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Imperilled Immunity — India’s ailing Vaccine PSUs

P Anima | Updated on July 29, 2021

Long run: Mumbai-based Haffkine Institute is one of the oldest vaccine PSUs in the country   -  The Hindu Archives

At one time the primary producers of the country’s vaccine requirements, the units are in terminal decline. Can they be revived?

* Haffkine’s finding would prove crucial in British India’s battle against recurring plague

* “The three central institutes catered to 83 per cent of the Universal Immunisation Programme vaccine needs”

* “When R&D and production happen together, it ensures vaccines are available at affordable cost for a larger section of the population. It is a no-brainer — if the government produces vaccines, they become far more affordable

****

In the latter half of 1896, when parts of colonial India were being wreaked by yet another wave of the plague, Waldemar Mordechai Haffkine, a microbiologist from the Russian Empire, spent most of his time in a small room in the Petit Laboratory in Bombay’s Grant Medical College. Over four months of research, Haffkine developed a prophylactic which he first tried on himself.

“His assistant, Dr [NF] Surveyor, administered him a dosage which was four times stronger than what came to be accepted as a standard dose,” says Mridula Ramanna, former head, department of history at South Indian Education Society College, Mumbai.

Ramanna, who wrote a chapter on the Haffkine Institute in the book Science and Modern India: An Institutional History c1784-1947, says: “Haffkine was working in Calcutta, administering the anti-cholera vaccine he had developed, when he was called to Bombay to work on an anti-plague vaccine.”

Haffkine’s finding would prove crucial in British India’s battle against recurring plague. The Plague Research Laboratory (PRL) was founded for the explicit purpose in 1899 with Haffkine as its director. “The recurrence of plague meant the demand for Haffkine’s vaccine grew steadily in the 20th century and its production increased,” Ramanna notes.

Over the years, the PRL was renamed the Bombay Bacteriological Laboratory, and subsequently christened Haffkine Institute, after its first director. Over 122 years since it was opened in a Parel complex, it has performed pivotal functions — from producing vaccines for plague, cholera, typhoid, and the anti-venom serum in the colonial era, to being a mainstay for vaccines under the Universal Immunisation Programme, primarily the Oral Polio Vaccine (OPV), until the fortunes of the vaccine Public Sector Units (PSUs) took a turn for the worse through 1990s and early 2000s.

A struggle for survival

The Haffkine Institute is among the few vaccine PSUs that survives today. Along with Central Research Institute (CRI) – Kasauli (1905), and Pasteur Institute of India (PII), Coonoor (1907), it is among the oldest; their functions, though, have been severely imperiled over the past decades. In 2008, vaccine production in three central government PSUs — CRI, PII and the BCG Vaccine Laboratory (BCGVL), Chennai — were halted for non-compliance with Good Manufacturing Practices (GMP). Though the licenses were restored in 2010 following the report of the Javid Chowdhury Committee, set up to determine the reasons for their suspension, the units have struggled to bounce back.

Shot take: The Pasteur Institute of India was set up in 1907 as a society, and research centred around finding an anti-rabies vaccine   -  SATHYAMOORTHY M

 

They have since become GMP compliant, but vaccine production at the facilities is either yet to start or is nowhere near capacity. A writ petition filed in the Supreme Court in May by Amulya Ratna Nanda, former secretary, health and family welfare, draws attention to the desperate need to revive the ailing PSUs to plug the chasm between vaccine demand and supply as well as to make vaccines affordable in the middle of a pandemic.

Drop by drop: The vaccine PSUs catered to over 80 per cent of the country’s UIP needs   -  RAMAKRISHNA G

 

“The three central institutes catered to 83 per cent of the UIP [Universal Immunisation Programme] vaccine needs,” points out Y Madhavi, senior principal scientist at Delhi-based National Institute of Science, Technology and Development Studies. “The situation is reversed now; 80 per cent of the required vaccines are procured by the government from private players at a higher price. The PSUs were once self-sufficient and self-reliant,” says the scientist who has extensively researched India’s vaccine policy. In her paper Meeting Local Needs in Global Times: The Case of Universal Vaccines in India published in the Journal of Health Studies, Madhavi documents the plight of 29 vaccine PSUs. By 2008 nearly 20 of them were either shut down or their production capacities suspended.

Of the seven vaccine PSUs that are operational, Haffkine is the only functional state-level unit, notes Nanda’s petition. The other, King Institute of Preventive Medicine in Guindy, has not engaged in vaccine production for nearly two decades. The five central vaccine PSUs are CRI, PII and BCGVL, Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL) and the Hyderabad-based Indian Immunologicals Limited (IIL).

The Integrated Vaccine Complex in Chengalpattu, set up in 2012 and meant to be the nodal centre for vaccine research and manufacturing in the country, is yet to be operational. Three PSUs — BIBCOL, IIL and Haffkine — recently entered into a technology transfer agreement with Bharat Biotech for the production of Covid-19 vaccine, the manufacture of which is expected to begin later this year.

