IRGMA supports CDSCO’s new guidelines, urges stronger measures to curb substandard glove imports

New Delhi: The Indian Rubber Gloves Manufacturers Association (IRGMA) has expressed strong support for the new guidelines introduced by the Central Drugs Standard Control Organization (CDSCO), which outline the responsibilities and functions of its Zonal, Sub-zonal, and Port offices. 

IRGMA emphasized the critical need for rigorous enforcement to curb the import of substandard rubber gloves in India.

The CDSCO released its revised Guidance Document for Functions and Responsibilities of Zonal, Sub-zonal, and Port Offices on September 12, replacing the 2011 guidelines. The updated document reflects changes in regulations, including the adoption of an online system through the SUGAM portal and the introduction of new rules to keep pace with current regulatory standards.

Man Mohan Singh Gulati, General Secretary of IRGMA, commented, “The new guidelines issued by CDSCO are a welcome step. However, the implementing authorities, including ADCs posted at ports, must be made aware of the document to effectively control the import of substandard bulk-packed gloves.”

IRGMA has consistently called for the introduction of a Quality Control Order (QCO) specifically for gloves, to safeguard public health and support local manufacturers. The association believes that the QCO would not only benefit Indian glove makers but also bolster the government’s Make in India initiative by reducing reliance on imports and encouraging self-sufficiency.

The revised guidelines are expected to bring greater transparency, consistency, and accountability across CDSCO offices, according to Gulati. The document introduces risk-based inspection protocols, aimed at ensuring compliance with both national and international Good Manufacturing Practice (GMP) standards.

Among the key changes are clearer timelines for processing various applications within the medical devices sector. This includes issuing licenses for the manufacture, testing, and analysis of drugs under the New Drugs & Clinical Trials Rules, 2019, as well as issuing No Objection Certificates (NOCs) for cargo clearance at CDSCO port offices.

A key feature of the updated guidelines is the structured sampling system. Under the new framework, drugs inspectors are required to collect a minimum of ten samples each month—nine related to active pharmaceutical ingredients (APIs), excipients, and formulations, and one sample from cosmetics or medical devices. This data will be used to shape future inspection strategies, improving oversight and ensuring compliance across the board.

IRGMA hopes that through robust enforcement of these new measures, the influx of substandard gloves can be significantly reduced, allowing Indian manufacturers to thrive in a more competitive and quality-focused environment. The association looks forward to collaborating with CDSCO and other regulatory bodies to ensure the highest standards are upheld across the industry.