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Thursday, July 09, 2020

N-95 masks: Pharma price regulator pushes for BIS certification

The National Pharmaceutical Pricing Authroty has also advised manufacturers and importers to bring down the Medical N 95 mask retail price in public interest due to pandemic conditions prevailing in the country.

Written by Navjeevan Gopal | Chandigarh | Published: June 29, 2020 2:08:47 am
Coronavirus cases, N95 masks, BIS certification, Pharma price regulator, Punjab news, indian express news As per NPPA, following its advisory, Mumbai-based Venus Safety & Health Limited (BIS certified) revised MRPs of various types of masks it manufactures. (Representational)

Pointing out that “non-standard” medical N 95 masks are being supplied in the market, the National Pharmaceutical Pricing Authroty (NPPA) in an office memorandum has “advised” manufacturers to obtain the requisite certification from Bureau of Indian Standards (BIS) expeditiously.

The June 23 memorandum which re-iterated that with effect from April 1 Maximum Retail Prices (MRPs) of Medical N 95 masks shall be monitored under Drugs Price Control Order (DPCO) to ensure that no manufacturers/importers can increase the MRP more than 10 per cent of the MRP during the next 12 months also read, “Further, it has been observed that non-standard Medical N 95 masks are being supplied in the market. In this regard, it is stressed that Government promotes selling of certified Medical N 95 masks (BIS/NIOSH/FFP-2) only. The manufacturers of Medical N 95 Masks are hereby advised to obtain the requisite certification of Bureau of Indian Standards (BIS) expeditiously.”

The NPPA has also advised manufacturers and importers to bring down the Medical N 95 mask retail price in public interest due to pandemic conditions prevailing in the country. It noted that eight major manufacturers and an importer of N 95 masks reduced the prices up to 67 per cent in about a month’s time after a government advisory.

The manufacturers and importers revised the prices between May 23 and June 20 in varying degrees.

As per NPPA, following its advisory, Mumbai-based Venus Safety & Health Limited (BIS certified) revised MRPs of various types of masks it manufactures.

For instance, for N95: 4400 Fold flat style A -US approved product, it revised MRP from Rs 160 in April to Rs 125 on May 26 and for N95-724 Beetle style with Vent valve from Rs 250 to Rs 165, correspondingly. Chandigarh-based importer Shamshree Lifesciences Ltd reduced the price of FFP-2 category mask from Rs 450 to Rs 270 from June 1 onwards. Ahmedabad-based Z Plus Disposable reduced the MRP of Disposable Mask FFP-2 from Rs 199 to Rs 65 from June 11 onwards.

On June 20, Coimbatore Midas Safety Private Limited (BIS certified) reduced the prices in two product categories from Rs 195 to Rs 125 and from Rs 220 to Rs 150. The NPPA has asked all the manufacturers/importers of Medical N 95 Masks to submit information about MRPs for the months of April and May and till June 22. apart from furnishing other details.

Ludhiana-based Paayas Incorporation owner Ashwani Garg said, “We have received the proforma and submitting the details soon.”

Paayas Incorporation got the BIS certification for the manufacture of FFP1 and FFP2 masks with or without valve, single use without resistance. Garg said FFP2 mask was equivalent to N 95 mask and Paayas Incorporation was the only manufacturer in the region to have received the BIS certification. Punjab Industries and Commerce Director Sibin C confirmed that Paayas Incorporation had received the BIS certification.

FFP2 better than N 95: BIS

In an official email accessed by The Indian Express where it was asked to clarify whether FFP2 (filtering face piece) certification given to a mask under BIS standards was deemed technically equivalent to N95 certification under NIOSH (National Institute for Occupational Safety and Health) standards, a BIS functionary recently noted that “FFP2 are technically better compared to N95 for protection against particular hazards”.

The functionary while referring to comparison of “existing Indian Standard IS 9473:2002 with the latest EN 149: 2001 (Along with its Amendment No. 1 dtd 2009), NIOSH 42CFR84 and ISO standards” concluded that “Requirements for FFP2 are more stringent compared to N95 because FFP2 requires 94 per cent filtration efficiency at 95 l/min whereas N 95 requires 95 per cent efficiency at 85 l/min”. The functionary pointed out that penetration increased and efficiency decreased at higher flow rates.

The functionary also pointed out that total inward leakage was “not prescribed for N95, whereas it is tested for FFP2” and that “clogging and flammability are tested for FFP2 whereas they are not tested for N95”.

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