The Indian Rubber Gloves Manufacturers Association (IRGMA) has expressed strong support for the new guidelines issued by the Central Drugs Standard Control Organisation (CDSCO), detailing the responsibilities of zonal, sub-zonal, and port offices. These updated guidelines, released on 12 September 2024, aim to modernise procedures and strengthen regulatory oversight. However, the IRGMA has urged the government to ensure strict implementation to prevent the import of substandard gloves into India.
The guidelines come after the introduction of new rules and an online system via the SUGAM portal, replacing the 2011 regulations. The IRGMA has long advocated for a Quality Control Order (QCO) for gloves to protect the domestic market from inferior imports, which pose risks to consumers and hinder the Make in India initiative.
“The new CDSCO guidelines are a positive development, but the authorities, including Assistant Drug Controllers (ADCs) at ports, need to be well-informed about the document to effectively manage the import of bulk-packed substandard gloves,” said IRGMA General Secretary Man Mohan Singh Gulati.
The revised guidelines introduce risk-based inspections to ensure compliance with Good Manufacturing Practice (GMP) standards, bringing greater uniformity, transparency, and accountability across CDSCO offices. Additionally, they set clear timelines for processing applications in the medical devices sector, including drug manufacturing licences and No Objection Certificates (NOCs) for cargo clearance at port offices.
To enhance quality control, the guidelines mandate each drugs inspector to collect at least ten samples monthly, comprising drugs, medical devices, and cosmetics. The data from these samples will guide future inspection strategies, ensuring continuous regulatory vigilance.
The IRGMA views these updates as a step forward in ensuring better quality control for medical gloves in India, supporting local manufacturers, and contributing to the broader national goal of self-reliance in the medical device sector.
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