Bharat Set to Crack Down on Illegal Import of Banned Medical Gloves as IRGMA Exposes Massive Import Scam

Government’s Quality Control Order (QCO) to Make BIS Certification Mandatory; Unscrupulous Importers Stockpiling & Repackaging Non-Medical Gloves to Bypass Regulations

Mumbai, National, March 6, 2025 – In a significant move to safeguard India’s healthcare ecosystem and domestic manufacturing industry, the Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilizers, has submitted the Medical and Surgical Gloves (Quality Control) Order, 2024 (QCO) to the World Trade Organization (WTO). Once enforced, the QCO will mandate BIS certification for all medical and surgical gloves, bringing much-needed quality assurance and regulatory oversight to a market that has been flooded with substandard and illegally imported gloves from Malaysia, Thailand, Vietnam, and China.

The announcement comes at a critical juncture, as the Indian Rubber Gloves Manufacturers Association (IRGMA) has uncovered a massive import scam where unscrupulous importers are stockpiling low-quality non-medical gloves before the QCO takes effect, repackaging them as medical gloves, and dumping them into hospitals and clinics. This dangerous practice is compromising patient safety, undermining India’s Make in India initiative and destabilizing the domestic industry.

Stockpiling Before QCO & China’s Trade Dumping Tactics

• Exploitative Import Practices: Importers are hoarding bulk shipments of non-medical gloves in anticipation of the QCO implementation, with plans to repackage and mislabel them as medical gloves once stricter BIS certification becomes mandatory.
• Dumping via Malaysia & Thailand: With U.S. tariffs restricting Chinese glove exports, Chinese manufacturers are funneling excess stock through Malaysia and Thailand, where gloves are repacked and sent to India at artificially low prices. These re-routed shipments evade regulatory scrutiny, allowing poor-quality gloves to enter India’s healthcare supply chain.
• Severe Patient & Healthcare Worker Risks: These substandard gloves fail essential AQL (Acceptable Quality Level) safety tests, leading to higher infection risks, contamination, and compromised hygiene in hospitals.
• Unfair Market Manipulation: While Indian manufacturers adhere to strict BIS and QCO standards, these illegally imported gloves are being sold at artificially low prices, pushing domestic manufacturers out of competition and threatening India’s self-reliance in medical manufacturing.

QCO: A Game Changer for India’s Healthcare & Manufacturing Sector

The QCO for gloves is expected to regulate ₹600-700 crore worth of annual glove imports, ensuring that only BIS-certified gloves—whether imported or manufactured domestically—can be sold for medical use in India. The order applies to disposable surgical gloves, single-use medical examination gloves, and post-mortem rubber gloves, preventing bulk imports of substandard gloves and ensuring only ISI-marked gloves are permitted for hospital use.

This is a much-needed intervention, given that over 70% of imported gloves currently fail BIS standards. Despite multiple CDSCO notifications and regulatory warnings, gloves rejected by the U.S. and other developed nations are still making their way into India, bypassing quality checks.

Commenting on the QCO implementation, Konda Anindith Reddy, Managing Director of Enliva – Wadi Surgicals, stated: “This Quality Control Order is crucial in protecting India’s healthcare workers and patients. Substandard gloves increase the risk of cross-contamination, endangering lives. Healthcare providers must proactively demand BIS-certified gloves, and regulatory agencies must ensure that illegal imports are curbed immediately.”

IRGMA Demands Immediate Government Crackdown

While the QCO is a strong step forward, IRGMA has called on multiple ministries to take urgent action to prevent stockpiling and illegal import practices before the new regulations take effect.

Ministry of Health & Family Welfare (MoHFW) & CDSCO

• Expand the definition of “medical gloves” to ensure all gloves intended for healthcare use fall under strict certification guidelines.
• Enforce mandatory hospital audits to prevent substandard gloves from being repackaged and supplied to healthcare facilities.
• Ministry of Commerce & Industry (DGFT & Customs)
• Ban misclassification of gloves as “non-medical” to evade BIS certification.
• Implement traceability checks to ensure gloves imported under non-medical categories are not repackaged and sold to hospitals.
• Enforce country-of-origin verification to prevent Chinese gloves from being rerouted through Malaysia & Thailand.
• Ministry of Consumer Affairs & BIS
• Extend BIS certification requirements to all disposable gloves, making it illegal to import, sell, or rebrand non-certified gloves for medical use.
• Conduct surprise inspections and impose penalties on companies stockpiling gloves for later repackaging.
• Ministry of Finance (Customs & GST)
• Increase port surveillance, conduct random quality tests, and seize non-compliant glove shipments.
• Impose higher import duties on non-certified gloves to prevent dumping practices.

IRGMA Warns of Public Health Disaster If No Action Is Taken

Mr. Vikas Anand, Spokesperson of IRGMA, issued a stark warning: “We are witnessing an orchestrated effort to flood India’s market with substandard gloves before the QCO kicks in. These gloves, falsely classified as non-medical at import, are being repackaged and sent to hospitals. Patients and doctors are unknowingly exposed to serious risks. To make matters worse, China’s excess glove stock is being funneled through Malaysia and Thailand, destabilizing Indian manufacturers and public health. We demand immediate government intervention before this turns into a full-blown national crisis.”

IRGMA Pledges to Support Government Efforts

With India now taking decisive steps towards quality control and domestic self-reliance, IRGMA is fully committed to working with authorities to clean up the supply chain, enforce BIS standards, and ensure that only high-quality, certified gloves are used in India’s healthcare system.