By V CARE IMPEX, 8th April, 2023
In recent news, poor quality gloves continue to enter Indian market due to poor oversight of custom officials and CDSO Office. This is raising serious concerns about the safety and effectiveness of medical products used in the country. Majority of this spurious quality gloves are being imported from Malaysia and China.
As per 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. There was no mandatory checking of gloves at ports. Importers are also not implementing CDSCO Gazette Notification which went into effect from October 1, 2022.
The Indian Rubber Gloves Manufacturers Association (IRGMA) has also expressed concern about the delay in issuing directives for compliance with the mandatory CDSCO license for class A and class B medical devices, which took effect on October 1, 2022.
IRGMA members have also written to the Chief Commissioner of Customs of all ports, requesting that Bills of Entry be prohibited, in line with Rule 44, Chapter 6 of MDR 2017. They have also requested that the samples be sent to the Bureau of Indian Standards (BIS), Southern Regional Office Laboratory (SROL), Chennai for testing compliance for Bill of Entries (if it meets the labeling requirements) in accordance with the above Rules.
According to quality assurance experts, the quality of the imported gloves blatantly defies the quality standards as laid down by the BIS. 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.
Repeatedly in the past, V CARE IMPEX insisted medical fraternity and Indian industries to opt for Certified and quality approved Gloves. Some believed in our vision while some gave too much importance to the pricing of the product rather than quality.
Through our independent investigation, it is being observed that the custom officials have taken serious note about the same and have immediately implemented above. Due to which hundreds of containers containing medical gloves are being inspected for quality assurance and held up at ports. There could be shortage of Medical Gloves for brief period in coming days and also expect prices to go up as well.
However, there is still time for our readers to opt for only Certified and quality gloves to serve the humanity as well as country.
V CARE IMPEX had the first mover advantage of coming up with Nitrile Gloves which were certified for number of applications and uses. These gloves are manufactured by M/s HARTALEGA, MALAYSIA one of the most reputed and largest manufacturers of Nitrile Gloves in India. They keep no stone unturned as far as the certifications and quality standards of Nitrile gloves are concerned.
Starting from 3g, 3.2g, 4.7g, 6g with Long Cuff, we have gloves for all applications and range. To know the gloves most suited to your requirements please drop us a mail on sales@vcareimpex.com or Whatsapp: +91 9920107524
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