BIS Extension Order for Medical Textiles (Quality Control Order, 2024)

Introduction to the BIS QCO for Medical Textiles

The Ministry of Textiles has introduced Quality Control Orders for medical as well as hygiene textile products in order to ensure safety, hygiene, as well as consistent quality, especially for products that come in direct contact with the human body.

Items such as sanitary napkins, baby diapers, reusable sanitary products, shoe covers, dental bibs, bed sheets, and pillow covers are widely used in healthcare and personal hygiene. The QCOs were considered necessary to protect public health, prevent the circulation of poor-quality products, and ensure that only products meeting Indian Standards are sold in the Indian market.

Key changes you should know

1. A new Medical Textiles (Quality Control) Order, 2024, has been issued on 23 October 2024, replacing the earlier 2023 order.
2. BIS certification with ISI Mark is mandatory for medical textile products that have been notified in the Order.
3. Products manufactured only for export are exempted.
4. Items that are manufactured by self-help groups, as defined in the Order, are also exempted.
5. BIS and the Textiles Committee, Ministry of Textiles, will act as certifying as well as enforcing authorities.
6. Different implementation dates apply to different product categories.

What is the date of implementation?

The implementation timelines under this Order are:

1. Effective from 1st January 2025:
   1. Sanitary napkins
   2. Baby diapers
   3. Reusable sanitary pads / sanitary napkins/period panties
2. Already enforced from 1st April 2024:
   1. Shoe covers
   2. Dental bibs/napkins
   3. Bed sheets and pillow covers

Manufacturers must comply as per the applicable product-wise date to stay compliant as well as ahead in the Indian economy.

Benefits of this Order for the Industry / Businesses

• Ensures hygienic and safe medical textile products are regulated.
• Builds consumer trust in certified hygiene products.
• Improves quality consistency across manufacturers.
• Protects healthcare users from substandard materials.
• Encourages fair competition in the medical textile sector.
• Supports long-term growth of the healthcare textile industry.

Now, what to do?

Manufacturers as well as suppliers of medical textile products should:

• Identify which of their products are covered under this QCO.
• Check the applicable Indian Standards as well as deadlines.
• Initiate BIS ISI certification under Scheme-I.
• Prepare for product testing, inspections, and documentation.
• Ensure compliance before the relevant implementation date.

Brand Liaison provides end-to-end support for Medical Textiles QCO compliance, including product scope assessment, standard interpretation, BIS testing coordination, certification assistance, as well as complete enforcement readiness, helping businesses meet deadlines smoothly and maintain uninterrupted market access.