The Indian Rubber Gloves Manufacturers Association (IRGMA) has expressed support for the new guidelines issued by the Central Drugs Standard Control Organization (CDSCO), highlighting the need for stringent enforcement to prevent the import of substandard gloves. The guidelines outlined the roles and responsibilities of the CDSCO’s Zonal, Sub-zonal, and Port offices and were released on September 12, marking the first update since 2011.
The revised guidelines, which align with updated regulations and the SUGAM online portal system, aim to enhance the efficiency of CDSCO offices. IRGMA General Secretary Man Mohan Singh Gulati commented on the development, stating, “The new guidelines are a step in the right direction, but it is crucial that the authorities, particularly ADCs at ports, are well-versed in the document to curb the influx of low-quality, bulk-packed gloves.”
IRGMA has consistently advocated for the implementation of a Quality Control Order (QCO) for gloves to block substandard imports and promote domestic manufacturing. The association urged the government to accelerate this process, aligning with the broader goals of the ‘Make in India’ initiative to boost self-reliance and reduce dependency on foreign suppliers.
The new guidance document is expected to promote uniformity, transparency, and accountability across CDSCO offices by incorporating risk-based inspections into the organisation’s technical operations. These inspections will ensure adherence to quality systems and infrastructure that meet both national and international Good Manufacturing Practice (GMP) standards.
The guidelines also introduce standardised procedures for the medical devices sector, including the issuance of licenses for drug manufacturing for testing and analysis, as well as No Objection Certificates (NOCs) for cargo clearance at port offices. Additionally, CDSCO has established timelines for processing these applications, further streamlining operations.
Under the new guidelines, each CDSCO drugs inspector will be required to collect ten samples per month, including nine from drugs (APIs, excipients, and formulations) and one from cosmetics or medical devices. This data will be submitted monthly to assist in planning future sampling strategies, thereby enhancing oversight and compliance.
