Medical Textiles
Baby Diaper (IS 17509:2021)
Strategic Recommendations for Baby Diapers
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Mandatory from 1 Jan 2025 for large/medium units and 1 Apr 2025 for small/micro enterprises. Early compliance avoids disruptions.
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Ensure Marking Before Sale
Every baby diaper pack must carry a valid ISI mark by the respective deadline to meet legal and BIS standards.
| Section | Details |
|---|---|
| Product Name | Baby Diaper |
| IS Standard | IS 17509:2021 |
| Title of IS | Disposable Baby Diaper – Specification |
| 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 product safety, hygiene, and quality in disposable baby diapers through standardized manufacturing and mandatory BIS certification. |
| Products Covered | Disposable baby diapers made from absorbent materials intended for one-time use. |
| Exemptions | Products meant exclusively for export, Pre-manufactured stock (Schedule A) can be sold without ISI mark until 31 Dec 2025. |
| Industries Impacted | Baby Care & Personal Hygiene Manufacturers, Technical Textile & Nonwoven Industries, FMCG and Healthcare Supply Chains. |
| Mandatory Compliance | Must conform to IS 17509:2021, BIS certification under Scheme-I is mandatory- ISI mark must be printed on packaging. |
| Next Steps for Stakeholders | Apply for BIS certification, Submit samples for testing at BIS-approved labs, Declare and label all stock by enforcement date. |
| Legal Framework & Enforcement | Enforced under BIS Act, 2016 by BIS and Textiles Committee with full inspection and certification authority. |
| Penalties for Non-Compliance | Seizure of non-compliant goods- Suspension or cancellation of license, Fines or imprisonment up to 2 years or both. |
| Conclusion | All baby diapers sold in India must be BIS-certified under IS 17509:2021 starting 1 Jan/1 Apr 2025. The 2024 QCO replaces the 2023 version and mandates full compliance. |
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Notification
Disposable baby diapers 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
Baby diapers are single-use hygiene products designed to absorb and retain urine and feces, providing dryness and comfort to infants. The standard IS 17509:2021 outlines the essential requirements for material safety, absorption performance, construction integrity, and skin compatibility. The regulation aims to eliminate substandard products from the market and enhance child health through certified, high-quality products.
Objective & Scope
The primary objective of IS 17509:2021 is to standardize the performance and safety criteria of disposable baby diapers. It specifies parameters like absorption capacity, retention, rewet characteristics, and pH neutrality. The standard ensures the product is safe, hygienic, and effective for prolonged baby use, and is suitable for use in both home and institutional care settings.
Products Covered
This standard applies to disposable baby diapers made from absorbent cores, nonwoven topsheets, and breathable back sheets. These are designed for single-use applications and include both tape-type and pant-style configurations intended for infants.
Exemptions Provided
- Products meant exclusively for export are exempt from BIS certification,
- Pre-manufactured stock, as listed in Schedule A of the QCO, can be sold without the ISI mark until 31 December 2025.
Industries Impacted
- Personal Hygiene & Baby Care Brands,
- Nonwoven and Technical Textile Manufacturers,
- Retail & FMCG Supply Chains,
- Government and NGO Procurement Programs for Infants.
Mandatory Compliance Requirements
From the notified enforcement date, it is mandatory for all baby diapers sold, manufactured, or imported in India to conform to IS 17509:2021 and be BIS-certified under Scheme-I of the BIS (Conformity Assessment) Regulations, 2018. The ISI mark must be clearly affixed to each retail pack to indicate compliance.
Next Steps for Stakeholders
Manufacturers and importers are required to:
- Apply for a BIS license under IS 17509:2021,
- Undergo product testing in BIS-recognized laboratories,
- Label products with the ISI mark prior to sale,
- Declare any non-marked inventory under Schedule A provisions, with clearance allowed until 31 December 2025.
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
Effective 1 January 2025 (or 1 April 2025 for MSMEs), all baby diapers sold in the Indian market must be BIS-certified under IS 17509:2021. The move ensures product quality, promotes child health, and mandates regulatory oversight. Stakeholders must complete the certification process in time to avoid supply chain disruption and penalties.
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.