On one summer morning in New Delhi – very possibly on August 17, 1987 – Prime Minister Rajiv Gandhi summoned his top biotechnology advisor, S Ramachandran, for a brief meeting.

Ramachandran, a towering figure in his field, was a quintessential product of the Indian establishment. From modest origins in Tamil Nadu, he had made his way first to Benares Hindu University, and subsequently to the United States, where he obtained a doctorate in biochemistry in 1961 from the University of Illinois.

The 1960s saw the first major wave of immigration – “brain drain” – from India to the US. But unlike many of his peers who chose to stay behind in the US, Ramachandran returned to India to work for Hindustan Antibiotics Limited in Pune. Within two decades, he would rise to the top of Delhi’s technocracy as Member-Secretary of India’s National Biotechnology Board, an institution the Indian government had presciently created in 1982.

In 1986, Rajiv Gandhi appointed him secretary to the newly created Department of Biotechnology. These were heady days in New Delhi: a young prime minister with a super-majority in the Lok Sabha was willing to wager India’s future at the cutting edge of technology. As Science magazine famously billed it, Gandhi had begun to “shake up Indian science”.

A brewing crisis

That morning, however, Rajiv Gandhi confronted a crisis. The
Press Trust of India had reported scathingly on the Vaccine Action Programme his government had signed with the US government. What’s worse, the criticism originated from within the establishment.

Astonishingly and without precedent, a number of government scientists spoke to PTI against the VAP on the record. The director of the Defence Research and Development Establishment – an umbrella institute of the Defence Research and Development Organisation – said he was “shocked to see the [VAP] agreement signed on television”.

The science advisor to the defence minister said he was “not aware” of the agreement’s details, and the Director-General of the Indian Council of Medical Research declared no vaccine would be trialed on Indians unless it was approved in the US.

A mock trial for vaccine delivery in Chennai on January 2. Credit: Arun Sankar/AFP

The scientific and security establishment’s concerns were three-fold: one, VAP could lead to the US harvesting valuable epidemiological data from India, and identify potential vulnerabilities in the population; two, biological weapons could be disguised as life-saving vaccines, and administered to Indians; and three, Indians would unwittingly become guinea pigs for all manner of dangerous biological experiments which would not otherwise receive authorisation in the US.

Challenged by scientists of formidable repute, and faced with concerns that struck at the root of India’s national security, Rajiv Gandhi knew he had a serious problem on his hands. Ramachandran was even more pessimistic. The Vaccine Action Programme, in his telling, had “flopped”.

If some of the allegations levelled at the VAP sounded incredulous, they were. In 1985, the Philadelphia-based Wistar Institute had surreptitiously trialed its experimental rabies vaccine on unsuspecting Argentinian cows – Argentina’s government too had no clue – and ended up infecting 17 farm workers. So there was some basis to the argument that US companies could trial vaccines in India to circumvent its own regulatory process.

Most importantly, the VAP agreement had been signed at a time when there was considerable US pressure on the Indian government to strengthen its Intellectual Property Rights regime. The risk of US pharmaceutical companies ringfencing their vaccines with IP restrictions, and thus restricting their affordability to ordinary Indians was also real.

Political undercurrents

But none of these concerns were insurmountable, as long as adequate policy safeguards were put in place on the Indian side. (Indeed, India’s compulsory licensing regime has managed to address precisely the problem of accessibility to generic drugs.) The lion’s share of criticism aimed at the VAP were simply attempts at fearmongering, and the lack of an adequate response from the Indian government on the security-related aspects did little to assuage public fears.

The deeper political undercurrents of criticism from within the establishment were clearly discernible. Rajiv Gandhi’s attempts at promoting foreign technology collaborations were being undone by a bureaucracy that had long been fed the myth of “self-reliance” (or atmanirbharta) by his mother and his grandfather.

When Indira Gandhi came to power for a second time in 1980, she had herself sought to correct past mistakes and gradually loosen the shackles of the Licence Raj regime. In 1982, with the US-India Science and Technology Initiative, she embarked on a highly visible bilateral dialogue on technology cooperation with President Ronald Reagan’s administration. Rajiv Gandhi followed up with a landmark, successful visit to the US in 1985, signing the Technology Cooperation Agreement with Reagan.

Rajiv Gandhi and Ronald Reagan. Credit: Reagan Foundation

The promise of “high technology” transfer through the agreement never quite materialised, but it undoubtedly opened the doors for more substantive talks and future cooperation between both countries: the Vaccine Action Programme, signed in 1987, was the outcome of such talks. The government’s approach to technology collaborations may have changed, but the ghost of “self-reliance” had not fully been exorcised from its officialdom.

