Lack of clarity and centralisation of procurement exacerbate PPE crisis in Maharashtra

By early May, the tide of the coronavirus pandemic had long overwhelmed a woefully underprepared Maharashtra. On 9 May, Maharashtra recorded 20,228 COVID-19 cases, with 12,864 in Mumbai alone. Even as the state’s healthcare system struggled to accommodate the rising number of the infected, at least two government hospitals and eight private hospitals in the city saw outbreaks of the novel coronavirus among its healthcare workers, due to which some had to be sealed. This brought the desperate need to provide safety gear for front line medical staff into public view. But as the state government failed to address these concerns, doctors and other healthcare workers in hospitals of Aurangabad and Mumbai staged protests against the absence of sufficient personal protective equipment and the substandard quality of the kits supplied.

The catastrophic shortage in PPE had been weeks in the making. The manufacturing has been slowed by vague guidelines issued by the central government and the absence of standardisation in their make, despite the excessively complicated requirements listed by multiple authorities. The state government saw its wing clipped by the central government overriding its decisions and its lack of willingness to recognise the immediacy required in the state hardest hit by the pandemic. I spoke to several PPE manufacturers, who discussed the gridlock of confusion in the government’s requirements and lack of clear estimations of the number and quality of PPE required.

Rajesh Tope, the health minister of Maharashtra, had repeatedly expressed the need for the supply of PPE kits from the central government, since early April, when the state was still in the early stages of the contagion. On 7 April, in a public statement, the state government demanded 3.25 lakh PPE kits and nine lakh N95 masks from the central government. Ten days later, a frustrated Tope told the press, “We are getting supplies of medical essentials from the centre but it is not enough. For instance, we made a demand for 3.5 lakh PPE but received only 30,000.” Meanwhile, the state government itself has not been entirely transparent about its PPE requirements. On 5 April, Tope told the Indian Express that the state had “no dearth of equipment.” But in a video message circulated on 16 April, he said there was a shortfall of equipment in the state because it was not being delivered by the central government.

There has been a consistent lack of clarity about the quantity of PPE Maharashtra needs to deal with the crisis. On 1 May, Tope told the Hindustan Times that as per official estimates the state has 2.82 lakh N95 masks, 80,000 PPE kits and 3,000 ventilators. Five days earlier, Tope told the media publication Free Press Journal that the state government is examining the possibility of reusing PPE kits which points to a persisting shortage. From government reports it is clear that there is a shortfall in PPE and that the state has requested the central government to deliver more kits. It is, however, unclear how much of a shortfall the state faces and how the state is planning to estimate this shortfall. When asked about the shortfall, a senior official in the state’s health department who spoke to me on the condition of anonymity said, “As of now, for today’s need, it is sufficient, right? If you go for one week, 15 days down the lane, then we may need additional requirements. For that we are procuring from government of India or whatever source we can have.” I called and emailed Pradeep Kumar Vyas, the principal secretary of the state’s health department, asking about the shortfall of PPE in the state and the lack of standardisation in procurement, but did not receive a response.

Maharashtra’s issues with procurement of PPE are also due to the vagueness of government guidelines. As early as the first two weeks of April, PPE manufacturers received confusing and contradictory orders from the government. On 3 April, Maharashtra’s public health department released a circular mandating that any manufacturer, distributor or agent selling PPE in the state has to get its quality certified by Haffkine Bio-Pharmaceutical Corporation Limited. HBPCL is a state government undertaking that manufactures drugs and vaccines. An unnamed health official quoted in a Press Trust of India report with reference to the circular, said that the decision was necessary to reduce chances of virus spread among healthcare workers.

But six days later, the notification was cancelled. RM Kumbhar, general manager of the procurement cell at HBPCL, confirmed this. “The specifications have been given by the central government and PPE kit should be certified by SITRA, Coimbatore, or DRDE, Gwalior,” Kumbhar said. He was referring to the South Indian Textile Research Association, a testing laboratory for protective wear under the union ministry of textiles, and the Defence Research and Development Establishment, the nodal lab for the development of Chem-Bio defence technologies. “As per that specification and quality, the manufacturer can get their own certification and they can sell to the private or government,” Kumbhar said.

Government-approved PPE distributors I spoke to expressed dissatisfaction with the constantly differing directives released by the government. “Every two days, the government releases a new circular,” a PPE vendor, speaking on the condition of anonymity, told me. “Now they want SITRA’s approval, so we have sought SITRA’s approval. We already have the approval of the BMC,” he said, referring to Brihanmumbai Municipal Corporation. “But our samples have not been approved as per the new norms.” He was referring to a fresh set of guidelines announced by SITRA on 24 April, after his kits had already been approved by them under earlier norms.

