In January, when India began its Covid-19 vaccination drive, several companies that manufacture syringes wrote letters to the health ministry, highlighting the need for the government to allow the use of conventional disposable syringes in the campaign.

Since 2005, India’s mass immunisation programme has used only auto-disable syringes whose safety locks break off after a single use, ensuring they are not reused. Conventional disposable syringes, on the other hand, can be reused, posing a risk of infection.

In their letters, the manufacturers noted that India lacked the capacity to produce the volume of auto-disable syringes required for the Covid-19 vaccination programme. Later in January, the health ministry invited them for a meeting.

“But nothing happened beyond that,” said Deepak Arora, the managing director of Bio-Med Healthcare Products Ltd, a company that makes conventional disposable syringes. “Officially, no orders came. We could not block any quantity for the government or scale up capacity.”

On July 1, as India’s Covid-19 vaccination drive was intensified, the government invited bids for 125 crore auto-disable syringes. It did not get enough bidders and was able to place just one order for 10 crore syringes.

The same month, the government finally did what the manufacturers had asked for in January – it relaxed the criteria to allow bids from even companies making conventional disposable syringes and invited bids for 90 crore syringes.

But by then, many companies had already made export commitments to other countries.

Export restrictions

Of the 90 crore syringes the Indian government sought, it was able to place orders for only 68 crore-70 crore, said several manufacturers who participated in the process. Senior government officials involved in the procurement process declined to comment on the number of syringes procured.

The shortfall eventually led to the government restricting the export of syringes last week – a move that has sparked concern around the world since Indian manufacturers export syringes to 149 countries, many of which are dependent on these instruments for Covid-19 vaccinations and other medical needs.

In India, the shortfall led to Covid-19 vaccinations being temporarily halted in cities like Pune and Kochi for a day each.

The government has justified the export curbs, arguing it needs to prioritise the needs of India’s people. “The export restriction is temporary, to help create a stock of syringes,” a senior official from the health ministry said, on condition of anonymity.

But has examined correspondence sent to the government by syringe-makers, as well as a series of tender documents issued this year. They suggest that Indian manufacturers could have met India’s needs and supplied to other countries as well if the government had assessed domestic demand and availability of auto-disable syringes and placed advance orders for conventional ones.

“We have been raising red flags since last April,” said Rajiv Nath, managing director of Hindustan Syringes and Medical Devices Ltd, the world’s largest auto-disable syringe manufacturer. sent an email to the health ministry on Friday asking for comment on the situation. There was no response till the time of publication.

Manohar Agnani, additional secretary in the Ministry of Health and Family Welfare, who oversaw the procurement process, and Suresh Puri, who heads the Central Medical Services Society, an agency under the ministry that issued the tenders, declined to comment on the syringe purchases that were made. But the senior official in the ministry, who did not want to be identified, insisted that they had been “in regular touch with manufacturers” and that the country had no shortage of syringes.

A health worker inoculates a student with a dose of the Covishield vaccine in Chennai on September 19. Credit: Arun Sankar/AFP

India has more than 20 syringe manufacturers that have capacity to produce 50 crore syringes per month. These syringes vary in size from 0.5 ml to 60 ml. But only three of these companies are capable of producing auto-disable syringes – Hindustan Syringes and Medical Devices Ltd, Iscon Surgicals Ltd, and Becton Dickinson India Pvt Ltd. Together, they can produce fewer than 15 crore auto-disable syringes per month.

In April 2020, Hindustan Syringes and Medical Devices Ltd wrote to health secretary Preeti Sudan, asking the government to plan for the timely availability of syringes ahead of the Covid-19 vaccine launch “to avoid having a status of availability of vaccines but shortage of syringes for vaccination”.

Nath, from Hindustan Syringes, said he did not receive any response. “We kept following up and finally had a meeting last October,” he said. “The government placed orders by December.”

In December 2020, the government issued a tender for 35.12 crore auto-disable syringes of 0.5 ml size. The three manufacturers that produce auto-disable syringes, participated. Hindustan Syringes won a bid for 26.5 crore syringes, BD India Pvt Ltd for 4.38 crore syringes and Iscon for 4.24 crore. They were given four months to deliver.

