The Ministry of Textiles, through its notification dated September 27, 2023, issued the Medical Textiles (Quality Control) Order, 2023 to ensure adherence to Indian Standards for specified products. To provide additional time for compliance, the Ministry has issued several extensions, culminating in the Medical Textiles (Quality Control) Amendment Order, 2025, published on January 1, 2025. 

Key Provisions

1. Title and Commencement

1.1. This Order shall be called the Medical Textiles (Quality Control) Amendment Order, 2025.
1.2. It shall come into force on the date of its publication in the Official Gazette. 

2. Scope and Application

2.1. This Order applies to Disposable baby diaper, which must conform to Indian Standard IS 17509:2021.

2.2. Exemptions:

• Goods manufactured exclusively for export.
• Goods or articles specified in Schedule-A, manufactured by self-help groups.
• Old stock products manufactured or imported prior to the implementation timeline, declared by the manufacturer, shall be permitted for sale until June 30, 2025. 

3. Implementation Timelines

The timelines for implementation are as follows:

• Large and Medium Enterprises: Implementation by January 1, 2025.
• Small and Micro Enterprises: Implementation by April 1, 2025. 

4. Definition of Self-Help Groups

For the purpose of this Order, self-help groups are defined as informal groups consisting of 10 to 20 individuals, homogeneous in social and economic backgrounds, voluntarily organized to promote savings and mutual resource management. In tribal or hilly regions, smaller groups with a minimum of five members may also qualify as self-help groups. 

5. Mandatory Certification

Goods or articles, specifically Disposable baby diaper, shall bear the Standard Mark (ISI Mark) under a license issued by the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018. 

6. Certification and Enforcement Authority

The following authorities are designated to enforce and certify compliance with this Order:

• Bureau of Indian Standards (BIS).
• Textiles Committee, Ministry of Textiles. 

7. Penalty for Contravention

Non-compliance with the provisions of this Order shall attract penalties as prescribed under the Bureau of Indian Standards Act, 2016 (11 of 2016). 

Stay compliant and prepare your business for these important regulatory changes to continue operating within the industry's guidelines!

BIS Certification for Disposable Baby Diapers IS 17509: 2021