The Association of Indian Medical Device Industry (AiMeD) has sought National Pharmaceutical Pricing Authority (NPPA)’s intervention to exercise its powers under the Essential Commodity (EC) Act and National Disaster Management Act (NDMA) to reduce prices of melt blown face masks so that this could result in cost reduction and ensure availability of quality masks for C-19 infection control at rational prices.
Every N-95 mask has 6 to 7 grams of melt blown fabric, so the direct cost of melt blown in the N-95 masks in the second quarter of financial year was Rs. 13 to Rs. 15. Every Rs 500 decrease/increase in price of melt blown impacts cost of N-95 masks by approximately Rs. 3.
“As a part of its representation, medical device manufacturers have shared AiMeD’s Report on IS:9473 Masks for NPPA for Price Controls with Shubra Singh, Chairman, NPPA and Secretary, Department of Pharmaceuticals (DoP) and Chairman of Empowered Committee of Essential Medical Equipment,” informed Rajiv Nath, Forum Coordinator, AiMeD.
Rational price cap fixation at national level will help protect consumers and take way the need to cap prices by individual states. Recently, Maharashtra capped prices of face masks towards making quality available in interiors pockets of the state. Price is also related to quality. Therefore, comparison of the various standards of N-95/IS 9473 equivalent masks also need to be considered for enabling better understanding.
For C-19, the recommended quality which would be safe for healthcare workers is a combination of N-95/IS 9473, FFP2 Masks and 3 Layer. IS 16289 Masks for splash resistance and bacteria filter tests with a higher filtration performance test of 95%. Until the Bureau of Indian Standards (BIS) IS 9473 standard is upgraded, the recommended standard is IS 9473, FFP2 Masks for medical use.
“Considering the large variety of imported masks and indigenous masks variations, the recommended pricing control strategy by AiMeD is aimed at basing the maximum retail price (MRP) at a maximum range of 3 times from the current ex-factory price (including GST) or the imported C&F Price of the N-95 or IS 9473 variants so that all variants can be freely available in supply chain and can co-exist, the AiMeD report recommended.
Government through HLL has reportedly been procuring and buying variety of N95 equivalent indigenous masks at Rs. 50 plus GST, N99 at Rs. 68 plus GST and imported 3M at Rs 66 plus GST with Honeywell mask at Rs. 77 plus GST.
The prices could have fallen more but for the high inflationary cost – logistics cost / lockdown challenges and runaway melt blown costs where the material price had initially gone up from Rs 215/kg in February to Rs.2,200/kg in the 2nd quarter and fell drastically in 3rd quarter as capacities got augmented by the suppliers. The IS 9473 Standard covers FFP1, FFP2 and FFP3 Masks which are for industrial pollution safety purpose but of these, the FFP2 has become the preferred choice in medical usage for C-19.
The masks which are having an intended medical usage are covered under definition of medical devices and are under regulations of Drugs and Cosmetics (D&C) Act with effect from April 1, 2020 and voluntary registration and compliance to medical device rules (MDR)- 2017.
The risk classification for the 3 layer surgical IS 16289 masks or the FFP2 IS 9473 masks has still to be defined by the drugs controller general of India (DCGI) but in US FDA there are treated as Class I for 3 layer masks and for N-95 masks also as Class I and similarly as Class I for 3 Layer Masks and Class I for N-95 masks in EU – CE.
Considering that these are under the Drugs Act w.e.f. 1st April, 2020 the 3 layer and FFP2 masks are also covered under the jurisdiction of NPPA and the DPCO.
The other masks of FFP1 which are not for Medical Use, will be under the jurisdiction of the Packaging Rules under Legal Metrology – Weights and Measures Act (for Consumer Protection) under the Department of Consumer Affairs.