India introduces quality control order for medical textiles

September 25, 2024 - India

In a significant move to enhance public health and safety, the Indian Ministry of Textiles has announced the implementation of the Medical Textiles (Quality Control) Order, 2023, set to take effect on October 1, 2024. This order introduces stringent quality standards for critical medical textile products, including sanitary napkins, baby diapers, reusable sanitary pads, and dental bibs.

The government aims to ensure that key products are safe and environmentally friendly, with a special focus on regulating phthalate levels in baby diapers due to potential health risks. The notified specifications (IS 5404:2019 for sanitary napkins and IS 17509:2021 for disposable baby diapers) cover critical performance criteria such as pH levels, hygiene testing, bacterial and fungal bioburden, biocompatibility evaluations, and biodegradability.

The Quality Control Order (QCO) mandates that these products meet essential benchmarks, with non-compliance resulting in potential fines or penalties. However, Self-Help Groups (SHGs) and small-scale enterprises have been exempted from these requirements.

Following the implementation, manufacturers, importers, and retailers will be required to obtain a Bureau of Indian Standards (BIS) license, further cementing the government’s commitment to consumer protection.