Loose packed spurious quality gloves continue to enter Indian market from Malaysia and China due to poor oversight of custom officials at ports and Central Drugs Standard Control Organisation (CDSCO) office, according to regulatory and industry experts.
Experts say that Rule 44 of chapter 6 of Medical Device Rules (MDR) 2017 clearly stipulates that the labelling requirements must be checked at the ports, while clearing Bill of Entries by the respective Commissioners of Customs.
This is resulting in spurious quality gloves still coming to government hospitals. There is no mandatory checking of gloves at ports. Importers are also not implementing CDSCO Gazette Notification which came into effect from October 1, 2022.
The Indian Rubber Gloves Manufacturers Association (IRGMA) has also raised an alarm on the delay taking place in issuing directives for compliance of the mandatory CDSCO license for class A and class B medical devices which came into effect on October 1, 2022.
IRGMA members have also written to the Chief Commissioner of Customs of all the ports that Bill of Entries must not be allowed, in line with Rule 44, chapter 6 of MDR 2017. They have also urged that the samples need to be sent Bureau of Indian Standards (BIS), Southern Regional Office Laboratory (SROL), Chennai for compliance of testing requirements for Bill of Entries (in case, it is meeting the labelling requirements) in line with Rule 7 of Chapter 2 of MDR 2017.
Medical grade gloves are a very basic and integral part of the medical and healthcare System deserving the highest attention to quality.
According to quality assurance experts, the quality of material of the imported gloves blatantly defies the quality standards as laid down by the BIS. This amounts to a crime against the country. They are just packed in India and defy the Make in India initiative of the nation as well. Such stuff is a huge risk and danger both to the healthcare system involving doctors, nurses, paramedics and patients. This may result in the spread of serious infections and medical hazards.
The conformance to respective BIS Standards is also required to comply with the requirements of Rule 7 of Chapter 2 of MDR 2017.
The IRGMA letter copy has also been sent to the Secretary, Union health ministry, secretary, Department of Pharmaceuticals (DoP), ministry of chemicals & fertilizers, Drugs Controller General of India, Director General, BIS, Appraisers, Superintendents and Preventive Officers of Air Cargo.
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