The National Pharmaceutical Pricing Authority (NPPA) has directed manufacturers, importers and suppliers of N-95 masks to maintain parity in prices for non-government procurements and make available the same at reasonable prices to curb black marketing.
The NPPA directive comes in the wake of grievances being received regarding hoarding and black marketing and differential higher pricing of N-95 masks in the country. “In the wake of the prevailing situation due to COVID-19, the government is striving to ensure uninterrupted supply of N-95 in adequate quantity of HCWs. For this government is procuring N-95 masks directly from the manufacturers, importers and suppliers at bulk rates and at ex-factory prices. However it has been noticed that other procurers (non-government entities) are getting N-95 masks at differential prices,” an NPPA order stated.
NPPA has also directed all the medical device industry associations like AiMeD, MTaI, CII, FICCI and PWMAI to follow the same.
In order to ensure availability of N-95 masks at affordable prices in the country, N-95 mask has been notified as an essential commodity under Essential Commodities (EC) Act, 1955 through a notification dated March 13, 2020. As per EC Act, hoarding and black marketing is an offence and punishable under the act. As per the drug pricing regulator, mismatch has been noted between demand and supply of N95 masks in the country. As per guidance issued by union health ministry and World Health Organization (WHO) for management of COVID-19, medical masks are meant for use of frontline healthcare workers (HCWs).
In view of the outbreak of COVID-19 in the country, union health ministry enacted the Disaster Management Act (DMA), 2005 with effect from March 13, 2020 throughout the country and directed all States/UTs to take steps to ensure sufficient availability of surgical and protective mask, hand sanitizers and gloves at prices not exceeding the maximum retail prices (MRP) printed on it.
The ministry of consumer affairs, food & public distribution also declared hand sanitizers and masks (2ply and 3ply surgical masks and N95 masks) as an essential commodity under the EC Act, 1955 for prevention of hoarding, black marketing and profiteering of these items.
Maharashtra Food and Drug Control Administration (FDCA) had submitted proposal to the ministry of consumer affairs, food & public distribution dated March 20, 2020 to fix the ceiling price for hand sanitizers and masks (2ply and 3ply surgical masks and N95 masks). Subsequent to which, the Ministry of Consumer Affairs vide notification dated March 21, 2020 fixed the ceiling prices of 2 ply mask, 3 ply mask and sanitizers to be effective till June 30, 2020.
However, demand of PPE kits, N-95 mask and its equivalent mask have drastically increased, so in the interest of public health and availability at reasonable rate to ensure sufficient availability, it is necessary to control the prices of these products also.
Following this, ministry of textiles through an order dated March 24, 2020 appointed nodal officers to regulate the production, quality and distribution for supply of masks, melt blown fabrics and other textiles supplies related to COVID-19 for supply of all types of medical protective textiles to the central government required to combat COVID-19. In the interest of public health and availability at reasonable rate to ensure sufficient availability of these products, Maharashtra FDA Commissioner Arun Unhale had written to NPPA to fix the ceiling prices of N-95 mask, its equivalent mask and PPE kits on top priority to overcome the outbreak of COVID-19 in the country.
In the current situation of COVID-19 outbreak the consumers are not aware about the exact MRP of these products and price printed by manufacturer is exorbitant and common public, private doctors, health workers and paramedical staff in private hospitals are forced to pay the said higher printed prices.