The medical textiles QCO in force in India is the Medical Textiles (Quality Control) Order, 2024 (S.O. 4634(E), Gazette of 23 October 2024). It covers six products. Shoe covers, dental bibs and napkins, and bed sheets and pillow covers have needed the BIS Standard Mark since 1 April 2024. Sanitary napkins, disposable baby diapers and reusable sanitary pads and period panties have needed it since 1 January 2025 for large and medium firms, and since 1 April 2025 for small and micro firms. On 3 October 2026, BIS’s standards portal listed 177 operative licences across the six standards, and none for dental bibs.
This page takes that one order item by item: the Indian Standard behind each product and its current edition, the tests BIS lists for it, the licences BIS shows, how the dates moved, who is exempt, and what a factory in India, a factory abroad and an importer each have to do. Our technical textiles QCO list sets this order beside every other technical-textile order; the products themselves are described in our medical textiles overview.
The short version
- The order. Medical Textiles (Quality Control) Order, 2024, made by the Ministry of Textiles under the BIS Act, 2016. It came into force on publication, 23 October 2024, and replaced the 2023 order.
- Six products in two schedules. Schedule A: sanitary napkins, baby diapers, and reusable sanitary pads, napkins and period panties. Schedule B: shoe covers, dental bibs and napkins, bed sheets and pillow covers.
- Dates. Schedule B from 1 April 2024. Schedule A from 1 January 2025 for large and medium enterprises and 1 April 2025 for small and micro enterprises.
- The obligation. Each product must conform to its Indian Standard and carry the Standard Mark under a BIS licence (Scheme-I of Schedule-II to the BIS (Conformity Assessment) Regulations, 2018).
- Who certifies. The order names BIS and the Textiles Committee of the Ministry of Textiles as the certifying and enforcing authorities. The mark itself comes under a BIS licence.
- Exempt. Goods meant for export, and Schedule A products made by self-help groups. The window for selling declared, unmarked old stock closed on 31 December 2025.
The six products, their standards and their licences
The first three columns are the order’s own. The current edition comes from BIS’s Know Your Standards portal; the order says the latest version of each standard applies from the date BIS publishes it. The last column is the number of operative licences that portal listed under each standard on 3 October 2026.
| Item | Product, as the order names it | IS in the order | Current edition (BIS) | Mark required from | Licences, 3 Oct 2026 |
|---|---|---|---|---|---|
| A1 | Sanitary napkins | IS 5405:2019 | IS 5405:2025, third revision; no amendment | 1 Jan 2025; small and micro firms 1 Apr 2025 | 109 |
| A2 | Baby diaper | IS 17509:2021 | IS 17509:2021, same edition; 3 amendments | 1 Jan 2025; small and micro firms 1 Apr 2025 | 45 |
| A3 | Reusable sanitary pad, sanitary napkin, period panties | IS 17514:2021 | IS 17514:2025, first revision; no amendment | 1 Jan 2025; small and micro firms 1 Apr 2025 | 12 |
| B1 | Shoe covers | IS 17349:2020 | IS 17349:2020, same edition; 1 amendment | 1 Apr 2024 | 8 |
| B2 | Dental bib/napkins | IS 17354:2020 | IS 17354:2020, same edition; 1 amendment | 1 Apr 2024 | 0 |
| B3 | Bed sheet and pillow cover | IS 17630:2021 | IS 17630:2021, same edition; BIS catalogue lists no amendment | 1 Apr 2024 | 3 |
Who holds the licences. Micro and small firms hold 82 of the 109 sanitary-napkin licences; large and medium firms hold 29 of the 45 diaper licences. Gujarat has the most of both, with 25 napkin and 18 diaper licences. Every listed licence is at an Indian address. The portal does not say whether licences under BIS’s scheme for foreign manufacturers appear in these lists, so do not read them as proof that no factory abroad holds one.
