Date: 04-Jun-2020

Maha FDA Directs DC Officers To Oversee PPE Manufacturers To Ensure Only Quality PPEs Are Entered In Retail Supply Chain

To ensure that only good quality personal protective equipments (PPEs) are entered in the retail supply chain in the state, the Maharashtra Food and Drug Administration (FDA) has 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.


PPEs in general, and coverall in particular, are important medical devices for healthcare workers handling COVID-19 patients.


Maharashtra FDA has till date carried out over 900 random inspections on identified PPE manufacturers who can supply products across Maharashtra. As of today, 107 manufacturers have been approved by the Central Drugs Standard Control Organisation (CDSCO) for supplies in the government healthcare institutions. This comes close on the heels of the central drug regulator asking all approved PPE manufacturers to voluntarily register at its medical device online for quality compliance and to create a database of authentic manufacturers in the country.


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 state drug regulator in the recent past has resolved around 11 cases of non-compliance to Essential Commodities (EC) Order and Drugs and Cosmetics (D&C) Act based on 58 calls at Toll free number 1800222365 and 022 26592362/26592263/26592365.The state regulator had seized stock worth Rs. 1.80 crore hand sanitisers and masks based on 10,339 inspections in the past one month.


The Central government had notified EC Order, 2020 to regulate the 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.