The Medical Textiles (Quality Control) Order, 2023 will go into force on October 1, 2024, as formally announced by the Ministry of Textiles. This new regulation aims to set stringent quality standards for essential medical textile products, including sanitary napkins, baby diapers, reusable sanitary pads, and dental bibs.
Important Qualitative Control Order Features
All critical medical textile products will require mandatory certifications to ensure they meet established quality standards. This covers products like dental bibs, period panties, reusable sanitary pads, infant diapers, and sanitary napkins.
Legally, adherence to these new requirements is required. If manufacturers don’t follow the rules, they risk paying hefty fines and penalties.
Self-Help Groups (SHGs), in recognition of the operational difficulties they encounter, are excused from this QCO’s standards in order to assist small-scale businesses.
The QCO highlights the critical role that products like disposable sanitary napkins and baby diapers play in protecting public health and ensuring environmentally responsible disposal practices.
Testing pertaining to public safety will be mandated for manufacturers. This includes evaluations of pH levels, hygiene testing, bacterial and fungal bioburden, biocompatibility assessments, and biodegradability tests.
Any product that falls under the purview of this QCO must have a BIS licence in order to be manufactured, imported, distributed, hired, leased, stored, or displayed for sale.
Implementation Schedule
The QCO mandates that all medical textile products sold in India after October 1, 2024, must display the Indian Standard (IS) Mark on their labels. This requirement applies to both domestic and foreign manufacturers wishing to sell these products in India. However, products intended solely for export or those produced by SHGs are exempt from this labelling requirement.
The Ministry of Textiles’ effort is a big step in the right direction towards improving the safety and quality of medical textile goods in India and helping smaller businesses overcome compliance issues.