Date: 24-Jun-2020

Maha FDA Directs PPE Manufacturers To Test & Certify PPE Kits In Mumbai-based Labs As Per Health Ministry Guidelines

The Maharashtra Food and Drug Administration (FDA), which has so far conducted a total of 1945 inspections on personal protective equipment (PPE) kit manufacturers to ensure quality of these products, has directed the PPE manufacturers to test and certify PPE kits in Mumbai-based labs as per Union health ministry guidelines.

There are currently 9 labs in the country which test and certify PPE kits for quality assurance. Cases were detected in Maharashtra wherein unregistered manufacturers were using sub-standard lamination on the Coveralls or PPEs for blood penetration resistance just to meet WHO stipulated specification of 100 GSM thickness putting the users’ safety at risk. WHO and the Union health ministry have also issued notifications in May 2020 to regulate the production of PPEs among Indian manufacturers in line with the global regulatory specifications.

Union ministry of textiles had designated Heavy Vehicles Factory (HVF), Avadi, Tamil Nadu and Small Arms Factory (SAF), Kanpur, UP under Ordnance Factory Board (OFB) in addition to notified labs earlier –SITRA and the Defence Research and Development Establishment (DRDE), Gwalior for testing and certifying PPE kits.

Maharashtra FDA earlier had directed its joint commissioners, assistant commissioners and district level drug control officers to review and oversee the 19 PPE manufacturers in the state for quality compliance. These manufacturers, who have a production capacity ranging from 500 to 15,000 PPE kits daily, are based in Sangli, Pimpri, Nashik, Navi Mumbai, Vasai, Andheri, Mulund, Palghar, Bhiwandi and Bhayander areas of the state.

The Central government had notified EC Order, 2020 to regulate production, quality, distribution and logistics of masks (2ply and 3ply surgical masks, N95 masks) which are part of PPE for COVID-19 management. There are two types of masks which are recommended for various categories of personnel working in hospital or community settings, depending upon the work environment - triple layer medical mask and N-95 respirator mask.

The Drugs Controller General of India (DCGI) has also issued an advisory to the PPE manufacturers to voluntarily register under the medical device rules, 2017. The registration will secure the manufacturers a registration number from the CDSCO, which will serve as a quality management system benchmark.

As of today, 107 PPE manufacturers have been approved by the Central Drugs Standard Control Organisation (CDSCO) for supplies in the government healthcare institutions. CDSCO has also directed all approved PPE manufacturers to voluntarily register at its medical device online portal---cdscomdonline.gov.in for quality compliance and to create a database of authentic manufacturers in the country