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The Indian Rubber Gloves Manufacturers Association (IRGMA) has called for stronger regulatory oversight, improved traceability and stricter procurement standards for medical gloves following concerns over the supply, import and sterilization of surgical gloves. The association has urged the government to restrict bulk imports, strengthen compliance with the Medical Devices Rules, 2017, and ensure that quality and traceability receive due weight alongside price in public procurement.
The issue has gained attention following a Maharashtra Food and Drug Administration (FDA) investigation into surgical gloves supplied to government hospitals by a manufacturer in Palghar. The regulator reportedly found that gloves labelled as sterile had allegedly not undergone the mandatory sterilization process and seized stock valued at more than Rs. 2 crore. The case has raised concerns about safeguards across the medical device supply chain, particularly for products used directly during invasive procedures.
IRGMA said the Maharashtra case, while involving one manufacturer, highlights wider vulnerabilities in the medical glove supply chain. The association has proposed that medical gloves imported into India should not be permitted in loose bulk quantities for subsequent repackaging. Instead, imports should be allowed in their original, properly labelled dispenser boxes to preserve product identity, traceability and accountability from the manufacturer to the end user.
According to IRGMA, every dispenser box should permanently display the original manufacturer's details, country of origin, product description, batch or lot information, applicable standards and a clear declaration stating whether the gloves are intended for “Medical” or “Non-Medical/Industrial” use. The association said such labelling would make it easier for regulators, hospitals and other buyers to establish the identity and responsibility of the manufacturer throughout the supply chain.
IRGMA has also called for stricter enforcement of the Medical Devices Rules, 2017, including verification that imported medical gloves meet applicable Bureau of Indian Standards (BIS) specifications before entering the Indian market. It has sought mandatory declarations by manufacturers and importers concerning the intended use of gloves and compulsory display of details of an ISO 13485-certified manufacturer on every dispenser box.
The association has further recommended a gradual phase-out of powdered gloves in line with international clinical practices. It said regulatory requirements should cover not only manufacturing quality but also packaging, labelling, import documentation, distribution and procurement so that the identity and intended use of medical gloves are maintained throughout the supply chain.
The Central Drugs Standard Control Organisation (CDSCO) has also directed stakeholders towards closer scrutiny of imported medical gloves, particularly consignments arriving in bulk for repackaging in India. The compliance approach includes verification of labelling, Quality Management System (QMS) requirements, applicable BIS standards and other relevant documentation, along with sampling and testing wherever required.
IRGMA said the requirement for proper labelling should be implemented in the context of importing gloves in their original labelled dispenser boxes rather than loose quantities or gunny bags that are subsequently repackaged. The association said this approach is consistent with established international supply-chain practices and could reduce the possibility of non-medical or industrial gloves being diverted for use in hospitals as medical examination gloves.
The association has also raised concerns over procurement practices in government hospitals, where millions of medical gloves are purchased every year through competitive tenders. IRGMA said procurement decisions based predominantly on the lowest price can create risks when quality, compliance and traceability are not given adequate consideration.
“Quality, traceability and compliance with Indian standards must carry equal weight with price in procurement decisions, particularly for products that directly impact patient safety,” IRGMA said.
The distinction between examination and surgical gloves is also central to the issue. While examination gloves are commonly used for routine patient care and may be supplied as non-sterile products, surgical gloves are higher-risk medical devices that come into contact with sterile body tissues during invasive procedures. They therefore require validated sterilization and controlled manufacturing and packaging processes before being supplied for use in operating theatres.
IRGMA has expressed concern that bulk imports followed by local repackaging can make it difficult to establish the original manufacturer, batch details and compliance status of gloves. The association has also alleged that lower-grade gloves rejected in some export markets could potentially enter India through such practices, although these allegations have not been confirmed by CDSCO.
The association said stronger controls are required across the entire supply chain, from manufacturing and sterilization to packaging, import clearance, transportation, procurement and hospital use. It believes that ensuring traceability at each stage would help regulators identify non-compliant products more quickly and enable hospitals to establish the source and quality status of gloves before use.
The Maharashtra FDA investigation and the subsequent regulatory focus on imported gloves have therefore brought medical glove quality and traceability into sharper focus. IRGMA said restoring confidence in the supply chain will require consistent enforcement of medical device regulations, original manufacturer identification, compliance with Indian standards and procurement policies that assess quality and patient-safety requirements alongside cost.
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