Is India ready to deliver a vaccine to a billion people?

On October 8, a day before government representatives met virtually with executives from about 20 syringe and needle manufacturers, an excel sheet was distributed by the office of the Drugs Controller General of India. The manufacturers had to fill in details around their annual production capacity, domestic supplies, exports over the past 18 months and whether the companies have additional capacity. The reason: the Union government is taking the first steps towards preparing for a mass covid-19 vaccination programme in 2021.

About 250 million Indians will be targeted for immunisation in the first phase, the manufacturers were told. Considering the vaccine chosen needs two doses per person, India would require half a billion syringes to begin with.

India is one of the largest syringe makers in the world with a current production capacity of over a billion a year when it comes to 0.5 ml syringes for intramuscular vaccination. By the middle of 2021, India could ramp up production to 1.4 billion, the manufacturers told Dr. V. G. Somani, India’s Drugs Controller General, and Shubhra Singh, chairperson of the National Pharmaceutical Pricing Authority, the two top government representatives who attended the meeting. About half this capacity, however, is planned for exports.

“They asked us on the issues manufacturers have in supplying to the government and in ramping up capacity,” Rajiv Nath, managing director of Hindustan Syringes & Medical Devices Ltd, one of the attendees, later told Mint. The syringe makers, he added, would be willing to invest in additional capacity for India’s vaccination needs but needed assurances around procurement and pricing. There are worries that the additional capacity invested in would remain idle once the pandemic passes.

Convincing device makers is just one piece of a gigantic and complicated puzzle that the Indian government is beginning to solve. Rolling out an immunisation programme for over a billion Indians requires an unprecedented level of preparation and implementation.

The larger pieces of the puzzle include getting warehouses, cold chains, the supply-chain and reverse logistics of disposed syringes ready, mobilising human resources who will administer the vaccine, training them, and pressing the accelerator on mass awareness campaigns.

Even before any of these, India needs to pick a vaccine that is safe and effective besides ensuring there is money to finance it — India could require over $10 billion in the first year itself. That said, India has two advantages. The country is one of the largest contract manufacturers of vaccines in the world and it has the administrative experience of running vaccination campaigns. This has led to a sense of optimism.

“In the past, India has been very successful in running public health programmes for immunisation on a large scale like the pulse polio vaccination programme,” Dr. Sharvil Patel, managing director of Cadila Healthcare Ltd said. “There is no reason why we shouldn’t be able to do this again. We have time to gear up for this (covid vaccination) over the next few months and I believe that the government has already started working on a programme,” he added.

Cadila is developing a covid vaccine, ZyCoV-D, which is currently in Phase 2 of clinical trials. Globally, there are 42 vaccines in clinical evaluation, according to World Health Organisation. About 10 of them, all from foreign developers, are at an advanced stage. Because one doesn’t know which of them could ultimately win the race, there is uncertainty. Some vaccines would require one dose; others two doses and at varying intervals. Every vaccine has its unique temperature requirements. The unknowns make planning for the programme a tricky affair. Indeed, many experts prefer to tread cautiously rather than sound optimistic.

“There are a lot of areas we are not informed about. First, are we going to get a safe and effective vaccine? Assuming we do, the next question is whether the vaccine is going to be an India-developed vaccine or will it be a vaccine developed abroad for which we have been contracted to manufacture?” K. Srinath Reddy, president of Public Health Foundation of India (PHFI), a body that works on health research and advocacy, asked.

This is a crucial question since it could determine the volume of vaccine India could have access to and on terms favourable to the country. For an internationally developed vaccine, there will be less leverage; India may need to negotiate hard to secure supplies at reasonable prices. “The government must have different plans and algorithms worked out,” Reddy suggested. “By the time the vaccine becomes available, there has to be an operational plan for every scenario.”

The first steps

For now, the central government’s planning appears to be around three buckets. Besides ensuring that there is manufacturing capacity for vaccines, syringes and vials, the government is tracking the journey of the vaccine while gearing up the human resources.

Secretary of the Ministry of Health & Family Welfare Rajesh Bhushan told Mint that PSU vaccine makers such as HLL Biotech Limited and Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL) have manufacturing lines available to be contracted.

A National Expert Committee on Vaccine Administration has been formed with various sub-committees to prepare for vaccine administration. A digital platform, Bhushan informed, is being readied to track the vaccine movement from procurement to storage to its administration in real time. “Another intervention is online training modules being developed for vaccinators because it will require large scale skilled manpower. We need skilled manpower not only for vaccinating people but also for reporting adverse events if they happen post vaccination,” the secretary added.

