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AiMeD asks to Maharashtra govt to rationalise price capping of N95, FFP2 face masks

Shardul Nautiyal, Mumbai
Friday, November 6, 2020, 08:00 Hrs  [IST]

The Association of Indian Medical Device Industry (AiMeD) has written to the Maharashtra government to rationalise price capping of N95, FFP2 face masks contesting that the prices fixed are too less, not workable and impractical as this may end up asking companies to supply sub-standard and out of specifications products endangering patient safety.

“If the mask may be of inferior quality, it may not protect healthcare workers from COVID-19. While your intentions are seemingly correct to seek to protect consumers and access to reasonably priced product with standard and high quality, the proposed prices need to be rational for good quality manufacturers to focus on manufacturing of quality products for sales in states other than Maharashtra,” the letter stated addressed to Dr. Pradeep Kumar Vyas, Principal Secretary (Public Health), Government of Maharashtra.

Maharashtra government on October 20, 2020 notified prices of masks based on state government constituted expert panel report to study manufacturing cost of masks in consultation with Maharashtra Food and Drug Administration (FDA) and major mask manufacturers, Venus Health and Safety Pvt Ltd and Magnum Health and Safety Pvt Ltd. This was done in view of the violations in sale and manufacture of face masks during the ongoing COVID-19 pandemic.

The panel headed by state health insurance CEO Dr Sudhakar Shinde also discussed interventions it made to reduce profiteering during the COVID-19 pandemic. 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.

Bureau of Indian Standards (BIS) has laid of specifications as to what is specification for a good mask. ISI is the pride of the nation but you have chosen to give more credibility to NIOSH which belongs to USA and inadvertently discredited the Indian organization like BIS which is run by the ministry of consumer affairs, Government of India. The ISI mark is a standards-compliance mark for industrial products in India since 1955. The mark certifies that a product conforms to an Indian standard developed by the Bureau of Indian Standards, the national standards body of India.

NIOSH develops numerous standard test methods for evaluating the performance of respiratory products. It regulates and certify products is 42 CFR Part 84. The FFP standards are mechanical filter standards used for protective respirator masks certified by the European Union. FFP-standard filters serve to protect against particulates such as dust particles, droplets, and aerosols. The EN 149 standard defines three classes of filter efficiency.

IS 9473 and N95 face masks have 95% filtration capacity whereas FFP2 face masks: 94% filtration capacity. While IS 9473 face mask falls under BIS, N95 face masks is associated with the American Association for Laboratory Accreditation and FFP2 face mask is associated with European standards.

“When these standards are same and fixed by different governments, ISI by Indian Government and NIOSH by American Government, then the question arises, why a preference is given to NIOSH over ISI especially when ISI is better? It regretfully sends a wrong message to the entire country, not to trust ISI mark or BIS. It seems that the standards fixed by BIS are substandard compared to NIOSH or European standards. It is a direct attack on the credibility of BIS and is akin to asking Indians to seek a US driving license to drive in India. Therefore it has been requested intervention on the same urgently,” questioned Rajiv Nath, Forum Coordinator, AiMeD.

There is a standard practice that MRP has to be at least over 3 times of ex-factory cost of below Rs.1,000. Medical devices to ensure that goods reach the last mile or they will be actual shortage of stocks in rural interiors at a distance from urban centres as traders will be unwilling to absorb the transportation and inventory carrying costs. This is a prevalent trade practice for last decade or so. It depends as per the expenses one has to incur to sell the product to consumer.

“We request an urgent consultation meeting with manufacturers and an amendment of this notification because of the following reasons and queries being raised by our members like MRP fixed by Maharashtra government is not workable at all, why there is a differential MRP for the same product. It is shocking to know that specific company’s name and product codes have been included in the list of MRP as if due protection has been given to those companies,” Nath stated.

“It is pertinent to note that different governmental organizations have bought masks from Venus and Magnum at higher prices than the suggested retail prices. MRP of N95 to be made at least Rs. 75/- or 3 times ex-factory price and similarly the MRP of surgical 3 layer mask to be 3 times the ex-factory price (including GST). Kindly look into this matter and get the notification amended on urgent basis or call a review meeting,” stated the AiMeD letter.


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