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The medical devices industry has recommended to the PPE manufacturers in the country to first comply with ISO 13485 certification before registering on the Central Drugs Standard Control Organisation (CDSCO)’s medical device online portal---cdscomdonline.gov.in.
The Drugs Controller General of India (DCGI) had recently issued an advisory to the manufacturers to voluntarily register on the portal. The registration will secure the manufacturers a registration number from the CDSCO, which will serve as a quality management system benchmark. PPE coverall is an important medical device for healthcare workers handling COVID-19 patients.
According to industry sources, as of today barely 25 manufacturers have ISO 13485 certification. As per official estimates, around 107 PPE manufacturers have been identified who have raised their daily production to over 2 lakh PPE kits. The total projected demand for PPE kits till June, 2020 is estimated to be over 2 crore.
Union health ministry on February 11, 2020 had notified all medical equipment used on humans or animals as "drugs" under Section 3 of the Drugs and Cosmetics (D&C) Act, with effect from April 1, 2020 to ensure that all medical devices including PPE kits meet certain standards of quality and efficacy. “It is important all the manufacturers of PPE coverall are aware of the latest rules governing medical devices, enabling them to also take advantage of the provisions of voluntary registration with CDSCO,” as per the CDSCO advisory.
Rajiv Nath, forum coordinator, AiMeD said, “Manufacturers need to follow Indian Certification for Medical Devices Scheme (ICMED)- the first indigenously developed international class certification scheme for the medical devices in India for compliance to quality management systems (QMS) in medical devices. The Certification Scheme is built over the base Standard ISO 13485 (Quality Management System for Regulatory Purposes). This will allow Indian manufacturer get access to lower cost indigenous QMS Certification rather than seeking it from overseas EU and US certification bodies with prohibitive travel and auditor costs’.
“PPE coverall manufacturers may also consider getting themselves voluntarily registered on the CDSCO medical device online portal cdscomdonline.gov.in to secure a registration number from CDSCO which will also be benchmark for their QMS,” the advisory has stated.
Looking at the national need in COVID-19 situation, with support from ministry of textiles, a large number of manufacturers have started producing PPE coveralls. These PPE coveralls are being procured by nominated agency of union health ministry only after these pass the prescribed test at the labs notified by ministry of textiles. As a major step towards indigenization and ensuring compliance to quality, government has kick-started indigenous manufacturing of PPE kits in the wake of rising cases of COVID-19 globally and in India.
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