Bharat Bhushan: Who destroyed India's vaccine self-sufficiency? // Top Virologist Shahid Jameel Quits Covid Panel After Criticising Government
On May 8 the Madurai Bench of the Madras High Court while hearing a PIL wondered why India, a pioneer in vaccine production before the current pandemic and a big exporter of vaccines, had to rely on just two private domestic manufacturers--Serum Institute of India (SII) and Bharat Biotech--to produce Covid-19 vaccines. It has also baffled many ordinary citizens.
India’s self-sufficiency in vaccine production was destroyed one and half decades ago under the UPA-I government. Anbumani Ramadoss, then the Union Health Minister in Dr. Manmohan Singh’s government effectively moved vaccine manufacture and government procurement to the private sector. In January 2008, the licences of three premier public sector vaccine manufacturers were suspended citing non-compliance with WHO good manufacturing practices (GMP). These public sector units (PSUs) were: Central Research Institute (CRI), Kasauli in Himachal Pradesh, BCG Vaccine Laboratory (BCGVL) in Guindy and Pasteur Institute of India (PII), Coonoor, both in Tamil Nadu.
The three PSUs manufactured cost-effective vaccines for India’s universal immunisation programme against tetanus, diphtheria, pertussis, measles, polio and tuberculosis. But after their licences were suspended, their stocks were rejected and self-reliance in vaccines went for a toss. Up to then 80% of India’s vaccines for the Universal Immunisation Programme were sourced from the public sector. Today, 90% are sourced from the private sector at a higher cost.
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A former civil servant and member of the Planning Commission, S P Shukla, moved the Supreme Court against the government’s decision which he said would undo a century-long effort to build vaccine self-sufficiency. He wanted the government to preserve a role in vaccine manufacture like several other countries including Brazil and Thailand. Shukla warned that erosion of the PSU’s vaccine-making capabilities would threaten India’s health security and bio-security. The Court sent notices to the government but did not overturn its decision. An investigation by Down to Earth magazine in July 2009 reported that the Parliamentary Standing Committee of Health and Family Welfare had questioned the ministry’s logic of shutting vaccine production and recommended that the closed PSUs should be restarted.
Even after the PSUs became compliant with GMP norms in 2016, the court rejected an appeal to overturn the earlier order. Instead of closing vaccine production in these three crucial PSUs in 2008, the government could have chosen to fund an upgradation of facilities to WHO GMP norms. Instead, Ramadoss directed government funding to the proposed Integrated Vaccine Complex (IVC) to be set up at Chengalpettu in Tamil Nadu. Established in 2012, IVC Chengalpettu is yet to produce a single dose of any vaccine. The present government has now initiated moves to make it functional through public-private partnership.
Ramadoss’s controversial decision led to vaccine shortages
in the country as predicted by critics. It also benefitted Ramadoss party
loyalists, according to S P Shukla’s petition. N. Elangeswaran, director in two
of the PSUs whose licences were cancelled, (BCGVL and PII), allegedly
facilitated the transfer of crucial public resources to private companies. One
beneficiary was Green Signal Bio Pharma, Chennai, owned by Sundarparipooranan
of Ramadoss’s party Pattali Makkal Katchi (PMK). The other beneficiary was
Vatsan Bio Pharma, co-owned by Sundarparipooranan, his wife, and the wife of N
Elangeswaran. Shukla’s petition details how BCGVL and PII made deals
benefitting these two private firms, and puts a question mark on the Health
Minister’s motives.
In UPA-II, Ghulam Nabi Azad as Health Minister, tried to
undo the damage. In 2010, the licences of the three PSUs were revived on the
recommendations of the Javid Chowdhury Committee which held the suspension of
their licences incorrect, illegal and flawed. About Rs. 49 crore was allocated
for the revival of CRI, Kasauli. By 2016, government funding had made two of
the PSUs GMP compliant. Despite this they did not receive any government orders
as India’s vaccine procurement had moved definitively to the private sector. So
the damage wrought by UPA-I persisted under the Modi government
In an interview to Down to Earth magazine, in 2009, Cyrus Poonawala of Serum Institute of India criticised the suggestion that government funding be used to make public sector vaccine manufacturers GMP compliant, calling it a “waste of money”. Instead he suggested “The few hundred staff members [of the PSUs] could be utilised elsewhere for tests or research.” He should know, having already cannibalised a state public sector unit, Haffkine Institute (now, Haffkine Biopharmaceutical Corporation Ltd) in Mumbai. According to a report in Forbes, Poonawala entered the vaccine business when he discovered that dead horses from his stud-farm in Pune were bought up by the Haffkine Institute to extract serum for vaccines. Apparently, he and a friend decided to go into vaccine production themselves, setting up a factory on a 12-acre burial ground for horses. He lured doctors and scientists from the Haffkine Institute to produce SII’s first anti-tetanus vaccine. Three former Haffkine employees made to the SII board.
Today the private sector is itself getting subsidies and advance funding from the government. A grant of Rs. 65 crore has been made to Bharat Biotech to repurpose one of its production facilities in Hyderabad to produce Covaxin. This is in addition to government advances of Rs. 1500 crore to Bharat Biotech and Rs. 3000 crore to Serum Institute to expand their existing facilities. Although the government has acceded to the Maharashtra Chief Minister’s demand for involving the Haffkine Institute, a state PSU, for manufacturing Covid-19 vaccine its capacities will have to be rebuilt. Haffkine will require not only technology transfer for Covaxin production but also funds for setting up Bio-Safety Level-3 production facilities.
It has received a government grant of Rs. 81 crore for this. Government grants are also being made to two other state owned companies – Indian Immunologicals Ltd. Hyderabad and Bharat Immunologicals and Biologicals Corporation Ltd. (BIBCOL) Bulandhshahar, UP, to manufacture Covaxin under licence. Nevertheless it will take nearly a year for them to produce the first batch of Covaxin. In hindsight this could have been a different story. But the moral remains that the Indian State can ill-afford to leave its citizens at the mercy of free market players in public health.
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