Dev 360 | A quality challenge for Atma Nirbhar Bharat

In the time of war or a pandemic, each country looks out for its own first. It comes as no surprise that the rules of global trade went out of the window between February and April this year with nations fighting one another to secure supplies of personal protective equipment (PPE).

India faced an acute crisis in the early weeks of Covid-19 as it was hugely dependent on imports for critical supplies of medical products, including PPEs. Much has changed since then.

The coronavirus pandemic has spawned a cottage industry in PPEs, hand sanitisers, masks, etc. India is now the second largest manufacturer of PPEs, after China.

Amid a global shortage and the world’s strictest lockdown that ground all production to a halt, barring that of essential items, many garment makers, for example, sensed a big opportunity and got into the protective wear space.

Now, there is an oversupply of indigenous PPE kits. Many are unsold. And prices have dipped.

Worryingly, there is another more serious problem. Atmanirbharta, or self-reliance, is facing a quality challenge in the protective gear market.

There has been a flood of complaints about low-quality PPEs, sanitisers, gloves and so on, raising concerns about the impact on India’s public health response to Covid-19 and infection control strategies.

This week, the Directorate-General of Foreign Trade issued a notification which said that the government had not found any applications from July 1 to 3 seeking to export PPE medical coveralls meeting the necessary criteria, and “all applications therefore have been found ineligible for allocation of export quota.” Last month, the government had decided to shift the export of PPEs from the “prohibited” to “restricted” category, with a permissible limit of 50 lakh kits.

Till the time of writing, no export licence has been issued. The Centre has given a new deadline to local PPE makers to put in their applications for approval of exports.

What is happening? What exactly is the problem?

Several health professionals I spoke to said while it was very creditable that India had managed to shed its import dependence on protective wear and certain medical products in barely two months, the mad rush to step up production had opened the floodgates to many fly-by-night operators who had skipped all quality norms. This, they said, posed a serious challenge for the domestic and export markets.

At the heart of the matter is the lack of standards.

The Central Drugs Standard Control Organisation has not defined any classification of PPE components intended for medical use, says Dr Sanjeev Relhan, chairman of the Preventive Wear Manufacturers Association of India (PWMAI).

Without classification under Medical Device Rules, it is not possible for the industry to understand the applicable regulatory requirements.

There are additional challenges. There are few testing laboratories to validate quality and even after an increase in their number, “these labs are not sufficient to enable manufacturers to follow global standards”, says Dr Relhan.

What needs to be done?

Even in a healthcare setting, everyone is not at equal risk. Dr Relhan and many others are seeking guidelines for choosing the right PPE after risk assessment for various levels of protection.

Another looming challenge is disposal of protective gear. Currently, there is no formal standard for the safe disposal of soiled PPEs. This can lead to a further spread of infections. “Hence, a standard for safe disposal of bioprotective PPEs is required on an urgent basis,” says PWMAI’s head.

What about exports?

Sections of the local protective gear industry want to tap the export market now that domestic demand has been met, but many insiders strike a cautionary note. Dr Relhan points out that the regulations of the importing countries are stringent, and the industry first needs to meet these quality standards. He says the government should allow the export of PPEs meant for medical use only after regulating the quality protocols required for manufacturing.

Since a large number of PPE manufacturers are in the MSME (micro, small and medium enterprises sector), the MSME ministry and state governments should support them financially by bringing in a scheme for funding technology upgradation, counselling and training for both the Medical Devices Rules 2017 (India’s new rules for medical devices) as well as global regulations, especially those of the United States and Europe, and the certification costs.

What about strict quality norms for domestic sales?

No doubt, we can’t afford to risk our reputation in the export market by sending out products which don’t meet international quality norms. The cautionary note struck by the DGFT is welcome. But it is equally important to ensure that Indian doctors, health workers and ordinary citizens are not at risk through use of low-quality protective wear, sanitizers, etc.

“Prof. Arvind Baronia, head of critical care, Sanjay Gandhi Post-Graduate Institute of Medical Sciences, Lucknow, said the facility returned 60-70 per cent of the PPEs supplied. It is difficult to spend even a few minutes in those made from cheap non-woven fabric with polyethylene lamination…” a recent report in the Indian Express noted.

Established manufacturers of infection-prevention clothing say that a regulatory mechanism must be in place for purchases by healthcare establishments to check the practice of buying substandard products. Hospitals should not become amplifers of infection.

Last year, the Niti Aayog, the government’s think tank, proposed bringing all medical devices under one regulatory regime in a phased manner and to have a separate Medical Devices Administration with four divisions. That plan is yet to materialise.

Arguably, low quality in protective wear is not just an Indian problem. Last month, Doctors Without Borders (Médecins Sans Frontières), which won the Nobel Prize in 1999, publicly urged for better regulation to ensure that personal protective equipment is distributed in an equitable and transparent manner during the ongoing coronavirus pandemic.

“The market for personal protective equipment is dominated by a lack of transparency about what is being produced and where, its quality, the amount in stock, and how they are allocated,” said MSF’s Thierry Allafort-Duverger.

The bottomline is that regulation can’t be a cuss word if PPE makers in India wish to nurture a reputation for quality and plug into global supply chains. The global PPE industry is expected to touch $92.5 billion by 2025. There may be a ready market for protective wear.

But to get a juicy slice of that, Atmanirbharta and “Make in India” must meet its quality challenge at home as well as abroad.