Dental bibs. Dental bibs and napkins have needed the mark since 1 April 2024, yet the portal listed no licence under IS 17354 on 3 October 2026. Under section 17 of the BIS Act, 2016, nobody may make, import, distribute, sell, store or display for sale a product covered by such an order without the mark under a valid licence. A buyer offered a marked dental bib should ask for the licence number and look it up.
The 2025 edition of IS 5405 widens the scope. The order names IS 5405:2019, a sanitary-napkin specification. Its third revision, IS 5405:2025, is titled for disposable sanitary napkins, panty liners, maternity pads and period panties, and BIS’s product manual for it sets licence scope across all four types. Column (2) of the order still says “sanitary napkins”. Whether a panty liner or a maternity pad sold on its own now falls under the order is a question to put to BIS in writing; this page does not answer it. Reusable period panties have their own standard, IS 17514, revised in 2025.
How the dates got here
The medical items were first notified in 2023, moved once, and then re-made as a new order. Each row links to the Gazette page it was read from.
| Notification | Dated | What it did |
|---|---|---|
| S.O. 4247(E), the 2023 order | 27 Sep 2023 | Schedule A from 1 Apr 2024, or 1 Oct 2024 for small and micro enterprises; Schedule B from 1 Apr 2024. BIS the only certifying authority |
| S.O. 830(E) | 22 Feb 2024 | Moved Schedule A to 1 Oct 2024 for every firm |
| S.O. 4634(E), the 2024 order | 23 Oct 2024 | Replaced the 2023 order from that day. Schedule A from 1 Jan 2025; Schedule B kept at 1 Apr 2024. Added the Textiles Committee as a certifying and enforcing authority |
| S.O. 04(E) | 1 Jan 2025 (Gazette of 2 Jan 2025) | Schedule A: 1 Jan 2025 for large and medium enterprises, 1 Apr 2025 for small and micro, as the MSMED Act, 2006 defines them. Licensed makers and applicants could declare unmarked stock made or imported before their date and sell it until 30 Jun 2025 |
| S.O. 3526(E) | 30 Jul 2025 | Extended the declared-stock window to 31 Dec 2025, and named importers alongside manufacturers |
BIS’s list of products under compulsory certification (updated 25 September 2026) shows these five notifications and no later one. Reports that give 1 October 2024 for the medical items are quoting the 2023 order (its small-firm date) or S.O. 830(E) (its date for everyone); the 2024 order replaced both. Unlike the 2023 order, the 2024 order has no penalty paragraph of its own; a breach is a breach of section 17 of the Act, punishable under section 29 (BIS’s copy of the Act).
What each standard tests
BIS publishes a product manual for each standard: the sample, the tests, which tests a licensee must be able to run in-house (“R”) and which it may send to a laboratory (“S”), and how often. The table names what each manual lists, with the method it cites. It does not reproduce the standards: the limits and the methods themselves are in the standards, which BIS sells.
