From Delay In Purchase To Slow Production: The Fault In India’s Vaccination Policy

This article is the second part of a series. You can read the first part here.

Vaccine Regulation

India on April 13th announced that it will fast track the approval of vaccines tested in western nations and Japan. This would set it in a position to import these vaccines and reach deals to manufacture some in India, in partnership with home manufacturers. The question here is, why was this not done before? Why wait until we are at the peak of the second wave of the pandemic to grant them approval when it was obvious that we would need a massive amount of vaccines to immunise the population?

If these vaccines have passed regulation and testing in other nations and the World Health Organization (WHO), why waste time on local tests? The earlier they are fast-tracked, the earlier they can be imported or manufactured for use. In a population of more than 1.3 billion, it was always known that we would need at least 2.5 billion vaccine doses to reach an acceptable immunity threshold. So, why the delay?

India gave approval to its own locally developed COVAXIN before the phase 3 trials were completed in January, drawing criticism from the scientific community. The All India Drug Action Network (AIDAN) expressed shock and concern over the move, and even wrote to the Drugs Controller General of India (DCGI), requesting a revoke of the approval. And there is a very good reason why this move may be risky and prove costly.

There exists a community of ‘anti-vax’ people in the world, including India. These people reject vaccines based on fake news, misconceptions, and conspiracy theories. The entire point of a vaccine is that people take it to immunise the public. A single mistake or safety concern can affect not just India, but beyond as well. It may add fuel to the fire of the anti-vax ideologies. This is why governments in countries like the USA spend so much time and effort to encourage people to get vaccinated.

These concerns are backed by surveys, like one from December which found that a majority of Indians were hesitant to get vaccinated.

All of this, while the government failed to approve international vaccines that had already passed trials, and unnecessarily withheld approval for local trials. Now after realising the expanse of the second wave of the virus, they are retracting from this position. This lack of foresight delayed the vaccination drive of trial-passed vaccines, and initiated the vaccination drive for the untested COVAXIN which was, in all probabilities, unsafe. While the Sputnik vaccine is now being granted emergency approval, other major vaccines are still miles away from use.

Vaccine Purchase

In January, the Serum Institute of India (SII) had a stockpile of 50 million vaccine doses ready. The government showed no urgency in signing contracts for supply, letting them sit in storage. Even after deciding to sign up, it only bought 11 million vaccines. There is no answer to why the delay was there.

How the government intended to vaccinate India’s 1.3 billion people with 11 million shots is a mystery. Having 50 million vaccines sitting in storage, SII pushed the brakes on further production due to storage being full. The CEO of SII, Adar Poonawalla remarked that he would have to store any more vaccines at his own house. So basically, we had the vaccines, approval was granted, and yet they were not used, forcing a halt in production.

Why? Maybe our ‘esteemed’ Prime Minister could answer that if he chooses to ever hold a press conference. (It is important to remember that Modi has not appeared for a single press conference in which he actually spoke, in his two terms in office.)

The government has also been criticised for not allowing the private sector in its vaccine drive. This would have been a way to circumvent the sluggish pace of government drives hindered by bureaucracy and politics. It could also have raised money from the rich who choose to go the private way at higher prices, and this money then could have been used to further expand production capacities.

We obviously cannot rely only on the private sector, and the government needs to provide vaccines for free to the poor and the underprivileged. Like the government announced recently that they would allow 50% of vaccine production to be used by the private sector, we could have done a similar thing previously to gain significant boosts, economically and time-wise.

Even in the midst of the second wave, the government is taking its sweet time to fulfill requests by SII and Bharat Biotech for grants to ramp up its vaccine production. So, we could be producing a lot more vaccines but are not being able to do so, because the government is slow in providing funds for this. First, they squeezed off funds from both manufacturers by restricting their prices to INR 150 per dose. While that is not a bad idea, it has resulted in the fact that both manufacturers are struggling to raise money to expand their production, which is why they sought grants from the government.

Remember, it was always known that vaccinating the world would be a difficult task and production capacities were limited. Even as far back as in the first wave, experts were warning us that even after making a vaccine, we would not have the logistics to actually manufacture it and distribute it due to great demand. Despite this, the government showed no hurry and took no steps to increase our production capacities.

