Draft BIS QCO 2025 for Medical & Surgical Gloves

Introduction to the BIS QCO Regarding Medical and Surgical Gloves

The Ministry of Chemicals and Fertilizers, Government of India, through the Department of Pharmaceuticals, has issued a Draft Quality Control Order (QCO) for Medical and Surgical Gloves in the public interest. The draft order has been issued under section 16 read with section 17 and sub-section (3) of section 25 of the Bureau of Indian Standards Act, 2016, after consultation with the Bureau of Indian Standards (BIS), to ensure quality, safety, and standardization of medical gloves used in healthcare settings across India.

The order is titled the Medical and Surgical Gloves (Quality Control) Order, 2024, and applies to manufacturers and importers supplying these products in the Indian market.

Key Changes of the QCO You Should Know

1. Under this Draft QCO,
   1. The specified goods must conform to the Indian Standards notified by the Bureau of Indian Standards.
   2. Products must bear the BIS Standard Mark (ISI Mark) under a license from BIS in accordance with Scheme-1 of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018.
2. Products Covered under this QCO:
   1. Disposable Surgical Rubber Gloves (IS 13422:2024).
   2. Single-use Medical Examination Gloves 
      (IS 15354 (Part 1): 2023 / ISO 11193-1: 2020 – Specification for gloves made from rubber latex or rubber solution).
   3. Post-mortem Rubber Gloves (IS 4149: 1967).

Exemptions to this QCO:

• Goods and articles manufactured domestically for export are exempt from this order.

What is the Date of Implementation?

The Medical and Surgical Gloves (Quality Control) Order, 2024 (Draft) shall come into force from a date to be notified in the Official Gazette after finalisation of the order.

What does this Order bring for all?

• BIS certification and ISI mark ensure high-quality standards, eventually boosting consumer trust.
• Hospitals, clinics, and healthcare providers gain assurance of product safety, thereby being able to contribute to the increasing demand for certified gloves.
• Businesses may invest in better materials and manufacturing processes in order to meet BIS norms.
• Compliance with strict standards minimizes defective products from reaching the market.
• Increased demand for testing, certification, and consultancy will open up new business avenues.

Now, What to Do?

Manufacturers and importers of Medical and Surgical Gloves should:

• Verify whether their products fall under the scope of this Draft QCO
• Identify the applicable Indian Standards
• Prepare for BIS certification under Scheme-1
• Invest in better testing, quality control, and manufacturing processes to meet BIS requirements
• Monitor the final notification and implementation timeline

Timely preparedness will help businesses avoid disruptions, penalties, and delays once the QCO is formally enforced.

Brand Liaison provides end-to-end compliance support for Medical and Surgical Gloves manufacturers and importers, including BIS certification assistance, documentation support, standard applicability analysis, and regulatory liaison. With over a decade of expertise in BIS compliance, Brand Liaison ensures smooth certification, timely readiness, and uninterrupted market access in India.