NEWS
Medical Textiles (Quality Control) Amendment Order, 2025
A Comprehensive Overview
With the healthcare sector expanding rapidly and the demand for high-quality medical supplies becoming increasingly critical, the Government of India has taken an important step to ensure safety, standardization, and quality control of medical textiles.
Through the Medical Textiles (Quality Control) Amendment Order, 2025, issued by the Ministry of Textiles, the government has introduced key changes to the original Medical Textiles (Quality Control) Order, 2024.
This amendment aligns with India’s commitment to strengthening its healthcare infrastructure and enhancing the quality of products used by healthcare professionals and patients alike.
Key Highlights
The 2025 amendment brings several significant updates:
– Introduction of Provisional Sales Permission up to 30th June, 2025.
– Revised Implementation Timelines for different enterprise categories.
– Continued Emphasis on BIS Certification.
– Public Safety Priority through stricter quality norms.
Products Covered
The Order covers a wide range of medical textile products including:
– Surgical gowns
– Surgical drapes
– Face masks
– Medical gloves
– Wound care dressings
– Sanitary materials
– Other specialized healthcare textile products
All products listed in Schedule A must comply with Indian Standards and bear the BIS Standard Mark.
Exemptions Provided
Recognizing industry needs, the following exemptions have been granted:
– Sale of Pre-Amendment Stock permitted till 30th June, 2025.
– Extended Compliance Timelines for Small and Micro Enterprises.
These exemptions allow smooth transition while maintaining strict quality compliance.
Timeline for Implementation
Type of Enterprise | Date of Mandatory Implementation
— | —
Large and Medium Enterprises | 1st January, 2025
Small and Micro Enterprises | 1st April, 2025
Next Steps for Manufacturers & Importers
Recommended actions include:
1. Assess Existing Stock and declare it to BIS.
2. Apply for BIS Certification urgently.
3. Update Manufacturing Processes and Labeling.
4. Educate Supply Chain and Retail Partners.
5. Maintain Proper Documentation for compliance and audits.
Conclusion
The Medical Textiles (Quality Control) Amendment Order, 2025, is a significant step towards ensuring superior healthcare product standards in India.
Manufacturers and importers must act promptly to align with these regulatory requirements, thereby enhancing their market credibility and contributing to India’s healthcare excellence.