Forget working on expanding capacities themselves, they are not even providing funds to the companies for this even in the second wave. On the 19th of April, they finally agreed to provide funding, a decision that could have and should have been made earlier. Yet, their PR machinery is working in full force to convince people otherwise. If you read any news recently, the health ministry has said that they are pumping cash to ramp up production. What it fails to mention is that the funds being provided by the government are a tiny percentage, compared to what the companies are asking for, and even more importantly, what we need.

For example, SII has asked for grant of USD 400 million, while the government is offering peanuts. And that is only what the companies are asking for. Even if the production is increased due to government grants that would still not be enough to be a game changer and would take time to build up. At this time, the government should be providing five times what is asked for, along with quick fast tracking through the infamous Indian bureaucratic red tapes and use emergency provisions to help where needed.

Imagine where we would be now if the government had heeded the warnings of a production shortfall and decided to grant access to limitless funds to start expanding capacities during the first wave or atleast by the end of it. We had a reprieve of months in between the first and second wave. That was a golden opportunity to build production capacities, get raw materials, and infuse massive funds. But no.

Not only did the government fail to act at the time, they are still not treating the problem with the urgency and importance it deserves. To everyone following the news, it has been pretty apparent that manufacturing vaccines for the world and distributing them would be a hard task. Why then was there no preparation by the government? When a problem is sudden, excuses can be made as they were in the first wave. However, we had plenty of time and resources to prepare for the second one.

What about human resources? I am certain that if the government made an announcement of the need of skilled and unskilled labourers, in a country with more than 1.3 billion people, they would find no shortage of manpower.

What about raw materials? It is only now in the midst of the second wave in India that western countries like the US have imposed restrictions on the export of raw materials. The SII has requested for that ban to be lifted, or else it would affect vaccine production. Nevertheless, the question stands, why exactly did we wait till the last possible moment to obtain raw materials? We could have stocked up on raw materials since the first wave struck, and imported whatever was needed well in advance to avoid facing the kind of shortage we face today.

Plus, in domestic industries, the government has emergency provisions to use to redirect all raw material usage to vaccine manufacturers, from private companies. Why have they not been used?

What about financial constraints? Nope. Not a good excuse. No matter how much the government spends on vaccine production, it will be a tiny fraction compared to the economic destruction wrought by lockdowns and curfews. Not only this, but if we had sufficiently ramped up production capacities during the time we had, we could have exported vaccines without shortage at home, and actually earned money commercially and gained diplomatic power.

What about the law? The constitution provides for a wide array of emergency provisions to the union government, from national and financial emergencies to the President’s rule. Few of these have been used. The government could direct every single resource in the country, no matter what kind if it wanted to. So, legality is no stopper.

Why Is There No Transparency?

I wrote above that the government failed to purchase 50 million doses of vaccines just sitting around. Unfortunately, that is not the end. The Modi government, even when purchasing them, relied on ad hoc, impulsive decisions rather than a transparent, long term plan over it. This led to companies having no idea of when, how, how many, and the pricing of the doses to be purchased.

Further on, such lack of planning has and can lead to confusion in corporations about imports, exports, domestic needs, and so on. This long term and practical plan was a much needed thing and should have been formulated in December 2020 by latest.

Additionally, a plan and process to decide allocation of vaccines and other necessary equipment and drugs, statewise, could have prevented the political blame game going on and accusations of partiality by state governments.

An even more ambitious step could have been a transparent all India plan, discussed with states and opposition leaders, to lay down a pragmatic path to end the pandemic. This plan could have included everything from drug production to equipment distribution to vaccine production.

The need of the hour to promote a transparent response along with accountability would be a commission or group of government officials tasked with holding regular press conferences and spreading awareness about the pandemic. This commission must be required to answer any questions asked by the public. This shall allow the citizens and experts know the reasoning behind the government’s thinking.

Writer’s Note: If my article enriched your knowledge the tiniest bit, please consider upvoting and sharing it. I will be writing the third part soon, which shall cover topics like Remdesivir shortage, beds, oxygen, and the implementation of the lockdown. Follow me by clicking on my profile to get updates on future articles.