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Tuesday, January 19, 2021

Vial manufacturers prepare to ramp up capacity, govt still unclear on demand

Given that the vaccines will likely be filled in multidose vials, industry executives feel this demand will easily be met.

Written by Prabha Raghavan | New Delhi | Updated: December 7, 2020 7:20:02 am
Panel seeks more vaccine data before emergency nodPfizer, which has received emergency authorisation use for its Covid-19 vaccine in the UK, with the first doses given out on Tuesday, had approached the DCGI with a request to waive the need for clinical trials in India.

With at least two Covid-19 vaccines closer to regulatory approvals and a couple of international candidates set to be manufactured in the country, makers of medical devices are ramping up capacity in anticipation of a potential surge in demand for vials and syringes.

Indo-German pharma packaging joint venture Schott Kaisha recently invested some Rs 122 crore to expand its vial capacity by 300 million pieces over the next year to prepare for increased demand, and not just in India.

Laboratory glassware maker Borosil Ltd has received a purchase order for an undisclosed quantity of vials from an Indian company that is currently testing its vaccine candidate, and is in discussions to supply vials to a few companies, including firms based outside the country.

The Indian arm of the German pharma packaging giant Gerresheimer has blocked an undisclosed portion of its capacity to cater to an order from a vaccine maker in another country.

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Hindustan Syringes and Medical Devices (HMD), which owns the DispoVan and Kojak brands, recently received an order from the Health Ministry to supply over 177 million 0.5 mL Kojak auto-disabled syringes for the country’s Covid-19 mass vaccination programme. Sixty million of these syringes are already available. HMD managing director Rajiv Nath said he expects another tender to be released this month for an additional quantity of syringes.

Schott Kaisha director Rishad Dadachanji said: “We have expanded (our) capacity proactively because it can be any day now that emergency use will be granted in some country and it will need a flock of vials immediately … we have to be ready now also for this.”

The company, which supplies around 5-6 million vials every month to Serum Institute of India (SII) for Covishield, the Indian variant of Oxford-AstraZeneca’s AZD1222 candidate, is also in talks with an undisclosed number of other companies in India, and is catering to players in other countries as well. The company said it is supplying to 10 vaccine candidates currently, including both Indian and international players, without disclosing specifics.

“The sense is that vaccine makers are starting to ramp up production now and are placing trial orders to judge the ability and speed of vial manufacturers to supply. Clinical trials are also expected to get over in the next few weeks, following which utilisation of capacities will certainly go up, keeping in mind that the country is planning to vaccinate 250-odd million people by July,” Shreevar Kheruka, MD of Borosil, said.

The manufacturers of these products, which are key to packaging and delivering doses of the vaccine, are however, still in the dark about whether and how much to earmark.

HMD’s Nath said the company was unclear how much the government already has in its inventory, and how much more it needs to procure. And with the inoculation drive imminent, BD India, the Indian arm of the New Jersey-based medical equipment major, is still waiting purchase orders from the government.

“The Indian government has approached us, but there is no confirmation on orders yet,” a spokesperson for BD India said, adding, “As on date we have some spare capacities available in our India facility and we would request (the government) to issue confirmed orders or (a) letter of intent, so that capacities can be blocked accordingly for India.

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Khasim Saheb, MD, Primary Packaging Glass-India, Gerresheimer, said: “We are still in discussions with some major players dealing in India, but we haven’t received any orders for the potential quantities (of vials) that would be required by them. However, we have commitments from a global player for the 2021-22 period.”

According to Saheb, “Companies should ideally be clear about their requirements of vials at least six months before they will need them. If vial manufacturers have already occupied existing capacities for other existing customers, they will have to spare that capacity for vaccinations or invest in building more capacity.

“Otherwise, there may be a situation where there will be a scarcity because of the timelines.”

He said capacities for both vaccines and syringes are available currently. “But when more supplies will be available from other companies (testing their vaccines in India), there may come a point in August or September (2021), where we’ll essentially fall short of auto-disabled syringes. If it comes to that, the fall-back option is disposable syringes.” His company, Saheb said, was in the process of increasing capacity.

The government has an early-phase vaccination target of up to 250 million people on priority by July 2021. This would mean at least 500 million doses will be required, given that frontrunners SII and Bharat Biotech are both testing vaccines that have to be administered in two doses.

Given that the vaccines will likely be filled in multidose vials, industry executives feel this demand will easily be met. However, the supply targets for Indian vaccine makers stretch beyond this figure, and it is unclear at this stage how much can be catered to over the course of the coming year.

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