The Central Drugs Standard Control Organisation (CDSCO) has produced guidelines outlining the roles and duties of its zonal, sub-zonal, and port offices; the Indian Rubber Gloves Manufacturers Association (IRGMA) has voiced its support for these rules. The group has urged the government to ensure proper enforcement of these regulations to curb the entry of low-quality rubber gloves into the nation.

On September 12, the new CDSCO guidelines resurfaced after a lengthy hiatus from 2011's rules. These updates are a direct result of the ever-changing regulatory environment, which has seen the adoption of new regulations and the launch of an online system via the SUGAM portal. In an effort to make the medical devices industry more open and efficient, the revised document lays out the rules that CDSCO offices must follow.

IRGMA General Secretary Man Mohan Singh Gulati emphasized the importance of the implementing authorities, particularly the Assistant Drugs Controllers (ADCs) stationed at ports, being more vigilant in their efforts to prevent the import of low-quality bulk-packed gloves, despite the positive reception of the new guidelines. He said, "It's great to see CDSCO has released new guidelines. In order to successfully regulate the import of low-quality bulk-packed gloves, it is necessary to inform the implementing authorities, such as ADCs stationed at ports, about the document.

For quite some time, the IRGMA has been pushing for a Quality Control Order (QCO) for gloves, which it thinks would be a beneficial way to stop the flood of low-quality imports. The group strongly requested that the government move quickly on the matter, highlighting the mutual benefits to local producers and the fact that it would be in line with the government's "Make in India" program, which seeks to promote independence and decrease dependency on foreign imports.

Among the many changes made to the new document is the implementation of risk-based inspections to check for compliance with GMP regulations on a global and national scale. In order to ensure consistency across all CDSCO locations, these inspections will include physical site visits to assess medical device quality processes and infrastructure.

The standards also lay out schedules for handling different medical device manufacturing applications, such as NOCs (No Objection Certificates) for cargo clearance at port offices and permits for testing and analysis.

To further reinforce quality control procedures in the sector, the guidelines state that each drug inspector must collect 10 samples every month. The data from these samples will then be utilised to shape future inspection tactics.

Manufacturers and consumers alike will reap the benefits of these reforms, which IRGMA says will provide regulatory clarity, openness, and responsibility.