Government’s quality control order to make BIS certification mandatory

Mumbai: In a significant move to safeguard India’s healthcare ecosystem and domestic manufacturing industry, the Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilizers, has submitted the Medical and Surgical Gloves (Quality Control) Order, 2024 (QCO) to the World Trade Organization (WTO).

Once enforced, the QCO will mandate BIS certification for all medical and surgical gloves, bringing much-needed quality assurance and regulatory oversight to a market that has been flooded with substandard and illegally imported gloves from Malaysia, Thailand, Vietnam, and China.

The announcement comes after the Indian Rubber Gloves Manufacturers Association (IRGMA) uncovered a massive import scam where unscrupulous importers are stockpiling low-quality non-medical gloves before the QCO takes effect, repackaging them as medical gloves, and dumping them into hospitals and clinics.

“This dangerous practice is compromising patient safety, undermining India’s Make in India initiative and destabilizing the domestic industry,” the IRGMA said in a statement.

The QCO for gloves is expected to regulate Rs 600-700 crore worth of annual glove imports, ensuring that only BIS-certified gloves—whether imported or manufactured domestically—can be sold for medical use in India. The order applies to disposable surgical gloves, single-use medical examination gloves, and post-mortem rubber gloves, preventing bulk imports of substandard gloves and ensuring only ISI-marked gloves are permitted for hospital use.

“We are witnessing an orchestrated effort to flood India’s market with substandard gloves before the QCO kicks in. These gloves, falsely classified as non-medical at import, are being repackaged and sent to hospitals. Patients and doctors are unknowingly exposed to serious risks,” IRGMA spokesperson Vikas Anand said.

“To make matters worse, China’s excess glove stock is being funneled through Malaysia and Thailand, destabilizing Indian manufacturers and public health. We demand immediate government intervention before this turns into a full-blown national crisis,” he added.

“With India now taking decisive steps towards quality control and domestic self-reliance, IRGMA is fully committed to working with authorities to clean up the supply chain, enforce BIS standards, and ensure that only high-quality, certified gloves are used in India’s healthcare system,” he assured.