Indian Government in a landmark initiative to strengthen public health and safety, has notified the Medical Textiles (Quality Control) Order, 2023. The Quality Control Order (QCO) is set to take effect on October 1, 2024. This regulation establishes stringent quality standards for critical medical textile products, including sanitary napkins, baby diapers, reusable sanitary pads, and dental bibs.
The introduction of mandatory certifications under this QCO is aimed at ensuring that these products consistently meet essential quality benchmarks. Compliance with these standards will be legally required, with non-compliance potentially leading to fines and other penalties. Recognizing the challenges faced by small-scale enterprises, particularly Self-Help Groups (SHGs), the government has exempted them from the requirements of this QCO.
Disposable Sanitary napkins and baby diapers are essential consumer products that play a vital role in safeguarding human health and the environment while disposing of them. Consequently, it is crucial that all mandatory testing related to public safety and satisfaction is incorporated into their manufacturing and import processes. 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. Notably, there is a strong emphasis on testing for phthalate levels in baby diapers, as these chemicals can pose risks to both the users and the environment.
The implementation of the QCO is part of the government’s comprehensive strategy to enhance the quality and safety of essential consumer products. Following the enforcement date of the regulations, all products falling under this QCO will require a Bureau of Indian Standards (BIS) license for manufacturing, importing, distributing, selling, hiring, leasing, storing, or displaying products for sale. This crucial measure is designed to ensure that widely used products adhere to the highest safety standards, safeguarding both children and adults.
