Ministry of Textiles Introduces Mandatory Quality Standards for Medical Textiles

New Delhi: To enhance public health and safety, the Ministry of Textiles has issued the Medical Textiles (Quality Control) Order, 2023, which will come into effect on October 1, 2024. The landmark regulation introduces stringent quality standards for essential medical textile products such as sanitary napkins, baby diapers, reusable sanitary pads, and dental bibs.

Under this new Quality Control Order (QCO), manufacturers and importers will be required to adhere to mandatory certifications to ensure that these products meet crucial safety and quality benchmarks. Non-compliance with the QCO could result in fines and other legal penalties. However, the government has recognized the challenges faced by small-scale enterprises, particularly Self-Help Groups (SHGs), and has granted them an exemption from these regulations.

The regulation particularly focuses on disposable sanitary napkins and baby diapers, which are key consumer products that directly impact human health and the environment. The new guidelines aim to incorporate all mandatory safety testing into the manufacturing and import processes of these products. The notified specifications, IS 5404:2019 for sanitary napkins and IS 17509:2021 for disposable baby diapers, set forth strict performance criteria. These include pH levels, hygiene testing, bacterial and fungal bioburden, biocompatibility evaluations, and biodegradability. Of particular note is the emphasis on testing phthalate levels in baby diapers due to the potential health and environmental risks posed by these chemicals.

From October 2024, all manufacturers, importers, distributors, and sellers of products covered under this QCO will need to obtain a Bureau of Indian Standards (BIS) license. This applies to anyone involved in manufacturing, importing, distributing, selling, hiring, leasing, storing, or displaying these products for sale. The QCO is part of the government’s broader strategy to ensure that commonly used products adhere to the highest safety standards, protecting the health of children and adults alike.