Government Calls For Voluntary Registration With CDSCO For PPE Coverall Manufacturers

On May 22, 2020, CDSCO (Central Drugs Standard Control Organisation) issued an advisory for voluntary registration of Personal Protection Equipment (PPE) coveralls and the testing at recognized labs under the Ministry of Textiles for effective and rapid tackling of Covid-19. Thus, this advisory gives permissions to all domestic manufacturers for producing Personal Protective Equipment with support from the Textile Industries.

At present, there are a total of 9 laboratories in India which are responsible for testing and certifying PPE kits for quality assurance. In some of the states, some cases have been detected where some of the unregistered manufacturers are using some below standard lamination on those PPE coveralls for resisting the blood penetration to meet WHO stipulated specification of 100 GSM thickness. This puts the safety of those using these coveralls at risk.

WHO along with Union Health Ministry has given advisory in May 2020 for the proper regulation of the manufacture of PPE among all Indian manufacturers in compliance with the regulatory specifications at the international level. All the PPE or coveralls produced by a manufacturer must go through and qualify the test that has been specified by the Ministry of Health and Ministry of Textiles. Earlier in February 2020, CDSCO had specified the exact definition of medical devices registration under the Drugs and Cosmetics Act in addition to regulations that includes the voluntary registration scheme for those PPE coveralls. For securing the required registration number from CDSCO, the PPE coverall manufacturer can also register their firms at the online portal which acts as a benchmark for their good quality management system. Some of the notified labs designated by Union Ministry of Textiles for testing and certifying the PPE kits are:

●       Heavy Vehicles Factory (HVF)

●       Avadi, Tamil Nadu

●       Small Arms Factory (SAF)Kanpur

●       UP under Ordnance Factory Board (OFB)

●       SITRA and the Defence Research and Development Establishment (DRDE), Gwalior

This step of voluntary registration will also help in securing the manufacturer's registration number from The CDSCO. As of today, a total of 107 PPE manufacturers have been recognized by CDSCO for supplying coveralls in all healthcare institutions. Registration in the online portal also helps in making a database of all authentic manufacturers present in the country.