IRGMA welcomes CDSCO’s new guidelines and calls for strict implementation

The Indian Rubber Gloves Manufacturers Association (IRGMA) has expressed support for the recent guidelines issued by the Central Drugs Standard Control Organization (CDSCO), which outline the functions and responsibilities of its Zonal, Sub-zonal, and Port offices. The association has also called on the government to ensure strict implementation of the guidelines to prevent the import of substandard gloves into the country.

CDSCO released the new guidance document on 12 September, updating the guidelines last issued in 2011. The changes reflect the introduction of new rules and an online system via the SUGAM portal, aligning the procedures followed in CDSCO offices across the country.

Commenting on the guidelines, IRGMA General Secretary Man Mohan Singh Gulati said, “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.”

The association has been advocating for a Quality Control Order (QCO) for gloves to prevent the entry of substandard imports and has urged the government to expedite the process. According to the IRGMA, this would not only benefit Indian manufacturers but also support the government’s “Make in India” initiative by promoting self-sufficiency and reducing reliance on foreign imports.

The IRGMA General Secretary added that the new CDSCO guidance document is expected to bring uniformity, transparency, predictability, and accountability to all offices, incorporating risk-based inspections as part of the organization’s technical functions.

The risk-based inspection guidelines provide a framework for uniform enforcement procedures during onsite inspections to assess compliance with quality systems and infrastructure, in line with both national and international Good Manufacturing Practice (GMP) standards.

The guidelines also establish timelines for processing applications in the medical devices sector. This includes procedures for granting licenses to manufacture drugs for examination, testing, or analysis under the New Drugs and Clinical Trials Rules, 2019, as well as the issuance of No Objection Certificates (NOCs) for cargo clearance at CDSCO port offices, among other matters.

According to the guidelines, each drugs inspector will collect a minimum of ten samples each month, including nine samples of drugs (APIs, excipients, and formulations) and one sample of cosmetics or medical devices. Inspectors are required to maintain data on sampling and submit it monthly to their controlling authority to facilitate the execution of the sampling plan. The monthly data will be used to develop the sampling strategy for the following month.