To compile data about Personal Protection Equipment (PPE) coveralls and monitor the quality of PPE kits in the country, the DCGI has asked manufacturers for voluntarily get registered on the CDSCO medical device online portal – cdscomdonline.gov.in. The registration will secure the manufacturers a registration number from the CDSCO, which will, reportedly, also be a quality management system benchmark.
A senior official from the CDSCO office informed that for the PPE Kit, fabric plays a major role, as it prevents the entry of the virus into the human body. Therefore, it is very important to monitor the quality of materials used in the manufacturing process of PPE coveralls. He also informed that though there are authorised laboratories for testing and accreditation of PPE kits, there are many unauthorised players who are involved in manufacturing them. This voluntary registration will help in recognising genuine PPE manufacturers of the country.
An insider source explained the procedure and informed that once a manufacturer gets the registration from the CDSCO, then after 18 months the factory gets inspected by the competent authority. Based on the inspection, carried as per the Quality Management System (QMS), the firm will be eligible for a proper registration/ license to manufacture the PPE kits.
He also informed that as per a notification released by MoH&FW vide S.O. 648(E), PPE kits are considered as a medical device, in pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940). However, they are not yet regulated, therefore any manufacturer following the given guidelines by the Ministry of Textiles can register and obtain the registration.
The Ministry of Health is procuring the PPE kits only after the manufacturers pass the prescribed tests at the labs recognised by the Ministry of Textiles. And it has notified eight laboratories for testing and accrediting the PPE kit materials which are manufactured and imported in India.
They are as follows:
1) South India Textile Research Association Coimbatore, Tamilnadu
2) Defence Research 86 Development Establishment Gwalior, now at INMAS (DRDO)
3) Heavy Vehicles Factory, Avadi, Tamilnadu
4) Small Arms Factory, Kanpur Uttar Pradesh
5) Ordnance Factory, Muradnagar, Uttar Pradesh
6) Ordnance Factory, Kanpur, Uttar Pradesh
7) Ordnance Factory, Ambernath (New Mumbai) Maharashtra
8) Metal and Steel Factory, Ishapore, Near Kolkata, West Bengal
The CDSCO has sent a letter to the Drug Controllers of all States and Union Territories, and all zonal and subzonal officers of CDSCO, updating about voluntary registrations of PPE manufacturers.
Commenting on this move, Pavan Choudary, Chairman and DG, Medical Technology Association of India, “This provision of voluntary registration is most welcome and I hope all manufacturers of PPE will avail of the option, as it will ensure that the quality of the product manufactured is up to the mark and consistent. Quality is a sine qua non for sustaining success as well as for determining the acceptance of other products which will emerge from Indian factories in the future. Its oversight will also greatly reduce the risk of counterfeit products undeservedly hurting the reputation of India made medical devices, as had happened in the pharma sector in some export markets,”
Cdsco also foccus on IR thermometer all categories of mask should also need registered on cdsco MD online portal. After 1 Jan 2021 thermometer need to import/mfg licence
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