Earlier, union minister Dr. Harsh Vardhan said that state governments have been asked to prepare a list of priority groups that would need to be vaccinated first. No one disputes the first group — health workers and other essential workers, which could include police forces, armed forces, sanitary workers, pilots and airline crew, train drivers, transporters of essential goods, school teachers.

The second priority group to be identified could be people who are at high risk, or those who have illnesses such as hypertension, diabetes, cardiovascular diseases, respiratory diseases. Health experts said many Indians don’t have medical records and therefore could remain difficult to identify, introducing an element of inequity since the educated and the affluent are more likely to have such records.

Next, the states may want to ponder if the vulnerable should be protected on priority or the super spreaders — the young — who go out to work and socialise frequently. Over the next few weeks, tough choices have to be made.

A covid cess?

On Twitter, Adar Poonawalla describes himself as being passionate about vaccines, public health and horse racing. He is the CEO of Serum Institute of India, one of the world’s largest vaccine manufacturers. On September 26, he tweeted out a pertinent question, one that was retweeted nearly 9,000 times.

“Will the government of India have 80,000 crore available, over the next one year? Because that’s what @MoHFW_INDIA needs, to buy and distribute the vaccine to everyone in India. This is the next concerning challenge we need to tackle. @PMOIndia.”

That question worries many economists who think financing the vaccine is India’s biggest nightmare. Raising money will not be easy because of the country’s tight fiscal situation.

Amir Ullah Khan, a professor of development economics, felt that the philanthropic route appears to be closed. “Therefore, the money can come from the PM Cares Fund or through a covid cess. There doesn’t seem to be any other way to raise a lakh crore,” he said. “Borrowing could be tough. The government could also put half the burden on the states and ask them to raise the money,” he added.

Sunil Kumar Sinha, principal economist and director of Public Finance at India Ratings and Research Pvt Ltd., a ratings agency, too thinks a cess is a possibility. And not everyone would get a free dose. The vaccine will be available through government regulated sectors free of cost. But private hospitals too can provide the vaccine and charge for it. “Do you want to stand in a queue and get it free or opt to pay? You leave it to the individual,” Sinha said.

Fixing logistics

Logistics company DHL recently mapped the vaccine delivery landscape. In a white paper titled ‘Delivering Pandemic Resilience’, the company stated that to ensure global coverage for the next two years, about 200,000 movements by pallet shippers on 15,000 flights may be needed; 15 million deliveries in cooling boxes would have to be shipped.

Even when India manufacturers a majority of the global vaccines, reaching the last mile — the villages — would be quite a task. India has 80,000 cold storage units that are used for vaccination supplies today. To vaccinate 250 million people, the country would need 10 times more this number, an executive from an Indian vaccine manufacturer who did not want to be identified, estimated. Depending on the technology platform, storing a covid vaccine may require temperatures ranging from an extreme of -70 degrees centigrade to eight degrees centigrade. Today, India has no capability of storing at -70°C, the executive said. The oral polio vaccine is stored at about -20°C. The central and state governments, therefore, need to bridge the storage gap over the next six months. The private sector will be roped in. Logistics companies Mint spoke to said they are preparing for a daunting 2021.

“While a majority of the vaccines will be distributed through the centre’s Universal Immunization Programme, the government is looking at roping in private cold chain operators for easier logistics operations. Indian cold chain operators are hence already working to prepare an efficient logistics network to ensure the smooth delivery and storage of covid-19 vaccines,” Anshul Singhal, managing director of Welspun One Logistics Parks, a warehousing company, said.

People matters

Beyond logistics, it is the human resources challenge that seems the most intimidating. Covid vaccines in trials have to be mostly injected through a syringe. Today, only doctors and nurses can administer a vaccine that is injected.

“To vaccinate 1.3 billion people, only the doctors and nurses won’t be sufficient. We have started training pharmacists at this point. Across the world, pharmacists are allowed to administer vaccines but not in India yet,” Dr Srinivasa Rao Pulijala, CEO at Apollo Medskills Limited, a skilling company, said. Over time, India has to build a new cadre of immunisation assistants, he added.

The immunisation staff wouldn’t manage a door-to-door campaign because of the volume involved. Camps in schools and stadiums — similar to election time — have to be set up. Also in the primary health centres (PHC), established to cover a population of 30,000 in rural areas. While India has over 30,000 PHCs, many of them don’t function too well. The next few months is a good time to fix them.

“The lesson we have to pick up from covid-19 is that emergency responses and vaccination programmes have a very short life,” A.K. Shiva Kumar, a development economist and policy advisor, said. “We need villages to have a nicely functioning healthcare centre.”