New Delhi / Mumbai, September 20, 2024: The Indian Rubber Gloves Manufacturers Association (IRGMA) has welcomed the fresh guidelines detailing the functions and responsibilities of the Zonal, Sub-zonal, and Port offices of the Central Drugs Standard Control Organization (CDSCO). The association urged the government to take stringent measures to implement the order effectively to stop the import of substandard gloves in the country.

CDSCO issued the new Guidance Document for Functions and Responsibilities of Zonal, Sub-zonal, and Port offices on September 12. The guidelines were last released in 2011, and the recent changes—including the introduction of new rules and regulations and the online system through the SUGAM portal—necessitated the revised order in line with the procedures followed in CDSCO offices.

Speaking on the new CDSCO guidelines, the 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 long been demanding the Quality Control Order (QCO) for gloves to keep substandard imports at bay and urged the government to expedite its process. This will not only help Indian manufacturers but also contribute to the union government’s Make in India initiative to achieve self-sufficiency and reduce dependence on other countries.

The IRGMA general secretary added that the new CDSCO guidance document will 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 outline uniform enforcement procedures for onsite inspections to evaluate compliance with quality systems and infrastructure, adhering to nationally and internationally accepted Good Manufacturing Practice (GMP) standards.

The guidelines also set timelines for processing various applications in the medical devices sector, including procedures for granting licenses to manufacture drugs for examination, testing, or analysis under the New Drugs & Clinical Trials Rules, 2019, and 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 at least ten samples each month, comprising nine samples of drugs (APIs, excipients, and formulations) and one sample of cosmetics or medical devices. Each inspector shall maintain data on sampling and submit it to their controlling authority monthly to facilitate the execution of the sampling plan. The inputs from the monthly sampling data will be used to plan the next month’s sampling strategy.