| Product manual for | Tests it lists | How often, per the manual |
|---|---|---|
| IS 5405:2025 (July 2025) | Materials of top sheet, core and barrier sheet; type, size, workmanship; pH (IS 1390); ability to withstand pressure after absorption; bacterial and fungal bioburden; Staphylococcus aureus; phthalates (IS 9873 (Part 6)). Optional: biocompatibility (cytotoxicity to IS/ISO 10993-5, irritation to IS 17932 (Part 7), skin sensitisation to IS 17932 (Part 6)), compostability (IS/ISO 17088), antibacterial activity (IS/ISO 20743) | pH and pressure test each control unit; hygiene tests every quarter and on any change of raw material, premises or supplier; phthalates once on the raw material, again on any change of it, and once a year on the product |
| IS 17509:2021 (July 2025) | Materials; fastening and securing; type and size; pH; rate of absorption, rewet under load and minimum absorption capacity; bioburden and S. aureus; phthalates. Optional: biocompatibility, biodegradability and compostability, antibacterial activity (IS/ISO 20743, absorption method) | pH and absorption each control unit; hygiene tests every quarter; phthalates every 3 months |
| IS 17514:2025 (July 2025) | Materials; fastening; sizes; washing, drying and handling instructions; fabric colour fastness to rubbing, perspiration and washing (IS/ISO 105-X12, E04, C06) and dimensional stability to washing; pH; ability to withstand pressure after absorption; bioburden (ISO 11737-1) and S. aureus (IS 5887 (Part 2)); phthalates. Optional: biocompatibility, antibacterial activity | Fabric tests each consignment; pH and pressure test each control unit or lot; hygiene tests every quarter |
| IS 17349:2020 (August 2025) | Microbial cleanliness (IS/ISO 11737-1); tensile strength dry and wet (IS 15891 (Part 3) for nonwovens, IS 1969 (Part 1) for wovens); bursting strength dry and wet (IS 1966 (Part 1)) | Strength tests each control unit; microbial cleanliness monthly |
| IS 17354:2020 (April 2024) | Waterproofness (IS 14944); microbial cleanliness (ISO 11737-1); tensile strength dry and wet (IS 15891 (Part 3)); liquid absorbency time and absorptive capacity (IS 15891 (Part 6)), for disposable bibs only | Each control unit; microbial cleanliness monthly. Disposable and reusable bibs are sampled separately |
| IS 17630:2021 (August 2024) | Tensile, bursting and seam strength, dry and wet (IS 15891 Parts 3 and 18 for nonwovens; IS 1969 (Part 1) and IS/ISO 13935 (Part 1) for wovens; IS 1966 (Part 1)); pH; water-soluble substances (IS 14944); microbial cleanliness; particle release (IS 15891 (Part 10)). For reusable sets, the fabric’s colour fastness (rubbing, perspiration, washing, light), dimensional stability, pilling and scouring loss. Optional: biocompatibility, water-vapour resistance (IS 17376) | Strength and pH each control unit; particle release monthly; microbial cleanliness every quarter; fabric tests each consignment |
The manuals also set out what the factory needs around those tests:
- The laboratory. A large firm keeps an in-house laboratory for the routine (“R”) tests, or uses BIS’s provisions for shared test facilities. For MSMEs the in-house laboratory is optional: a cluster-based test facility, a shared facility, or a laboratory recognised or empanelled by BIS or accredited by NABL to ISO/IEC 17025 will do.
- Subcontracted tests (“S”) go to a BIS-recognised or empanelled laboratory, or one with NABL accreditation, and the reports are kept for BIS to inspect.
- The licence sample. 50 pieces for sanitary napkins, diapers and reusable pads; 20 shoe covers; one pack of at least 20 dental bibs; two packs of bed sheet and pillow cover sets.
- Optional claims such as biocompatibility, compostability, antibacterial activity or water-vapour resistance enter the licence scope only after the sample has been tested for them.
- Marking. Every pack carries the Standard Mark as the licence gives it, and a line telling the buyer where on BIS’s website to check the certification.
Two ways to get the licence in India
BIS’s Guidelines for Grant of Licence, dated 25 February 2026, give an Indian factory two options.
| Option 1 | Option 2 | |
|---|---|---|
| Who tests first | BIS visits the factory and draws samples for a third-party laboratory | The applicant registers on BIS’s system, has its own samples tested by a laboratory BIS runs or recognises, or a government laboratory BIS has empanelled, and applies with the reports |
| Age of test reports | Not applicable | Not more than 90 days old at application; with several reports, the oldest not more than 180 days |
| Factory visit | Yes: assessment and sampling | Yes: assessment and a verification sample |
| Expected time to grant | Within 90 days of the application, if everything passes first time | Within 30 days of the application, on the same condition |
| Open to factories outside India | Yes, and it is their only option | No |
The guidelines’ Annexure II(C), the list of products processed under option 2, includes five of the six standards: IS 5405, IS 17509, IS 17514, IS 17349 and IS 17630. IS 17354, dental bibs, is not on it; ask the BIS branch office which option applies before preparing samples.