In January 2021, soon after India’s vaccination drive began, the managing director of Bio-Med Healthcare Products Ltd, Deepak Arora, wrote to the health ministry highlighting the limited availability of auto-disable syringes. “In these constrained circumstances, it can lead to heavy shortage of the product and hence delays in executing [the] vaccination program,” his letter said.

Other companies that manufacture conventional syringes wrote similar letters urging the government to buy their syringes along with auto-disable ones. Among them was PH Healthcare Pvt Ltd director Ritesh Brahmecha. “Conventional disposable syringes of all sizes have received worldwide acceptance for use in vaccination drive against Covid-19…,” he wrote. “Even WHO [World Health Organisation] has released a press note clarifying that each country should follow whatever is convenient to ensure massive outreach.”

‘Adequate stocks’

But the government did not modify its policy, saying that it had an adequate stock of auto-disable syringes. In February, the health ministry asked Hindustan Syringes to supply more auto-disable syringes at the same rate, Nath said. Iscon’s vice president Sandeep Bhandari said his company was also asked to supply more syringes.

However, the government did not share any projections about demand with the companies, which the companies said was necessary to plan capacity addition.

In April 2021, Nath wrote a second letter to Union health secretary Rajesh Bhushan, saying Hindustan Syringes could produce 84 crore auto-disable syringes of 0.5 ml size per annum and ramp up production to 30 crore syringes per year, if the government provided clarity on orders for 2022.

But this did not happen, Nath said.

Iscon’s managers also wrote to the government asking for its annual forecast for syringe requirements. “We didn’t know how long the vaccination drive would continue,” said vice president Sandeep Bhandari. “We did double our capacity last year but that was planned well before the pandemic began. The government gave no projections.”

A health worker at a vaccination centre in Mumbai. Credit: Punit Paranjpe/AFP

By the time the government issued a tender for 125 crore auto-disable syringes (of 0.5 ml and 1 ml size) on July 1, Iscon could not participate – it had already accepted other orders. Hindustan Syringes, too, had made other commitments and could only supply 10 crore syringes to the government. “Even that 10 crore we diverted from UNICEF to supply to the Indian government,” Nath said.

The same month, the health ministry contacted UNICEF seeking its assistance to arrange supplies from other countries on behalf of India. Within days, UNICEF invited bids for 50 crore syringes but it remains unclear how much stock it was able to procure.

Struggling to procure enough auto-disable syringes, on July 9, the government invited bids for 90 crore syringes, this time expanding from 0.5 ml and 1 ml auto-disabled syringes to conventional disposable syringes in sizes of 0.5 ml, 1 ml, 2 ml, and 3 ml.

The Covid-19 vaccine is administered in India in doses of 0.5 ml, so syringes of 0.5 ml or 1 ml size are best suited to the task since they avoid the possibility of wastage. But left with limited options, the government had to invite tenders for bigger syringes.

Despite the expanded criteria, according to the manufacturers, the government was able to place orders for only 68 crore-70 crore out of 90 crore syringes, leaving a shortfall of more than 20 crore syringes.

Vaccination interrupted

While the government struggled to source syringes, monthly vaccination numbers continued to rise, depleting the stockpile of syringes.

Until July 1, India had delivered 33.5 crore Covid-19 vaccine doses. That month alone, it administered 13.45 crore vaccinations, which went up to 18.35 crore in August and 23 crore in September.

In Odisha, immunisation officer Dr Tapas Patra said that he state faced a shortage of syringes for over three days in September.

In Rajasthan, a senior health official said the state’s buffer stock of syringes was depleted by September. “Every night we used to take stock of syringes left in vaccination centres and the diversion would begin from one centre to another,” the official said, requesting anonymity. “A month or so ago, the [Central] government asked us to use 1 ml, 2 ml and 3 ml syringes, if 0.5 ml syringes were not in stock.”

Odisha and Rajasthan did not shut down the vaccinations due to the syringe shortage, but Pune in Maharashtra had to halt vaccinations on October 1 and Kochi on August 16.

