Gazette Tracker
Gazette Tracker

Core Purpose

Notification of the Medical Textiles (Quality Control) Order, 2023, made under sections 16 and 17 read with section 25(3) of the Bureau of Indian Standards Act, 2016, mandating compulsory BIS certification for specified medical textile products.

Detailed Summary

The Ministry of Textiles issued S.O. 4247(E) dated 27th September 2023, notifying the Medical Textiles (Quality Control) Order, 2023, in exercise of powers under sub-sections (1) and (2) of section 16 read with section 17 and sub-section (3) of section 25 of the Bureau of Indian Standards Act, 2016 (11 of 2016), after consultation with the Bureau of Indian Standards; the Order applies to goods listed in Schedules A and B (excluding goods meant for export, and excluding Schedule A items manufactured by Self Help Groups of 10 to 20 individuals, or a minimum of 5 members in hilly and tribal areas) and requires that they conform to the corresponding Indian Standard and bear the Standard Mark under a licence from the Bureau of Indian Standards in accordance with Scheme-I of Schedule-II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018, with the Bureau of Indian Standards as the certifying and enforcing authority and contravention punishable under the Bureau of Indian Standards Act, 2016; Schedule A covers sanitary napkins (IS 5405:2019), baby diapers (IS 17509:2021), and reusable sanitary pads/napkins/period panties (IS 17514:2021), effective 1st April 2024 (1st October 2024 for Small and Micro Enterprises), while Schedule B covers shoe covers (IS 17349:2020), dental bibs/napkins (IS 17354:2020), and bedsheets and pillow covers (IS 17630:2021), effective 1st April 2024; the notification bears file number 6/1/2021-R&D(Pt.4) and is signed by Rajeev Saxena, Joint Secretary.

Full Text

6152 GI/202 3 (1) रजिस्ट्री सं. डी.एल.- 33004/99 REGD. No . D. L. -33004/99 EXTRAORDINARY PART II —Section 3 —Sub-section ( ii) PUBLISHED BY AUTHORITY No. 4077 ] NEW DELHI, WEDNESDAY , SEPTEMBER 27, 2023/ ASVINA 5, 1945 CG-DL-E-27092023-249027 (1) (2) (3) (4) (5) (1) (2) (3) (4) (5) MINISTRY OF TEXTILES ORDER New Delhi, the 27th September , 2023 S.O. 4247(E).—In exercise of the powers conferred by sub -sections (1) and (2) of section 16 read with section 17 and sub -section (3) of section 25 of the Bureau of Indian Standards Act, 2016 (11 of 2016), the Central Government is of the opinion that it is necessary so to do in the public interest and after consulting the Bureau of Indian Standards, hereby makes the following Order, namely: - 1. Short title and commencement . – (1) This Order may be called the Medical Textiles (Quality Control) Order, 2023. (2) It shall come into force immediately after such periods, as specified item -wise in column (5) of the Schedule - A and Schedule - B annexed to this Order, from the date of its publication in the Official Gazette. 2. Application. – This Order shall a pply to goods or article s specified in column (2) of the said Schedule s, but shall not apply to such goods or article meant for export and items specified in Schedule A to this order that are manufact ured by Self Help Groups (SHGs) . [Explanation. — For T he purpose of This para, — Self Help Groups (SHGs) means small informal group of 10 to 20 individuals, who are homogenous with respect to social and economic background and come together voluntarily for promoting savings habit among members and for a comm on cause to raise and manage resources for the benefit of group mem bers. However, in hilly tracts or regions and predominantly tribal dominated areas where communities are dispersed, smaller groups of minimum 5 members are also formed into Self Help Groups (SHGs) .] 3. Compulsory use of Standard Mark. – The goods or article specified in column (2) of the said Schedule shall conform to the corresponding Indian Standard specified in column (3) thereof and shall bear the Standard Mark under a license from the B ureau of Indian Standards in accordance with Scheme – I of Schedule – II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. 4. Certif ying and enforcement authority. – The Bureau of Indian Standards shall be the certifying and enforcing authority in respect of the goods or article specified in column (2) of the said Schedule - A and Schedule - B. 5. Penalty for contravention .– Any person , who contravenes the provisions of this Order , shall be punisha ble in accordance with the provisions of the Bureau of Indian Standards Act, 2016 (11 of 2016). SCHEDULE –A Sl. No. Goods or article Indian Standard (IS) Title of Indian Standard Timeline for implementation (1) (2) (3) (4) (5) 1 Sanitary napkins IS 5405:2019 Sanitary napkins - Specification (second revision) For Small & Micro Enterprises (SME) – 1st October 2024 For Others – 1st April 2024 2 Baby Diaper IS 17509:2021 Disposable baby diaper - Specification 3 Reusable Sanitary Pad Sanitary Napkin Period Panties IS 17514:2021 Reusable sanitary pad/ sanitary napkin/ period panties -Specification SCHEDULE - B Sl. No. Goods or article Indian Standard (IS) Title of Indian Standard Timeline for implementation (1) (2) (3) (4) (5) 1 Shoe covers IS 17349:2020 Medical textiles - Shoe covers - Specification 1st April 2024 2 Dental bib/Napkins IS 17354:2020 Medical textiles - Dental Bib or Napkins - Specification 3 Bedsheet and Pillow Cover IS 17630:2021 Medical Textiles - Bed sheet and pillow cover -Specification Note : For the purposes of the Schedule - A and Schedule - B, it is clarified that the latest version of Indian Standards established and published by the Bureau of Indian Standards from time to time in accordance with the provisions of clause (17) of section 2 of the Bureau of Indian Standards Act, 2016 (11 of 2016), shall apply from the date of such publication. [F. No. 6/1/2021 -R&D(Pt. 4)] RAJEEV SAXENA , Jt. Secy. Uploaded by Dte. of Printing at Government of India Press, Ring R oad, Mayapuri, New Delhi -110064 and Published by the Controller of Publications, Delhi -110054.

Never miss important gazettes

Create a free account to save gazettes, add notes, and get email alerts for keywords you care about.

Sign Up Free