Experts Ask Govt To Develop Harmonized Standard For Community Face Mask

Mumbai, 19 Jan 2021:

Experts have recommended to the Union health ministry and Bureau of Indian Standards (BIS) to develop harmonized standard for community face coverings or ordinary cloth/fabric masks used by communities or common public to control Covid-19 in a more effective way.

This according to them is a relevant step and need to be done on priority as European Union (EU) is currently working on harmonized standard for community face coverings.

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 or patients.

The Union health ministry’s guidelines on personal protective equipment (PPEs) as of today do not specify the need to get the BIS certification except for 3-ply masks. As of today, community face masks are not subject to a mandatory requirement of conformity assessment by notified bodies or laboratories.

This comes close on the heels of union health ministry’s guidelines to adopt Covid-19 protocols and behaviour following the national vaccine rollout programme aimed at covering 3 crore beneficiaries including frontline healthcare workers.

It has also been recommended that community face masks besides satisfying the criteria of safety should also take care of breathability with reference to World Health Organisation (WHO) guidelines on airborne transmission of Covid-19. N95 masks can be hot and humid on the face and recent research has found that when one wears an N95 mask, one can breathe in 5% to 20% less oxygen than normal unfiltered air and higher proportions of carbon dioxide being exhaled in the process.

There are two types of masks which are recommended for various categories of personnel working in hospital or community settings, depending upon the work environment - Triple layer medical mask and N-95 respirator mask.

It is recommended to add BIS in health ministry guidelines. This will give industry choice and adherence to compliance levels based on certification by notified bodies until new MDR regulations are effectively implemented. Since Medical Device Rules (MDR) -2017 uses the concept of notified bodies, certificates of conformity from any notified body of the Central Drugs Standard Control Organisation (CDSCO) should be acceptable.

As of today, PPEs are not being effectively regulated as medical devices as manufacturers have yet to get themselves registered voluntarily on the Drugs Controller General of India (DCGI) portal-cdscomcdonline.gov.in as per the mandate of new MDR -2017.

To regulate the production of PPEs among Indian manufacturers in line with the specifications of the WHO and the union health ministry, the government issued a notification on April 6, 2020. Conformity to BIS as per MDR 2017 will complement the government’s self-reliant and Make in India campaign to boost domestic industry in the wake of Covid-19 crisis.Pharmabiz