India Enforces New Medical Textiles Quality Control Order 2024

On October 23, 2024, India’s Ministry of Textiles issued the Medical Textiles (Quality Control) Order, 2024, under the Bureau of Indian Standards Act, 2016, replacing the previous order from 2023. This new Order, which came into effect following its publication in the Official Gazette, mandates stringent quality standards for various medical textiles, including products such as sanitary napkins, baby diapers, and medical bedding. 

Scope and Exemptions 

The Order applies to specific medical textiles listed in the Schedules, but excludes products intended for export and those produced by self-help groups, as listed in Schedule-A. Self-help groups are informal groups of 10 to 20 individuals who come together voluntarily for collective savings, resource management and mutual benefit. In rural or tribal areas, smaller groups of at least five members are also considered self-help groups. 

Mandatory Compliance and Certification 

Standard Mark: The items listed in column (2) of the Schedules must comply with the relevant Indian Standard outlined in column (3) and bear the Standard Mark. The mark must be obtained through a license issued by the Bureau of Indian Standards in accordance with the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. 

Certification:  The Bureau of Indian Standards and the Textiles Committee, under the Ministry of Textiles, will be responsible for certifying and enforcing compliance for the goods or articles listed in column (2) of the Schedules. 

Schedules and Implementation Deadlines 

The Order sets out compliance requirements for a range of medical textiles in Schedule A (consumer-oriented products) and Schedule B (industrial and healthcare products), specifying Indian Standards and timelines for implementation: 

SCHEDULE A 

SCHEDULE B 

Significance of the Order 

This Order enforces compliance with Indian Standards for medical textiles, ensuring quality manufacturing and improving public health and consumer safety. Domestic manufacturers must ensure compliance to access the Indian market, while exporters and self-help groups are exempted. 

For more details, see the full gazette notification here.