BIS Starts Testing Of FFP2 Grade Masks At Venus Safety And Health, Panvel

Mumbai, 24 July 2020:

The Bureau of Indian Standards (BIS) has started indigenous FFP2 masks testing for quality control assurance at Venus Safety and Health Laboratory located at Panvel near Mumbai. These masks, also called respiratory protective device filter half masks, have been found to be effective to protect frontline healthcare workers from COVID-19 infection.

BIS has instructed Venus Safety and Health, Panvel to do testing of Made in India respiratory protective device filter half masks to protect against particles of Class FFP2 as per IS 9473:2002 under BIS supervision. “In order to ensure that quality products reach the consumer, BIS has instructed us to test masks based on its inspections of our lab done for quality compliance. We have adequate testing machines to do quality control on the samples provided to our lab. The lab is working under the supervision of BIS to ensure that quality products reach consumer on time,” informed Mahesh Kudav, founder & managing director, Venus Safety and Health Pvt Ltd.

BIS has directed manufacturers to expedite their licensing modalities to boost production and supply of FFP2 masks. It has given additional time period to new manufacturers to develop in house testing capabilities. It has circulated notices to all the concerned to apply for certifications and licenses so that indigenous masks could be manufactured with an ISI logo as a mark of quality compliance to meet the growing demand. Currently, there are N-95 masks in the market which are certified by NIOSH which is an American agency.

BIS has the mandate to come out with Made in India masks as per the government agenda of Self Reliant India.

The Occupational Safety and Health Act of 1970 established NIOSH as a research agency focused on the study of worker safety and health. NIOSH is part of the US Centers for Disease Control and Prevention (CDC), in the US Department of Health and Human Services.

BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods for minimizing health hazards to consumers.

Across the world, several national agencies, including the BIS, certify masks that meet IS:9473 standards. So even though BIS and the UK’s INSPEC certify so-called FFP2 masks, which are broadly equivalent to NIOSH’s N95, people often refer to FFP2 masks as N95 mask. It is recommended that gloves, coveralls and masks intended for medical use should conform to BIS as per Medical Device Rules 2017. This also complements the government’s self-reliant and Make in India campaign to boost domestic industry in the wake of COVID-19 crisis.

As of today, personal protective equipment (PPE) which include gloves, coveralls, goggles and masks are not being effectively regulated as medical devices as manufacturers have yet to get themselves registered voluntarily on the portal-cdscomdonline.gov.in- as per the mandate of Medical Device Rules, 2017. The Drugs Controller General of India (DCGI) has also recently issued an advisory to the PPE manufacturers to voluntarily register on the portal. PPE coverall is an important medical device for healthcare workers handling COVID-19 patients.

To promote the supply of quality PPEs during the ongoing pandemic, BIS in June permitted relaxation in its norms of having in-house testing facilities for the following PPEs like filter half masks to protect against particles of Class FFP2 as per IS 9473:2002, surgical face masks as per IS 16289:2014 and eye protectors as per IS 5983:1980.

This has been done to enable more manufacturers to be brought in the ambit of BIS product certification scheme, which will in turn result in greater quantity of BIS certified PPEs being made available to the users.

However, for such manufacturers, testing of samples for conformity to the specified requirements is being done in laboratories of BIS licensees who have in-house testing facilities, or in BIS recognized or empanelled private/government labs. Those domestic manufacturers who are interested in applying for a BIS licence may register themselves and submit their application online through BIS website ‘www.bis.gov.in’. Pharmabiz