Gap Healthcare: Market Opportunities in the UAE for Rubber Medical Devices
March 7, 2025
The Indian medical glove industry is under serious threat due to widespread violations of import regulations, unethical business practices, and the deliberate misclassification of gloves to bypass government policies. Several companies have been named in multiple complaints filed with the Drugs Controller General of India (DCGI). These complaints, submitted by the Indian Rubber Gloves Manufacturers Association (IRGMA), highlight the illegal importation of banned gloves, tax evasion, false product certifications, and dangerous health hazards posed by low-quality gloves.
The growing demand for medical gloves in India has led to an increase in unscrupulous import practices, making the country a dumping ground for low-cost, substandard gloves. This blog delves deep into the violations committed by these importers, the health risks involved, and the urgent need for regulatory enforcement to ensure safety in healthcare settings.
Major Violations in the Medical Glove Industry
The complaints filed with the Central Drugs Standard Control Organization (CDSCO) detail multiple infractions that threaten the integrity of India’s healthcare system. Below are the most alarming violations.
- Import of Banned Chlorinated Gloves
One of the most egregious violations involves the illegal import of chlorinated gloves, which have been banned under the Biomedical Waste Management Rules, 2016. These gloves were phased out by March 27, 2019, due to their harmful environmental impact and health risks. Despite this clear regulation, major importers have been caught bringing these prohibited gloves into India.
Why is this a concern?
- Chlorinated gloves contain toxic chemicals that can cause skin irritation, allergic reactions, and long-term health hazards.
- Their disposal is environmentally harmful as they release toxic chlorine compounds.
- The import of banned goods shows a blatant disregard for Indian laws, making regulatory enforcement crucial.
- Import of Non-BIS Compliant Gloves
Under the Medical Device Rules (MDR) 2017, medical gloves must conform to Bureau of Indian Standards (BIS) guidelines to ensure quality and safety. However, major importers have been found importing gloves that do not meet BIS standards.
The lab reports attached in the complaint letters confirm that the gloves failed quality tests, meaning that:
- They do not provide adequate protection for healthcare workers and patients.
- They do not meet sterility requirements, increasing the risk of infections and contamination in hospitals.
- They mislead buyers by falsely claiming compliance with medical-grade standards.
- Non-Compliance with Legal Metrology Rules
The Legal Metrology (Packaged Commodities) Rules, 2011, require all packaged goods, including medical gloves, to display:
✔️ Maximum Retail Price (MRP)
✔️ Country of Origin
✔️ Batch Details
✔️ Consumer Care Information
Despite these clear requirements, companies such as Ganesh Healthcare, Tulip International, and Primo International have been found violating these labeling laws. This misleads consumers, making it difficult for hospitals and retailers to verify product authenticity.
Tax Evasion and Unethical Business Practices
Apart from import violations, several companies are engaging in large-scale tax fraud and financial misdeclarations to maximize profits at the expense of government revenue and fair competition.
- GST Fraud and Market Manipulation
How are importers committing GST fraud?
- An Importer from Mumbai was found selling the same gloves at two different GST rates—charging 18% GST to traders while misrepresenting them as medical gloves at 12% for hospitals.
- An Importer from Delhi declares gloves as medical-grade (12% GST) at customs, but later sells them as industrial gloves (18% GST) in retail, overcharging customers and concealing GST payments.
These unethical practices harm domestic manufacturers who comply with taxation laws, leading to:
- Massive revenue loss for the Indian government.
- Unfair market competition, forcing legitimate businesses to struggle.
- Higher costs for hospitals and medical institutions, which ultimately affects patients.
- Dumping Cheap, Low-Quality Gloves in India
The complaints include import data proving that some companies are underreporting the price of gloves to bypass regulations.
For instance:
- An Importer from Mumbai declared glove unit prices at $0.015 per piece, whereas the actual international market price is $0.020 per piece.
- An Importer from Delhi also manipulated import costs, making India a dumping ground for low-quality gloves.
This price manipulation raises multiple concerns:
- Low-cost gloves often fail quality tests and do not provide adequate protection.
- It undermines Indian glove manufacturers, pushing them out of the market.
- Hospitals unknowingly purchase these substandard gloves, putting patients at risk.
Health Hazards Due to Unhygienic Practices
- Repacking in Unhygienic Conditions
The most disturbing revelation in the letters of complaint is that imported gloves are being shipped in bulk sugar bags, repacked in unsanitary warehouses, and sold as medical-grade gloves.
This highly dangerous practice leads to:
❌ Risk of bacterial contamination.
❌ No guarantee of sterility or proper handling.
❌ Potential health hazards in hospitals due to unhygienic conditions.
- False Certification and Misleading Marketing
Several importers have been caught using fake CE markings and ISO certifications on their products.
Why is this a problem?
- Hospitals and medical stores rely on these certifications to ensure the safety of products.
- Fake certifications mislead buyers, making them believe they are purchasing high-quality medical gloves.
- This compromises the safety of healthcare workers and patients, increasing infection risks.
The Urgent Need for Regulatory Action
Given the scale of these violations, the Indian Rubber Gloves Manufacturers Association (IRGMA) has requested the Drugs Controller General of India (DCGI) to immediately intervene and take enforcement actions. Their demands include:
✅ Conducting enforcement raids at warehouses and repacking centers.
✅ Implementing strict BIS compliance checks to prevent the sale of substandard gloves.
✅ Investigating GST fraud and taking legal action against importers evading taxes.
✅ Prohibiting the bulk import of gloves in unhygienic conditions.
✅ Verifying all product certifications to eliminate false marketing practices.
Conclusion: Protecting India’s Healthcare Industry
The illegal importation and misrepresentation of medical gloves pose a serious risk to India’s healthcare system. Hospitals, healthcare professionals, and patients depend on high-quality gloves for safety. If regulatory authorities fail to act swiftly, the situation could lead to widespread health crises.
This issue is not just about tax fraud or import violations—it is about protecting public health, supporting ethical businesses, and ensuring that India’s medical industry operates under lawful regulations.
Join the Movement for Safer Medical Products
💡 Support ethical glove manufacturers that comply with BIS standards.
📢 Raise awareness by sharing this blog and urging government intervention.
🔎 Report non-compliant importers to authorities for strict action.
👉 Together, we can ensure safer healthcare standards in India!