This was hardly surprising: after all, it was Indira Gandhi who sold the dream of “appropriate technology” and frugal, local innovation to the public for decades. That chicken had come home to roost during Rajiv Gandhi’s term.

‘Transformative’ programme

The Vaccine Action Programme was stuck in science purgatory for years, but foreign assistance gave it a new lease of life. In response to my criticism of the VAP in Midnight’s Machines, India’s Principal Scientific Advisor K VijayRaghavan – who graciously agreed to be part of the book launch – argued it was “transformative” for Indian industry.

“Today, because of the Indo-US Vaccine Action Programme, not in spite of it, two out of three vaccines in the world are made by Indian companies,” he said. To defend his claim, he cited the example of the rotavirus vaccine, developed through the VAP, and whose clinical trial results were announced in 2013.

The rotavirus vaccine was indeed a major breakthrough – the disease is a major cause of diarrhea in Indian children, and often lethal – and VijayRaghavan (then the Department for Biotechnology secretary) deserves much credit for this achievement.

The rotavirus vaccine was not an exclusively Indian victory, although it was branded as one. Bharat Biotech – whose Covid-19 vaccine Covaxin has now been approved by the Drug Controller General of India for “restricted emergency use” – was the commercial partner for producing the prototypes of the rotavirus vaccine in India. In March 2015, Prime Minister Narendra Modi himself launched its market roll-out, felicitating the “first indigenously developed and manufactured” rotavirus vaccine.

Rotavac may have been marketed as the first “Make in India” vaccine, but even Bharat Biotech and the prime minister himself had to acknowledge the foreign partners involved in this project, especially the Bill and Melinda Gates Foundation and doctors from Stanford University. Rotavac was possible because the VAP facilitated collaborative study between doctors at the All Indian Institute for Medical Sciences and Stanford, among others, into a naturally weakened strain of the virus discovered in India in 1986.

A Gates Foundation-backed NGO “became the project’s new funding source” in 2001, providing millions of dollars for clinical trials. It took nearly 30 years for the vaccine to materialise, but the VAP ultimately proved to be beneficial for the country. Bharat Biotech, of course, should be credited for manufacturing the prototype vaccine at scale, and at low cost.

But no amount of politicking around self-reliance can marginalise the significant contributions of the vaccine’s foreign collaborators, who poured their talent and resources into the Research and Development process.

Hasty approval

With the hasty approval of Bharat Biotech’s Covaxin by India’s drug controller on Sunday, despite lacking clinical trial data – some of the country’s top experts have questioned the regulator’s decision – the Indian government appears once again to be singing the siren song of atmanirbharta.

There is a lot to celebrate in the conditional approval granted the same day to the Serum Institute of India’s Covishield vaccine: developed in collaboration with Oxford and Astra Zeneca, its efficacy is atleast based on data from clinical trials in UK and Brazil. Covaxin’s approval is seemingly not. What is the need to skip a critical process of regulatory evaluation for safety and efficacy, merely to score a political point: namely, that India too has developed its “indigenous” Covid-19 vaccine?

In response to legitimate protests from opposition leaders on the bypassing of regulatory protocols, a Bharatiya Janata Party minister has already accused them of being “unhappy with Made in India vaccines”.

Prime Minister Narendra Modi should heed lessons from history. Governments before his have co-opted technology for narrow political ends, invariably leading ordinary Indians to become sceptical of its benefits for society. There is no bigger illustration of this problem than the blowback Rajiv Gandhi received against the VAP soon after its announcement.

If the VAP could still eke out some successes like the rotavirus vaccine despite political difficulties, one can only speculate what it would have looked like with popular backing.

Whether Covaxin is designated as a “back-up” vaccine or not, public trust in India’s imminent Covid-19 vaccination programme will suffer if it is not based on verifiable data. India’s government scientists should speak up and demand its review.

They can do no better than follow S Ramachandran’s words from 1987: “We are no longer looking at self-reliance to mean that everything we need we must be able to do ourselves; [it is more] the capacity to do something as the situation requires it.”

Atmanirbharta is good for politics, but in this case, it may quite literally be injurious to health.

Arun Mohan Sukumar is a PhD candidate at the Fletcher School, Tufts University. His first book, Midnight’s Machines: A Political History of Technology in India, was shortlisted for the New India Foundation’s 2020 Kamaladevi Chattopadhyay Book Prize.