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The Indian Rubber Gloves Manufacturers Association (IRGMA) has sought immediate intervention of the Commissioner of Customs General, Mundra Port, Gujarat with respect to the poor quality medical and surgical gloves being supplied to government hospitals. It has asked for guidance to prevent import of spurious disposable examination gloves in India.
“We as Bureau of Indian Standards (BIS) Certified manufacturers would like your good offices to immediately enforce the provision of the Medical Device Rules (MDR) 2017 Rules, for effective implementation of MDR 2017 and from October 1, 2022, all the health departments must procure gloves only from manufacturers having Central Drugs Standard Control Organisation (CDSCO) License and should be mandatory BIS Certified. This will ensure compliance to rule 20 and 36 of MDR 2017,” an IRGMA letter addressed to TV Ravi, Commissioner of Customs General, Mundra Port, Gujarat stated.
IRGMA has also made representation dated December 27, 2022, to Union Ministry of Health, Central Drugs Standard Control Organisation (CDSCO) and dated January 9, 2023 requested Directorate General Of Systems & Data Management, Central Board of Indirect Taxes and Customs (CBIC), Department of Revenue, Ministry of Finance, Government of India to communicate their offices at different ports to forward the bill of entries of the medical devices to the concerned Assistant Drug Controller (ADC) (1) Office at the port for ensuring the compliance of the requirements for import the medical devices under the new Medical Device Rules (MDR)- 2017.
Currently, disposable medical and surgical gloves at all government and private hospitals are being procured without any registration/license issued by CDSCO/BIS. The imported gloves are of very low quality posing serious health and safety issues for the health professionals.
“The quality and specified standards, as specified by BIS, can be met by the BIS licensed manufacturers having the adequate capability to supply and they also have the capacity to counter the spurious low grade imported gloves. The directives will enable BIS certified gloves manufacturing units to add to the "Make in India '' initiatives started by Government of India (GoI),” the IRGMA letter stated.
According to an IRGMA official, “We, may therefore request for the effective enforcement of CDSCO Directives with effect from October 1, 2022, as it will help the Indian manufacturers to produce good quality disposable gloves, adhering to the "Make in India '' initiatives as well as providing quality medical devices to our health professionals and protecting them.”
This has reference to the circular issued, for the implementation of union health ministry notification on MDR, and in pursuance of CDSCO Notification no G.S.R 102 (E), dated February 11, 2020, IRGMA may need your kind attention to issue directives for compliance of the mandatory CDSCO licence for class A and class B medical devices, with effect from October 1, 2022.
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