‘Your N95 Mask, PPE Kit May Be Unsafe’: Top Quality Control Expert

Video Editor: Purnendu Pritam

Ever since the COVID-19 pandemic has hit us, the markets are flooded with protective health gear such as masks, PPE kits, gloves, face shields, etc.

But do these health wearables undergo proper quality checks in India before they are sold in the market?

Are manufacturers of protective health gear penalised for selling substandard masks or PPE kits?

The Quint spoke to Anil Jauhri, former CEO of the National Accreditation Board For Certification Bodies (NABCB) and Bureau of Indian Standards (BIS), to answer these questions.

Jauhri points out that masks, PPE kits, gloves which are now part of our lives are still not regulated by the government of India due to which health gear sold in the markets could well be of questionable quality.

Since protective wear such as PPE kits are worn primarily by our healthcare and frontline workers, if such products cannot be legally held to a stipulated standard, it puts all such professionals at a serious health risk.

“It is unfortunate that protective medical devices (masks, PPE kits) have remained unregulated in India. It will take India at least 15 months more to start regulating masks and PPE kits.”

Anil Jauhri, Ex-CEO NABCB; BIS

Here is what he said:

Do we have proper quality checks on medical devices like masks and PPE kits at the moment?

Medical devices like PPEs are regulated in most developed countries. But in India we are still an unregulated market. Unlike medical drugs, a manufacturer needs no licence to make N95 masks. Medical devices have not got proper attention from successive governments

What should a consumer look for while purchasing an N95 mask to be sure of its quality?

A consumer must look for the ISI mark on N95 mask packaging.

Does the Union Textile Ministry have strict quality parameters in place for manufacturers of masks or PPE kits?

The Textile Ministry started a quality assurance program in 2020. It said that PPE kits & masks must get a nod from the Bureau of Indian Standards (BIS). But BIS clearance is still not a legal requirement. Until a law says you cannot make product X without a license, it remain a voluntary act, which some may ignore.

Since medical devices are not regulated, what are the problems that we are facing right now?

It is a free market, anybody can start manufacturing or importing (masks, PPE kits) and start supplying in the market. There is no legal bar in doing so.

Regulating medical devices is important? Why has it not been done in India?

There has been a reluctance on the part of the government and a lack of realisation that health and safety related products should be regulated. The process to regulate them has now started but it takes time. India will take at least 15 months before it starts regulation of masks and PPE kits.

During the pandemic shouldn’t it have been done on a fast-track basis?

Under the Disaster Management Act and Epidemiology Act, there are provisions that enable you to act in an emergency. Government should have thought of fast tracking the regulations on these products because they do affect safety. Specially for N95 masks and PPE kits which are used by healthcare workers who are at maximum risk. A defective mask or kit could have major consequences for them.

Are government agencies and hospitals aware of BIS certification?

Many of the government agencies themselves are not aware (of the BIS certificate). In the absence of regulation, it is safest to inquire about BIS certification.

But can’t BIS certificates or ISI marks be forged?

With BIS certification people might still play dirty. BIS is not policing everybody. It operates on a certain system of trust. I have been in BIS for 26 years before I came to National Accreditation Board for Certification Bodies (NABCB). I have handled issues of ISI marks and raids.

People with BIS certificate may also supply sub-standard but that is the best protection at the moment.

BIS has a system of periodic checks in the factory, buying samples in the market and so on, but there are still ways of beating that. In the Indian market integrity at all levels is poor.

Masks and PPE Kits are the most crucial amongst all the protective gear available to frontline workers. Since most of these products are still not being put through rigorous and mandatory quality checks by the government, it raises serious concerns about their effectiveness.

Yet another 'sarkari' miss in the fight of COVID-19 pandemic.