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Mumbai: The rubber gloves manufacturers have filed official complaints with the Drugs Controller General of India (DCGI) and flagged concerns regarding four major importers of medical gloves that are violently flouting safety norms, mislabelling their products, and evading all rules under the Medical Device Rules, 2017 and the Legal Metrology Act, 2009.
The Indian Rubber Gloves Manufacturers Association (IRGMA) has intensified its fight against prohibited medical gloves which come into India through extensive unlawful import channels.
These violations include importing expired and otherwise mislabelled gloves, repackaging of gloves in unhygienic conditions, as well as conferring inaccurate certification which puts the placing in jeopardy the safety associated with critical medical procedures, including those relating to radiation and chemotherapy.
"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,” IRGMA spokesperson Vikas Anand said in a press statement.
According to him, 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 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 per cent 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 statement reads.
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.