IRGMA calls for nationwide crackdown as imported medical gloves violate every safety norm in the book

~ Demands prompt regulatory intervention & strict consequences through blacklisting and heavy fines for four major non-compliant importers ~

Mumbai / National, 21st February 2025: The Indian Rubber Gloves Manufacturers Association (IRGMA) has intensified its continuous fight against prohibited medical gloves which come into India through extensive unlawful import channels and distribution activity. The unsafe practices endanger healthcare providers as well as patients and their caregivers while making it impossible for the sector to operate in a fair, regulated market environment. In a complaint to the Drugs Controller General of India (DCGI), IRGMA has cited four major importers of medical gloves that are violently flouting safety norms, mislabelling their products, and evading all norms under the Medical Device Rules, 2017 and the Legal Metrology Act, 2009. These violations include 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.

Mr. 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 call upon all stakeholders – the Government, healthcare institutions, and the policymakers to take immediate remedial action in response to these violations.”

IRGMA’s findings have revealed a disturbing pattern of malpractice, raising serious concerns about the integrity of India’s medical supply chain:

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
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

The widespread import of inferior quality gloves has caused two major problems that harm both public health security and local glove manufacturing stability. 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.

The IRGMA has demanded prompt regulatory intervention to ensure compliance under MDR 2017 along with the CDSCO Gazette Notification. The organization 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 healthcare facilities. Additionally, IRGMA stresses 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.

IRGMA remains committed to ensuring that only high-quality, safe medical gloves are available in the Indian marketplace. The Association continues to work closely with regulatory authorities, relentlessly monitoring violations, and advocating for stricter enforcement to protect both healthcare workers and the integrity of India’s medical device industry.