Importer of medical gloves violating safety norms under Medical Device Rules: Indian Rubber Gloves Manufacturers Association

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Indian Rubber Gloves Manufacturers Association (IRGMA) has filed official complaints with Drugs Controller General of India (DCGI) stating that there is proof that some major importers of medical gloves are violently flouting safety norms, mislabelling their products, and evading all norms under the Medical Device Rules, 2017.

“We have now intensified our fight against prohibited medical gloves which come into India through extensive unlawful import channels and distribution activity. The unsafe practices endanger health-care providers as well as patients and their caregivers while making it impossible for the sector to operate in a fair, regulated market environment,’’ the Association has said.

These violations listed by the Association in their letter to DCGI includes — importing expired and otherwise mislabelled gloves, repackaging of gloves in unhygienic conditions, as well as conferring inaccurate certification, placing in jeopardy the safety associated with critical medical procedures, including those relating to radiation and chemotherapy.

Speaking about the issue Vikas Anand, spokesperson for IRGMA said that these unsafe medical gloves are being allowed into the Indian market owing 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 call upon all stakeholders — the Government, health-care institutions, and the policymakers to take immediate remedial action in response to these violations,” said Mr. Anand.

The Association in its communication said IRGMA’s findings have revealed a disturbing pattern of malpractice, raising serious concerns about the integrity of India’s medical supply chain.

According to IRGMA data, substandard exports valued between ₹1 million and ₹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 Association. 

The IRGMA has demanded prompt regulatory intervention to ensure compliance under MDR 2017 along with the CDSCO Gazette Notification. The organisation demands strict consequences 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 health-care facilities. Additionally, IRGMA stresses the need for mandatory declarations of MRP, country of origin, and certification details to enhance transparency and consumer safety.