Six medical textile items sanitary pads, diapers, dental bib/napkins, shoe covers, bedsheet and pillow cover are likely to be soon brought under the mandatory ambit of the BIS certification keeping in view protection and safety of human health and for ensuring optimum quality of product. This is for the first time medical textile products will come under BIS cover.
However, since self-help groups (SHGs) are mostly manufacturing these products particularly diapers and sanitary pads, the move might have an impact on these multiple small players manufacturing sectors.
The Ministry of Textiles is working with the Central Drugs Standard Control Organisation on regulatory aspects of different medical textiles. We will soon be notifying Quality Control Orders (QCOs) for 6 medical textile items including sanitary pads and diapers, among others, Rajeev Saxena, joint secretary, Union Textiles Ministry revealed at an event in Mumbai on Thursday.
He said that these QCOs will strive to provide best value to users and end consumers, fostering Indian product quality that is comparable to global standards.
Saxena highlighted on the vitality of medical textiles due to its direct correlation with quality of life, despite low share compared to Packtech and Mobiltech in India.
“The market share of medical textiles is growing strongly in India on the back of profound R&D and skilling in the area. Further, there’s a need for repositioning of product focus in medical textiles in terms of global market and domestic market,” he further emphasized.
The official stressed on wider innovation and research in the medical textiles, especially focusing on novel technologies and indigenizing the highly-imported medical textile items such as sanitary pads, diapers and other surgical sutures, among others.
Commenting on the move, Rajiv Nath , Forum Coordinator, AiMeD said, “Medical devices are already regulated under the Drug Act and Medical Devices Rules. Hygiene products that are not necessarily medical devices are not regulated currently under the Drugs Act but yes their quality needs to be controlled so it’s understandable for the government to come out with QCOs based on BIS Standards as done in many sectors.
“The government can also encourage quality based criteria in public procurement by seeking institutional buyers to seek Quality Council of India’s voluntary ICMED ( Indian certification for Medical Devices) from manufacturers certified by NABCB accredited certification bodies which is based on ISO global standards. “
Nath, however, felt that “To use CDSCO for regulation of non drug/ non medical devices will be incorrect and may end up as over regulation and needless harassment of the medical textile based hygiene product manufacturers considering lack of technical expertise and competence. “
The Government has already announced the launch of two QCOs for 31 items consisting of 19 Geo Textiles and 12 Protective Textiles including protective clothing for firefighters and welders in the first phase, a move aimed to prevent "dumping".