In order to raise compliance to medical device norms, the Maharashtra Food and Drug Administration (FDA) is planning to sensitise mask manufacturers on expediting registration on online Sugam medical device portal as per Union health ministry directive in accordance with new Medical Device Rules (MDR) -2017.
This comes close on the heels of over 150 cases of price violations of face masks being detected since the state government price capping notification on masks dated October 20, 2020.
According to officials, violations can be attributed to the fact that masks have not been notified as yet as a medical device. Besides this, the said notification is pending because manufacturers have to first register themselves on the online Sugam medical device portal on or before October 2021, as per Union health ministry directive in accordance with new MDR-2017.
The Maharashtra government for the first time in the country had to notify prices of masks amidst rampant violation of Essential Commodities (EC) Act and Disaster Management Act (DMA), The Drugs Controller General of India (DCGI) had earlier directed manufacturers to voluntarily get registered on the Central Drugs Standard Control Organisation (CDSCO) medical device online portal –cdscomdonline.gov.in to monitor quality of masks in the country. The registration will secure the manufacturers a registration number from the CDSCO, which will, reportedly, also be a quality management system benchmark.
Around 3,938 inspections were carried out in a special drive with the close coordination of 24 assistant drug commissioners and 78 drug inspectors (DIs) across Maharashtra in which cases of violations were detected. DIs in the state have been directed to enhance inspections in wholesale and retail premises to curb overcharging following price capping notification of masks by the state government recently.
The price capping exercise was done on the basis of State health insurance CEO Dr Sudhakar Shinde led state government constituted expert panel report which was finalised in consultation with Maharashtra FDA and mask manufacturers.
As per the new rates, an N-95 mask would cost between Rs. 19 to Rs. 45 depending on its kind, while a 3-ply would cost Rs 4 and a 2-ply mask Rs. 3. At present, an N-95 mask costs Rs. 150 to Rs. 600 in the market, while a 3-ply mask costs anywhere between Rs. 20 to Rs. 40.
Maharashtra FDA had conducted 1945 inspections related to masks in the month of June and July with a major crackdown on establishments for selling N95 masks at exorbitant prices. It raided premises of establishments selling reputed brands of N95 masks at higher rates despite price control. Brands included Venus, Magnum and 3M, among others.
DCGI had also earlier asked manufacturers, importers and suppliers of the N95 masks to maintain parity in prices for non-government procurement and make them available at reasonable prices.
The state government move to fix prices of masks comes close on the heels of raids.