FDA identifies 120 distributors to provide PPE kits

FDA officials shared the list of around 19 PPE and N95 mask manufacturers with the FDA Minister


The Maharashtra Food and Drug Administration (FDA) has identified 120 distributors across all the districts of Maharashtra to provide personal protective equipment (PPE) in all district level hospitals in the state.

Taking serious view of the fact that PPE kits are to be made available to frontline healthcare workers in taluka and district level hospitals in the far flung and remote areas of the state, Dr Rajendra Shingne, FDA Minister took review of the availability of PPE kits with the Maharashtra FDA officials. FDA officials shared the list of around 19 PPE and N95 mask manufacturers with the FDA Minister and discussed to resolve the issue of availability of PPE kits in present COVID 19 situation.

Total 2562 inspections were done by Maharashtra FDA from May 14, 2020 to May 28, 2020 related to sanitizer, masks and PPE kits. Maharashtra FDA control room also resolved 42 cases of non-compliance to Drugs and Cosmetics (D&C) Act and Essential Commodities (EC) Act based on 148 calls received during this period.

Reports of unapproved PPE kits being sold at exorbitant costs ranging from Rs. 900 to Rs. 1,500 in the open market due to lack of effective price control policy and standards had earlier prompted health activists to suggest to the government to bring PPE kits under price control to curb unethical marketing. A PPE kit usually costs not more than Rs. 330. Cases of overcharging of PPE kits have been detected in Maharashtra wherein PPE kits were sold at three times its current cost to government and private healthcare institutions.

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As a major step towards indigenization and ensuring compliance to quality, government has kick-started indigenous manufacturing of PPE kits in the wake of rising cases of COVID-19 globally and in India. Department of Pharmaceuticals (DoP) secretary PD Vaghela has also stated that out of the total 2.49 crore N-95 masks order, 1.49 crore of masks have been ordered from domestic manufacturers.

There are around 101 mask manufacturers in the country. The total projected demand of N-95 masks till June, 2020 has been estimated to be 2.72 crore. As of now, about 49.12 lakh N-95 masks have been received and additional domestic supply in the next two months would be more than 1.40 crore.

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