Medical and Surgical Gloves (Quality Control) Order, 2024: Ensuring Compliance and Quality Standards

Introduction

The medical and surgical gloves industry is critical for healthcare, ensuring safety and hygiene for medical professionals and patients. Recognizing the need for stringent quality control, the Government of India has introduced the Medical and Surgical Gloves (Quality Control) Order, 2024, under the Bureau of Indian Standards (BIS) Act, 2016. This order mandates compliance with specific Indian Standards to enhance quality and reliability.

Companies like Omega QMS Pvt Ltd play a significant role in ensuring compliance with these standards, helping manufacturers obtain BIS certification and adhere to the required quality norms.

Overview of the Quality Control Order (QCO), 2024

The Medical and Surgical Gloves (Quality Control) Order, 2024 is aimed at enforcing mandatory quality standards for medical and surgical gloves. The key highlights of this order include:

Mandatory BIS Certification:
- All medical and surgical gloves must conform to relevant Indian Standards (IS)and bear the Standard Mark under a BIS license.
Applicable Standards:
- IS 13422:1992– Disposable Surgical Rubber Gloves.
- IS 15354 (Part 1): 2023 / ISO 11193-1:2020– Single-use medical examination gloves (rubber latex or rubber solution).
- IS 4149:1967– Post-mortem rubber gloves.
Enforcement Authority:
- The Bureau of Indian Standards (BIS)is responsible for enforcing compliance and issuing licenses.
Applicability:
- The order applies to all medical and surgical gloves sold in India, except those meant for export.

By making compliance with BIS certification compulsory, the government aims to eliminate substandard products, ensuring that only safe and high-quality gloves are available in the market.

Role of Omega QMS Pvt Ltd in Ensuring Compliance

As a quality management and compliance consultancy, Omega QMS Pvt Ltd assists manufacturers in navigating the complex process of BIS certification and maintaining regulatory compliance. Their role includes:

BIS Certification Assistance

Helping manufacturers understand the specific IS standards applicable to their gloves.
Preparing and submitting the BIS license application.
Coordinating with BIS officials for audits and inspections.

Facilitating BIS Licenses for Domestic and Foreign Manufacturers

For Domestic Industry:
- Assisting Indian manufacturers in applying under the BIS Grant of Licence (GoL) Scheme-I, ensuring manufacturing infrastructure, production processes, quality control, and testing capabilities meet BIS regulations.
- Conducting pre-certification audits to identify and rectify non-conformities before the official BIS inspection.
- Coordinating factory inspections as per BIS guidelines to verify testing infrastructure and conformity to standards.
For Foreign Manufacturers:
- Assisting international glove manufacturers in obtaining a BIS Foreign Manufacturers Certification Scheme (FMCS) license, which is processed exclusively under Option-1 of the BIS Grant of Licence process.
- Handling documentation, sample testing, and factory audits to ensure compliance with Indian standards.
- Coordinating with BIS-approved third-party laboratories for product testing and quality assurance.
- Managing factory visits by BIS officials, which are typically longer for foreign manufacturers (two days instead of one).

Product Testing and Compliance Audits

Assisting manufacturers in conducting mandatory product testing at BIS-approved laboratories.
Addressing compliance gaps through corrective measures.
Providing guidance on continuous quality improvement.

Regulatory Updates and Training

Keeping manufacturers updated with amendments in BIS standards.
Conducting training programs for staff to maintain regulatory awareness.

Conclusion

The Medical and Surgical Gloves (Quality Control) Order, 2024 is a crucial step towards improving product safety and standardization in the healthcare sector. With BIS certification now mandatory, manufacturers—both domestic and foreign—must adhere to strict quality control measures.

Omega QMS Pvt Ltd plays a pivotal role in this transition by guiding manufacturers through BIS certification, product testing, and regulatory compliance. Whether assisting Indian manufacturers in obtaining a BIS license or facilitating foreign manufacturers in securing a BIS FMCS certification, Omega QMS ensures that businesses meet the regulatory requirements efficiently.

By leveraging their expertise, glove manufacturers can ensure compliance, enhance product quality, and maintain market credibility. This proactive approach will not only protect consumers but also strengthen India’s position as a global supplier of high-quality medical and surgical gloves.