The Indian Rubber Gloves Manufacturers Association (IRGMA) has ramped up its efforts against the illegal import of medical gloves that fail to meet critical safety regulations. These unsafe gloves, which enter the Indian market through illicit channels, pose a severe risk to both healthcare providers and patients, undermining fair competition in the industry. In a formal complaint to the Drugs Controller General of India (DCGI), IRGMA highlighted the actions of several major importers who are violating safety standards, mislabeling products, and circumventing regulations outlined in the Medical Device Rules, 2017, and the Legal Metrology Act, 2009. These offenses include importing expired gloves, repackaging them in unsanitary conditions, and providing false certifications, putting the safety of medical procedures—especially those related to chemotherapy and radiation—at great risk.
Vikas Anand, spokesperson for IRGMA, expressed concern over the lack of enforcement, stating, “These unsafe gloves continue to flood the market due to weak regulatory oversight. We have provided clear evidence of these violations to the authorities and demand immediate action. If allowed to continue, the sale of substandard gloves will not only jeopardize lives but also hinder compliant domestic manufacturers who uphold rigorous quality standards. We urge the government, healthcare institutions, and policymakers to take urgent corrective measures.”
IRGMA’s investigation has uncovered serious malpractice within India’s medical supply chain, raising concerns about public health and safety. Expired gloves are being repackaged in unhygienic conditions, putting users at risk of infections. Additionally, many imported gloves contain 18-20 hazardous chemicals, making them unsafe for medical procedures like chemotherapy and radiation therapy. Misleading certifications are also a growing issue, with some companies falsely claiming CE and ISO 13485 approvals to deceive consumers about product quality.
Beyond health risks, these unethical practices have financial and regulatory implications. Importers are avoiding taxes through under-invoicing, leading to substantial revenue losses for the government. Hygiene standards are being violated as bulk shipments of gloves are transported in non-sterile sugar bags, disregarding import regulations. Furthermore, foreign suppliers are exploiting loopholes in the ASEAN Free Trade Agreement (FTA), flooding the market with low-quality, rejected gloves. This influx of substandard imports severely impacts local MSMEs that adhere to stringent quality standards, threatening their viability in the industry.
This widespread influx of substandard gloves has created two major problems: it threatens public health and destabilizes local glove manufacturers. According to IRGMA, substandard gloves valued between ₹1 million and ₹6.6 million, primarily from Malaysia and the USA, continue to enter the Indian market, bypassing key regulatory requirements. These importers often fail to meet packaging regulations, display proper MRP, or state country-of-origin information, leading to substantial losses in GST revenue through tax evasion and under-invoicing. Furthermore, the 0% import duty under the ASEAN FTA has allowed low-quality, rejected gloves to flood the Indian market, undermining local businesses that follow strict quality standards.
IRGMA is calling for immediate regulatory action to enforce compliance with the Medical Device Rules 2017 and the CDSCO Gazette Notification. The association is demanding severe penalties, including blacklisting and heavy fines, for non-compliant companies involved in illegal trading. Additionally, IRGMA is urging a ban on substandard medical gloves used in healthcare settings and a mandatory declaration of MRP, country of origin, and certification details to improve transparency and consumer safety. The association also advocates for closing the FTA loophole that allows inferior gloves to dominate the market.
IRGMA remains steadfast in its mission to ensure that only high-quality, safe medical gloves are available in India. The association continues to work closely with regulatory authorities to monitor violations and push for stricter enforcement to protect healthcare workers and uphold the integrity of India’s medical device sector.