Kerala, Tamil Nadu, Rajasthan, Maharashtra are among the few states that are making local procurements. “It is true that the [Central] government is unable to fulfil our requirements,” said Dr Archana Patil, who heads the Directorate of Health Services in Maharashtra. On October 6, Maharashtra received 30 lakh syringes from the Central government, a stock that will last three days.

India has administered 94.5 crore Covid-19 doses so far. In addition, regular immunisation programmes continue – 12.7 crore children and 3 crore pregnant women are immunised in India annually.

KL Sharma, a former joint secretary in the Ministry of Health and Family Welfare, said the normal procurement process for syringes is based on the previous year’s trend. “This is a very uncertain time for the government to plan in such a dynamic situation,” he said. “What the government could have done is taken stock every three months for syringes and kept manufacturers informed.”

Source: CoWIN site.

Setback to exporters

Since the two tenders for syringes in July yielded little response, on September 21, the government wrote to the Syringe Manufacturer’s Association of India about a possible “partial control on export”.

Within a week, several manufacturers wrote back to the government in alarm.

In its letter, Lifelong Meditech Private Ltd, India’s biggest syringe exporter, pointed out that it had participated in government tenders and even started supplying syringes to the government ahead of the delivery schedule. It has committed to supplying 10.75 crore syringes to the government before December.

In 2020-’21, Lifelong was responsible for 47% of syringe exports from India, exporting 67.3 crore syringes.

“We have established our customer base after many years of efforts and against stiff competition from China,” said H Srivastava, Director and CEO of Lifelong. “This industry takes years to develop, if they put restrictions like this for even four months, the entire business will move on to Chinese firms.”

Altogether, in 2019-’20, India had exported 106 crore syringes, which rose to 143 crore in 2020-’21. Between April and July this year, the country has exported 55.2 crore syringes – a 15% rise in monthly exports between last year and this year. Average monthly exports have risen from 8.8 crore in 2019-’20, to 11.9 crore in 2020-’21, and 13.8 crore since April this year.

On October 4, the Directorate General of Foreign Trade restricted exports for up to four months for all kinds of syringes, including those that are not even used for immunisation. After manufacturers asked for those syringes to be exempted, on October 9, the government restricted exports only of syringes with sizes of 0.5 ml, 1ml, 2 ml and 3 ml. But it allowed the export of syringes with a capacity of 5 ml and more, which are used for other medical purposes such as administering insulin shots to diabetic patients. The duration of the restrictions was reduced to three months.

The curbs will still affect Brazil and Argentina, which are India’s biggest clients, followed by the United Arab Emirates, Sudan, Russia, Nigeria, Germany, Philippines. Manufacturers say this will setback India’s efforts to compete with China, which remains the biggest exporter in the global syringe market.

Chart supplied by manufacturers.

This year, Iscon has so far taken orders for 22 crore auto-disable syringes, to be delivered by March 2022. Hindustan Syringes has accepted orders for 67.5 crore syringes, and already supplied 48.4 crore. Becton Dickinson Ltd has supplied 4.38 crore syringes.

Arora from Biomed said he has orders for 3 crore syringes for October, including from Ethopia and Palestine that rely on Indian manufacturers for supplies. In a letter to the health ministry, he wrote: “Non-honouring of our export contracts can bring legal liability on us and will be set back to Government of India’s Atamanirbhar Bharat Program.”

Instead of banning exports, Arora said the government should force all manufacturers to compulsorily supply a minimum of 20% of their production for local use.

But scaling up production itself will take time. Nath, from Hindustan Syringes, said the full capacity of a manufacturing unit can’t be utilised at short notice since inputs like needles, cannulas, rubber gaskets, stainless steel tubing and plastics need to be arranged. Most of these raw materials need to be imported, a process that could take weeks. A batch of syringes could take 20 days-24 days from production to pass quality tests.

Manufacturers say this situation could have been averted had the government taken a decision to use conventional disposable syringes for Covid-19 vaccinations in January itself.

“We would have enough syringe capacity in India, if this was well thought of six or nine months ago,” said Srivastava, the CEO of Lifelong.

This reporting was supported by a grant from the Thakur Family Foundation. Thakur Family Foundation has not exercised any editorial control over the contents of this article.