BIS Draft Quality Control Order 2025: Ensuring Safety in Medical and Surgical Gloves

In recent years, the healthcare industry has witnessed increasing growth, particularly in the use of medical and surgical gloves. Gloves have become an essential product of rigorous use as they work as a protective barrier for both healthcare professionals as well as patients. Ensuring the quality and safety of these gloves is not just a regulatory requirement but an essential step in safeguarding public health. This is why the BIS QCO draft for Medical & Surgical Gloves has been introduced, marking a new milestone for product quality in India. Let us explore what the new BIS QCO draft for Medical and surgical gloves includes, and know how Brand Liaison is guiding businesses at every step of their compliance journey. 

The Importance of Medical and Surgical Gloves

Medical and surgical gloves usually act as the first line of defense against contamination, infections, and the risk of cross-transmission of diseases. Healthcare workers rely heavily on these gloves to perform routine examinations, surgeries, and various other important procedures in a safe manner. Any compromise in the quality of gloves could expose both patients and practitioners to health risks. Hence, the manufacturing and distribution of these gloves must definitely follow the strict market standards, such as gaining a BIS Certification.

Why BIS Certification Matters

The BIS Certification is a mandatory requirement for certain products like medical and surgical gloves, in order to make sure that these products, in addition to being compliant with the BIS standards, are also safe and reliable for long-term use. The Bureau of Indian Standards (BIS) is India’s national standard-setting body and is tasked with ensuring that products meet consistent safety and quality benchmarks. Here is why BIS certification for medical and surgical gloves matters:

1. BIS certification and the ISI mark for gloves are indeed symbols of trust, indicating that a product complies with Indian Standards and can be relied upon for long-term use.
2. Opting for BIS certification medical gloves and BIS certification surgical gloves provides assurance that the products are safe, reliable, and effective for medical use.
3. Certification is not just a regulatory tick box; in fact, it builds consumer trust, reassures hospitals and clinics, and helps manufacturers adopt improved materials and processes in order to meet global standards.
4. It also minimizes the risk of defective products from entering the market and being accessed by consumers.

QCO Draft Regarding Medical and Surgical Gloves

The Ministry of Chemicals and Fertilizers has recently issued the BIS QCO draft for Surgical and Medical Gloves 2025. As per this draft, all domestically sold gloves must follow certain regulations in order to be compliant and eligible for the Indian economy:

1. These gloves must carry an ISI mark under a BIS license for surgical glove manufacturers.
2. These should also comply with Indian Standards as mentioned below:
   1. IS 13422:2024 for Disposable surgical rubber gloves
   2. IS 15354 (Part 1):2023/ISO 11193-1:2020 for Single-use medical examination gloves
   3. IS 4149:1967 for Specification for post-mortem rubber gloves
3. It’s important to note that this draft excludes goods produced for export purposes.
4. BIS will act as the enforcing authority, and non-compliance with the regulations of this Quality Control Order can result in penalties under the BIS Act.

The implementation of this QCO ensures higher quality, safer gloves, increased consumer confidence, and reduced circulation of substandard products. It also opens opportunities for testing, certification, as well as smooth and unhindered compliance for BIS gloves certification in order to support manufacturers in meeting these standards.

Read the complete BIS QCO (Draft) 2025 for Medical and Surgical Gloves.

What This BIS QCO Brings to the Industry

The proposed BIS QCO draft for Medical & Surgical Gloves is not just a regulatory step but a move to uplift the entire glove manufacturing ecosystem in India. Here’s why it holds so much significance:

• Higher Quality Assurance: It ensures that only those gloves that meet strict BIS standards reach hospitals and clinics.
• Boost in Consumer Trust: Patients and healthcare providers gain confidence in purchasing and using certified products.
• Competitive Advantage: Manufacturers with BIS certification stand out in both domestic as well as international markets.
• Improved Manufacturing Practices: The BIS Certification encourages investment in better raw materials and advanced processes.
• Reduced Market Defects: This also minimizes the risks of substandard or unsafe products being circulated in the Indian market.
• Export Readiness: Complying with Indian and international standards helps businesses access the many emerging global opportunities.

This QCO, therefore, acts as a win-win, protecting public health while also raising the bar for industry practices and creating new growth avenues for businesses dealing with such products and aiming to enter the competitive Indian economy.

Brand Liaison’s Scope of Work

Navigating BIS certification and QCO compliance may often seem a bit complex for manufacturers, importers, and distributors. However, this is where Brand Liaison, a trusted BIS certificate consultant, steps in to make the process quite simple and efficient. With over a decade of experience, we provide end-to-end support to ensure that your products meet regulatory requirements without having to face any delays or hassle.

• Technical Assistance

  Brand Liaison guides businesses in understanding BIS norms, QCO, and technical documentation requirements, and the various applicable Indian Standards for their respective products.

• Comprehensive Guidance

  From initial planning to final certification, Brand Liaison offers step-by-step guidance to keep you informed at every stage, so compliance for BIS gloves certification is straightforward and absolutely transparent.

• Paperwork and Quality Checks

  Our team handles documentation, labeling requirements, and pre-audit quality inspections in order to streamline the entire process.

• Factory Audit Support

  We assist with factory audits, ensuring your manufacturing processes comply with BIS standards. Our experts identify gaps and suggest improvements, thereby reducing the chances of non-compliance.

• Experience in the Industry

  With more than 10 years of experience in compliance management, Brand Liaison has helped 500+ businesses achieve hassle-free certification. Our expertise goes beyond BIS, WPC, BEE, TEC, EPR, LMPC, and various other product certifications and compliance requirements for the Indian market.

• Complete Support for Worry-Free Compliance

  From technical support to final certification, Brand Liaison ensures that your journey toward BIS certification and QCO compliance is absolutely smooth, efficient, and worry-free. 

Conclusion

The BIS QCO for Surgical and Medical Gloves 2025 is definitely a significant step toward ensuring safer healthcare products in India. Compliance with BIS standards protects patients, builds trust, and also encourages manufacturers to maintain high-quality production processes. With the expert guidance of Brand Liaison, navigating this regulatory landscape becomes quite simple, reliable, as well as stress-free.

By partnering with a trusted BIS certificate consultant, businesses can easily focus on innovation and growth while ensuring that every glove reaching the market is safe, certified, and of the highest quality. Still unsure where to begin? Get in touch with our team of professional consultants today and start your BIS compliance journey without any further delays.