Medical fabric items such as sanitary napkins, child diapers, multiple-use sanitary pad/ feminine napkins/ period panties, dental bib/ napkins, bedsheet, pillow cover, and footwear covers have been regulated for high quality in India by the Medical Textiles (Quality Control) Order, 2023 (the “Order”). The Order needs all makers and importers of medical fabric products to label the items with the Indian Standard (IS) Mark. A certificate over the IS Mark is issued by Bureau of Indian Standards (BIS) after it has determined that the clinical textiles and the production procedure consult with the criteria suggested by BIS. Such certificate is frequently described as the BIS license.
Which are the standards prescribed by BIS that medical fabrics need to meet?
The medical textiles covered by the Order need to mandatorily meet with the requirements described in the table below.
Just how to get permit to utilize Indian Standard mark on medical textiles?
The process to get certificate over the Indian Standard (IS) mark is described in Scheme– I of Schedule– II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018 (the “Conformity Assessment Regulations”). The process requires on-site factory inspection, testimonial of producing procedure, sampling/testing of items at BIS identified labs, and stringent adherence to suggested labelling and noting requirements.
Do all makers and importers of medical fabrics call for statement of Indian Standard (IS) mark on tag?
Yes, the Order applies to all producers (Indian and international) of clinical textiles that desire to sell clinical textiles in India. For that reason, such producers will have to get certificate over IS mark from BIS.
Nonetheless, the Order does not apply to:
The above-mentioned goods/articles need not be mandatorily classified with IS Mark.
a.) Goods/articles planned for export, or
b.) Sanitary napkin, infant diaper, recyclable sanitary napkin/ sanitary napkins/ period panties manufactured by Self Help Groups (SHG).
What are the timelines for the Order to become reliable?
It generally takes around 4– 6 months, relying on the hold-up caused in reacting to inquiries raised (if any), organizing examination( s), sample deposition, and clearance of cost dues, etc, to obtain license over IS Mark from BIS. Consequently, producers and importers of medical textiles must make sure that they make the license application in time so that the business does not endure.
All suppliers (domestic and foreign) of sanitary napkins, child diapers, reusable sanitary pad/ sanitary napkins/ duration underwears need to guarantee that any one of their products marketed in India on or after October 1, 2024, ought to include an IS Mark on their tag.
Conclusion:
All producers (residential and international) of oral bib/ napkins, bedsheet, pillow cover, and footwear covers have to make certain that any of their products offered in India on or after April 1, 2024, should consist of an IS Mark on their tag.