The Indian Rubber Gloves Manufacturers Association (IRGMA)
has voiced its strong support for the new guidelines released by the Central
Drugs Standard Control Organisation (CDSCO) on September 12, 2024. These
guidelines outline the roles of zonal, sub-zonal, and port offices, aiming to
modernize regulatory processes and enhance oversight. However, the IRGMA has
called on the government to enforce these guidelines rigorously to prevent the
influx of substandard gloves into India.
These updated regulations respond to the
introduction of new rules and an online system through the SUGAM portal, which
replaces the 2011 regulations. The IRGMA has long advocated for a Quality
Control Order (QCO) for gloves to safeguard the domestic market against
low-quality imports that endanger consumers and undermine the Make in India
initiative.
“The new CDSCO rules
are a step in the right direction, but to properly regulate the import
of bulk-packed, subpar gloves, authorities—including Assistant Drug Controllers
(ADCs) at ports—must be fully aware of them.,” stated IRGMA General Secretary
Man Mohan Singh Gulati.
The revised guidelines implement risk-based inspections to
ensure adherence to Good Manufacturing Practice (GMP) standards, fostering
greater uniformity, transparency, and accountability within CDSCO offices. They
also establish clear timelines for processing applications related to medical
devices, including drug manufacturing licenses and No Objection Certificates
(NOCs) for cargo clearance at ports.
To strengthen quality control, the guidelines require each drug inspector to collect at least ten samples monthly, covering drugs,
medical devices, and cosmetics. The data gathered will inform future inspection
strategies, ensuring ongoing regulatory oversight.
The IRGMA views these updates as a significant advancement
in enhancing quality control for medical gloves in India, supporting local
manufacturers, and contributing to the national goal of self-reliance in the
medical device industry.