Concerns over the import of sub-standard examination gloves, some that are close or have passed their expiry date, for example, have been raised by representatives of the local industry with the drug regulatory authority.
Companies are importing non-BIS compliant gloves and selling them in the country without proper labelling, price declarations, or adherence to consumer protection norms, alleged Manmohan Singh, General Secretary of Indian Rubber Gloves Manufacturers Association (IRGMA). These are violations of rules including the Medical Device Rules (MDR) 2017, he said.
The IRGMA has called for action against such practices, as mis-labelled and poor-quality examination gloves pose a threat to healthcare workers and patients, Singh told businessline, adding that they have raised this concern with several Government authorities including the Drugs Controller General of India (DCGI).
Gloves manufactured three years ago, with an expiry date of 01/2025 were imported into India, on 12/2024, says an IRGMA letter to the regulatory authority. “As per the Notification of CDSCO Rule 31 the medical products cannot be imported and custom cleared if they have a residual shelf life of less than 60 per cent ,” the letter pointed out. The complaint letters also raised the issue of gloves that claim to be “Chemotherapy Drug Resistant”, and urged the drug regulator to verify the certification and authenticity of the product.
The domestic gloves industry, an estimated ₹1000 crore segment, has been in existence for about 40 years, and comprises 45 companies, according to industry estimates. A query on the issue was sent to the drug regulatory authority by businessline, and a response is awaited.
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Post-Covid surge
The surge of sub-standard gloves has been post-Covid, Singh said, alleging they come from Malaysia, Pakistan, Bangladesh and Nepal. Recognising the problem, the Centre had imposed a ban on these imports and mandated Bureau of Indian Standards (BIS) certification for all surgical and examination gloves, whether domestically manufactured or imported, a note from IRGMA said.
The sub-standard imports do not just hurt the local industry that has invested in producing examination gloves, but also causes a revenue loss to the country, points out Singh. Giving the price differential, he said, an A-grade non-rejected glove costs about $18-$20 for 1,000 pieces, while the same quantity of rejected and substandard gloves are sold at $5-$10. This is possible “by tax evasion, misdeclarations at customs, and the illegal sale of banned chlorinated gloves,” the IRGMA alleged.