The Textiles Committee. The order names it alongside BIS as a certifying and enforcing authority, but paragraph 3 ties the mark to a licence from BIS. On 3 October 2026 the Textiles Committee’s certification page described no scheme under this order, so the route this page could confirm is a BIS licence.
A factory outside India, and the importer
A maker in Bangladesh, Pakistan, Sri Lanka, China or anywhere else outside India applies under BIS’s Foreign Manufacturers Certification Scheme, always under option 1. BIS’s pages set out what it takes:
- Who can apply. The factory must make the product on its own premises, be equipped and staffed to test it to the Indian Standard there, and accept BIS’s scheme of testing and inspection and its marking fee. Each product or standard, and each factory, needs its own application.
- An Authorised Indian Representative (AIR), resident in India and nominated on Form VI of Scheme-I, answers for the licence, and the AIR’s name is endorsed on it. An AIR represents one foreign manufacturer only, except within one group of companies or where a related importer is the AIR.
- The grant. BIS inspects the factory and draws samples for independent testing. After the grant the licensee furnishes a performance bank guarantee of USD 10,000 from a bank with an RBI-approved branch in India. The licence runs for one to two years at first and can be renewed for up to five. BIS gives about six months from a complete application as the usual time to grant.
The importer. Section 17 of the Act bars importing, distributing, selling, storing or displaying for sale any of the six products without the mark under a valid licence, and section 18 makes the distributor or seller responsible for buying marked goods from a licence holder. Before an order is placed, check that the factory’s licence names the standard and edition, covers the variety (type, size and any optional claim) and is operative on BIS’s portal.
Who is exempt
| Exemption | What it covers | Source |
|---|---|---|
| Exports | All six products, when meant for export | Order, paragraph 2 |
| Self-help groups | Schedule A products only. A self-help group is an informal group of 10 to 20 people of similar social and economic background who pool savings and resources for their members; in hilly or tribal areas with dispersed communities, groups of at least five qualify | Order, paragraph 2 and its explanation |
| Declared old stock | Schedule A stock made or imported before the start date and declared to BIS beforehand by a licensed maker or an applicant. Closed on 31 Dec 2025 | S.O. 04(E); S.O. 3526(E) |
| Small and micro firms | No exemption: only a later start, 1 Apr 2025, now passed | S.O. 04(E) |
The self-help group exemption does not reach Schedule B: a group making shoe covers, dental bibs or hospital bed linen needs the mark like anyone else.
What the order does not cover
Several medical textiles have Indian Standards but sit outside this order, and outside BIS’s compulsory list for Scheme-I as updated on 25 September 2026: surgical gowns and drapes (IS 17334:2025, the first revision), surgical face masks (IS 16289), coveralls (IS 17423), nonwoven wipes and wipe fabric (IS 17787 and IS 17788), and adult incontinence diapers (IS 17508). BIS’s licence guidelines list each of these standards, so a maker can still hold a licence for them. Whether any of them is regulated as a medical device is outside this page. For a barrier gown, the gown hydrostatic head calculator compares fabric and seam against the head a buyer requires, and shows which one governs.
Firefighter, heat and high-visibility clothing fall under the Protective Textiles order instead; our protective clothing certification guide sets that order against the EU route.
How this page is kept
Last verified: 3 October 2026. The order, its predecessor and its amendments are read from the Gazette of India, each linked where it is used; the list of notifications from BIS’s compulsory-certification list (updated 25 September 2026); editions, amendments and licence counts from BIS’s Know Your Standards portal on 3 October 2026; the tests from BIS’s product manuals; the licence routes from BIS’s Guidelines for Grant of Licence (25 February 2026) and its foreign manufacturers scheme pages; and sections 17, 18 and 29 from BIS’s copy of the BIS Act, 2016. Licence counts change daily, so check a supplier on the portal itself. This page describes what the instruments say; it is not legal advice for a particular product or shipment. Corrections are welcome through the contact page.