The vendor, amid the confusion, has continued distributing PPE, reasoning that they already meet the guidelines released by HBPCL. He also said that the specifications mandated by certifying agencies do not match what the doctors need. “The circular released by central government’s textile ministry stated that the lamination should be 60 GSM and above. But doctors tell us that they feel too hot wearing it,” the vendor said. GSM refers to gram per square metre. The higher the GSM, more the weight of the fabric. “The central government should release circulars keeping doctors in mind and not just based on lab reports,” he added. He has delivered more than forty thousand PPE kits to hospitals in Maharashtra. Keeping up the supply chain, however, is now a struggle for the vendor.

In addition to the lack of clarity in the certification process, the system for distribution has been equally complicated. “For now, I take orders from under the health ministry, government of India,” a Mumbai-based manufacturer of coveralls, who requested anonymity, told me. “Then they distribute it in accordance with the needs of different states.”

Hindustan Latex Limited, incorporated under the union ministry of health, is in charge of the emergency procurement of PPE kits. HLL’s monopoly over distribution became a matter of controversy when the union ministry of health and family welfare issued a directive, on 2 April, to all states and union territories disallowing them to directly procure PPE. The directive stated, “State governments/UTs may not go for procurement of crucial medical equipment like PPEs, N95 masks and ventilators and that these should be procured centrally by ministry of health & FW and distributed to the states.” Maharashtra was among the states that protested the decision as an overreach by the centre. The official in the state health department said the circular had been advisory in nature. “As far as I know, they never said that state government cannot procure. They said state governments need not procure because we are procuring in enough quantities, we will be supplying to you, so why do you need to hurry into procurement? They never prohibited anybody. But they said we will be providing you enough.” However, if the circular was advisory in nature as the official claimed, it is not clear why several states including Maharashtra protested against the move. The 2 April circular seems to have been consequently withdrawn; and is no longer available on the MoHFW’s website. It is unclear why it was withdrawn. On 7 April, the ministry unveiled the “India COVID-19 Emergency Response and Health System Preparedness Package,” which allowed states to procure PPEs and N95 masks “over and above what is being procured and supplied by the govt of India.”

Experts have argued that the central government’s attempt to centralise procurement is not only short-sighted, it also overestimates their abilities. “The central government has no capacity to actually process all the requests for PPE,” Amar Jesani, a doctor and researcher in public health and bioethics, said. “They have to be decentralised. They have to give resources at the ground level. Not even Maharashtra government level. It has to be at the district and sub-district level.” Given the size of the country, the varying levels of spread in each state and the participation of government hospitals, large corporate hospitals and NGOs, a one-size-fits-all solution is not practical. Jesani told me that in several places, NGOs were left with the responsibility of mobilising resources, including protective gear, for healthcare workers, and that the central government’s plans are unlikely to properly deliver gear at that localised a level.

According to Kumbhar from HPBCL, each district’s administration has certain decision-making powers with regard to the procurement of kits. “At present, all district collectors have been given the powers to decide rates at their level depending upon the situation, transport and other things. They have been given some guidelines,” he said. He added that this would mean that the cost of PPE kits would differ depending on the location of the manufacturing unit and how far it needs to be transported. On 24 March, the Maharashtra government’s health department released a notification allowing district collectors in the state to procure medical equipment. The notification required all procurement to meet the rate lists mentioned in the tenders released by HBPCL, Brihanmumbai Municipal Corporation, HLL, Karnataka Antibiotics and Pharmaceuticals Ltd—a government owned pharmaceuticals manufacturer based in Bengaluru—or the “medical service corporations” of other states. The senior health official who spoke to us said that a price rate for public procurement of PPE had not been set yet. “We have not at all encountered this thing because as of now we are getting the supply from government of India,” he said. “In future, if we go for procurement, if need would be, we would see that it should be priced appropriately. Some basic price benchmark would be arrived at. And we will obviously check the quality of the products.”

Even with the requisite approvals, there is no uniformity in the quality of PPE kits manufactured by certified agencies, the owner of a PPE manufacturing company, who wished to remain anonymous, told me. The manufacturing company already had SITRA’s certification for its PPE gowns and on that basis, HBPCL had approved it before 9 April for production for the COVID-19 crisis. “There is absolutely no standardisation,” the manufacturer said. “Our kit has N95 masks. Others have three-ply masks. We have nitrile gloves. Many others sell latex gloves which are uncomfortable for doctors. Also, our leggings are knee-length. But others make shoe covered that are ankle-length which makes no sense as it exposes the part above the ankles.”

