comply by 1 January 2025,
- Small and Micro Enterprises must comply by 1 April 2025.
Overview
Sanitary napkins are absorbent personal hygiene products designed for use during menstruation to maintain cleanliness, comfort, and prevent leakage. Given their direct contact with sensitive skin and their wide-scale use, ensuring product quality and safety is essential. IS 5405:2019, the second revision of the Indian Standard for sanitary napkins, provides comprehensive specifications related to performance, absorbency, material safety, and construction.
Objective & Scope
The purpose of IS 5405:2019 is to regulate and improve the quality of sanitary napkins available in the Indian market by specifying essential requirements related to absorption capacity, pH levels, microbial load, adhesive strength, and barrier protection. The standard ensures that products are hygienic, safe, and effective for menstrual care.
Products Covered
The specification applies to disposable sanitary napkins, typically made from nonwoven textiles with an absorbent cellulose and a moisture barrier backing. These are intended for single-use applications for menstrual hygiene and comfort.
Exemptions Provided
As per Schedule A of the 2025 Amendment Order, the following categories are exempted from mandatory ISI marking:
- Sanitary napkins meant exclusively for export,
- Products manufactured by Self-Help Groups (SHGs), and
- Pre-certified or pre-manufactured non-marked stock declared by license holders, which can be sold without ISI marking until 31 December 2025.
Industries Impacted
- Personal Hygiene Product Manufacturers – Directly responsible for BIS compliance in design, production, and packaging,
- Sanitary Napkin Manufacturers – Must comply with the standard and obtain BIS certification,
- Nonwoven & Technical Textile Sector – As suppliers of absorbent core and cover fabrics,
- Healthcare & Sanitation Programs – Especially in government-led distribution of sanitary products.
Mandatory Compliance Requirements
BIS certification under IS 5405:2019 is mandatory for all sanitary napkin products. The ISI mark must be clearly visible on packaging, and compliance is governed under Scheme-I of the BIS (Conformity Assessment) Regulations, 2018. The enforcement deadline is 1 January 2025 for large and medium enterprises, and 1 April 2025 for small and micro enterprises.
Next Steps for Stakeholders
Manufacturers must initiate certification by:
- Applying to BIS with the required documentation,
- Testing products through BIS-recognized laboratories,
- Ensuring product packaging carries the ISI mark before distribution or sale,
- Declaring non-marked stock as per Schedule A to avail temporary exemptions.
Legal Provisions, Enforcement & Penalties
Compliance is monitored and enforced under the BIS Act, 2016, and supported by the Textiles Committee Act, 1963. BIS and the Textiles Committee have authority to conduct inspections, withdraw licenses, and prosecute offenders. Penalties for non-compliance include seizure of products, fines, license suspension, and up to two years of imprisonment, or both.
Conclusion
From 1 January 2025 (and 1 April 2025 for smaller enterprises), sanitary napkins must conform to IS 5405:2019 and carry valid BIS certification. The 2024 QCO, as amended in 2025, replaces the earlier 2023 Order, setting a new benchmark for menstrual hygiene product quality and safety in India. Timely action is necessary to ensure uninterrupted manufacturing, sales, and distribution.
Ready to start your certification journey?
Let us help you navigate regulatory challenges and achieve certification with ease. Leave us your details, and we’ll get back to you—or request a free consultation today.