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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.
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.
Vikas Anand, spokesperson for IRGMA said, “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 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
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
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.