The company supplies PPE kits in both Mumbai and Pune, epicentres of COVID-19 in Maharashtra, and even places as far as Sangli district, in southern Maharashtra. Transporting the kits was an issue in the beginning, he told me. “But DTDC”—Desk to Desk Courier and Cargo—“and Blue Dart have resumed services now,” he said. “It has become slightly easier. And this is so urgent as cases continue to rise.”

Government authorities were quick to shun responsibility for the variation in the quality of PPE kits in the market. “That is the responsibility of the purchaser, no?” Kumbhar said. “I don’t know about private, but under government, there is a committee that will verify the documents as per the specifications given by ICMR,” he said, referring to the Indian Council of Medical Research. “The purchase committee is physically verifying the kit along with the documentation. I don’t think somebody is procuring without it. If the staff gets the infection by any means, that is the responsibility of the management.” Though HBPCL is no longer a certifying authority, the public-sector company is still handling the procurement for government hospitals in the state. In government procurement for zilla parishads, civil hospitals and medical colleges in the state, too, there did not seem to be any standardisation. “We have supplied near about 3,85,000 N95 masks and near about forty lakhs three-ply masks,” Kumbhar told me, when we spoke over the phone on 26 April.

While Kumbhar said that no hospital will take the risk of purchasing substandard kits for their own staff, due to the shortfall, there are healthcare workers who are willing to compromise on quality as long as they can access any kind of protective wear. “Doctors have purchased in desperation,” Avinash Bhondwe, the president of the Indian Medical Association’s Maharashtra chapter, said. “Whatever is available, they are wearing it. It is not protecting them. That’s why so many doctors are getting infected. People don’t understand, they just see the price and purchase. 400 ka hai, le lo”—It is for 400, buy it. “It is only of 20 GSM, it won’t help you,” he added.

The lack of standardisation in PPE kits is a major worry for frontline health workers. “There is no shortage of PPE kits now. But sometimes, we get good PPE and sometimes we don’t,” a nurse who works in the COVID-19 ward of one of the busiest private hospitals in South Mumbai, who requested anonymity, said. “We ask the management to give us good quality ones. It comes from different companies. The name of the companies are not there on the kits we get, nothing is mentioned.” She was referring to the lack of any label on the cover of the kits to identify whether they were certified. Certified kits are supposed to have a unique certification code and a sticker as mandated by the union textile ministry. The nurse said that they had gotten low quality PPE kits several times and had raised the issue with the hospital’s administration.

On 8 April, Bhondwe and other IMA members in Maharashtra had a meeting with the state’s health minister. “We informed all our members in Maharashtra that we will only purchase whatever is authorised by the government. Authorised, standardised, subsidised, all these things are important,” Bhondwe said. He added that the IMA also asked for an “anti-germ layer” to be added to PPEs during their discussion with the minister. Bhondwe on 21 April, said he was optimistic about the government’s procurement efforts, stating that the manufacturing norms have been clarified and the issues should be resolved soon. He also pointed out the need for healthcare workers to be trained in how to correctly wear PPE. “It is a life-saving material. The cost of protection cannot be measured in money,” he told me.

Doctors and nurses directly dealing with COVID-19 patients have been at the centre of conversations surrounding the shortage of PPE kits. Those working in non-COVID areas of the healthcare sector are hardly taken into account while measuring the requirements of PPEs, Brinelle D’Souza told me. D’Souza is a member of the Mumbai chapter of Jan Swasthya Abhiyan—the Indian wing of the People’s Health Movement. “I could go to the hospital for some routine ailment and I could be an asymptomatic carrier,” she said. “I could transmit that infection to someone else, especially the healthcare provider who is interacting. So, the supply is not even. There is almost exclusive attention now with the limited resources towards the COVID response. The non-COVID areas is where the shortfall really is. It gets more acute when it comes to class four employees.” Class four employees such as ambulance drivers and cleaners are often the poorest paid in hospitals and are usually the first point of contact for patients.

D’Souza said that decentralisation of the procurement of resources was required, citing an account of a resident doctor at a Mumbai hospital. “He said that the local hospital doesn’t have a say in determining the actual quantity of PPE,” D’Souza told me. “It is being directed from above, at the state level or to a centralised agency. Now the centralised agency is not really getting feedback from the ground. It is basically doing an allocation based on its wisdom.” D’Souza added that the Maharashtra government is far too dependent on the central government’s guidelines. “They simply don’t have the ear-on-the-ground response that is required.”