“The PSUs were the primary producers of tetanus, DT, DPT, OPV, BCG and typhoid vaccines to meet UIP demands,” says Madhavi. Yet, it is a role the vaccine PSU’s have had to steadily relinquish over the years. The BCGVL, for instance, had gone from producing 923 lakh doses of BCG in 2003-04 to a mere 24 lakh doses in 2020-21, dotted with blank years in between when production was suspended. At one point, BCGVL supplied BCG to the entire country, Madhavi notes in her paper. CRI-Kasauli, on the other hand, was the only institute in South-East Asia to produce the yellow fever vaccine. “So too the Japanese Encephalitis vaccine. Not any more,” Madhavi adds. A refurbished, GMP compliant PII, according to media reports, has applied for license to produce DPT vaccines again.

Colonial era to modern times

For vaccine PSUs, the ride has been long and often choppy. The older institutes, products of colonial India, catered to the demands of the time, and were forced to adapt and re-invent post-independence. “Dog and snake bites were pressing problems for the British. Most of the Imperial Army was dying of tropical diseases,” Madhavi explains the beginnings of the CRI-Kasauli and PII. Serum for snake bites was among the early remedies to be found at CRI, and work on anti-venom sera and anti-rabies vaccine were the initial preoccupations at Haffkine and PII. “The PII was set up in south India initially as a society and research centred around finding an anti-rabies vaccine,” she adds.

The World Wars proved a turning point. The staff and personnel at the institutes were deployed across the empire, and, also imports were banned. “At the institutes, they were left with few options but to develop one’s own anti-sera for the Imperial Army. It worked as an incentive for self-reliance too, leading to work on cholera and typhoid vaccines,” Madhavi says. However, the colonial state had a narrow vision and only short term research and production needs were encouraged.

Indian independence set forth a phase of transition as British researchers and officials left. The institutions, she observes, continued to be, but without any radical research and development (R&D) taking place. “There was a lack of vision around organisational restructuring and R&D. It was accompanied by funding crunch,” notes Madhavi. The lull of the 1940s would have an impact on vaccine technology developments, and India, which was at par with the rest of the world in the1930s, would fall behind. But, in the newly-independent country, attention would also fall on the high mortality among children due to infectious diseases. The existing vaccine institutes were adapted and new ones subsequently set up to meet immunisation requirements.

Swati Birla, doctoral candidate in Sociology at the University of Massachusetts Amherst, illustrates how the public sector took the lead in meeting vaccine requirements in the decades after Independence. “In the first three decades, from the 1950s to 1970s, the emphasis of the Indian state was on building domestic competence for development and manufacturing of vaccines”. Birla, who also studies public health, observes: “There were about 19 public sector and 12 private sector vaccine manufacturing units. This was achieved through material support and a leadership role for the public sector.”

However, the 1990s and liberalisation policies would set off another churn. Both vaccine manufacturing and distribution had deepened with the polio vaccination programme between 1985 and 1991, notes Birla. “From the 1990s the Indian state gradually relinquished this responsibility to the private sector. This was achieved through the amendment of Patents Acts, foreign investment regulations, and industrial policies.” The public sector, which assumed leadership in vaccine production till then, found its clout steadily diminishing from the late-1980s. “The private sector steadily received greater state support, including tax and other subsidies. The [private player] Serum Institute of India’s take over of both domestic and international market is facilitated by this,” she adds.

The ride has not eased since for the public sector vaccine units, in fact, it has only got more perilous. Smaller PSUs have been progressively shut down, while others have been forced to diversify into manufacturing other vaccines. Without patronage, the units floundered, even as the private sector firmed its grip in the field. Institutes such as CRI-Kasauli, PII and BCGVL are still trying to shake off the effects of the suspension.

Needed: A Revival Dose

A petition to look into a wholehearted revival of the PSUs is already with the top court. Public health experts, meanwhile, stress the need for those revival plans to be long-sighted. Chandrakant Lahariya, Delhi-based epidemiologist, public policy and health systems expert, says the revival of PSUs doesn’t just ensure greater production capacity, but they make vaccines more affordable. “We have learned by now — in this pandemic — that government cannot be solely dependent on the private sector for vaccine manufacture. More so, if it wants to be self-sufficient and have vaccines at affordable rates,” Lahariya says.

The country, traditionally a leading manufacturer of vaccines, has little reason not to have fully functional and productive vaccine PSUs, observes the public policy expert. Would we have fared better in terms of vaccine availability if the PSUs were shipshape? “We could have been at a better place. It would have been possible for them to switch to Covid-19 vaccine production,” responds Lahariya. But with three of them still struggling to be fully functional, the prospect gets tougher. “When you are re-starting, there are standard processes to go through which takes time,” he notes.

It is imperative, Lahariya insists, to not view the revival of PSUs as a short-term plan. “It should be considered on a broader perspective, not just to scale up the production of Covid- 19 vaccines.” The PSUs, he points out, have the know-how to producing multiple vaccines and so should be producing a range of them. The approach, he adds, should be holistic, with equal stress on research as well as production. They need not incremental financial support, but a many- fold rise in budget. “We have over a hundred years of history in vaccine research and development. Vaccine development has two aspects – R&D and production. When you invest in vaccine production in the public sector, it also benefits R&D. When these two happen together, it ensures vaccines are available at affordable cost for a larger section of the population. It is a no-brainer — if the government produces vaccines, they become far more affordable.”

No-brainer, it might be. The vaccine PSUs, though, are still waiting for a long-term commitment. Madhavi sums it up: “Their revival should not be short-term. They have shown us that they are reliable.”

Published on July 29, 2021

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