Medical Textiles (Quality Control) Order, 2023

The Ministry of Textiles, on September 27, 2023, introduced the “Medical Textiles (Quality Control) Order, 2023,” empowered by the Bureau of Indian Standards Act, 2016. This order aims to regulate and uphold the quality standards for various medical textile products. In this comprehensive article, we provide a detailed analysis of this order, its significance, and the regulatory framework it establishes.

Short Title and Commencement: Officially named the “Medical Textiles (Quality Control) Order, 2023.” Effective commencement dates are item-specific and mentioned in column (5) of Schedule – A and Schedule – B, immediately after publication in the Official Gazette.

Application: This order is applicable to goods or articles listed in column (2) of Schedules – A and B. It does not extend to goods or articles meant for export. Additionally, products specified in Schedule A that are manufactured by Self Help Groups (SHGs) are exempted. SHGs are defined as small informal groups voluntarily formed for a common cause, often consisting of 10 to 20 individuals.

Compulsory Use of Standard Mark: Products listed in column (2) of Schedules – A and B must conform to the respective Indian Standard mentioned in column (3). Manufacturers must obtain a license from the Bureau of Indian Standards (BIS) and display the Standard Mark, adhering to Scheme – I of Schedule – II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.

Certifying and Enforcement Authority: The Bureau of Indian Standards (BIS) is designated as the certifying and enforcing authority for goods or articles specified in column (2) of Schedules – A and B.

Penalty for Contravention: The order imposes penalties for contravention. Individuals or entities found violating its provisions will be subject to punishment in accordance with the provisions of the Bureau of Indian Standards Act, 2016.

Schedule – A: Lists medical textile products such as sanitary napkins, baby diapers, and reusable sanitary pads, along with their respective Indian Standards and implementation timelines. Implementation timelines vary for Small & Micro Enterprises (SMEs) and others.

Schedule – B: Encompasses medical textile products like shoe covers, dental bibs or napkins, bedsheets, and pillow covers, specifying the corresponding Indian Standards and implementation timelines.

Application of Latest Standards: The order clarifies that the most recent versions of Indian Standards established and published by the Bureau of Indian Standards will apply from the date of publication.

Conclusion: The introduction of the Medical Textiles (Quality Control) Order, 2023, by the Ministry of Textiles represents a significant step toward ensuring the quality, safety, and conformity of various medical textile products in India. By enforcing compliance with Indian Standards and the display of the Standard Mark, this order safeguards the interests of consumers and promotes reliability in the healthcare textile industry. The provision for exemption of products manufactured by Self Help Groups (SHGs) reflects a balanced approach to regulatory compliance. The Bureau of Indian Standards (BIS) takes on the pivotal role of certifying and enforcing these quality standards, contributing to enhanced product quality and safety. Overall, this order reinforces the importance of stringent quality control measures in the medical textile sector, benefiting both manufacturers and consumers.

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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 Or-der, 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 apply to goods or articles specified in column (2) of the said Schedules, but shall not apply to such goods or article meant for export and items specified in Schedule A to this order that are manufactured by Self Help Groups (SHGs).

[Explanation. — For The 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 sav-ings habit among members and for a common cause to raise and manage resources for the benefit of group members. 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 Bureau of Indian Standards in accordance with Scheme – I of Schedule – II to the Bureau of Indian Standards (Conformity Assess-ment) Regulations, 2018.

4. Certifying 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 punishable in accordance with the provisions of the Bureau of Indian Standards Act, 2016 (11 of 2016).

SCHEDULE–A

SCHEDULE – B

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.