Maha FDA: PPE manufacturers directed to test & certify PPE kits in Mumbai-based labs

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

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.

An advisory had also been issued by The Drugs Controller General of India (DCGI) 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— for quality compliance and to create a database of authentic manufacturers in the country.


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