In a recent representation to the government, the industry claimed that large volumes of low-quality medical examination gloves are entering India without adhering to prescribed standards.
It urged authorities to immediately enforce quality regulations that have remained pending despite being in the works for over a year.
Cheap imports, weak checks create market distortion
According to the industry submission, imported gloves are often not certified under Indian or internationally recognised standards and are brought in bulk packaging, such as gunny bags, before being repacked locally.
Manufacturers flagged multiple compliance gaps, including a lack of BIS certification, absence of adherence to acceptable quality level (AQL) norms, and violations of biomedical waste rules due to chlorinated materials.
These products also fail to meet critical parameters such as tensile strength, barrier integrity, and biocompatibility.
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The absence of testing and compliance costs allows such imports to be priced significantly lower, creating what the industry describes as an “uneven playing field” for domestic manufacturers.
COVID-era capacity now under stress
The concerns come at a time when Indian glove makers, many of whom expanded capacity during the pandemic under the Atmanirbhar Bharat push, are facing demand and pricing pressures.
Companies say they are operating below optimal utilisation levels and, in some cases, incurring losses due to unfair competition from cheaper imports. Some units are also facing viability challenges, with the risk of shutdowns rising if the situation persists.
Industry players argue that compliant manufacturers are effectively being penalised, as they are forced to dilute specifications and reduce prices to remain competitive.
Patient safety risks come to the fore
Beyond the economic impact, manufacturers have flagged serious public health concerns. Medical gloves are a frontline safety product in healthcare delivery, and substandard variants increase the risk of tearing, permeability failures, allergic reactions, and infection transmission.
The continued use of such gloves in hospitals and clinics could pose a “silent but serious” risk to patient safety, the industry warned.
Call for immediate policy enforcement
Manufacturers have urged the government to act swiftly by notifying and enforcing mandatory quality certification norms. Among the key demands are stricter customs checks to block non-compliant imports and clear directions to healthcare institutions to procure only certified gloves.
They maintain that the regulatory framework already exists and that only its implementation is pending.
Govt had moved to mandate standards in 2024
The industry’s concerns come against the backdrop of a draft Quality Control Order (QCO) issued in 2024 by the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilisers.
The draft order, circulated for stakeholder comments via the World Trade Organization, proposed making it mandatory for medical and surgical gloves sold in India to conform to standards set by the Bureau of Indian Standards and to carry the ISI mark.
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It covered key categories such as disposable surgical gloves, single-use examination gloves, and post-mortem gloves, with BIS designated as the certifying and enforcement authority. Exports were kept outside the scope of the order.
Policy intent yet to translate into action
While the draft QCO signalled the government’s intent to tighten quality norms, industry stakeholders say the lack of timely implementation has allowed non-compliant products to continue entering the market.
They argue that swift enforcement of the proposed standards would not only level the playing field but also strengthen India’s push to build self-reliance in critical medical consumables.
As pressure mounts from domestic manufacturers, the spotlight is now on whether the government will fast-track the notification and enforcement of the long-pending quality control order.
