The Indian Rubber Gloves Manufacturers Association (IRGMA) has raised alarm over the large-scale import of substandard medical gloves that violate essential safety and regulatory norms and sought urgent action against the violators.
In a formal complaint to the Drugs Controller General of India (DCGI), IRGMA has named four major importers accused of mislabelling, repackaging expired gloves in unhygienic conditions, and falsely certifying products, posing severe risks to healthcare professionals and patients.
The association has demanded immediate regulatory action, including blacklisting of these importers, heavy fines, and an outright ban on unsafe gloves that fail to meet the Medical Device Rules, 2017 (MDR 2017) and the Legal Metrology Act, 2009.
Vikas Anand, spokesperson for IRGMA said, “These unsafe medical gloves are being allowed into the Indian market due to complete lack of enforcement. IRGMA has provided indisputable proof of these violations to the relevant authorities and demands immediate action. If left unchecked, the sale of substandard gloves will continue to endanger lives while simultaneously crippling compliant domestic manufacturers who adhere to stringent quality norms.”
We urge the Government, healthcare institutions, and the policymakers to take immediate remedial action in response to these violations, he added as per a statement issued by the Association here.
The IRGMA findings have revealed that expired gloves are being repackaged in unhygienic conditions, exposing users to significant health risks. “Many imported gloves contain 18-20 hazardous chemicals, making them unsuitable for chemotherapy and radiation therapy. Companies are falsely leveraging CE and ISO 13485 certifications to mislead buyers on product quality. Importers are engaging in large-scale tax evasion by under-invoicing shipments and misrepresenting import values, causing substantial revenue losses to the government,” said the statement.
Bulk shipments of medical gloves are transported in non-sterile sugar bags, violating essential hygiene and import regulations. Foreign suppliers are exploiting loopholes in the ASEAN Free Trade Agreement (FTA) to flood India with rejected, low-quality gloves, severely impacting MSMEs in the organized sector, it alleged.
According to IRGMA data, substandard exports valued between Rs 1 million and Rs 6.6 million originating from Malaysia and the USA persist to enter Indian markets while evading essential regulatory conventions.
Such importers have consistently failed to adhere to packaging regulations, display of MRP and country-of-origin, resulting in severe revenue losses under GST through measures of under-invoicing and tax evasion. Furthermore, the loophole of 0% import duty under the ASEAN FTA has resulted in noncompliance to virtually flood the Indian market with rejected gloves, which unequivocally harms the MSMEs upholding stringent quality requirements in India, said the statement.
The IRGMA has demanded prompt regulatory intervention to ensure compliance under MDR 2017 along with the CDSCO Gazette Notification.
The Association has also demanded strict actions through blacklisting and heavy fines for non-compliant companies that participate in illegal trading activities together with an instant ban on substandard medical gloves used in healthcare facilities.
Additionally, it has also stressed on the need for mandatory declarations of MRP, country of origin, and certification details to enhance transparency and consumer safety.
To protect the organized sector from unfair competition, the Association insists on closing the FTA loophole that allows rejected gloves to flood the Indian market, said the Association.
